Company announcement – No. 55 / 2020

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Zealand Pharma increases its share capital as a consequence of exercise of employee warrants

- SPEARHEAD-1 enrolment on track; planning to launch ADP-A2M4 in 2022 in the US for people with synovial sarcoma -

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Adaptimmune to Showcase Market Potential for SPEAR T-cell Portfolio and Pipeline with Multiple Cell Therapy Platforms During Virtual Investor Day

High sensitivity and high negative predictive value (NPV) observed for ruling out the risk of preeclampsia High sensitivity and high negative predictive value (NPV) observed for ruling out the risk of preeclampsia

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New Test for Triaging Preeclampsia Passes Key Development Milestone: Progenity Releases Prospective Clinical Verification Data for its Preecludia™...

NASHVILLE, Tenn., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Harrow Health, Inc. (NASDAQ: HROW) today announced that Mark Baum, Harrow’s Chief Executive Officer, and Andrew Boll, Harrow’s Chief Financial Officer, will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference taking place December 1 – 3, 2020.

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Harrow Health Announces Participation at the Piper Sandler 32nd Annual Healthcare Conference

NEW YORK, NY, REHOVAT, ISRAEL, SINGAPORE, Nov. 20, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire  -- Todos Medical (OTCQB: TOMDF), an in vitro diagnostics company focused on distributing comprehensive solutions for COVID-19 screening and diagnosis, and developing blood tests for early detection of cancer and Alzheimer’s disease, today announced positive in vitro data by its joint venture partner NLC Pharma for the Company’s dietary supplement Tollovid™, demonstrating its ability to inhibit the 3CL protease. The 3CL protease is an enzyme that is required for the intracellular replication of coronaviruses. Tollovid received a certificate of free sale from the FDA in August 2020 and is being launched commercially into the US market initially at botanical wellness store The Alchemist’s Kitchen™ in New York City.

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Todos Medical Announces Positive In Vitro Data for Tollovid™ Confirming 3CL Protease Inhibition Mechanism of Action

CAMBRIDGE, Mass. and NEW YORK, Nov. 20, 2020 (GLOBE NEWSWIRE) --  Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, today announced the nomination of BDTX-1535 as the Company’s development candidate for the treatment of glioblastoma multiforme (GBM), as well as the commencement of Investigational New Drug (IND)-enabling studies.

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Black Diamond Therapeutics Provides Update on GBM Program and Presents Pre-Clinical Data at the 2020 SNO Annual Meeting

MALVERN, Pa., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced that Mel Sorensen, M.D., President and Chief Executive Officer, will participate in a fireside chat as part of the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held December 1-3, 2020.

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Galera Therapeutics to Participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference

Voorhies has Extensive Business and Industry Experience in Diagnostics & Monitoring

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Aditxt Appoints Anthony Voorhies as Head of Business Development for AditxtScore™

CAMBRIDGE, Mass., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance, today announced that management will participate in the following upcoming virtual investor conferences:

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Praxis Precision Medicines to Participate in Upcoming Investor Conferences

NEEDHAM, Mass., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Chiasma, Inc. (NASDAQ: CHMA), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases on burdensome and painful injections, today announced that it will host an expert panel on acromegaly and the results from its recently completed MPOWERED® Phase 3 clinical trial on Monday, November 30, 2020 at 11:00 am Eastern Time.

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Chiasma to Host an Expert Panel on Acromegaly and the MPOWERED® Phase 3 Trial Results

RALEIGH, N.C., Nov. 20, 2020 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced that Jeff Bailey, Chief Executive Officer, and Terry Coelho, Chief Financial Officer, will participate in a fireside chat and 1x1 investor meetings at the Piper Sandler 32nd Annual Healthcare Conference.

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BioDelivery Sciences to Participate in the Piper Sandler 32nd Annual Healthcare Conference

WOODCLIFF LAKE, NJ, Nov. 20, 2020 (GLOBE NEWSWIRE) -- NewMediaWire -- Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that it has signed waiver agreements with certain of its existing institutional investors.

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Timber Pharmaceuticals Signs Waiver Agreement with Warrant Holders

Hamilton, Bermuda, November 20, 2020 – Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today announced the launch of a dedicated website for its affiliate Altamira Medica Ltd. The website, www.altamiramedica.com, offers quick and easy access to information about the Company’s development of AM-301, a drug-free nasal spray intended for self-protection against risks from exposure to airborne viruses and allergens.

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Auris Medical Launches Website for AM-301-focused Subsidiary, Altamira Medica

PORTLAND, Ore., Nov. 20, 2020 (GLOBE NEWSWIRE) -- Golden Leaf Holdings Ltd. (CSE:GLH) (OTCQB:GLDFF) (“Golden Leaf” or the “Company”), a premier, consumer-driven cannabis company specializing in production, processing, wholesale, distribution and retail, announces that Chalice Farms, a wholly owned subsidiary of Golden Leaf, will spread holiday cheer by launching a “Holiday in Color” pre-roll pack, along with weekly promotions and specials through the holidays, available now.

