AsianScientist (Mar. 9, 2017) – Cellular Biomedicine Group Inc., a clinical-stage biopharmaceutical firm engaged in the development of effective immunotherapies for cancer and stem cell therapies for degenerative diseases, has been awarded US$2.29 million by the governing Board of the California Institute for Regenerative Medicine (CIRM) to support pre-clinical studies of AlloJoin™, CBMG’s “Off-the-Shelf” allogeneic human adipose-derived mesenchymal stem cells for the treatment of knee osteoarthritis in the United States.
While CBMG recently commenced two Phase I human clinical trials in China using CAR-T to treat relapsed/refractory CD19+ B-cell acute lymphoblastic leukemia (ALL) and refractory diffuse large B-cell lymphoma (DLBCL) as well as an ongoing Phase I trial in China for AlloJoin™ in knee osteoarthritis, this latest announcement represents CBMG’s initial entrance into the United States for its “off-the-shelf” allogeneic stem cell candidate AlloJoin™.
The US$2.29 million was granted under the CIRM 2.0 program, a comprehensive collaborative initiative designed to accelerate the development of stem cell-based treatments for people with unmet medical needs. After the award, CIRM will be a more active partner with its recipients to further increase the likelihood of clinical success and help advance a pre-clinical applicant’s research along a funding pipeline towards clinical trials.
CBMG’s knee osteoarthritis pre-clinical program is considered late-stage, and therefore it meets CIRM 2.0’s intent to accelerate support for clinical stage development for identified candidates of stem cell treatments that demonstrate scientific excellence.
“We are deeply appreciative to CIRM for their support and validation of the therapeutic potential of our knee osteoarthritis therapy,” said Mr. Tony (Bizuo) Liu, Chief Executive Officer of CBMG. “The CIRM grant is the first step in bringing our allogeneic human adipose-derived mesenchymal stem cell treatment for knee osteoarthritis (AlloJoin™) to the U.S. market.”
“In order to demonstrate comparability with cell banks previously produced in China for our U.S. IND filing, we are addressing the pre-clinical answers required for the FDA. With the funds provided by CIRM, we will replicate and validate the manufacturing process and control system at the cGMP facility located at Children’s Hospital Los Angeles to support the filing of an IND with the FDA.”
CBMG recently announced promising interim three-month safety data from its Phase I clinical trial in China for AlloJoin™, its off-the-shelf allogeneic stem cell therapy for knee osteoarthritis. The trial is on schedule to be completed by the third quarter of 2017.
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Source: Cellular Biomedicine Group Inc; Photo: Shutterstock.
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