FDA Selects Wugen's Soficabtagene Geleucel for CMC Development Pilot Program
The U.S. Food and Drug Administration (FDA) has chosen Wugen, Inc.'s investigational therapy, Soficabtagene Geleucel (Sofi-cel), to participate in its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. This program is designed to support the manufacturing readiness of therapies with expedited clinical development timelines. Sofi-cel is an allogeneic, anti-CD7 CAR-T cell therapy currently under evaluation in a pivotal trial for patients with relapsed or refractory T cell acute lymphoblastic leukemia or T cell lymphoblastic lymphoma. The FDA's selection allows Wugen to engage more frequently with the agency on CMC strategy, facilitating the therapy's advancement towards a Biologics License Application (BLA) submission. Sofi-cel has already received multiple designations from the FDA, including Breakthrough Therapy and Regenerative Medicine Advanced Therapy, which aim to expedite the development of promising therapies. 