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Chalice Farms to Launch “Holiday in Color” Pre-Roll Packs, Festive Promotions through Holiday Season

NEW YORK, Nov. 20, 2020 (GLOBE NEWSWIRE) -- LifeSci Acquisition II Corp. (NASDAQ: LSAQ), a blank check company targeting the biopharma sector, announced today that it priced its initial public offering of 7,500,000 shares at $10.00 per share. The shares will begin trading today on the NASDAQ Capital Market (“NASDAQ”) under the symbol “LSAQ.”

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LifeSci Acquisition II Corp. Announces Pricing of $75 Million Initial Public Offering

CALGARY, Alberta, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Zenith Capital Corp. (“Zenith” or the “Company”) today announces the filing on SEDAR (www.sedar.com) of the Notice of Meeting and Management Information Circular (the “Notice”) related to its Annual and Special Meeting of Shareholders (the “Meeting”) being held on Tuesday, December 22, 2020 commencing at approximately 2:00 pm (MT).

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Zenith Files Notice of Annual and Special Meeting of Shareholders

CALGARY, Alberta, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announced today the filing on SEDAR (www.sedar.com) of the Notice of Meeting and Management Information Circular (the “Notice”) related to its Annual and Special Meeting of Shareholders (the “Meeting”) being held on Tuesday, December 22, 2020 commencing at approximately 1:00 pm (MT).

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Resverlogix Files Notice of Annual and Special Meeting of Shareholders

Since losing her cousin to leukemia during childhood, Heather Lynn made it her mission to ensure others battling blood cancers get a second chance at life. Earlier this year, the St. Louis native fulfilled that life purpose: saving a stranger by donating her stem cells.

Five years ago, Lynn became the director of global special events for DKMS, the worlds largest bone marrow and blood stem cell donor center, and registered as a potential donor with the hope that someday she could give a blood cancer patient what her cousin didnt have a second chance at life and more time with the patients family.

Amid this years coronaviral pandemic, Lynn received the life-changing call from a colleague that she was a match for a 58-year-old man battling acute myeloid leukemia. I screamed with joy, Lynn recalls. I was a match for someone with blood cancer and was about to be the first employee at DKMS to donate and ultimately save someones life. After the call, Lynn realized she would be giving more than stem cells: I was giving something much bigger: hope.

Despite the uncertainty surrounding COVID-19, Lynn felt a strong sense of purpose to help this man and donated her stem cells to save his life. I have seen how much someones life can change with a blood cancer diagnosis, Lynn says. The fear, the pain, the loss it can be devastating. I have spent the past five years working to elevate the message about donating and how easy it is to sign up and give back it simply requires swabbing the inside of each cheek for 60 seconds.

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St. Louis Native Heather Lynn Discusses Motivation for Donating Her Stem Cells - Ladue News

Community Cord Blood Banking, a stem cell banking initiative introduced by LifeCell in 2017, has helped save the life of a seven-year-old girl from Nashik in Maharashtra who was suffering from aplastic anaemia, a rare and serious blood disorder.

In a major breakthrough, a team of senior doctors from LOTUS Institute of Haematology, Oncology and Bone Marrow Transplantation, recently conducted Indias first dual cord blood transplant through an unrelated donor using Community Stem Cell Banking. People familiar with the development said the transplant was challenging because no apt bone marrow donors were available and the cost of retrieval of matching units from public cord blood banks would have been high.

The girls parents, as members of LifeCell Community Bank, placed a request for two matching cord blood units after the childs sibling was found to be only a 50% (4/8) match. Two high-quality matches (7/8) were found in the registry, which fulfilled the requirement for umbilical cord blood transplantation. The parents could withdraw the matched units at no extra expense, which would have cost around 45 lakh per unit.

Mayur Abhaya, MD, LifeCell International said, The purpose of Community Cord Blood Banking is to ensure easy and rapid access to stem cells for every Indian without the hurdles of public and private banking models. While stem cells from the umbilical cord blood can be procured from global public banks, the probability of finding a match for a patient of Indian origin is less than 10% because of the low inventory of available units plus the big issue of donor dropouts.

Mr. Abhaya said, Luckily, since the family was a part of LifeCells community banking programme, they could gain quick, free access to the huge inventory of over 50,000 qualified and consented units available at LifeCell, which provides greater than 97% probability of finding a match.

In majority of blood-related disorders treatable by transplants, patients own stem cells are not suitable. Hence, the best donor is a close family member, usually a sibling. However, in this case, there was only a 50% match with the sibling, thus needing a match from an unrelated donor, LifeCell said in a statement. It said while a regular stem cell transplant requires a dose of 25 million cells per kg of the patients weight, for aplastic anaemia, the recommended minimum dose is 40 million cells per kg, which is not easy to find.

