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Key Trends of Autologous Stem Cell Based Therapies Market 2021 Business Opportunities, Market Dynamics, Growth Size and Forecasts to 2026 – Clark…

By daniellenierenberg

New research report on Autologous Stem Cell Based Therapies market size by In4Research provides the latest developments in the market has attained and the latest news regarding the market and its building blocks. Some of the most accurate topics mentioned in the report include market drivers and restraints, challenges, opportunities, COVID-19 information related to the market, key players of the market, and the entire market segmentation.

This report provides data for the base year 2020 as well as the forecast period (2021-2026) along with the CAGR. This report contains detailed research of the market from the industry level to the market players and how the market is functioning at present along with all the relevant data and information. Thereby, the Autologous Stem Cell Based Therapies research report has been formulated encompassing all the key points that are present in the form of tables and graphs to make it more specific for decision-makers.

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The segmental analysis offered in the report pinpoints key opportunities available in the Autologous Stem Cell Based Therapies market through leading segments. The regional study of the Autologous Stem Cell Based Therapies market included in the report helps decision-makers to gain a sound understanding of the development of different geographical markets in recent years and going forth.

By Type:

By Applications:

By Region:

To comprehend Global Autologous Stem Cell Based Therapies market dynamics in the world mainly, the worldwide Autologous Stem Cell Based Therapies market is analyzed across major regions. A customized study by region and country can be provided considering the below splits.

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Major Companies included in the Autologous Stem Cell Based Therapies market:

The report provides in-depth information about profitable showing markets and examines the markets for the global Autologous Stem Cell Based Therapies market with business strategies of the key players and the new entering market industries are considered in detail and it presents the deep-dive eyesight of this Autologous Stem Cell Based Therapies market from 2021 to 2026 and prospective prediction market trends.

Key Questions answered by the Report:

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Key Trends of Autologous Stem Cell Based Therapies Market 2021 Business Opportunities, Market Dynamics, Growth Size and Forecasts to 2026 - Clark...

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Global Autologous Stem Cell Based Therapies Market Survey Report, 2020-2027 KSU | The Sentinel Newspaper – KSU | The Sentinel Newspaper

By daniellenierenberg

From an insight perspective, this research report has focused on various levels of analysis industry trends analysis, top players analysis, company profiles, which discuss the basic views on the competitive landscape, emerging and high-growth segments of Autologous Stem Cell Based Therapies market, and high-growth regions. Besides, drivers, restraints, challenges, and opportunities pertaining to Autologous Stem Cell Based Therapies market are also predicted in this report.

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Major Participators LandscapeThese market players enjoyed broad industry coverage, outstanding operational ability, and strong financial resources. Manufacturers are focusing on product innovation, brand extension, and the introduction of new brands to cater to the preferences of consumers. Some of them will be endowed with vital future while others will show a weak growth during the prospective timeframe.Major market participators covered in our report are:US STEM CELL, INC. Med cell Europe Pluristem Therapeutics Inc Mesoblast Tigenix Brainstorm Cell Therapeutics Regeneus

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Autologous Stem Cell Based Therapies Application AbstractThe Autologous Stem Cell Based Therapies is commonly used into:Neurodegenerative Disorders Autoimmune Diseases Cardiovascular Diseases

Autologous Stem Cell Based Therapies Type AbstractBased on the basis of the type, the Autologous Stem Cell Based Therapies can be segmented into:Embryonic Stem Cell Resident Cardiac Stem Cells Umbilical Cord Blood Stem Cells

Table of Content1 Report Overview1.1 Product Definition and Scope1.2 PEST (Political, Economic, Social and Technological) Analysis of Autologous Stem Cell Based Therapies Market2 Market Trends and Competitive Landscape3 Segmentation of Autologous Stem Cell Based Therapies Market by Types4 Segmentation of Autologous Stem Cell Based Therapies Market by End-Users5 Market Analysis by Major Regions6 Product Commodity of Autologous Stem Cell Based Therapies Market in Major Countries7 North America Autologous Stem Cell Based Therapies Landscape Analysis8 Europe Autologous Stem Cell Based Therapies Landscape Analysis9 Asia Pacific Autologous Stem Cell Based Therapies Landscape Analysis10 Latin America, Middle East & Africa Autologous Stem Cell Based Therapies Landscape Analysis 11 Major Players Profile

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Major countries of North America, Europe, Asia Pacific, and the rest of the world are all exhaustive analyzed in the report. Apart from this, policy mobilization, social dynamics, development trends, and economic development in these countries are also taken into consideration.

Target Audience for this Report Autologous Stem Cell Based Therapies manufacturers Autologous Stem Cell Based Therapies traders, distributors, and suppliers Autologous Stem Cell Based Therapies industry associations Product managers, Autologous Stem Cell Based Therapies industry administrator, C-level executives of the industries Market Research and consulting firms Research & Clinical Laboratories

Report SpotlightsDetailed overview of marketChanging market dynamics in the industryIn-depth market segmentationHistorical, current and projected market size in terms of volume and valueRecent industry trends and developmentsCompetitive landscapeStrategies of key players and products offeredPotential and niche segments, geographical regions exhibiting promising growthA neutral perspective on market performanceMust-have information for market players to sustain and enhance their market footprints

About Global Market MonitorGlobal Market Monitor is a professional modern consulting company, engaged in three major business categories such as market research services, business advisory, technology consulting.We always maintain the win-win spirit, reliable quality and the vision of keeping pace with The Times, to help enterprises achieve revenue growth, cost reduction, and efficiency improvement, and significantly avoid operational risks, to achieve lean growth. Global Market Monitor has provided professional market research, investment consulting, and competitive intelligence services to thousands of organizations, including start-ups, government agencies, banks, research institutes, industry associations, consulting firms, and investment firms.ContactGlobal Market MonitorOne Pierrepont Plaza, 300 Cadman Plaza W, Brooklyn,NY 11201, USAName: Rebecca HallPhone: + 1 (347) 467 7721Email: info@globalmarketmonitor.comWeb Site: https://www.globalmarketmonitor.com

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Kaytlyn Gerbin is blazing trails in cell science and as an ultrarunner who has conquered Mount Rainier – GeekWire

By daniellenierenberg

Kaytlyn Gerbin, left, runs the Wonderland Trail around Mount Rainier. She completed the 93-mile loop in just under 19 hours. Her friend Tara Fraga helped with pacing between miles 30-55. (Ryan Thrower Photo)

When Kaytlyn Gerbin moved to Seattle 10 years ago to attend graduate school at the University of Washington, a friend took her to Kerry Park in the Queen Anne neighborhood on her first visit. The celebrated viewpoint offered Gerbin a glimpse of Mount Rainier that ignited an ongoing passion.

At the time, I had absolutely no idea there was a trail all the way around it, and didnt know the first thing that went into climbing to the summit or running even a few miles on the trails, Gerbin said. Since then, Ive climbed Rainier 10 times, and spent countless hours on the mountain and trails in that park.

Along with her drive to get to know Washington states most famous landmark more intimately, Gerbin achieved her PhD in bioengineering at UW, where her research was focused on the therapeutic and regenerative potential of cardiac cells. For the past four years shes been a scientist at Allen Institute for Cell Science, where she studies stem cells and cardiomyocytes, or cardiac muscle cells.

Our latest Geek of the Week, Gerbin is an accomplished ultrarunner, and she now knows a lot more about that trail that encircles Mount Rainier.

With COVID-19 lockdowns impacting her international race season last summer, Gerbin, a sponsored athlete for The North Face, went after the fastest known time, or FKT, for a run around the Wonderland Trail. Together with teammate Dylan Bowman of Portland and a small crew of local filmmakers, they made Summer of Wonder, a short film about the experience, which you can watch in full here:

The average thru-hiker takes 10-14 days to complete the 93-mile Wonderland Trail, with its 24,000 feet of elevation gain. Gerbin did it in 18 hours, 41 minutes, 53 seconds, and the film is a breathtaking look at her endurance feat.

Gerbins passion for running started with 3-mile commutes back and forth between her apartment, her research lab, and campus during grad school. Eventually she started trail running,essentially as a life hack to see if she could squeeze a five-day backpacking route into a weekend between experiments.

It turned out I was actually pretty good at that, and that opened up opportunities to start racing at some of the most competitive trail races in the U.S. and Europe, Gerbin said.

Shes since raced with Team USA at the Trail World Championships, reached the podium at the iconic Western States 100, and won races such as the Canary Islands Transgrancanaria and Cascade Crest 100 in Washington. She also still holds the womens self-supported FKT for the Rainier Infinity Loop (set in 2019), which combines the Wonderland Trail with two summits and descents of Mount Rainier.

Her preferred racing distance is anything between 50-100 miles long, the more elevation gain and technical the trail, the better. During peak training, Gerbin is usually hitting between 70-90 miles with over 20,000 feet of elevation gain each week. She calls the Pacific Northwest the best outdoor playground there is.

Although I love running fast, Im also really excited about pushing myself on more challenging terrain. So many of my other FKT goals and route ideas are along these lines, with more technical traveling than actual running, she said.

COVID permitting, her highest race priority this year is Ultra Trail du Mont Blanc, which is the most competitive world-stage for ultrarunning, at the end of August. The race circumnavigates Mont Blanc, passing through France, Italy, and Switzerland and covering around 105 miles and 33,000 feet of elevation gain.

While Gerbins experience as a scientist does inform her appreciation for what shes putting her body through during ultrarunning, shes equally passionate in the lab. At the Allen Institute shes seeking answers to broad questions about how cells work, including how single cells and all of their components are integrated into a functional system, while using imaging to build predictive models of cell behavior.

I get the opportunity to work with a multidisciplinary team of badass scientists, biologists, and engineers on really cool problems in cell biology, she said.

Learn more about our latest Geek of the Week, Kaytlyn Gerbin:

What do you do, and why do you do it? Science and ultrarunning for me have always come down to problem solving.

As a scientist, problem solving is inherent to experimental design, data analysis, and interpreting results. By asking hard questions, Im interested in pushing the field of cell biology forward, and challenging the current way of thinking.

As an ultrarunner, its a different kind of problem solving, but I lean on the same mindset to figure out how to push my athletic limits further and faster.

One thing that always amazes me is how adaptable the human body is. My training in cell science gives me context for how all of these stressors and inputs were putting on our bodies are fundamentally happening at the single cell level, and it keeps me thinking about the cells response to external cues in my research.

Whats the single most important thing people should know about your field? Yes, I do think about science and when Im running, and no, I do not geek out on heart rate monitors and training zones and all those numbers when Im running.

Where do you find your inspiration? Im inspired by brilliant women that are pushing whats possible in both science and in sports. I think we often set boundaries for ourselves about what we think is possible, without ever letting ourselves really hit that limit. Im inspired by women who set bold goals and bring others up and along for the ride, redefining whats possible.

Whats the one piece of technology you couldnt live without, and why? My Garmin 935. I use this watch daily to track miles run, elevation gain, etc. The battery life has lasted me for 100 miles of running and ~24 hrs, but its small enough to wear every day.

Whats your workspace like, and why does it work for you? Prior to 2020, I was splitting my time between the tissue culture hood (passaging cells, differentiating cardiomyocytes, setting up experiments), conference rooms (team science and collaboration means a lot of group discussions!), and my computer for writing and analysis. Since then, Ive shifted my work to be more remote while I work on a few different manuscripts. I have an office set up at home with a window, some good tunes, plenty of coffee, and a chair for my dog to wait impatiently on.

Your best tip or trick for managing everyday work and life. (Help us out, we need it.) I have always been a to-do list person. Most mornings start with me listing out tasks (and breaking those down into many sub-tasks). I feel productive as I cross things off, and it also helps me prioritize and plan ahead to make sure I can also fit my training runs in.

Mac, Windows or Linux? Mac as a personal preference, Windows for my work computer (I do work at the Paul Allen Institute 🙂

Transporter, Time Machine or Cloak of Invisibility? Transporter. I just promise not to use it in races.

Greatest game in history: Lode Runner. I havent played it since I was a kid, but the memories of yelling at the computer with my sister frantically hitting up-down-up-down arrows make me feel like it was just yesterday.

Best gadget ever: Garmin inReach mini satellite messaging and SOS call, all in a device small enough to throw in the bottom of a pack (or shorts pocket) and forget its there. I bring this with me anytime Im headed out into the wilderness/mountains, but I hope I never need to use it.

