Bluebird bio of Massachusetts Still Waiting for California Stem Cell Money

By Dr. Matthew Watson

Seven months after the California stem
cell agency awarded $9.4 million to bluebird bio of Cambridge, Mass.,
the company has yet to receive any of the cash from the Golden State.

Kevin McCormack, a spokesman for the $3
billion agency, this week said negotiations are still underway with
the bluebird, which is planning to go public, but did not elaborate. Post-award negotiations are
common at the agency, but generally take much less time.

The cash from CIRM is scheduled to
assist in clinical trials for a stem cell-gene therapy to correct a genetic disease in young patients with B-thalassemia, a
rare blood disorder that can cause widespread organ damage
and premature death.

Earlier this month, bluebird bio, which
prefers the lower case lettering for its name, announced that it
intends to take the company public in an $86 million offering. In
March, it announced a collaboration with Celgene that provided for an upfront payment of $75 million and promised up to $225 million per
product in potential option fees and clinical and regulatory
milestones. The CIRM grant is conditioned on a matching commitment
from bluebird.

Cash from the stem cell agency can only
be spent on operations within California. According to the CIRM summary of the review of the bluebird application, which was scored
at 73, the company said,

“We will have at least two clinical
sites in California, and more likely up to 4 sites, 2) our viral
vector manufacturing will occur in California, 3) our cell processing
will occur in California, 4) we will hire several consultants and
full-time employees within California to support the program.
Overall, several million dollars will be spent employing the services
of people, academic institutions, and other companies within the
state of California.”

The company has said that it is working
with Donald Kohn at UCLA and Elliot Vichinsky at Oakland's Children's
Hospital.

The bluebird web site lists a
California location for bluebird at 1001 Bayhill Dr, Suite 200, in
San Bruno, which is south of San Francisco. An Internet search
indicates that is a generic address for a number of business
including a realty firm, a roof repair business and a family law
attorney. The California Stem Cell Report has asked bluebird to
clarify the nature of the address.

In an interview last October with Ron Leuty of the
San Francisco Business Times, David Davidson, the lead scientist on
the project, said,

“We began the process (with CIRM)
early in (2012) but discussions have been going on for over a year
about potentially pursuing this.

“The interaction with CIRM has been
extraordinarily collaborative. We had contact with the coordinators
at CIRM that helped us manage the process. It took a lot of effort on
our part to put together a dossier providing support for our program.
It was really like a mini-regulatory filing — on the science, the
preclinical toxicology work that we’ve done, a detailed plan for
the trial, a detailed plan for the budgets, a detailed plan on how we
intended to spend the CIRM money in California. That was an important
part of it. They wanted a clear plan on how this investment would be
spent."

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