The community banking model made it possible and the child received a timely transplant with an encouraging prognosis. Just 18 days after the transplant, white blood cells were completely engrafted, and platelets and red blood cell production also increased drastically, the statement added.

Dr. Pritesh Junagade, director, LOTUS Hospital, expressed surprise that the retrieval process for two cord blood units was smooth and at no additional cost to the patient as compared to other banking models.

Tasneem Bohari, the childs father, said: It was two years ago that my daughter was diagnosed with aplastic anaemia. At the time of diagnosis, the doctors had suggested she would need a stem cell transplant eventually and it would be the best possible treatment in the future.

The family did research and made enquiries about which stem cell bank to opt for as they were expecting their second child. It was during this time that their friends and relatives suggested LifeCell to them. Their doctor also suggested that they could go ahead and preserve their babys stem cell with LifeCell.

At the time of preservation, we didnt have much idea about Community Stem Cell Banking and its benefits, but today we are happy to associate with LifeCell, who have helped my daughter lead a quality life through cord blood transplant, Mr. Bohari said.

Community Cord Blood Banking allows sharing of preserved umbilical cord stem cells from a common pool amongst the members of the community. The model offers greater and easier access to donor stem cells, unlimited retrievals at the cost of one enrolment, and a higher probability for finding a close match for potentially life-saving treatments.

This facility ensures complete protection to the child, siblings, parents, and maternal and paternal grandparents from more than 80 disorders treatable by stem cells.

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Community Cord Blood Banking saves life of child with aplastic anaemia - The Hindu

Results from a phase 2 study demonstrated that treatment with Jakafi (ruxolitinib) and Dacogen (decitabine) was well tolerated and contributed to favorable overall survival (OS) in patients with myeloproliferative neoplasm (MPN) in the accelerated or blast phase.

MPN is a blood cancer that develops when a stem cell mutation in the bone marrow leads to an overproduction of white cells, red cells and/or platelets. The accelerated phase of MPN refers to when 10% to 19% of blasts, or immature blood cells, are in the blood circulating through the body or in the bone marrow, whereas the blast phase refers to 20% or greater blasts in the circulating blood or bone marrow, according to the study published in Blood Advances.

This study was important, as patients with an antecedent (pre-existing) myeloproliferative neoplasm that evolves into an acute myeloid leukemia have a dismal prognosis of several months, and induction chemotherapy alone does not improve outcome unless followed by consolidation hematopoietic stem cell transplantation, Dr. John O. Mascarenhas, director of the adult leukemia program and leader of the myeloproliferative neoplasm clinical research program at Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai, said in an interview with CURE.

The study authors previously assessed this therapy in a multicenter, phase 1 trial.

We had previously shown that the epigenetic modifying agent decitabine can be administered (on) an outpatient (basis) and improve outcome with a median survival of nine to 10 months, Mascarenhas said. This prospective, phase 2, multicenter, investigated-initiated trial built on the phase 1 trial of combination decitabine and ruxolitinib based on supportive preclinical data from the laboratory of our collaborator, (Dr.) Ross Levine.

In this current trial, 25 patients (median age, 71 years; 56% women) with MPN either in the accelerated phase (10 patients; median age, 70.1 years; 70% women) or blast phase (15 patients; median age, 71.6 years; 46.7% women) were treated with Jakafi and Dacogen. A 25 mg dose of Jakafi was administered orally twice per day for 28 days in addition to a 20 mg/m2 dose of Dacogen intravenously during days 8 through 12. After that first cycle, the dose of Jakafi was reduced to 10 mg.

The prespecified primary endpoint, or goal, was best response by six months, and the predetermined secondary endpoint focused on the safety and tolerability of Jakafi and Dacogen. Study authors defined OS as the time from the first dose of Jakafi to death from any cause.

During follow-up, 19 patients died from causes including respiratory failure, disease progression, sepsis and pneumonia. Patients in this study had a median OS of 9.5 months. Overall response rate, which included complete remission, incomplete platelet recovery and partial remission, occurred in 44% of patients. Response to this treatment was not linked with improved survival.

This combination is well tolerated and can provide spleen symptom benefit and survival advantage compared to cytotoxic chemotherapy, Mascarenhas said. This study supports the use of this approach to maintain ambulatory care of these very advanced patients with a limited lifespan. This is one therapeutic approach that is now included in the (National Comprehensive Cancer Network) guidelines.

Mascarenhas added that more research is needed in this area. Ultimately, we need to identify active agents that can fully eliminate the malignant hematopoietic stem cell and attain molecular remissions that afford patients long-term survival, he said. This is an ongoing area of active translational research of our group.

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Jakafi and Dacogen May Improve Overall Survival in Patients with MPN - Curetoday.com