First computer: iMac G3.

Current phone: iPhone 11.

Favorite app: I have a love/hate relationship with Strava. Ive also been using DuoLingo during the pandemic and have a strong daily streak going!

Most important technology of 2021: COVID vaccines!!

Most important technology of 2023: Advancements in remote/low-resource medical care.

Final words of advice for your fellow geeks: Most problems can be solved with more snacks and some time (works for science and running).

Twitter: @kaytlyn_gerbin

LinkedIn: Kaytlyn Gerbin

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Durable B-ALL Control With Allogeneic Transplant After CAR T-Cell Therapy – Cancer Therapy Advisor

By daniellenierenberg

Children and young adults who underwent an allogeneic hematopoietic stem cell transplant (alloHSCT) after achieving complete response with CD19 CAR T-cell therapy experienced durable B-cell acute lymphoblastic leukemia (B-ALL) control, according to the results of a phase 1 trial (ClinicalTrials.gov Identifier: NCT01593696) published in the Journal of Clinical Oncology.

Although a proportion of patients who undergo CAR T-cell therapy go on to receive alloHSCT, the study authors stated that The role for [alloHSCT] following CD19-CAR T-cell therapy to improve long-term outcomes in [children and young adults] has not been examined.

The phase 1 trial evaluated 50 children and young adults with B-ALL who received CD19.28 CAR T-cell therapy. The primary objective was to determine the maximum tolerated dose of CAR T cells, toxicity, and feasibility of generating CAR T cells in the study population. In addition, this analysis retrospectively evaluated the effect of alloHSCT on survival after CAR T-cell therapy.

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At baseline, the median age was 13.5 years (range, 4.3-30.4), and 40 (80%) of the patients were male. The median number of prior regimens was 4 (range, 4.3-30.4); 22 (44%) patients had at least 1 prior HSCT, 2 (4%) had prior CD19-targeted therapy, and 5 (10%) of the patients had prior treatment with blinatumomab.

Complete response was achieved in 31 (62%) of the patients. Among these patients, 28 (90.3%) were negative for minimal residual disease. Higher rates of complete response were associated with primary refractory disease, fewer prior lines of therapy, M1 marrow, or fludarabine/cytarabine-based lymphodepletion. The median overall survival was 10.5 months (95% CI, 6.3-29.2) during a median follow-up of 4.8 years.

Of the 28 patients who achieved complete response, 21 (75%) proceeded to undergo consolidative alloHSCT. The median overall survival for these patients was 70.2 months (95% CI, 10.4-not estimable), with an event-free survival not yet reached. The rate of relapse after alloHSCT was 4.8% (95% CI, 0.3-20.3) at 12 months and 9.5% (95% CI, 1.5-26.8) at 24 months.

Any grade cytokine release syndrome (CRS) developed among 35 (70%) patients, with 9 (18%) experiencing grade 3 to 4 CRS. Of the 10 patients (20%) who developed neurotoxicity, 4 cases were severe. One cardiac arrest occurred during CRS. All patients with CRS, neurotoxicity, and cardiac arrest recovered.

The authors concluded that CD19.28 CAR T cells followed by a consolidative alloHSCT can provide long-term durable disease control in [children and young adults] with relapsed or refractory B-ALL.

Disclosure: Please see the original reference for a full disclosure of authors affiliations.

Reference

Shah NN, Lee DW, Yates B, et al. Long-term follow-up of CD19-CAR T-cell therapy in children and young adults with B-ALL. J Clin Oncol. Published online March 25, 2021. doi:org/10.1200/JCO.20.02262c

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The Physiological Challenges of Spaceflight – Cambridge Wireless

By daniellenierenberg

By Guest Blogger Rich Whittle, Bioastronautics & Human Performance Lab at Texas A&M UniversityThe recent landing of the probe Perseverance on Mars, and the excitement generated by the high-resolution images currently being broadcast back to Earth, has inevitably started people thinking about human exploration of the Red Planet. However, the challenges faced by a manned journey to Mars are much more than just technical, but reflect some fundamental aspects of human physiology. In this guest article, Rich Whittle of the Bioastronautics and Human Performance Lab at Texas A&M University, reflects on some of the key issues.

NASA has ambitious plans to begin manned exploration of Mars, although its current focus is on sending the next man and first woman to the Moon as part of the Artemis programme, which will establish a permanent human presence there in the coming decade. A key part of this latter objective is to place a spaceship called Gateway in orbit around the Moon, from which landers will take astronauts to the surface and support their activities. Gateway will also conduct a wide variety of human and scientific missions, and in particular study the physiological effects of long journeys into space, in preparation for that first manned voyage to Mars.

The human body has evolved over hundreds of thousands of years to flourish on the surface of the Earth, and it is perhaps not surprising that the stresses of spaceflight pose unique physiological and medical problems. In fact, many of the basic issues associated with spaceflight, such as hypoxia, dysbarism, acceleration, and thermal support, have been well studied through aviation and diving medicine in the years prior to spaceflight. But while the last 50 years of manned space exploration have shown that humans can adapt to space, remaining productive for up to 1 year and possibly longer, there are still many problems associated with the prolonged exposure to a unique combination of stressful stimuli including acceleration, radiation, and weightlessness. The latter condition is a critical feature of spaceflight and has significant effects on human physiology, many of which were quite unexpected at the beginning of space exploration.

Scientists have known for a long time that the human body responds in specific ways to the microgravity environment of spaceflight. For example, a person who is inactive for an extended period loses overall strength, as well as muscle and bone mass. Unsurprisingly spaceflight has a similar effect, resulting in loss of bone mineral density (BMD), and increasing the risk of bone fractures in astronauts. It is predicted that a third of astronauts will be at risk for osteoporosis during a predicted 7-month long human mission to Mars. It is however possible to compensate for this loss of muscle and bone mass using resistive exercise devices that NASA has developed to allow for more intense workouts in zero gravity.

Overall, the pathophysiological adaptive changes that occur during spaceflight, even in well-trained, highly selected, and healthy individuals, have been likened to an accelerated aging process, and are being studied in research groups around the world. My own research at Texas A&M focuses on changes to the cardiovascular system caused by the microgravity environment of spaceflight. In an upright position under the Earths standard 1G gravity, arterial blood pressure is lower above the heart and higher below the heart. But in a weightless environment the body experiences a uniform arterial pressure, which decreases the cardiac workload, and reduces the need for blood pressure regulatory mechanisms. As a result, the muscles of the heart and blood vessels begin to atrophy, and consequently some astronauts experience orthostatic intolerance, the difficulty or inability to stand because of light headedness after return to Earth. During spaceflight, cardiovascular changes are noticeable immediately after the onset of weightlessness, with astronauts exhibiting characteristically puffy faces, stuffed noses, and chicken legs, as approximately 2L of fluid is shifted from the legs towards the head.

These fluid shifts affect not only the cardiovascular system but also the brain, eyes, and other neurological functions. The apparent increase in fluid within the skull is potentially linked to a collection of pathologies of the eye known as Spaceflight Associated Neuro-ocular Syndrome (SANS). This is principally manifested through a hyperopic shift in visual acuity, which in some cases does not resolve on return to Earth.

We believe that many of these problems can be overcome through effective countermeasures during spaceflight, and are often reversible after landing. Physical exercise programs are the main countermeasure used during spaceflight to protect the cardiovascular system. The technology involved has advanced from a rowing ergometer used in the early Skylab missions, through a motorized treadmill used in the ISS. This has been recently joined by a device for performing resistive exercise, and now rowing ergometers are once again being looked at for longer duration missions to Mars due to their small footprint.

However, some astronauts have returned from the ISS with unexpectedly stiff arteries, of a magnitude expected from 10 20 years of normal aging. Arterial stiffening is often linked to an increased blood pressure and elevated risk for cardiovascular disease. Additionally, other studies have suggested that insulin resistance occurs during spaceflight, possibly due to reduced physical activity, which could lead to increased blood sugar and increased risk of developing type 2 diabetes. These results suggest that the astronauts exercise routine did not always counteract the effect of the microgravity environment and indicated that further countermeasures might be needed to help maintain astronaut health. Here at Texas A&M we are looking at both lower body negative pressure (LBNP) and artificial gravity generated through short radius centrifugation as exciting new countermeasures that could be used in long duration spaceflight.

As we begin to further understand the effects of spaceflight on human physiology, scientists are now starting to study some of the underlying cellular mechanisms using model organisms, cell cultures, organs on a chip and stem cells. And because many of the observed changes seen in space, such as cardiovascular dysfunction due to inflammation, lack of exercise, intracranial hypertension, and hormonal and metabolic changes, resemble those caused by aging or illnesses, the research we conduct may have important applications on Earth. Hopefully, our push for manned exploration of the planets of the solar system will lead to tangible benefits to the health and well-being of humans on our home planet.

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5 Novel Therapies Using Synthetic Biology – Nanalyze

By daniellenierenberg

The 1997 film Gattaca promised a future where humans would be free of disease and babies born on demand with the latest upgrades, including enhanced speed, intelligence, and beauty. Much like a new Tesla Roadster. However, despite the technological predictions offered by Hollywood moviemakers, were still living in a time when synthetic biology is working hard to make a dent in the world. No designer babies in sight. And stem cell technology promised so many radical breakthroughs back in the late 1990s, including growing organs for transplants and regenerating whole body parts, but the challenge of growing whole organs has been shown to be more complex than previously believed, including technologies like 3D bioprinting and xenotransplantation.

Despite the challenges and setbacks, investors believe were living in a different time, with more money pouring into the space over the last few years:

Indeed, the science and technology behind manipulating biological matter are still promising when it comes to health and medicine, especially with the rise of CRISPR gene editing. The idea that we could potentially switch on or off genes that cause disease using a cocktail of enzymes is just fantastical. While inserting CRISPR enzymes into a live human being is a bit challenging, there are regions of the body that are easily accessible, such as the eye. In a landmark clinical trial approved by the FDA and led by Editas Medicine (EDIT) and Allergan, now owned by AbbVie (ABBV), a CRISPR-Cas9 gene therapy was administered directly to patients to remove rare mutations that can cause childhood blindness.

McKinsey is calling this emerging technological renaissance the next Bio Revolution, with advances in biological sciences being accelerated by automation and artificial intelligence. The speed at which scientists and researchers were able to sequence the genome of the Rona virus is a testament to the power of these converging technologies. McKinsey predicts that synthetic biology could have a direct economic impact of $4 trillion per year, nearly half of which will be in the domain of human health.

Lets take a look through five companies that are harnessingthe revolutionary power of synthetic biology to design new therapies and treathuman diseases.

Founded in 2017 and headquartered in Alameda, California, Scribe Therapeutics is a biotechnology startup that is producing therapeutics using custom-engineered CRISPR enzyme technology. The company has raised a whopping $120 million from the likes of Andreessen Horowitz to build out a suite of CRISPR technologies designed to treat genetic diseases. Scribe Therapeutics was co-founded by Dr. Jennifer Doudna, the UC Berkeley biochemist who discovered and developed CRISPR gene-editing technology and won the Nobel Prize in Chemistry in 2020 for her pioneering work.

The team at Scribe Therapeutics has designed its XEditing (XE) technology by evolving the native CRISPR gene-editing enzymes available to us to redesign and engineer them to suit different needs. More specifically, they want to be able to modify or silence the genes of live humans to treat genetic diseases such as Huntingtons, Parkinsons, Sickle Cell Anemia, and Amyotrophic Lateral Sclerosis (ALS). Anything your parents unwittingly handed down to you, Scribe Therapeutics is looking to treat it. The research team tests thousands of redesigned enzymes and selects those with greater editing ability, specificity, and stability compared to current enzymes. Scribe Therapeutics is starting with a pipeline of therapeutics to treat neurodegenerative diseases and has its sights set on other, less common genetic conditions down the road.

Canadian biotechnology startup Notch Therapeutics was founded in 2018 and has raised $86 million to develop immune cell therapies against pre-cancer cells. The companys cell therapies are based on induced pluripotent stem cells (iPSC), which are pre-differentiated cells with the limited capacity to transform into different mature cell lines. Based on its Engineered Thymic Niche (ETN) platform, the company is developing universally compatible stem cell-derived immune cell therapies.

