Cullinan Therapeutics Submits IND for CLN-978 to FDA for Treating Lupus

Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company from Cambridge, MA, USA, has announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). This application aims to evaluate their CD19xCD3 bispecific T cell engager, CLN-978, for treating systemic lupus erythematosus (SLE). The announcement was made on September 16, 2024.

Jeffrey Jones, MD, MBA, Chief Medical Officer of Cullinan Therapeutics, emphasized the significance of this step, citing the Centers for Disease Control and Prevention (CDC) estimate that SLE affects over 160,000 people in the U.S. Current treatments for SLE often do not lead to treatment-free remission, requiring patients to undergo lifelong immune suppression that only manages symptoms without altering the disease’s progression. Jones highlighted the potential of CLN-978 as a promising new treatment option that could modify the disease and offer an off-the-shelf solution for patients.

CLN-978 is a highly potent, half-life extended CD19xCD3 bispecific T cell engager construct. It has shown powerful activity in redirecting the lysis of CD19-expressing target cells both in vitro and in vivo. The drug is engineered for high affinity binding to CD19, which allows it to target B cells expressing low CD19 levels. The inclusion of a human serum albumin (HSA)-binding domain extends the serum half-life of CLN-978, enabling subcutaneous delivery that could make dosing more patient-friendly and potentially reduce toxicity. The drug contains two single-chain variable fragments that bind with high affinity to CD19 and CD3 on T cells, as well as a single-domain antibody that binds to HSA. CLN-978, developed internally by Cullinan, represents a novel therapeutic option for autoimmune diseases such as SLE and rheumatoid arthritis.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease where the immune system attacks the body’s own tissues. Common symptoms of SLE include skin rashes, arthritis, swelling in the feet and around the eyes, extreme fatigue, and low fevers. Lupus nephritis (LN), a severe kidney disease, is a common manifestation of SLE, affecting about 40% of patients and having a 30% mortality rate over ten years. SLE predominantly affects women, people of color, and women of childbearing age. The CDC estimates that there are approximately 160,000 to 320,000 cases of SLE in the U.S. The existing treatments do not typically induce treatment-free remission, necessitating lifelong immune suppression that manages symptoms without changing the disease course.

Cullinan Therapeutics, Inc. is dedicated to developing new standards of care in both autoimmune diseases and cancer. The company has built a diverse portfolio of clinical-stage assets that either inhibit key disease drivers or harness the immune system to target diseased cells. Their portfolio includes a range of modalities, each with the potential to be either best-in-class or first-in-class. With a strong foundation in oncology, immunology, and translational medicine, Cullinan aims to develop transformative therapeutics for a variety of autoimmune and cancer indications. They apply rigorous criteria at each development stage to expedite the most promising molecules to clinical trials and commercialization.

The company emphasizes deep scientific expertise and a commitment to delivering new therapeutic solutions to patients.