The California stem cell agency is
considering adding more cash to its upcoming $30 million award round
aimed at aiding projects that can complete – within the next four
years – a clinical trial for a therapy.
CIRM Chairman J.T. Thomas,
a Los Angeles bond financier, last month told agency directors that
there is "some real quality in the mix" among the firms
that have expressed initial interest. Depending on the judgment of
CIRM award reviewers later this year, Thomas said the board could
well be asked to increase the funding.
The "strategic partnership"
round has already exceeded expectations in terms of volume. CIRM told
the California Stem Cell Report that the agency has received
letters of intent from 37 enterprises, including 29 biotech
companies.
The round is an outgrowth of
recommendations two years ago from an "external review"
panel that said that CIRM needed to do a better job of engaging the
biotech industry. The
RFA for the round said the agency's intent is
to "enhance the likelihood that CIRM-funded projects will obtain
funding for phase III clinical trials" and attract additional
financing.
Elona Baum, the agency's general
counsel and vice president for business development,, said in a
news release earlier this spring,
“The Strategic Partnership Funding
Program represents a new era for CIRM, one that is increasingly
focused on moving therapies from the lab to the clinic, while still
recognizing the importance of maintaining investments in early stage
science,”
As the RFA is currently configured, CIRM
will provide grants or loans of up to $10 million to three
recipients. Applicants will have to match the size of the award. For
the first time, CIRM will also require applicants to demonstrate the
financial ability to carry the project forward.
In response to a query, CIRM spokesman
Kevin McCormack said,
"We received 37 letters of intent
(LOIs), including 8 from non-profits and 29 from biotech companies.
Based on the information in the LOIs, and on discussions with
applicants, we were able to determine that some of the proposals were
for projects that were outside the scientific scope of the RFA and
that some of the applicants did not meet the minimum specified
criteria in the RFA for 'Commercial Validation.' We currently expect
to receive 10-15 applications for projects that appear to be
eligible."
A "commercial validation"
review is scheduled for this fall by the directors' Intellectual
Property and Industry Subcommittee, which is co-chaired by
Stephen Juelsgaard, former executive vice president of Genentech,
and Duane Roth, CEO of CONNECT, a San Diego nonprofit
that supports technology and life sciences business development. The
others on the six-member panel are Chairman Thomas, Michael
Goldberg, a general partner at the MDV venture capital
firm, and two academics, Os Steward, chair and director of the
Reeve-Irvine Research Center for Spinal Cord Injury at UC
Irvine, and Susan Bryant, former vice chancellor for research,
also at UC Irvine.
CIRM's short version of commercial
validation says that applications must have "the financial
capacity to move the project through development or of being able to
attract the capital to do so. This may be evidenced by, for example,
(i) significant investment by venture capital firms, large
biotechnology or pharmaceutical companies and/or disease foundations;
(ii) a licensing and development agreement with a large biotechnology
or pharmaceutical company, or a commitment to enter into such an
agreement executed prior to the disbursement of CIRM funding; and/or
(iii) financial statements evidencing significant liquid assets."
Applications are due June 26 with
reviews in September. The directors' Industry Subcommittee will meet
following the reviews. CIRM said funding would come no earlier than
January of next year.
Source:
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