Normally, human immune cells only recognize othercells found in the same individual and will target cells from other individuals,which appear foreign to the immune system. Thats why donor organs can sometimesbe rejected by the recipients body the immune system sees the organ as a foreignobject. Notch Therapeutics is designing a system where the immune cellsproduced from the stem cells will be universally recognizable by allindividuals, bypassing the need to create immune cells from pluripotent stemcells derived from each recipient. These manufactured immune cells, whichinclude T cells or natural killer cells, can be programmed to target cancercells and eliminate them from the patient.

Founded in 2016, Massachusetts-based bit.bio is a synthetic biology startup thats working on merging the world of coding with biology. The company has secured $42 million after a Series A round that was completed in June 2020. A spinout of Cambridge University, bit.bio is looking to commercialize its proprietary platform, opti-ox, which can reprogram human stem cells to do its bidding cure diseases. Touted as the Cell Coding Company, bit.bio was founded by Dr. Mark Kotter, a neurosurgeon at the University of Cambridge who studied regenerative medicine and stem cell technology.

While the ability to program mammalian stem cells has been around since 1981, the company claims it can consistently reprogram human adult cells into pluripotent stem cells, and then transform them into other mature human cells within days. Currently, stem cell technology produces a statistical mixed bag of mature, differentiated cells, some of which can have potential side effects. opti-ox uses a precise combination of transcription factors to ensure stem cells mature into cardiac, muscle, liver, kidney, or lung cells with high efficiency. The holy grail for the company is to be able to produce every cell in the human body for any cell therapy safely, on-demand, and with purities approaching 100%. And well be here, waiting for that stem cell therapy for erectile dysfunction promised by the medical community.

Founded in 2020, Delonix Bioworks is a Shanghai-based synthetic biology company designing therapeutic solutions against infectious diseases. The startup received $14 million from a Seed round just back in March. The Delonix Bioworks team is focusing its initial efforts on anti-microbial resistant (AMR) infections. The emergence of resistance in some bacteria species against common antimicrobial compounds, so has led to an increasing number of infections that are difficult to treat with conventional strategies. These superbug strains are mostly spread in hospital or clinical settings due to the overuse of antibiotics.

The company is engineering attenuated, live bacteria thatcan act as vaccines against these types of infections. By introducing reprogrammed,but weakened, bacteria to express specific antigens on the surface of theirmembrane that match those of the strains that cause AMR infections into anindividual, the individuals immune system can recognize those antigens andrespond to future infections with greater speed. Its no different from how antiviralvaccines are designed, except most vaccines introduce an attenuated or inactivatedvirus to activate the immune system instead. And for those of you who skipped highschool biology, no, this is not a mind-control scheme orchestrated by biotech companies.

Founded in 2018, Octarine Bio is a Danish synthetic biology company thats building out a pipeline for high-potency cannabinoids and psilocybin derivatives for the pharmaceutical industry. Octarine Bio has brought in $3 million after a Seed round that was also completed in March. Medical studies on psychotropic compounds have been shown to help reduce anxiety, depression, and pain, and may have the potential to serve as novel psychiatric medications. A few companies have recently emerged to commercialize existing psychedelics. Octarine Bio believes it can do better by harnessing the power of synthetic biology to engineer microorganisms to produce these psychotropic compounds with better pharmacokinetic and therapeutic effects.

Normally, natural products are produced by plant and fungal species as an ill-defined mixture. The psychoactive properties of these compounds primarily stem from only a handful of compounds because their natural concentration is much higher than other derivatives in the organic material. For example, tetrahydrocannabinol (THC) is the main psychoactive agent in marijuana while psilocybin is the one found in mushrooms from the Psilocybe and other psilocybin-producing genera. However, these are just a few out of hundreds of potential psychoactive derivatives produced by these species.

Molecular derivatives may be produced at too low of concentration to test and analyze, or the plant or mushroom may have a deactivated metabolic pathway that could lead to a superior compound. By tweaking the molecular structure of the product compounds using both synthetic biology and traditional organic chemistry, the team at Octarine Bio is creating a platform to discover new potential therapeutics that may not have been available before. Magic mushrooms are about to get an upgrade for an extra potent trip.

Much like what was said about software by Marc Andreessen back in 2011, synthetic biology is starting to eat the world. While were a long way away from a dystopian future where babies are engineered with supernatural talents, were already seeing the potential side-effects of using CRISPR on the Chinese twin girls originally to immunize them from HIV, including enhanced cognition and memory. The cure for stupid is possibly lurking in the vaults of this pioneering technology. For now, well wait and see how synthetic biology and CRISPR gene editing shape up as potential therapeutics for real diseases.

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Australian scientists discover secret switch for the heart to heal itself – The New Daily

By daniellenierenberg

Cut off a piece of a zebrafish heart, and the little creature wont be at the top of its game for a few days.

But after a month, the heart will grow back to normal and life goes on as normal.

Given that a heart attack in humans known as a myocardial infarction is akin to losing a piece of your heart (because tissue dies), scientists for years have been trying to understand how zebrafish heal themselves, with a view to replicating the process in people.

Now, scientists at the Victor Chang Cardiac Research Institute have identified the genetic switch in zebrafish that prompts heart cells to divide and multiply after a heart attack, resulting in the complete regeneration and healing of damaged heart muscle in these fish.

Dr Kazu Kikuchi, who led the research, published in Science on Friday, said he was astonished by the findings.

Our research has identified a secret switch that allows heart muscle cells to divide and multiply after the heart is injured, Dr Kikuchi said in a statement.

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It kicks in when needed and turns off when the heart is fully healed. In humans where damaged and scarred heart muscle cannot replace itself, this could be a game changer.

The researchers investigated a critical gene known as Klf1, which previously had only been identified in red blood cells.

They discovered Klf1 plays a vital role in healing damaged hearts.

The gene works by making uninjured heart muscle cells called cardiomyocytes more immature and changing their metabolic wiring, a process called dedifferentiation.

This allows them to divide and make new cells

Cardiomyocytes are the heart cells primarily involved in the contractile function of the heart that enables the pumping of blood around the body.

Ordinarily, adult mammalian hearts have a limited ability to generate new cardiomyocytes whereas zebrafish will keep making new cells until their hearts are completely healed.

Its been known for more than a decade that cardiomyocytes become more youthful in order to regenerate and Dr Kikuchi was one of the researchers to demonstrate this.

What wasnt known was how this was made to happen.

Our new paper suggests it is Klf1 which triggers this, Dr Kikuchi said.

This isnt the same as stem cell technology. In fact, dedifferentiating cardiomyocytes has proved to be a more effective healing process than stem cells.

It all comes down to that genetic switch.

Dr Kikuchi said that when the gene was removed, the zebrafish heart lost its ability to repair itself after an injury such as a heart attack, which pinpointed it as a crucial self-healing tool.

Professor Bob Graham, head of the Institutes Molecular Cardiology and Biophysics Division, says this world-first discovery made in collaboration with the Garvan Institute of Medical Research may well transform the treatment of heart attack patients and other heart diseases.

The team has been able to find this vitally important protein that swings into action after an event like a heart attack and supercharges the cells to heal damaged heart muscle. Its an incredible discovery, Professor Graham said.

The gene may also act as a switch in human hearts. We are now hoping further research into its function may provide us with a clue to turn on regeneration in human hearts, to improve their ability to pump blood around the body.

Importantly, the team also found the Klf1 gene played no role in the early development of the heart and that its regenerative properties were only switched on after a heart injury.

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Xenobots 2.0 are Here and Still Developed With Frog Stem Cells – Unite.AI

By daniellenierenberg

The same team of biologists and computer scientists from Tufts University and the University of Vermont that created the Xenobots last year have now developed Xenobots 2.0. Last years version were novel, tiny self-healing biological machines created from frog cells, and they could navigate, push payloads, and act as a collective unit in some cases.

The new Xenobots 2.0 are life forms that can self-assemble a body from single cells. They do not require muscles to move, and they have even demonstrated recordable memory. Compared to their previous counterparts, the new bots move faster, navigate even more environments, and have longer lifespans. At the same time, they can still work together and heal themselves when damaged.

The new research was published in Science Robotics.

With the Xenobots 1.0, the millimeter-sized automations were constructed top down, with the manual placement of tissue and surgical shaping of frog skin and cardiac cells, which produces motion. With the new version of the technology, they were constructed bottom up.

Stem cells were taken from the embryos of the African frog called Xenopus laevis, and this enabled them to self-assemble and grow into spheroids. After a few days, the cells differentiated and produced cilia that moved back and forth or rotated in a specific way.

These cilia provide the new bots with a type of legs that enables them to rapidly travel across surfaces. In the biological world, cilia, or tiny hair-like projections, are often found on mucous surfaces like the lungs. They help by pushing out foreign material and pathogens, but in the Xenobots, they offer rapid locomotion.

Michael Levin is a Distinguished Professor of Biology and director of the Allen Discovery Center at Tufts University. He is the corresponding author of the study.

We are witnessing the remarkable plasticity of cellular collectives, which build a rudimentary new body that is quite distinct from their default in this case, a frog despite having a completely normal genome, said Levin. In a frog embryo, cells cooperate to create a tadpole. Here, removed from that context, we see that cells can re-purpose their genetically encoded hardware, like cilia, for new functions such as locomotion. It is amazing that cells can spontaneously take on new roles and create new body plans and behaviors without long periods of evolutionary selection for those features.

Senior scientist Doug Blackiston was co-first author of the study along with research technician Emma Lederer.

In a way, the Xenobots are constructed much like a traditional robot. Only we use cells and tissues rather than artificial components to build the shape and create predictable behavior. said Blackiston On the biology end, this approach is helping us understand how cells communicate as they interact with one another during development, and how we might better control those interactions.

Over at UVM, the scientists were developing computer simulations that modeled different shapes of the Xenobots, which helped identify any different behaviors that were exhibited in both individuals and groups. The team relied on the Deep Green supercomputer cluster at UVMs Vermont Advanced Computing Core.

Led by computer scientists and robotics expert Josh Bongard, the team came up with hundreds of thousands of environmental conditions through the use of an evolutionary algorithm. The simulations were then used to identify Xenobots that could work together in swarms to gather debris in a field of particles.

We know the task, but its not at all obvious for people what a successful design should look like. Thats where the supercomputer comes in and searches over the space of all possible Xenobot swarms to find the swarm that does the job best, says Bongard. We want Xenobots to do useful work. Right now were giving them simple tasks, but ultimately were aiming for a new kind of living tool that could, for example, clean up microplastics in the ocean or contaminants in soil.

The new version of the bots are faster and more efficient at tasks like garbage collection, and they can now cover large flat surfaces. The new upgrade also includes the ability for the Xenobot to record information.

The most impressive new feature of the technology is the ability for the bots to record memory, which can then be used to modify its actions and behaviors. The newly developed memory function was tested and the proof of concept demonstrated that it could be extended in the future to detect and record light, the presence of radioactive contamination, chemical pollutants, and more.

When we bring in more capabilities to the bots, we can use the computer simulations to design them with more complex behaviors and the ability to carry out more elaborate tasks, said Bongard. We could potentially design them not only to report conditions in their environment but also to modify and repair conditions in their environment.

The new version of the robots are also able to self-heal very efficiently, demonstrating that they are capable of closing the majority of a severe full-length laceration half their thickness within just five minutes.

The new Xenobots carry over the ability to survive up to ten days on embryonic energy stores, and their tasks can be carried out with no additional energy sources. If they are kept in various different nutrients, they can continue at full speed for months.

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Scientists Create Living Machines That Move, Heal, Remember and Work in Groups – Genetic Engineering & Biotechnology News

By daniellenierenberg

Scientists have created small, synthetic living machines that self-organize from single cells, move quickly through different environments without the need for muscle cells, can remember their experiences, heal themselves when damaged, and exhibit herd behaviors.

Earlier, scientists have developed swarms of robots from synthetic materials and moving biological systems from muscle cells grown on precisely shaped scaffolds. But until now the creation of a self-directed living machine has remained beyond reach.

Biologists and computer scientists from Tufts University and the University of Vermont have created novel, tiny self-healing living machines from frog cells (Xenopus laevis) that they call Xenobots. These can move around, push a payload, and even exhibit collective behavior in a swarm.

In an article titled A cellular platform for the development of synthetic living machinespublished in the journal Science Robotics, the researchers report a method for creating these of Xenobots from frog cells. This cellular platform can be used to study self-organization, collective behavior, and bioengineering and provide versatile, soft-body, living machines for applications in biomedicine and environmental biology.

