In its latest batch of grants the California Institute for Regenerative Medicine divided a smaller pool of funding among fewer research teams than it did in 2009, reflecting the institute's interest in funding projects that are close to entering the clinic.

Last month, CIRM announced awards totaling $151 million to teams from 7 academic institutions and 1 company-StemCells Inc.-that are expected to submit INDs or complete Phase I or Phase II testing when work on the 4-year grants is complete (see "2012 CIRM grants").

StemCells will use its $20 million grant to develop HuCNS-SC, purified human neural stem cells, to treat spinal cord injury (SCI) in the neck. The company already has the technology in Phase I/II testing to treat SCI in the back.

Two of CIRM's partners will contribute additional funding to specific projects. The Andalusian Initiative for Advanced Therapies will provide $1.6 million to the Spanish collaborators of a team at the University of California, Davis that is developing an intramuscular injection of VEGF-producing mesenchymal stem cells (MSCs) to treat critical limb ischemia.

The U.S. NIH will provide undisclosed funds and resources to a team at University of California, Los Angeles that is developing stem cells engineered to express melanoma-specific T cell receptors (TCRs) to treat melanoma.

"NIH's dollar commitment is difficult to quantify because the project will involve the time of staff scientists already on the NIH payroll, along with the use of existing equipment" at the agency, said CIRM spokesperson Don Gibbons.

Gibbons said CIRM selected the 8 projects from a total of 21 applications, including 6 from industry. Of the 13 projects that did not receive grants, 2-including 1 from OncoMed Pharmaceuticals Inc.-have been sent back to CIRM's panel for re-review in light of new data submitted by the applicants. Those data address the reasons the review panel originally decided those projects did not meet CIRM's criteria, he said.

Gibbons noted that, compared with in 2009, the pool of applicants and number of awards were smaller this year because "the call for applications was more specific about how close to clinical trials the teams needed to be for funding."

In 2009, CIRM awarded a total of $229.8 million to 14 projects that were expected to result in IND submissions during the 4-year grant period.1 CIRM has reviewed the progress of each of those projects annually in conjunction with the Clinical Development Advisory Panel (CDAP), which is composed of industry and other experts outside CIRM, Gibbons said.

According to a CDAP report issued by CIRM in March, 12 of the projects from 2009 are on track to meet their original goals with no changes in funding levels (see "Update on 2009 CIRM grants"). Moreover, 2 of those 12 projects have spawned new companies: in 2011 the City of Hope brain cancer project leader founded TheraBiologics Inc., and also in 2011 the University of Southern California (USC) age-related macular degeneration (AMD) project team spun out Regenerative Patch Technologies Inc.

Also according to the CDAP report, CIRM recommended that the University of California, San Diego-led leukemia project team focus its efforts on developing two potential antibody therapeutics targeting leukemia stem cells to treat acute myelogenous leukemia (AML) and chronic lymphocytic leukemia (CLL). The team's project originally aimed to identify up to three antibodies and three small molecules to treat AML, CLL and three other hematological malignancies.

The CDAP report also noted that CIRM discontinued the grant to a University of California, San Francisco-led brain tumor project because it failed to reach an undisclosed milestone.

Gibbons declined to say which of the 2009 projects might reach the clinic first but added that CIRM president Alan Trounson "has indicated he thinks the HIV team at City of Hope and the macular degeneration team of USC are pretty close."

Haas, M.J. SciBX 5(32); doi:10.1038/scibx.2012.833
Published online Aug. 16, 2012

REFERENCES

1.   Fulmer, T. SciBX 2(44); doi:10.1038/scibx.2009.1621

COMPANIES AND INSTITUTIONS MENTIONED

      Andalusian Initiative for Advanced Therapies, Seville, Spain

      California Institute for Regenerative Medicine, San Francisco, Calif.

      City of Hope, Duarte, Calif.

      National Institutes of Health, Bethesda, Md.

      OncoMed Pharmaceuticals Inc., Redwood City, Calif.

      Regenerative Patch Technologies Inc., Glendale, Calif.

      StemCells Inc. (NASDAQ:STEM), Newark, Calif.

      TheraBiologics Inc., Los Angeles, Calif.

      University of California, Davis, Calif.

      University of California, Los Angeles, Calif.

      University of California, San Diego, La Jolla, Calif.

      University of California, San Francisco, Calif.

      University of Southern California, Los Angeles, Calif.