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Cullinan Therapeutics Receives U.S. FDA Clearance of Investigational New Drug Application for CLN-978 Administered Subcutaneously in Patients with Moderate to Severe Systemic Lupus Erythematosus
CLN-978 is the first development stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases CAMBRIDGE, Mass., Oct. 16, 2024 (GLOBE
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"CLN-978 is the first development stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases CAMBRIDGE, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) Application for CLN-978 and its global Phase 1 clinical trial may proceed in the U.S. to assess CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE). The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have had an inadequate response to at least two treatments, including one immunosuppressive or biologic standard-of-care agent. Part A is a dose escalation phase that will determine the target dose for further development, with a starting dose of 10 micrograms. Part B is a dose expansion phase which will explore multiple dose schedules informed by data from Part A of the study. The primary objective of the study is to evaluate the safety of CLN-978 for treatment of active moderate to severe SLE. Secondary objectives include pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity. “We are pleased to continue progressing our global Phase 1 clinical trial in the U.S. with FDA clearance of our IND Application,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “There remains a significant unmet medical need among patients with systemic lupus erythematosus, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978, our novel bispecific T cell engager, targets CD19, offering a highly differentiated approach to deliver the potency of T cell redirecting therapy with off-the-shelf access and convenient dosing through subcutaneous administration.” The Company previously announced in September that it was cleared to initiate its global clinical trial in Australia (NCT06613360). About CLN-978 CLN-978 is a novel, highly potent CD19xCD3 bispecific T cell engager. CLN-978 triggers redirected lysis of CD19-expressing target cells in vitro and in vivo. CLN-978 is engineered to achieve very high affinity binding to CD19 to efficiently target...