The next version of Xenobots have been createdtheyre faster, live longer, and can now record information [Doug Blackiston, Tufts University]

We are witnessing the remarkable plasticity of cellular collectives, which build a rudimentary new body that is quite distinct from their defaultin this case, a frog despite having a completely normal genome, says Michael Levin, Distinguished Professor of Biology and director of the Allen Discovery Center at Tufts University, and corresponding author of the study. In a frog embryo, cells cooperate to create a tadpole. Here, removed from that context, we see that cells can re-purpose their genetically encoded hardware, like cilia, for new functions such as locomotion. It is amazing that cells can spontaneously take on new roles and create new body plans and behaviors without long periods of evolutionary selection for those features.

Xenobots can move around in a coordinated manner with the help of cilia present on their surface. These cilia grow through normal tissue patterning and do not require complicated architectural procedures such as scaffolding or microprinting, making the high-throughput production of Xenobots possible. And while the frog cells are organizing themselves into Xenobots, they are amenable to surgical, genetic, chemical, and optical stimulation. The researchers show that the Xenobots can maneuver through water, heal after damage and exhibit predictable collective behaviors.

The scientists also provide a proof of principle for a programmable molecular memory using a light-controlled protein that can record exposure to a specific wavelength of light.

Compared to their first edition, Xenobots 1.0, that were millimeter-sized automatons constructed in a top down approach by manual placement of tissue and surgical shaping of frog skin and cardiac cells to produce motion, this updated version of Xenobots 2.0 takes a bottom up approach. The biologists took stem cells from frog embryos and allowed them to self-assemble and grow into spheroids, where some of the cells after a few days differentiated to produce ciliatiny hair-like projections that move back and forth or rotate in a specific way. Cilia act like legs to help the new spheroidal Xenobots move rapidly across a surface.

In a way, the Xenobots are constructed much like a traditional robot. Only we use cells and tissues rather than artificial components to build the shape and create predictable behavior. Says Doug Blackiston, PhD, senior scientist and co-first author on the study with research technician, Emma Lederer. On the biology end, this approach is helping us understand how cells communicate as they interact with one another during development, and how we might better control those interactions.

Scientists at UVM ran computer simulations that modeled different shapes of the Xenobots and analyzed its effects on individual and collective behavior. Robotics expert, Joshua Bongard, PhD, and a team of computer scientists used an evolutionary algorithm on the Deep Green supercomputer cluster at UVMs Vermont Advanced Computing Core to simulate the behavior of the xenobots under numerous random environmental conditions. These simulations identified Xenobots that excelled at working together in swarms to gather large piles of debris in a field of particles.

We know the task, but its not at all obviousfor peoplewhat a successful design should look like. That is where the supercomputer comes in and searches over the space of all possible Xenobot swarms to find the swarm that does the job best, says Bongard. We want Xenobots to do useful work. Right now, were giving them simple tasks, but ultimately were aiming for a new kind of living tool that could, for example, clean up microplastics in the ocean or contaminants in soil.

Xenobots can quickly collect garbage working together in a swarm to sweep through a petri dish and gather larger piles of iron oxide particles. They can also cover large flat surfaces and travel through narrow capillaries.

The Tufts scientists engineered the Xenobots with a memory capability to record one bit of information, using a fluorescent reporter protein called EosFP that glows green but when exposed to blue light at 390nm wavelength, the protein emits red light instead.

The researchers injected the cells of the frog embryos with messenger RNA coding for the EosFP protein before the stem cells were excised to create the Xenobots so that the mature Xenobots have a built-in fluorescent switch which can record exposure to blue light.

To test the memory capacity, the investigators, allowed 10 Xenobots to swim around a surface on which one spot is illuminated with a beam of blue light. After two hours, they found that three bots emitted red light. The rest remained their original green, effectively recording the travel experience of the bots. This molecular memory in Xenobots could be harnessed to detect the presence of radioactive contamination, chemical pollutants, drugs, or a disease condition.

When we bring in more capabilities to the bots, we can use the computer simulations to design them with more complex behaviors and the ability to carry out more elaborate tasks, said Bongard. We could potentially design them not only to report conditions in their environment but also to modify and repair conditions in their environment.

The biological materials we are using have many features we would like to someday implement in the botscells can act like sensors, motors for movement, communication and computation networks, and recording devices to store information, says Levin. One thing the Xenobots and future versions of biological bots can do that their metal and plastic counterparts have difficulty doing is constructing their own body plan as the cells grow and mature, and then repairing and restoring themselves if they become damaged. Healing is a natural feature of living organisms, and it is preserved in Xenobot biology.

Cells in a biological robot can also absorb and break down chemicals and work like tiny factories, synthesizing and excreting chemicals and proteins.

Xenobots were designed to exhibit swarm activity, moving about on cilia legs. [Doug Blackiston, Tufts University]

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AgeX Therapeutics Reports Fourth Quarter and Annual 2020 Financial Results and Provides Business Update – Business Wire

By daniellenierenberg

ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics, Inc. (AgeX; NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported its financial and operating results for the fourth quarter and the full year ended December 31, 2020.

Recent Highlights

Liquidity and Capital Resources

Amendment to 2019 Loan Agreement

On February 10, 2021, AgeX entered into an amendment to its 2019 Loan Facility Agreement with Juvenescence Limited (Juvenescence). The Amendment extends the maturity date of loans under the agreement to February 14, 2022 and increases the amount of the loan facility by $4.0 million. All loans in excess of the initial $2.0 million that AgeX previously borrowed are subject to Juvenescences discretion.

At-the-market Offering Facility

During January 2021 AgeX entered into a sales agreement with Chardan Capital Markets LLC (Chardan) for the sale of shares of AgeX common stock in at-the-market (ATM) transactions. In accordance with the terms of the sales agreement, AgeX may offer and sell shares of common stock having an aggregate offering price of up to $12.6 million through Chardan acting as the sales agent. Through March 26, 2021, AgeX raised approximately $496,000 in gross proceeds through the sale of shares of common stock.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, AgeX believes that its cash and cash equivalents and available sources of debt and equity capital would not be sufficient to satisfy AgeXs anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Annual Report on Form 10-K for the year ended December 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

Balance Sheet Information

Cash, and cash equivalents, and restricted cash totaled $0.6 million as of December 31, 2020, as compared with $2.5 million as of December 31, 2019. Since January 1, 2021, AgeX had cash proceeds of approximately $3.2 million through loans from Juvenescence, sales of shares of AgeX common stock, and the disposition of its subsidiary LifeMap Sciences, Inc. (LifeMap Sciences) through a cash-out merger.

Fourth Quarter and Annual 2020 Operating Results

Revenues: Total Revenues for the fourth quarter of 2020 were $0.5 million. Total revenues for the year ended December 31, 2020 were $1.9 million, as compared with $1.7 million in the same period in 2019. AgeX revenue was primarily generated by its subsidiary LifeMap Sciences, Inc. which AgeX disposed of on March 15, 2021 through a cash-out merger. Revenues for the year ended December 31, 2020 also included approximately $0.3 million of allowable expenses under a research grant from the NIH as compared with $0.2 million in the same period in 2019.

Operating expenses: Operating expenses for the three months ended December 31, 2020, were $2.9 million, as reported, which was comprised of $2.5 million for AgeX and $0.4 million for LifeMap Sciences, and were $2.3 million, as adjusted, comprised of $2.0 million for AgeX and $0.3 million for LifeMap Sciences.

Operating expenses for the full year 2020 were $12.4 million, as reported, which was comprised of $10.4 million for AgeX and $2.0 million for LifeMap Sciences, and were $10.2 million, as adjusted, comprised of $8.7 million for AgeX and $1.5 million for LifeMap Sciences.

Research and development expenses for the year ended December 31, 2020 decreased by $0.9 million to $5.0 million from $5.9 million in 2019. The decrease was primarily attributable to the layoff of research and development personnel in May 2020.

General and administrative expenses for the year ended December 31, 2020 decreased by $0.7 million to $7.4 million from $8.1 million in 2019. Increases in personnel costs related to an increase in administrative staffing were offset to some extent by a decrease in noncash stock-based compensation expense, general office expense and supplies and travel related expenses with the shelter in place mandates since March 15, 2020 resulting from the COVID-19 pandemic, and the elimination of shared facilities and services fees from AgeXs former parent Lineage Cell Therapeutics, Inc. following the termination of a Shared Facilities and Services Agreement on September 30, 2019.

The reconciliation between operating expenses determined in accordance with accounting principles generally accepted in the United States (GAAP) and operating expenses, as adjusted, a non-GAAP measure, is provided in the financial tables included at the end of this press release.

Other expense, net: Net other expense for the year ended December 31, 2020 was $0.5 million, as compared with net other income of $0.3 million in the same period in 2019. The change is primarily attributable to increased amortization of deferred debt costs to interest expense following the consummation of loan agreements.

Net loss attributable to AgeX: The net loss attributable to AgeX for the year ended December 31, 2020 was $10.9 million, or ($0.29) per share (basic and diluted) compared to $12.2 million, or ($0.33) per share (basic and diluted), for the same period in 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeXs PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. HyStem is AgeXs delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

(In thousands, except par value amounts)

December 31,

2020

2019

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

527

$

2,352

Accounts and grants receivable, net

326

363

Prepaid expenses and other current assets

1,430

1,339

Total current assets

2,283

4,054

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Insulin 100: How the road to a diabetes cure is yielding better treatments – News@UofT

By daniellenierenberg

The pancreas, saysGary Lewis, an endocrinologist at Toronto General Hospital and director of the Banting & Best Diabetes Centre at the University of Torontos Temerty Faculty of Medicine, is like an exquisitely sensitive and perfectly networked computer.

Second by second,he notes,the pancreassecretesjust the right amount ofinsulinor glucagontolower or raiseblood sugarintotheportal veinthat leadsdirectlyto the liver, the site of key metabolic processes. Insulingis then distributedto every tissue in the body via general circulation.

Thats one reason a cure for diabetes has proven elusive 100 years after the discovery of insulin.

Another big reason is the complexity of how the disease arises. In type 1 diabetes, the immune system destroys the insulin-producing beta cells of the pancreas, creating a life-threatening spike in blood sugar. Type 2 diabetes usually comes on more slowly, as the body becomes resistant to insulin or the pancreas cant produce enough of it.

Genetics play a role in both types. Exposure to viruses and other environmental effects may be a factor in type 1. Lifestyle factors, including weight gain and physical inactivity, are strongly linked to type 2.

The bottom line, says Lewis, is that diabetes is a multifactoral disease, and were not close to a cure.

Ask about treatments, though, and Lewis gets excited.

The last two decades have brought a plethora of clinical and research advances, from new drugs to boost and sensitize the body to insulin and promote weight loss, to lifestyle interventions that improve diet, continuous monitoring of blood sugar, long- and short-lasting insulin, better insulin pumps, pancreatic transplantsand pre-clinical stem cell and immunosuppressive therapies.

Progress on treatments has been fantastic, especially for type 2, Lewis says. Im very, very hopeful.

The distinction between treatment and cure in medicine is often unclear. And for the 3.6 million Canadians living with diabetes, the distinction matters less and lessif the goal is a full and healthy life.

Type 2 diabetes accounts for about 90 per cent of diabetes cases in Canada. Prevalence is rising, but Canadians with type 2 diabetes are living longer and have fewer diabetes-related complications.

The clinic doesnt look like it did 30 years ago, says Lewis, who mainly treats patients with type 2. We see fewer amputees, less blindness. Patients are generally healthier, and their prognosis is often excellent if they maintain their blood sugar target and other key parameters.

Weight loss is a cornerstone of treatments to lower blood sugar, and recent research has strengthened the link between weight reduction and type 2 diabetes management. Some people with type 2 can lose weight and control blood sugar through dietary changes and exercise alone.

Bariatric surgery is very effective for weight loss and often results in diabetes remission, although it comes with surgical risks and is expensive.

If we could prevent obesity, we could greatly reduce the incidence of type 2, Lewis says. And experiments have shown wecan get a remission withlifestyle changes, so we know what works.

The problem is broad implementation.

Ive tried to lose weight and I know how difficult it can be, especially in an environment of convenient and inexpensive calories, Lewis says. Moreover, factors such as income, education, ethnicity, access to healthy food and living conditions can make lifestyle changes that curb obesity nearly impossible.

