Cullinan Therapeutics Gets EMA Nod for Phase 1 Trial of CLN-978 in Rheumatoid Arthritis

Cullinan Therapeutics, a biopharmaceutical company headquartered in Cambridge, Massachusetts, has announced that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA) for the experimental drug CLN-978. This approval allows the company to initiate a Phase 1 clinical trial to evaluate the safety and efficacy of CLN-978 in individuals suffering from active, challenging-to-treat rheumatoid arthritis. This study, anticipated to begin in the second quarter of 2025, will take place at prominent research institutions, including FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Rome.

Rheumatoid arthritis is a debilitating autoimmune disease characterized by inflammation of the joints, leading to pain, swelling, stiffness, and potentially irreversible joint damage. The condition often affects multiple joints, particularly in the hands, wrists, and feet, but can also impact other body systems. Despite advancements in treatment, many patients continue to experience inadequate responses or lose efficacy over time, necessitating new therapeutic options.

The clinical trial will explore various aspects of CLN-978, including its safety profile, pharmacokinetics, pharmacodynamics, and impact on disease activity. CLN-978 represents a novel approach in the treatment landscape; it is a CD19xCD3 bispecific T cell engager designed to redirect T cells to destroy CD19-expressing B cells, which play a significant role in autoimmune diseases. This bispecific antibody is engineered with high-affinity binding to CD19, enabling it to target B cells with low CD19 expression effectively. The drug is also designed for convenient subcutaneous administration, providing an off-the-shelf treatment option.

Jeffrey Jones, MD, MBA, Chief Medical Officer at Cullinan Therapeutics, emphasized the significance of this regulatory milestone, highlighting the drug's potential to modify disease progression and provide easier access and adaptability for patients with autoimmune conditions. CLN-978 is particularly noteworthy as it is the only CD19-targeting T cell engager with a comprehensive global regulatory development plan, including clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application. This positions CLN-978 as a pioneering therapy in addressing unmet needs in autoimmune diseases.

Ricardo Grieshaber-Bouyer, MD, PhD, MHBA, who serves as the global Principal Investigator for the study, emphasized the importance of exploring innovative therapies like CLN-978, which could potentially offer more profound B cell depletion compared to existing treatments. The collaboration aims to develop solutions for patients with refractory rheumatoid arthritis, a group that currently lacks effective treatment options.

Cullinan Therapeutics has built an extensive portfolio of clinical-stage assets targeting key disease drivers or leveraging the immune system to combat diseases, especially in the fields of autoimmune disorders and cancer. The company applies rigorous selection criteria to ensure only the most promising therapeutic candidates progress through development stages, ultimately aiming for commercialization. With a strong foundation in oncology, immunology, and translational medicine, Cullinan Therapeutics is committed to creating transformative therapies that deliver new solutions to patients worldwide.