Cullinan Therapeutics, Inc. (NASDAQ: CGEM) has received clearance from the U.S. Food and Drug Administration (FDA) for its investigational new drug (IND) application for CLN-978, marking a significant milestone for the company. The global Phase 1 clinical trial for CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE) can now proceed in the U.S.
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 of the trial is a dose escalation phase, starting at 10 micrograms, while Part B is a dose expansion phase exploring multiple dose schedules informed by data from Part A. The primary objective is to evaluate the safety of CLN-978 for the treatment of active moderate to severe SLE, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity.
CLN-978 is a novel, highly potent CD19xCD3 bispecific T cell engager designed to target B cells, including those with very low CD19 levels. It is engineered to achieve very high affinity binding to CD19 to efficiently target B cells and is administered subcutaneously. The company's Chief Medical Officer, Jeffrey Jones, MD, MBA, emphasized the significant unmet medical need among SLE patients and the potential of CLN-978 to offer a differentiated approach with convenient dosing.
Systemic Lupus Erythematosus (SLE) is a chronic, heterogeneous autoimmune disease that affects approximately 3.4 million individuals globally, with a higher prevalence in women and people of color. Current treatments often fail to fully control disease activity and prevent long-term organ damage, necessitating lifelong immune suppression for most patients.
Cullinan Therapeutics, Inc. is dedicated to creating new standards of care for patients and has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. The company's portfolio encompasses a wide range of modalities, with the potential to be best and/or first in class.
This FDA clearance represents a significant step forward for Cullinan Therapeutics, Inc. as it continues to progress its global Phase 1 clinical trial for CLN-978, offering hope for improved treatment options for patients with moderate to severe SLE. The market has reacted to these announcements by moving the company's shares 7.8% to a price of $17.51. Check out the company's full 8-K submission here.