Social determinants of health are overwhelmingly the most important influence on who gets type 2 diabetes, and how well or poorly they do with it, Lewis says.

Fortunately, dozens of new drugs for diabetes have hit the market in the last two decades.

Medications for weight loss round out the armamentarium, and some also protect against kidney damage and lower cardiac risk. Current therapies can reduce body weight up to 10 per cent, although a loss of 20 per cent or more would have a greater effect on outcomes for patients with type 2 diabetes, saysJacqueline Beaudry, an assistant professor of nutritional sciences at U of T who studies links between obesity, hormones and diet.

Beaudry is probing the biology that underpins these medications, including the gut hormones GLP-1 and GIP. They control blood glucose and reduce appetite, but scientists are unsure how.

If we could understand their mechanisms of action, we could design better drugs, Beaudry says.

For people with type 1 diabetes, continuous glucose monitors, insulin pumps and even automated closed-loopsystems that run on mobile apps to deliver insulin as-needed have radically changed the patient experience.

Sara Vasconcelos left),an assistant professor at U of Ts Institute of Biomedical Engineering, has worked withCristina Nostro (right), an associate professor in the department of physiology,and her team in the McEwen Stem Cell Institute at UHNto extend the survival and functionality of pancreatic precursor cells generatedfrom human stem cells.

Cell therapy could prove more liberating still.

University labs and biotechs are working on implantable devices that house insulin-producing cells derived from stem cells.

To that end,Cristina Nostro, an associate professor in the department of physiology in the Temerty Faculty of Medicine,and her team in the McEwen Stem Cell Institute at University Health Network recently discovered a more efficient way to generate and purify pancreatic precursor cells from human stem cells in the lab.

They have also found a way to vascularize those cells by working withSara Vasconcelos, an assistant professor at U of Ts Institute of Biomedical Engineering. Together, they have extended the survival and functionality of the cells in animal models of diabetes.

The biggest problem with these therapies is that the immune system rejects them. The same challenge currently hinders pancreas and islet transplants.

The immune system is an amazing machine, were luckyits so good, says Nostro. But its very difficult to control when it goes awry, as in autoimmune conditions.

Nostro is working with immunologists at the university on a method to protect insulin-producing beta cells from immune rejection, and she says many researchers in the field are now focused on immune-protective approaches.

Another strategy for type 1 diabetes is to tamp down the autoimmune response before the disease progresses. The idea is to prevent immune cells that damage the pancreas while the body still produces beta cells.

Groups around the world are bringing different ideas and creative approaches to treat type 1 diabetes, thats the beauty of science, says Nostro. I am very hopeful about what the future holds. Who knows? Maybe we will see hybrid technologies combining a pump and cells. We have to keep an open mind.

This story was originally published in U of T Med Magazines Insulin Issue.

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Pericardial Injection Effective, Less Invasive Way to Get Regenerative Therapies to Heart – Newswise

By daniellenierenberg

Newswise Injecting hydrogels containing stem cell or exosome therapeutics directly into the pericardial cavity could be a less invasive, less costly, and more effective means of treating cardiac injury, according to new research from North Carolina State University and the University of North Carolina at Chapel Hill.

Stem cell therapy holds promise as a way to treat cardiac injury, but delivering the therapy directly to the site of the injury and keeping it in place long enough to be effective are ongoing challenges. Even cardiac patches, which can be positioned directly over the site of the injury, have drawbacks in that they require invasive surgical methods for placement.

We wanted a less invasive way to get therapeutics to the injury site, says Ke Cheng, Randall B. Terry, Jr. Distinguished Professor in Regenerative Medicine at NCStates Department of Molecular Biomedical Sciences and professor in the NCState/UNC-Chapel Hill Joint Department of Biomedical Engineering. Using the pericardial cavity as a natural mold could allow us to create cardiac patches at the site of injury from hydrogels containing therapeutics.

In a proof-of-concept study, Cheng and colleagues from NCState and UNC-Chapel Hill looked at two different types of hydrogels one naturally derived and one synthetic and two different stem cell-derived therapeutics in mouse and rat models of heart attack. The therapeutics were delivered via intrapericardial (iPC) injection.

Via fluorescent imaging the researchers were able to see that the hydrogel spread out to form a cardiac patch in the pericardial cavity. They also confirmed that the stem cell or exosome therapeutics can be released into the myocardium, leading to reduced cell death and improved cardiac function compared to animals in the group who received only the hydrogel without therapeutics.

The team then turned to a pig model to test the procedures safety and feasibility. They delivered the iPC injections using a minimally invasive procedure that required only two small incisions, then monitored the pigs for adverse effects. They found no breathing complications, pericardial inflammation, or changes in blood chemistry up to three days post-procedure.

Our hope is that this method of drug delivery to the heart will result in less invasive, less costly procedures with higher therapeutic efficacy, Cheng says. Our early results are promising the method is safe and generates a higher retention rate of therapeutics than those currently in use. Next we will perform additional preclinical studies in large animals to further test the safety and efficacy of this therapy, before we can start a clinical trial.

I anticipate in a clinical setting in the future, iPC injection could be performed with pericardial access similar to the LARIAT procedure. In that regard, only one small incision under local anesthesia is needed on the patients chest wall, says Dr. Joe Rossi, associate professor in the division of cardiology at UNC-Chapel Hill and co-author of the paper.

The research appears inNature Communicationsand was supported by the National Institutes of Health and the American Heart Association. Dr. Thomas Caranasos, director of adult cardiac surgery at UNC-Chapel Hill, also contributed to the work.

-peake-

Note to editors: An abstract follows.

Minimally invasive delivery of therapeutic agents by hydrogel injection into the pericardial cavity for cardiac repair

DOI:10.1038/s41467-021-21682-7

Authors: Dashuai Zhu, Zhenhua Li, Ke Cheng, North Carolina State University; Thomas Caranasos, Joseph Rossi, University of North Carolina at Chapel HillPublished:March 3, 2021 inNature Communications

Abstract:Cardiac patch is an effective way to deliver therapeutics to the heart. However, such procedures are normally invasive and difficult to perform. Here, we developed and tested a method to utilize the pericardial cavity as a natural mold for in situ cardiac patch formation after intrapericardial (iPC) injection of therapeutics in biocompatible hydrogels. In rodent models of myocardial infarction (MI), we demonstrated that iPC injection is an effective and safe method to deliver hydrogels containing induced pluripotent stem cells-derived cardiac progenitor cells (iPS-CPCs) or mesenchymal stem cells (MSCs)-derived exosomes. After injection, the hydrogels formed cardiac patch-like structure in the pericardial cavity, mitigating immune response and increasing the cardiac retention of the therapeutics. With robust cardiovascular regeneration and stimulation of epicardium-derived repair, the therapies mitigated cardiac remodeling and improved cardiac functions post MI. Furthermore, we demonstrated the feasibility of minimally-invasive iPC injection in a clinically-relevant porcine model as well as in human patients. Collectively, our study establishes iPC injection as a safe and effective method to deliver therapeutics to the heart for cardiac repair.

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COVID-19 kills heart muscle cells, interferes with a patients heartbeat – Study Finds

By daniellenierenberg

ST. LOUIS, Mo. Researchers in St. Louis are providing some much needed clarity about how COVID-19 impacts the human heart. COVID has been linked to cardiovascular complications for some time, but up until now its been a mystery as to how exactly the virus is interfering with the heart. For example, does the virus actually infect the heart itself? Or does it just cause inflammation which effects the cardiovascular system? Now, a team from Washington Universitys School of Medicine says theres evidence COVID-19 infects and replicates within carriers heart muscles cells.

This is of course bad news for the heart, which experiences cell death and muscle contraction issues as a result. In pursuit of an answer, the team used stem cells to create heart tissue modeling a COVID-19 infection.

Early on in the pandemic, we had evidence that this coronavirus can cause heart failure or cardiac injury in generally healthy people, which was alarming to the cardiology community, says senior author Kory J. Lavine, MD, PhD, in a university release.

Even some college athletes who had been cleared to go back to competitive athletics after COVID-19 infection later showed scarring in the heart. There has been debate over whether this is due to direct infection of the heart or due to a systemic inflammatory response that occurs because of the lung infection, the associate professor of medicine continues. Our study is unique because it definitively shows that, in patients with COVID-19 who developed heart failure, the virus infects the heart, specifically heart muscle cells.

Researchers also used stem cells to create tissues simulating heart muscle contractions. This process helped researchers to conclude that besides just killing heart muscle cells, COVID interferes with the organs contractions.

Notably, study authors add all of this heart damage can happen to an infected individual even if they show no signs of bodily inflammation.

Inflammation can be a second hit on top of damage caused by the virus, but the inflammation itself is not the initial cause of the heart injury, Lavine explains.

While this certainly isnt the first virus to impact the heart, the research team reports nothing is status quo when it comes to COVID-19. They explain that COVID-19 evokes a unique immune response dissimilar to anything seen when other viruses make contact with the heart.

COVID-19 is causing a different immune response in the heart compared with other viruses, and we dont know what that means yet, the researcher reports. In general, the immune cells seen responding to other viruses tend to be associated with a relatively short disease that resolves with supportive care. But the immune cells we see in COVID-19 heart patients tend to be associated with a chronic condition that can have long-term consequences. These are associations, so we will need more research to understand what is happening.

Researchers further confirmed their stem cell findings when they examined the real heart tissues from four COVID-19 patients.

Even young people who had very mild symptoms can develop heart problems later on that limit their exercise capacity, Lavine concludes. We want to understand whats happening so we can prevent it or treat it. In the meantime, we want everyone to take this virus seriously and do their best to take precautions and stop the spread, so we dont have an even larger epidemic of preventable heart disease in the future.

The study is published in JACC: Basic to Translational Science.

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Network pharmacology and RNA-sequencing reveal the molecular mechanism of Xuebijing injection on COVID-19-induced cardiac dysfunction – DocWire News

By daniellenierenberg

This article was originally published here

Comput Biol Med. 2021 Feb 22;131:104293. doi: 10.1016/j.compbiomed.2021.104293. Online ahead of print.

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is an emerging infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Up to 20%-30% of patients hospitalized with COVID-19 have evidence of cardiac dysfunction. Xuebijing injection is a compound injection containing five traditional Chinese medicine ingredients, which can protect cells from SARS-CoV-2-induced cell death and improve cardiac function. However, the specific protective mechanism of Xuebijing injection on COVID-19-induced cardiac dysfunction remains unclear.

METHODS: The therapeutic effect of Xuebijing injection on COVID-19 was validated by the TCM Anti COVID-19 (TCMATCOV) platform. RNA-sequencing (RNA-seq) data from GSE150392 was used to find differentially expressed genes (DEGs) from human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) infected with SARS-CoV-2. Data from GSE151879 was used to verify the expression of Angiotensin I Converting Enzyme 2 (ACE2) and central hub genes in both human embryonic-stem-cell-derived cardiomyocytes (hESC-CMs) and adult human CMs with SARS-CoV-2 infection.

RESULTS: A total of 97 proteins were identified as the therapeutic targets of Xuebijing injection for COVID-19. There were 22 DEGs in SARS-CoV-2 infected hiPSC-CMs overlapped with the 97 therapeutic targets, which might be the therapeutic targets of Xuebijing injection on COVID-19-induced cardiac dysfunction. Based on the bioinformatics analysis, 7 genes (CCL2, CXCL8, FOS, IFNB1, IL-1A, IL-1B, SERPINE1) were identified as central hub genes and enriched in pathways including cytokines, inflammation, cell senescence and oxidative stress. ACE2, the receptor of SARS-CoV-2, and the 7 central hub genes were differentially expressed in at least two kinds of SARS-CoV-2 infected CMs. Besides, FOS and quercetin exhibited the tightest binding by molecular docking analysis.

CONCLUSION: Our study indicated the underlying protective effect of Xuebijing injection on COVID-19, especially on COVID19-induced cardiac dysfunction, which provided the theoretical basis for exploring the potential protective mechanism of Xuebijing injection on COVID19-induced cardiac dysfunction.

