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 and refractory diffuse large B-cell lymphoma 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 $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 Tony (Bizuo) Liu, CEO of CBMG. “We thank Dr. C. Thomas Vangsness, Jr., in the Department of Orthopaedic Surgery at the Keck School of Medicine of the University of Southern California and Dr. Qing Liu-Michael at the Broad Center for Regenerative Medicine and Stem Cell Research at USC, who helped significantly with the grant application process. 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."
CBMG recently announced promising interim three-month safety data from its Phase I clinical trial in China for AlloJoin. The trial is on schedule to be completed by the third quarter of 2017.
"Our AlloJoin program has previously undergone extensive manufacturing development and pre-clinical studies and is undergoing a Phase I clinical trial in China," added Liu. "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 [U.S. Food and Drug Administration] 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. The outcome of this grant will enable us to have qualified final cell products ready to use in a Phase I clinical trial with Dr. Vangsness as the principal investigator and the Keck School of Medicine of USC as a trial site. Dr. Vangsness is familiar with both stem cell biology and knee osteoarthritis, and has led the only randomized double-blind human clinical study to investigate expanded allogeneic mesenchymal stem cells to date. Our endeavor in the U.S. market will further strengthen our commercialization pipeline.”
The California Institute of Regenerative Medicine was created by the people of California to accelerate stem cell treatments to patients with unmet medical needs. Its team of professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development the most promising stem cell technologies. With $3 billion in funding and more than 280 active stem cell programs in its portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of medicine closer to reality.
According to the Foundation for the National Institutes of Health, there are 27 million Americans with osteoarthritis (OA), and symptomatic knee osteoarthritis (KOA) occurs in 13 percent of persons aged 60 and older. The International Journal of Rheumatic Diseases, 2011, reports that approximately 57 million people in China suffer from knee osteoarthritis. Currently no treatment exists that can effectively preserve knee joint cartilage or slow the progression of the disease. Current common drug-based methods of management, including anti-inflammatory medications only relieve symptoms and carry the risk of side effects. Patients with knee osteoarthritis suffer from compromised mobility, leading to sedentary lifestyles; doubling the risk of cardiovascular diseases, diabetes, and obesity; and increasing the risk of all causes of mortality, colon cancer, high blood pressure, osteoporosis, lipid disorders, depression and anxiety. According to the Epidemiology of Rheumatic Disease, 53 percent of patients with knee osteoarthritis will eventually become disabled.
Cellular Biomedicine Group Inc. develops proprietary cell therapies for the treatment of cancer and degenerative diseases. Its immuno-oncology and stem cell projects are the result of research and development by CBMG’s scientists and clinicians from both China and the United States. The company's GMP facilities in China, consisting of 12 independent cell production lines, are designed and managed according to both China and U.S. GMP standards.