CLN-978

CLN-978 is the first and only development-stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases Sjögren’s disease represents the third indication under development for CLN-978, and is a disease with high unmet need and no currently approved therapies CAMBRIDGE, MA, USA I April 29, 2025 I Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the Company is initiating a study of CLN-978 in patients with Sjögren’s disease (SjD) in the U.S. The Company previously received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) Application clearance to study the CD19 T cell engager in patients with moderate to severe systemic lupus erythematosus (SLE) and European Medicines Agency (EMA) approval to study CLN-978 in active, difficult-to-treat rheumatoid arthritis. The trial will enroll patients with active, moderate to severe Sjögren’s disease who fulfill the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria and are positive for anti-SSA/RO antibodies and/or rheumatoid factor. The dose escalation scheme will be similar to the SLE study. The primary objective of the study is to evaluate the safety and tolerability of CLN-978 in patients with SjD. Secondary objectives include pharmacokinetics, pharmacodynamics, immunogenicity, and effect on disease activity. The Company expects to initiate the study this quarter. “We are pleased to rapidly progress our global clinical development program for CLN-978, now open for patients living with systemic lupus erythematosus, rheumatoid arthritis, and soon Sjögren’s disease,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “CLN-978, our investigational novel bispecific T cell engager, targets CD19 and offers a highly differentiated approach to deplete B cells deeply with an off-the-shelf product and convenient subcutaneous administration. We are grateful to the investigators in our systemic lupus erythematosus trial who have been enthusiastic partners in our research, and we look forward to opening this new trial to patients with Sjögren’s disease in the U.S.” “Systemic lupus erythematosus and Sjögren’s disease share a complex and often debilitating overlap, leaving many patients struggling with chronic pain, fatigue, and organ involvement,” said Teja Kapoor, MD, Assistant Professor of Medicine at Columbia University College of Physicians and Surgeons in the Division of Rheumatology. “Despite advancements, there remains a significant unmet need for targeted therapies that address the root causes of these autoimmune conditions. I am encouraged by new research approaches such as CLN-978 that aim to modify the disease and offer sustainable relief to patients.” “There are an estimated four million Americans living with Sjögren’s disease, yet it is underdiagnosed and frequently misunderstood,” said Janet Church, President and Chief Executive Officer of the Sjögren’s Foundation. “There are currently no treatments that comprehensively address the complexities of Sjögren’s or slow the progression of the disease. We are encouraged to see new research approaches aimed at providing patients with better treatment options to improve their quality of life.” CLN-978 is being studied in people with SLE in the U.S., Australia, and Europe. CLN-978 will also be studied in people with rheumatoid arthritis at multiple sites in Europe, and in people with SjD at multiple sites in the U.S. and globally. About CLN-978 CLN-978 is a novel, differentiated and 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 B cells, including those with very low CD19 levels. Small in molecular size (65 kDa), 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 human serum albumin to extend serum half-life. CLN-978 was developed by an internal Cullinan team and is a wholly owned asset. CLN-978 has the potential to offer a convenient, off-the-shelf, subcutaneously delivered therapeutic option for patients with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s disease. About Sjögren’s Disease Sjögren’s disease (SjD) is a chronic autoimmune disease that affects the entire body. 1 While SjD most commonly manifests with extensive dryness, it can also present other serious complications including profound fatigue, chronic pain, major organ involvement, swelling of lymph nodes and glands, arthritis, hematologic abnormalities, neuropathies, and an increased risk of lymphoma. 1-4 SjD can occur alone or alongside other autoimmune diseases such as lupus, rheumatoid arthritis, or scleroderma. 1 Studies suggest the prevalence of SjD in the U.S. is estimated to impact over 250,000 individuals, making it one of the most common rheumatic diseases. 5 Many more people have SjD associated with other autoimmune diseases, and some people with SjD go undiagnosed. While available therapies address dryness and other symptoms, currently no approved treatment has been shown to comprehensively slow disease progression or treat all aspects of SjD. 1,2 About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan 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. Cullinan’s portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at https://cullinantherapeutics.com/ , and follow us on LinkedIn and X . SOURCE: Cullinan Therapeutics