PMID:33662681 | DOI:10.1016/j.compbiomed.2021.104293

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Biomarkers Help Predict the Role of Chemotherapy in Biologic Aging – OncLive

By daniellenierenberg

Biologic aging is a complex process. There are several theories on why and how we age, and it is probable that none of them account for all the aspects. We are constantly exposed to both internal and external stimuli that, over time, facilitate the aging process. These stimuli include ionizing radiation, ultraviolet light, diet, exercise, oxidative stresses, and perhaps, worst of all, smoking. All of these can trigger intracellular processes, including DNA methylation, or epigenetic change, telomere shortening and damage, DNA damage, and mitochondrial dysfunction. These factors accelerate cellular senescencewhat is thought to be the critical factor in aging and has been shown to increase with age.1,2

Cellular senescence is a condition in which a cell has lost the ability to proliferate, and senescent cells increase in almost all organs and tissues as we age. Over time, these changes ultimately lead to the development of significant comorbidities and the cumulative functional deficits we acquire during aging. However, senescent cells are metabolically active and can produce cytokines and inflammatory proteinsthe senescence-associated secretory phenotypefurther accelerating aging and promoting malignancy. FIGURE 1 illustrates the effect of age and insults on senescence.

Accumulation of senescent cells is implicated as a cause of tissue reprogramming, osteoporosis, glaucoma, neurodegeneration, type 2 diabetes, changes in the microbiome, immune system dysfunction, dysfunctional tissue repair and fibrosis, and cancer.3 Recent data have shown the potential role of chemotherapy and radiation therapy in accelerating aging. Nowhere is chemotherapys effect in accelerating aging more apparent than in children and adolescents treated successfully for childhood malignancy.4 In these patients, by the time they reach aged 35 years, approximately 30% have the clinical phenotype of a person aged 65 years, as evidenced by dramatic increases in cardiac disease and new second malignancies.

At the University of North Carolina Lineberger Comprehensive Cancer Center, we have focused on the effects of chemotherapy and accelerated aging in cancer. To date, we have studied the effects of chemotherapy on childhood cancer, early breast cancer, and bone marrow transplantation. Our research has explored the role of p16INK4a expression, a robust marker of biologic aging, following on the work of Norman E. Ned Sharpless, MD, director of the National Cancer Institute. p16INK4a encodes for a protein that blocks cyclin-dependent kinase, analogous to the cyclin-dependent kinase inhibitors now used in breast cancer, including palbociclib (Ibrance), ribociclib (Kisqali), and abemaciclib (Verzenio), that prevent cells from entering the cell cycle.5 This leads to cellular senescence. In murine models, aging is associated with dramatic changes in p16INK4a expression in almost all organs over the animals lifespan.6 In human studies, p16INK4a expression is measured in T lymphocytes using a reverse transcription-polymerase chain reaction as a surrogate for aging in other tissues. Studies of p16INK4a expression using other immunohistochemistry methods suggest changes in T cells represent mirror changes in other tissue, and further research in this area is underway.

The change in p16INK4a with aging is not linear, and after 60 years, it appears to plateau for unclear reasons.7 It is possible that those older persons who would have had high levels of p16INK4a expression have already died of age-related illness such as cardiovascular disease, and current studies are addressing this issue.

The large dynamic range of p16INK4a expressionapproximately 10-fold over the human lifespanmakes it an ideal biomarker for study. In healthy children and adolescents, p16INK4a expression is low to undetectable, with high levels appearing in older persons. FIGURE 2 shows the effect of age on p16INK4a expression in 594 patients. These data give p16INK4a expression the potential to be an accurate predictor of cell senescence in an individual patient.

For example, if one hypothesizes that senescent cells are less likely to replicate to ameliorate the adverse effects of chemotherapy (ie, myelosuppression or mucositis), then investigators might be able to accurately predict between 2 patients of the same ageone with high p16INK4a expression and one with lowthat the patient with higher expression would have less cellular reserve and be more vulnerable to adverse effects. Studies are underway to determine if p16INK4a expression measured before treatment will prove to be a predictive marker of toxicity for currently used adjuvant chemotherapy regimens.

Investigators have examined several hundred patients with early breast cancer and a smaller number with childhood cancer and after bone marrow transplantation, and they have found that most chemotherapy regimens cause rapid and sustained increases in p16INK4a expression. Changes are seen shortly and dramatically after beginning chemotherapy, persist over time, and are irreversible.5,8,9 In adolescents and young adults treated with chemotherapy, significant increases in p16INK4a expression were associated with frailty and represented a 35-year acceleration in age among frail young adult cancer survivors. These data mimic what has been clinically noted in large study of adults who had childhood cancer: Approximately one-third of young adults and childhood cancer survivors aged 35 years have a disease phenotype of a person aged 65 years.4 Our group has also found that p16INK4a expression rose markedly in patients treated with allogeneic or autologous stem cell transplants for hematologic malignancies. These patients had a 2- to 3-fold increase in p16INK4a expression corresponding to 16 to 28 years of accelerated aging.10

We have noted similar findings in women with early-stage breast cancer. In patients treated with adjuvant or neoadjuvant chemotherapy, especially with anthracycline-based regimens (doxorubicin, cyclophosphamide, and taxanes with or without carboplatin), p16INK4a expression rose dramatically during chemotherapy and persisted during follow-up. On average, chemotherapy accelerated aging by approximately 17 years of life span, with acceleration of 23 to 27 years for those treated with anthracycline-based treatment.

Of note, docetaxel/cyclophosphamide regimens were associated with only 11 years of aging, and we found no evidence that anti-HER2 therapy affected p16INK4a expression. In these studies, accelerated aging due to chemotherapy represents estimates based on the trajectory of p16INK4a expression in normal patients over their lifespan. We are uncertain of the long-term implications of these changes. In our breast cancer studies, baseline p16INK4a expression was also associated with fatigue. In a recent unpublished analysis (Mitin N, et al), the difference between a patients baseline p16INK4a expression and a normal value for a patient of the same agethe p16 gapwas highly predictive of chemotherapy-induced peripheral neuropathy with taxane chemotherapy. We also found that baseline p16INK4a expression is a significant predictor of a p16 change, independent of age or chemotherapy type, with those patients having lower baseline p16INK4a expression being more likely to have greater changes with any chemotherapy regimen. The reasons for this are unclear, but patients of similar age with higher p16INK4a less ability to overcome tissue and organ damage. Not all chemotherapeutic agentsfor example, taxanes used as a single agentmay be associated with accelerated aging.11 More detailed studies of patients treated with different agents, including immunotherapeutic and other biologic therapies, and for different types of cancer are needed.

The long-term implications of changes in p16INK4a expression with chemotherapy are unknown, but our data suggest that higher levels may be indicators of frailty, a syndrome associate with increased comorbidity, poor quality of life, and shortened survival. p16INK4a expression has been associated with other diseases of aging, including cardiovascular disease, osteoporosis, and other common illnesses, and our chemotherapy-treated patients with accelerated aging may experience major problems 10 to 20 years after treatment, similar to young adults with cancer, and at a time when they are not likely to be followed by their oncologists.

However, these concerns should not mitigate the use of what has proven to be markedly effective treatment regimens that have dramatically improved overall survival in childhood cancer and breast cancer. It is too early to speculate, especially in breast cancer, whether nonanthracycline regimens with similar effectiveness to anthracyclines may be worth considering for patients with long life expectancy. The use of biomarkers in aging research, geroscience, is an exciting area of exploration, and p16INK4a expression is just one of the markers currently being studied.12 The implications of accelerated aging are being studied in other scenarios, and a broad range of studies are exploring interventions to ameliorate biological changes suggesting accelerated aging.

An excellent review of these issues and potential interventions is available13 and describes studies of exercise, diet and nutrition strategies, and senolytics. Learning about the effects of cancer treatment on aging is of major importance, as the clinical scenario of cancer is dominated by older adults who already may have a substantial comorbid illness at the time of diagnosis that might be accelerated by treatment. In children and young adults with cancer, learning how to assess and, in the future, intervene to prevent treatment-related accelerated aging is also a major need.

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Progenitor Cell Product Market 2021 Competitive Insights And Global Outlook ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, …

By daniellenierenberg

The reportbegins with an overviewofProgenitor Cell Product andpresents throughout its development.It provides a comprehensive analysis of all regional and key player segments providing closer insights into current market conditions and future market opportunities, along with drivers, trend segments, consumer behavior, price factors and market performance and estimates.Forecast market information, SWOT analysis, Progenitor Cell Product market scenario, and feasibility study are the important aspects analyzed in this report.

The Progenitor Cell Product was valued at 12500 Billion US$ in 2021 and is projected to reach 17700 Billion US$ by 2025, at a CAGR of 5.1% during the forecast period.

Top Companies in the Global Progenitor Cell Product Market:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific

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This report segments the global Progenitor Cell Product Market based onTypesare:Pancreatic progenitor cells

Cardiac Progenitor Cells

Intermediate progenitor cells

Neural progenitor cells (NPCs)

Endothelial progenitor cells (EPC)

Others

Based on Application, the Global Progenitor Cell Product Market is Segmented into:Medical care

Hospital

Laboratory

For the comprehensive understanding of market dynamics, the global Progenitor Cell Product Market is analysed across key geographies namely: United States, China, Europe, Japan, South-east Asia, India and others. Each of these regions is analysed on the basis of market findings across major countries in these regions for a macro-level understanding of the market.

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Impact of the Progenitor Cell Product market report:

A comprehensive evaluation of all opportunities and risks in the market. Progenitor Cell Product market ongoing the developments and significant occasions. A Detailed study of business techniques for the development of the market-driving players. Conclusive study about the improvement plot of Progenitor Cell Product market for approaching years. Top to a bottom appreciation of market-express drivers, targets and major littler scale markets. Favorable impression inside imperative mechanical and publicize latest examples striking the market.

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What are the Progenitor Cell Product market factors that are explained in the report?

-Key Strategic Developments:The study also includes the key strategic developments of the Progenitor Cell Product market, comprising R&D, new product launch, M&A, agreements, collaborations, partnerships, joint ventures, and regional growth of the leading competitors operating in the market on a global and regional scale.-Key Market Features:The report evaluated key market features, including revenue, price, capacity, capacity utilization rate, gross, production, production rate, consumption, import/export, supply/demand, cost, market share, CAGR, and gross margin. In addition, the study offers a comprehensive study of the key market dynamics and their latest trends, along with pertinent market segments and sub-segments.Analytical Tools:The Global Progenitor Cell Product Market report includes the accurately studied and assessed data of the key industry players and their scope in the market by means of a number of analytical tools. The analytical tools such as Porters five forces analysis, SWOT analysis, feasibility study, and investment return analysis have been used to analyze the growth of the key players operating in the market.

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Stem Cells Market to Inspire a Growth up to US$ 18289.9 Million at a 9.1% CAGR by 2027 – PharmiWeb.com

By daniellenierenberg

Stem cells are undifferentiated cells which are capable of differentiating into any type of cell that make-up the human body and thus, are capable of producing non-regenerative cells such as neural and myocardial cells.

Statistics:

The global stem cells market is estimated to account forUS$ 9,941.2 Mnin terms of value in2020and is expected to reachUS$ 18,289.9 Mnby the end of2027.

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GlobalStem CellsMarket: Drivers

Approval and launch of new products is expected to propel growth of the global stem cells market over the forecast period. For instance, in December 2019, BioRestorative Therapies, Inc. received a Notice of Allowance on its patent application for a method of generating brown fat stem cells from Israeli Patent Office.

Moreover, increasing number of stem cell banking resource centers is also expected to aid in growth of the market. For instance, in March 2020, Stemlife Berhad, a cord blood bank in Malaysia, started a Stem Cell Banking Resource Center in Jerudong Park Medical Center, Brunei.

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Statistics:

Adult stem cells held dominant position in the global stem cells market in 2019, accounting for81.2%share in terms of value, followed by Human Embryonic Stem Cells and Induced Pluripotent Stem Cells, respectively

Figure 1. GlobalStem CellsMarket Share (%), by Value, by Cell Type, 2019.

GlobalStem CellsMarket: Restraints

High cost of stem cell therapy is expected to hinder growth of the global stem cells market. For instance, Bioinformant a research firm engaged in stem cell research, reported that the cost of stem cell therapy ranges between US$ 5,000-8,000 per patient and in some cases it may rise as much as US$ 25,000 or more depending on the complexity of the procedure.

Moreover, restrictions on research activities related to stem cells had hampered the growth of embryonic stem cells historically and resulted in its meager share in the total market in spite of its advantages over adult stem cells.

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GlobalStem CellsMarket: Opportunities

R&D in stem cell donation is expected to offer lucrative growth opportunities for players in the global stem cells market. For instance, in March 2020, researchers from Dankook University and Catholic University, South Korea, reported investigation of the types and degrees of physical and psychological discomfort experienced by hematopoietic stem cell donors before, during, and after the donation process.

