FDA Clears the IND for UCARTCS1, the First Allogeneic CAR-T to Treat Multiple Myeloma Patients
Cellectis S.A. - American Depositary Shares (CLLS)
Last cellectis s.a. - american depositary shares earnings: 3/4 04:30 pm
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Source: Business Wire
Successful manufacturing and release of GMP vials of UCARTCS1 NEW YORK--(BUSINESS WIRE)-- Regulatory News: Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a biopharmaceutical company focused on developing immunotherapies based on gene-edited CAR T-cells (UCART), announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application to initiate a Phase 1 clinical trial for UCARTCS1, in patients with multiple myeloma (MM). The IND for UCARTCS1 was filed on December 28, 2018 and approved by the FDA within a month, on January 25, 2019. Cellectis is the sponsor of the UCARTCS1 clinical study (MUNDI-01) and successfully ensured the manufacturing and release of UCARTCS1 GMP batches, as well as an IRB approval. UCARTCS1 is based on a tailored manufacturing process developed by Cellectis, which removes both the CS1 antigen and
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