CASI Pharmaceutical Inc. (NASDAQ: CASI) has announced that US FDA has granted its partner Juventas Cell Therapy Ltd. an Orphan Drug Designation for its experimental CD-19 directed CART-T therapy, CNCT19, for treatment of Acute Lymphoblastic Leukemia patients.
CNCT19 received CTA approval for r/r B-ALL and B-NHL
Juventas is now developing CNCT19 on its own to answer the urgent clinical requirements of hematologic malignancies patients around the world. CNCT19 received CTA approval from the National Medical Products Administration (NMPA) in November 2019 for refractory/relapsed B-ALL and B-NHL. CNCT19 is now undergoing Phase II clinical studies (for both B-NHL and B-ALL). The company presented encouraging clinical data for pediatric and adult patients with refractory/relapsed B-ALL showing the safety and efficacy profile of the drug at the December 2021 ASH annual meeting. CNCT 19 is projected to be China’s first CD19-directed CAR-T treatment with its own set of intellectual property rights.
CEO and Chairman of CASI, Dr. Wei-Wu He, said, “Our partner Juventas continues to make encouraging progress in developing their CD19 CAR-T therapy. The Orphan Drug Designation, from the FDA, and the Breakthrough Designation status, granted by the China Center of Drug Evaluation (CDE) in December 2020, represent significant milestones that demonstrate our belief that CNCT19’s commercialization will not only be successful in China, but potentially on a global scale. CASI has worldwide co-commercial rights of CNCT19, and will start the global commercialization process according to CNCT19’s regulatory progress outside China.”
Juventas researching and commercializing cellular immunotherapies
Juventas is a Chinese biopharma firm focused on cell treatments research and global marketing. The company has created a diversified cellular immunotherapies pipeline for solid tumors, hematological malignancies, and other non-oncological illnesses treatment in China and worldwide, using novel and integrated technological platforms. CNCT19 is now being tested in two critical clinical studies in China for the treatment of adult r/r-B-NHL and r/r-B-ALL. CNCT19 is likely to be China’s maiden CD19 CAR-T therapy to be released, as well as the first CAR-T treatment for adult R/R B-ALL.
