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Cullinan Therapeutics Announces Submission of Investigational New Drug Application to U.S. Food and Drug Administration for CLN-978 to Treat Systemic Lupus Erythematosus

Cullinan Therapeutics, Inc. (CGEM) 
Company Research Source: GlobeNewswire
CAMBRIDGE, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today shared that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE). “We are pleased to take the next step to advance our global study of CLN-978 in SLE in the U.S.,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “The Centers for Disease Control and Prevention (CDC) estimates SLE impacts more than 160,000 people in the U.S., and currently available treatments do not routinely induce treatment-free remission, with most patients requiring lifelong immune suppression that treats symptoms without modifying the course of disease. We are committed to developing new and better treatment options Show less Read more
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