Moreover, adoption of online distribution channel is also expected to aid in growth of the global stem cells market. For instance, The US Direct-to-Consumer Marketplace for Autologous Stem Cell Interventions, published in the journal Perspectives in Biology and Medicine, in 2018, the number of new stem cell businesses with websites doubled on average every year between 2009 and 2014, in the U.S.

The global stem cells market was valued atUS$ 9,112.0 Mnin2019and is forecast to reach a value ofUS$ 18,289.9 Mnby2027at aCAGR of 9.1%between2020 and 2027.

Figure 2. GlobalStem CellsMarket Value (US$ Mn), and Y-o-Y Growth (%), 2019-2027

Market Trends/Key Takeaways

Adoption of stem cells for the treatment of various diseases is expected to propel growth of the global stem cells market. For instance, in January 2020, researchers at University of Houston developed biologic cardiac pacemaker-like cells by taking fat stem cells and reprogramming them as an alternative treatment for heart conditions such as conduction system disorders and heart attacks.

Moreover, increasing investment in stem cell therapies is also expected to aid in growth of the market. For instance, in July 2018, the Emory Orthopaedics & Spine Center, in collaboration with Sanford Health, Duke University, Andrews Institute, and Georgia Institute of Technology, received US$ 13 million grant from the Marcus Foundation for a multicenter clinical trial studying stem cell options for treating osteoarthritis. The Phase 3 trial was initiated in March 2019, and is expected to complete by December 2021.

GlobalStem CellsMarket: Competitive Landscape

Major players operating in the global stem cells market include Advanced Cell Technology, Inc., Angel Biotechnology Holdings PLC, Bioheart Inc., Lineage Cell Therapeutics., BrainStorm Cell Therapeutics, Inc., California Stem Cell Inc., Celgene Corporation, Takara Bio Europe AB, Cellular Engineering Technologies, Cytori Therapeutics Inc., Osiris Therapeutics, and STEMCELL Technologies Inc.

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GlobalStem CellsMarket: Key Developments

Major players in the market are focused on adopting collaboration and partnership strategies to expand their product portfolio. For instance, in September 2018, STEMCELL Technologies signed an exclusive license agreement with Brigham and Womens Hospital for rights to commercialize technologies for the generation of human pluripotent stem cell-derived kidney organoids.

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The Untapped Potential of Cell and Gene Therapy – AJMC.com Managed Markets Network

By daniellenierenberg

We can absolutely cut the number of cancer deaths down so that one day in our lifetimes it can be a rare thing for people to die of cancer, said Patrick Hwu, MD, president and CEO of Moffitt Cancer Center in Florida and among gene therapys pioneers. It still may happen here and there, but itll be kind of like people dying of pneumonia. Its like, He died of pneumonia? Thats kind of weird. I think cancer can be the same way.

The excitement returned in spades in 2017 when the FDA signed off on a gene-therapy drug for the first time, approving the chimeric antigen receptor (CAR) T-cell treatment tisagenlecleucel (Kymriah; Novartis) for the treatment of B-cell precursor acute lymphoblastic leukemia. At last, scientists had devised a way to reprogram a persons own T cells to attack tumor cells.

Were entering a new frontier, said Scott Gottlieb, MD, then the FDA Commissioner, in announcing the groundbreaking approval.

Gottlieb wasnt exaggerating. The growth in CAR T-cell treatments is exploding. Although only a handful of cell and gene therapies are on the market, FDA officials predicted in 2019 that the agency will receive more than 200 investigational new drug applications per year for cell and gene therapies, and that by 2025, it expects to have accelerated to 10 to 20 cell and gene therapy approvals per year.1

Essentially, you can kill any cancer cell that has an antigen that is recognized by the immune cell, Hwu said. The key to curing every single cancer, which is our goal, is to have receptors that can recognize the tumor but dont recognize the normal cells. Receptors recognizing and then attacking normal cells is what can cause toxicity.

Cell therapy involves cultivating or modifying immune cells outside the body before injecting them into the patient. Cells may be autologous (self-provided) or allogeneic (donor-provided); they include hematopoietic stem cells and adult and embryonic stem cells. Gene therapy modifies or manipulates cell expression. There is considerable overlap between the 2 disciplines.

Juliette Hordeaux, PhD, senior director of translational research for the University of Pennsylvanias gene therapy program, is cautious about the FDAs predictions, saying shed be thrilled with 5 cell and/or gene therapy approvals annually.

For monogenic diseases, there are only a certain number of mutations, and then well plateau until we reach a stage where we can go after more common diseases, Hordeaux said.

Safety has been the main brake around adeno-associated virus vector (AAV) gene therapy, added Hordeaux, whose hospitals program has the institutional memory of both Jesse Gelsingers tragic death during a 1999 gene therapy trial as well as breakthroughs by Carl June, MD, and others in CAR T-cell therapy.

Sometimes there are unexpected toxicity [events] in trials.I think figuring out ways to make gene therapy safer is going to be the next goal for the field before we can even envision many more drugs approved.

In total, 3 CAR T-cell therapies are now on the market, all targeting the CD19 antigen. Tisagenlecleucel was the first. Gilead Sciences received approval in October 2017 for axicabtagene ciloleucel (axi-cel; Yescarta), a CAR T-cell therapy for adults with large B-cell non-Hodgkin lymphoma. Kite Pharma, a subsidiary of Gilead, received an accelerated approval in July 2020 for brexucabtagene autoleucel (Tecartus) for adults with relapsed or refractory mantle cell lymphoma.

On February 5, 2021, the FDA approved another CD19-directed therapy for relapsed/refractory large B-cell lymphoma, lisocabtagene maraleucel (liso-cel; JCAR017; Bristol Myers Squibb). The original approval date was missed due to a delay in inspecting a manufacturing facility (see related article).

Idecabtagene vicleucel (ide-cel; bb2121; Bristol Myers Squibb) is under priority FDA review, with a decision expected by March 31, 2021. The biologics license application seeks approval for ide-cel, a B-cell maturation antigendirected CAR therapy, to treat adult patients with multiple myeloma who have received at least 3 prior therapies.2

The number of clinical trials evaluating CAR T-cell therapies has risen sharply since 2015, when investigators counted a total of 78 studies registered on the ClinicalTrials.gov website. In June 2020, the site listed 671 trials, including 357 registered in China, 256 in the United States, and 58 in other countries.3

Natural killer (NK) cells are the research focus of Dean Lee, MD, PhD, a physician in the Division of Hematology and Oncology at Nationwide Childrens Hospital. He developed a method for consistent, robust expansion of highly active clinical-grade NK cells that enables repeated delivery of large cell doses for improved efficacy. This finding led to several first-in-human clinical trials evaluating adoptive immunotherapy with expanded NK cells under an FDA Investigational New Drug application. He is developing both genetic and nongenetic methods to improve tumor targeting and tissue homing of NK cells. His eff orts are geared toward pediatric sarcomas.

The biggest emphasis over the past 20 to 25 years has been cell therapy for cancer, talking about trying to transfer a specific part of the immune system for cells, said Lee, who is also director of the Cellular Therapy and Cancer Immunology Program at Nationwide Childrens Hospital, at The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital, and at the Richard J. Solove Research Institute.

The Pivot Toward Treating COVID-19 and Other Diseases

However, Lee said, NKs have wider potential. This is kind of a natural swing back. Now that we know we can grow them, we can reengineer them against infectious disease targets and use them in that [space], he said.

Lee is part of a coronavirus disease 2019 (COVID-19) clinical trial, partnering with Kiadis, for off-the-shelf K-NK cells using Kiadis proprietary platforms. Such treatment would be a postexposure preemptive therapy for treating COVID-19. Lee said the pivot toward treating COVID-19 with cell therapy was because some of the very early reports on immune responses to coronavirus, both original [SARS-CoV-2] and the new [mutation], seem to implicate that those who did poorly [overall] had poorly functioning NK cells.

The revolutionary gene editing tool CRISPR is making its initial impact in clinical trials outside the cancer area. Its developers, Jennifer Doudna, PhD, and Emmanuelle Charpentier, PhD, won the Nobel Prize in Chemistry 2020.

For patients with sickle cell disease (SCD), CRISPR was used to reengineer bone marrow cells to produce fetal hemoglobin, with the hope that the protein would turn deformed red blood cells into healthy ones. National Public Radio did a story on one patient who, so far, thanks to CRISPR, has been liberated from the attacks of SCD that typically have sent her to the hospital, as well from the need for blood transfusions.4

Its a miracle, you know? the patient, Victoria Gray of Forest, Mississippi, told NPR.

She was among 10 patients with SCD or transfusion-dependent beta-thalassemia treated with promising results, as reported by the New England Journal of Medicine.5 Two different groups, one based in Nashville, which treated Gray,5 and another based at Dana-Farber Cancer Institute in Boston,6 have reported on this technology.

Stephen Gottschalk, MD, chair of the department of bone marrow transplantation and cellular therapy at St Jude Childrens Research Hospital, said, Theres a lot of activity to really explore these therapies with diseases that are much more common than cancer.

Animal models use T cells to reverse cardiac fibrosis, for instance, Gottschalk said. Using T cells to reverse pathologies associated with senescence, such as conditions associated with inflammatory clots, are also being studied.

Hordeaux said she foresees AAV being used more widely to transmit neurons to attack neurodegenerative diseases.

The neurons are easily transduced by AAV naturally, she said. AAV naturally goes into neurons very efficiently, and neurons are long lived. Once we inject genetic matter, its good for life, because you dont renew neurons.

Logistical Issues

Speed is of the essence, as delays in producing therapies can be the difference between life and death, but the approval process takes time. The process of working out all kinks in manufacturing also remains a challenge. Rapid production is difficult, too, because of the necessary customization of doses and the need to ensure a safe and effective transfer of cells from the patient to the manufacturing center and back into the patient.7

Other factors that can slow down launches include insurance coverage, site certification, staff training, reimbursement, and patient identification. The question of how to reimburse has not been definitively answered; at this point, insurers are being asked to issue 6- or even 7-figure payments for treatments and therapies that may not work.8

CAR T, I think, will become part of the standard of care, Gottschalk said. The question is how to best get that accomplished. To address the tribulations of some autologous products, a lot of groups are working with off -the-shelf products to get around some of the manufacturing bottlenecks. I believe those issues will be solved in the long run.

References

1. Statement from FDA Commissioner Scott Gottlieb, MD, and Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research on new policies to advance development of safe and effective cell and gene therapies. News release. FDA website. January 15, 2019. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-and-peter-marks-md-phd-director-center-biologics. Accessed January 13, 2021.

2. Bristol Myers Squibb provides regulatory update on lisocabtagene maraleucel (liso-cel). News release. Bristol Myers Squibb; November 16, 2020. Accessed January 11, 2021. https://news.bms.com/news/details/2020/Bristol-Myers-Squibb-Provides-Regulatory-Update-on-Lisocabtagene-Maraleucel-liso-cel/default.aspx

3. Wei J, Guo Y, Wang Y. et al. Clinical development of CAR T cell therapy in China: 2020 update. Cell Mol Immunol. Published online September 30, 2020. doi:10.1038/s41423-020-00555-x

4. Stein R. CRISPR for sickle cell diseases shows promise in early test. Public Radio East. November 19, 2019. Accessed January 11, 2021. https://www.publicradioeast.org/post/crisprsickle-cell-disease-shows-promise-early-test

5. Frangoul H, Altshuler D, Cappellini MD, et al. CRISPR-Cas9 gene editing for sickle cell disease and -Thalassemia. N Engl J Med. Published online December 5, 2020. DOI: 10.1056/NEJMoa2031054

6. Esrick EB, Lehmann LE, Biffi A, et al. Post-transcriptional genetic silencing of BCL11A to treat sickle cell disease. N Engl J Med. Published online December 5, 2020. doi:10.1056/NEJMoa2029392

7. Yednak C. The gene therapy race. PwC. February 5, 2020. Accessed January 11, 2021. https://www.pwc.com/us/en/industries/healthindustries/library/gene-therapy-race.html

8. Gene therapies require advanced capabilities to succeed after approval. PwC website. Accessed January 11, 2021. https://www.pwc.com/us/en/industries/health-industries/library/commercializing-gene-therapies.html

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Grayson-Jockey Club Research Foundation Board approves record funding for Equine Research – Past The Wire

By daniellenierenberg

LEXINGTON, Ky. Board of directors of Grayson-Jockey Club Research Foundation announced today that it has authorized expenditure of $1,638,434, the most that the foundation has ever allocated in a year, to fund 12 new projects at 12 universities, 12 continuing projects, and two career development awards worth $20,000 each. This marks the seventh straight year that more than $1 million has been approved. The 2021 slate of research brings Grayson-Jockey Club Research Foundations totals since 1983 to more than $30.6million to underwrite 396 projects at 45 universities.

