Cullinan Therapeutics Receives Approval From EMA to Initiate Phase 1 Trial of a Bispecific CD19 T Cell Engager Administered Subcutaneously in Patients With RA

Cullinan Therapeutics, Inc. recently announced the European Medicines Agency (EMA) approved the company’s Clinical Trial Application (CTA) for CLN-978.

The Phase 1 clinical trial will assess CLN-978 in patients with active, difficult-to-treat rheumatoid arthritis meeting the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria. This open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics, and effects of CLN-978 on disease activity.

“We are pleased to announce the achievement of an important regulatory milestone allowing us to initiate a clinical trial of CLN-978 in rheumatoid arthritis in the second quarter of this year, with leading research institutions in Europe, as we simultaneously advance our systemic lupus erythematosus trial at sites around the globe,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “CLN-978 is the only CD19-targeting T cell engager advancing a global regulatory development plan that includes a U.S. FDA-cleared IND. Delivering the potency of T cell redirecting therapy with the potential for disease modification, CLN-978 offers off-the-shelf access and convenient subcutaneous dosing for improved accessibility and treatment flexibility for patients with a range of autoimmune diseases.”

“Rheumatoid arthritis remains a challenging disease, where effective treatment is critical to altering its course. Although some patients can achieve remission with current therapies, the majority do not achieve this or lose response and become refractory to treatment,” said Ricardo Grieshaber-Bouyer, MD, PhD, MHBA, Professor of Clinical Systems Immunology and Head of the Clinical Trials Unit at FAU Erlangen-Nuremberg, and global Principal Investigator for this trial. “This unmet need underscores the importance of advancing novel approaches like CLN-978, which has the potential to offer deeper B cell depletion than existing therapies. We are excited to collaborate on research that could bring new solutions to patients with refractory rheumatoid arthritis, a population in need of better treatment options.”

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 and rheumatoid arthritis.

Rheumatoid arthritis is a chronic autoimmune disease primarily characterized by inflammation of the joints, which can lead to pain, swelling, stiffness, and permanent joint damage. The disease often affects multiple joints simultaneously, commonly the hands, wrists, and feet, but it can also involve other organ systems. Roughly 5.3 million adults live with rheumatoid arthritis across the US, France, Germany, Italy, Spain, the UK, Japan, and Australia, and the disease is more common in women than men. While disease-modifying antirheumatic drugs (DMARDs) have improved treatment outcomes, many patients continue to rely on chronic immunosuppression, have inadequate responses, experience disease flares, and face significant impairments in quality of life.

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.