Cullinan Therapeutics, Inc. 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).
CLN-978 is a novel, highly potent, half-life extended CD19xCD3 bispecific T cell engager construct. CLN-978 potently 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 B cells expressing very low CD19 levels. A human serum albumin (HSA)-binding domain increases the serum half-life of CLN-978 and, with subcutaneous delivery, may permit more patient-friendly dosing and potentially reduced toxicity.
CLN-978 contains two single-chain variable fragments, one binding with very high affinity to the CD19 target and the other binding to CD3 on T cells, and a single-domain antibody binding to HSA.
“We are pleased to take the next step to advance our global study of CLN-978 in SLE in the U.S.,” says Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics, in a news release. “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 and are focused on advancing CLN-978, a novel, highly potent, half-life extended CD19xCD3 bispecific T cell engager that could offer a potentially disease-modifying, off-the-shelf option for patients.”