We are heartened by the continued commitment of universities to supporting equine veterinary research throughout these difficult times and that we are able to distribute more funding than ever before, enabling us to help horses of all breeds and disciplines, said Dell Hancock, chair of Grayson.

Despite a challenging year, Grayson-Jockey Club was excited to receive 51 grant applications from a variety of veterinary institutions in North America as well as five other countries, said Dr. Stephen M. Reed, chair of Graysons research advisory committee. The subject matter is diverse and ranges from identifying new methods to treat and prevent infectious disease to development of computational models using big data to investigation of novel imaging techniques to prevent orthopedic injuries.

Below is an alphabetical list by school of the new projects:

Passive Immunization of Foals with RNA-AB against R Equi

Jeroen Pollet, Baylor College of Medicine

By inhalation therapy, we intend to deliver the genetic code for a protective antibody against Rhodococcus equi into the lung cells of newborn foals, to rapidly protect them against infection.

Hyperthermia and Acidosis in Exertional Muscle Damage

Michael Davis,Oklahoma State University

This project will identify an underlying cause of exercise-associated muscle fatigue and soreness and allow trainers to more precisely condition horses with fewer training days lost to muscle soreness.

Developing an Improved Serological Test for Strangles

Noah Cohen, Texas A&M

We propose to develop a more accurate blood test to identify horses infected with the bacterium that causes strangles to improve control and prevention of strangles.

Mitigation of Equine Recurrent Uveitis through SOCS

Joseph Larkin, University of Florida

We seek to design a topical eye drop, using a natural protein, which helps to prevent pain and blindness associated with equine recurrent uveitis.

Environmental Origins of Equine Antimicrobial Resistance

Brandy Burgess, University of Georgia

This study will elucidate how antimicrobial resistance and virulence determinants are shared among horses and hospital environment, as well as the role antimicrobial exposure plays at this interface.

Treatment of Joint Injury with Mesenchymal Stromal Cells

Thomas Koch, University of Guelph

Evaluation of equine umbilical cord blood-derived mesenchymal stromal cells to treat joint injuries in horses.

Optimizing Bone Growth to Reduce Equine Fracture

Mariana Kersh, University of Illinois UrbanaChampaign

Reduction in distal limb fractures through exercise in young horses would have a significant positive impact on horse welfare and the economics and public perception of the horse industry.

New Generation Equine Influenza Bivalent VLP Vaccine

Thomas Chambers, University of Kentucky

We propose to create a novel, safe and effective vaccine for equine influenza based on the 21st-century technology of noninfectious virus-like particles produced in plants.

Injury Prediction from Stride Derived Racing Load

Chris Whitton, University of Melbourne

By studying patterns in bone fatigue accrual over time in racehorses, we will better, and earlier, identify horses at risk of limb injury, facilitating timely evidence based preventative strategies.

Predicting Exercising Arrhythmias with Resting ECGs

Molly McCue, University of Minnesota

We will use at rest ECGs to identify horses with irregular heart rhythms at exercise that can cause sudden cardiac death (SCD), allowing for increased monitoring and improved understanding of SCD.

Understanding and Preventing Supporting Limb Laminitis

Andrew Van Eps,University of Pennsylvania

We aim to make supporting limb laminitis preventable through analysis of archived model tissues, a multi-center limb motion study of horses at risk, and development of a prototype therapeutic device.

Diagnosis of Incipient Condylar Stress Fracture

Peter Muir,University of Wisconsin-Madison

This study will save the lives of racehorses by establishing screening using fetlock CT for diagnosis of horses with a high risk of imminent serious injury for personalized clinical care.

The Storm Cat Career Development Award, inaugurated in 2006, grants $20,000 to an individual considering a career in equine research.This years recipient is Dr. Callum G. Donelly of the University of California, Davis. Dr. Donelly has completed his residency program and is in a research training position under the mentorship of Dr. Carrie Fino. His project, Proteomic Investigation of Equine Spinal Ataxia, is expected to identify novel protein biomarkers that differentiate normal horses from those with spinal ataxia, with high sensitivity and specificity.

The Elaine and Bertram Klein Career Development Award was first awarded in 2015 and grants $20,000 to a prospective equine researcher. This years recipient is Dr. Aileen Rowland of Texas A&M University. Dr. Rowlands research focuses on the efficacy of xenogeny-free mesenchymal stem cells for osteoarthritis.

We are pleased to continue our funding of two career development awards to support individuals passionate about equine research, said Dr. Johnny Mac Smith, consultant to the research advisory committee. Dr. Donelly and Dr. Rowland are worthy recipients of these grants, and I look forward to seeing how their current and future projects contribute to improving equine health in the future.

Details on the new projects are available at the following link:grayson-jockeyclub.org/default.asp?section=2&area=Research&menu=2.

Grayson-Jockey Club Research Foundation is traditionally the nations leading source of equine research funding. The projects it supports enhance the health and safety of horses of all breeds. Additional information about the foundation is available atgrayson.jockeyclub.org.

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Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the US FDA for PADCEV (enfortumab vedotin-ejfv) in…

By daniellenierenberg

TOKYOand BOTHELL, Wash., Feb. 18, 2021 /PRNewswire/ --Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) today announced completion of submissions for two supplemental Biologics License Applications (sBLAs) to the U.S. Food and Drug Administration (FDA) for PADCEV (enfortumab vedotin-ejfv). One submission, based on the phase 3 EV-301 trial, seeks to convert PADCEV's accelerated approval to regular approval. The second submission, based on the pivotal trial EV-201's second cohort, requests an expansion of the current label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.

The FDA is reviewing both applications under the Real-Time Oncology Review (RTOR) pilot program. The RTOR program aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.

"The FDA's review of our applications under Real-Time Oncology Review supports our efforts to expand PADCEV's availability as a treatment option for more patients as quickly as possible," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas. "Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options."

The sBLA for regular approval of PADCEV in the U.S. is supported by data from the global EV-301 phase 3 confirmatory trial, which compared PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The trial's primary endpoint was overall survival of patients treated with PADCEV vs. chemotherapy, and full results were presented at the 2021 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) and published in the New England Journal of Medicine.[1]

The second submission, for a label expansion in the U.S., is based on results from the second cohort of EV-201, a pivotal phase 2 clinical trial evaluating PADCEV in patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but were not eligible for cisplatin. The trial's primary endpoint was objective response rate, and full results were presented at ASCO GU.[2]

"Advanced bladder cancer patients urgently need more treatment options," said Roger Dansey, M.D., Chief Medical Officer, Seagen. "Based on recently presented clinical trial results, PADCEV could address a significant unmet need for more patients with advanced urothelial cancer after initial immunotherapy treatment."

In 2019 PADCEV received accelerated approval in the U.S. for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery in a locally advanced or metastatic urothelial cancer setting. PADCEV is currently only approved for use in the U.S.

About the EV-301 TrialThe EV-301 trial (NCT03474107) is a global, multicenter, open-label, randomized phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in approximately 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-based therapies. The primary endpoint is overall survival and secondary endpoints include progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters.

About the EV-201 TrialThe EV-201 trial (NCT03219333) is a single-arm, dual-cohort, pivotal phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1 or PD-L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy in this setting and who are ineligible for cisplatin (cohort 2). The trial enrolled 128 patients in cohort 1 and 91 patients in cohort 2 at multiple centers internationally. The primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability.

About Urothelial CancerUrothelial cancer is the most common type of bladder cancer (90 percent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.[3] Globally, approximately 549,000 new cases of bladder cancer and 200,000 deaths are reported annually.[4]

About PADCEV (enfortumab vedotin-ejfv)PADCEV was approved by the U.S. Food and Drug Administration (FDA) in December 2019 and is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting. PADCEV was approved under the FDA's Accelerated Approval Program based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.[5]

PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.5,[6] Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).5 PADCEV is co-developed by Astellas and Seagen.

PADCEV Important Safety Information

Warnings and Precautions

Adverse ReactionsSerious adverse reactions occurred in 46% of patients treated with PADCEV. The most common serious adverse reactions (3%) were urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%), and rash (3%). Fatal adverse reactions occurred in 3.2% of patients, including acute respiratory failure, aspiration pneumonia, cardiac disorder, and sepsis (each 0.8%).

Adverse reactions leading to discontinuation occurred in 16% of patients; the most common adverse reaction leading to discontinuation was peripheral neuropathy (6%). Adverse reactions leading to dose interruption occurred in 64% of patients; the most common adverse reactions leading to dose interruption were peripheral neuropathy (18%), rash (9%) and fatigue (6%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common adverse reactions leading to dose reduction were peripheral neuropathy (12%), rash (6%) and fatigue (4%).

The most common adverse reactions (20%) were fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common Grade 3 adverse reactions (5%) were rash (13%), diarrhea (6%) and fatigue (6%).

Lab AbnormalitiesIn one clinical trial, Grade 3-4 laboratory abnormalities reported in 5% were: lymphocytes decreased (10%), hemoglobin decreased (10%), phosphate decreased (10%), lipase increased (9%), sodium decreased (8%), glucose increased (8%), urate increased (7%), neutrophils decreased (5%).

Drug Interactions

Specific Populations

For more information, please see the full Prescribing Information for PADCEV here.

About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website athttps://www.astellas.com/en.

About Seagen Seagen Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people's lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit http://www.seagen.com and follow @SeagenGlobal on Twitter.

About the Astellas and Seagen CollaborationAstellas and Seagen are co-developing enfortumab vedotin under a collaboration that was entered into in 2007 and expanded in 2009.

Astellas Cautionary NotesIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice.

Seagen Forward Looking StatementsCertain statements made in this press release are forward looking, such as those, among others, relating to the potential conversion of PADCEV's current accelerated approval in the U.S. to regular approval and the potential expansion of the current PADCEV label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin, and the therapeutic potential of PADCEV, including its efficacy, safety and therapeutic uses. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation, the possibility that the sBLA submissions based on the EV-301 and EV-201 second cohort clinical trials may not be accepted for filing by, or ultimately approved by, the FDA in a timely manner or at all; that the results of the EV-301 clinical trial may not be sufficient to convert PADCEV's accelerated approval in the U.S. to regular approval and that the results of the second cohort of the EV-201 clinical trial may not be sufficient to support the requested label expansion; that, even if PADCEV receives regular approval and even if the PADCEV label is expanded based on the results of the second cohort of the EV-201 clinical trial, the product labeling may not be as broad or desirable as requested or anticipated; and that setbacks in the development and commercialization of PADCEV could occur as a result of the difficulty and uncertainty of pharmaceutical product development, the risk of adverse events or safety signals, the failure of ongoing and subsequent clinical trials to establish sufficient efficacy, or as a result of adverse regulatory actions. More information about the risks and uncertainties faced by Seagen is contained under the caption "Risk Factors" included in the company's Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

[1]Powles T, Rosenberg J, Sonpavde G, et al. Primary Results of EV-301: A Phase 3 Trial of Enfortumab Vedotin vs Chemotherapy in Patients With Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma. ASCO Meeting Library 2021. https://meetinglibrary.asco.org/record/194738/abstract. Accessed February 11, 2021.[2] Balar AV, McGregor B, Rosenberg J, et al. EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors. ASCO Meeting Library 2021. https://meetinglibrary.asco.org/record/194731/abstract. Accessed February 11, 2021.[3]American Society of Clinical Oncology. Bladder cancer: introduction (5-2019). https://www.cancer.net/cancer-types/bladder-cancer/introduction. Accessed January 27, 2021.[4]Cancer today: data visualization tools for exploring the global cancer burden in 2020. https://gco.iarc.fr/today/home. Accessed January 27, 2021.[5]PADCEV [package insert] Northbrook, IL: Astellas Pharma Inc.[6]Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13.

SOURCE Astellas Pharma Inc.

http://www.us.astellas.com

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