Cullinan Therapeutics Files Investigational New Drug Application with FDA for CLN-978 for Treatment of Systemic Lupus Erythematosus

Cullinan Therapeutics has filed an investigationalnew drug application with the U.S. Food and Drug Administration (FDA) for CLN-978 for the treatment of systemic lupus erythematosus (SLE). 

CLN-978 is an advanced, highly potent CD19 x CD3 bispecific T-cell engager designed to target and destroy harmful cells by binding to both CD19 on B cells and CD3 on T cells. It is engineered to have a very high affinity for CD19, allowing it to effectively target B cells expressing very low CD19 levels in vitro (outside of a living organism or in an artificial environment) and in vivo (inside of a living organism). The structure of CLN-978 includes two single-chain variable fragments: one binds strongly to the CD19 target on B cells, while the other binds to CD3 on T cells, helping direct the immune system to attach harmful cells. Additionally, CLN-978 has a single-domain antibody binding to human serum albumin (HSA, an abundant protein in human blood plasma, which may help to extend CLN-978 time in the blood stream). An abnormal amount of HSA may suggest a problem with the liver or kidneys. The design of CLN-978 permits more patient-friendly dosing and potentially reduced toxicity. 

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