Gracell Biotechnologies Inc. (NASDAQ: GRCL) has reported that the U.S. FDA has granted Orphan Drug Destination for GC012F, Gracell’s FasTCARE-enabled BCMA/CD19 dual targeting CAR-T cell therapy for treatment of multiple myeloma. “As our lead candidate currently being developed on Gracell’s FasTCAR next-day manufacturing technology platform, GC012F is a unique BCMA and CD19 dual-targeting CAR-T cell therapy,” commented Dr. Martina Sersch, Chief Medical Officer of Gracell. “GC012F has demonstrated fast, deep and durable responses in patients with Relapsed/Refractory Multiple Myeloma in an ongoing IIT study in China with most patients on study being high risk according to mSMART 3.0 criteria, a difficult-to-treat patient population. We are very excited about being granted Orphan Drug Designation for the treatment of Multiple Myeloma by the U.S. FDA, another key milestone in advancing our program globally. Multiple Myeloma patients are in need of more efficacious and tolerable therapies providing deep and durable responses and ultimately extending progression free and overall survival.”
The follow up data for GC012F was presented back in June at the ASCO 2021 Annual Meeting and the EHA 2021 Congress. It is currently being evaluated within trials in China, including new Multiple Myleloma patients. Multiple myeloma (MM) is the third most common type of blood cancer in the United States, originating from plasma cells, a type of immune cell that is typically responsible for secreting antibodies to fight infection. Globally, approximately 160,000 patients are diagnosed with MM every year.