FDA Clears Cullinan Therapeutics' CLN-978 for Subcutaneous Use in Lupus Patients

Cullinan Therapeutics, Inc., a company developing targeted therapies across a range of modalities, has announced FDA clearance for its Investigational New Drug (IND) Application for CLN-978. This approval allows the company to commence a global Phase 1 clinical trial in the U.S. to investigate CLN-978 in patients suffering from moderate to severe systemic lupus erythematosus (SLE).

The clinical trial is designed to enroll patients who have a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or higher and who have not responded adequately to at least two prior treatments, which must include an immunosuppressive or biologic agent. The trial is structured in two parts: Part A will focus on dose escalation to identify the target dose for further development with an initial dose of 10 micrograms, whereas Part B will explore multiple dosing schedules based on data from Part A.

The primary goal of this study is to evaluate the safety of CLN-978 in treating active, moderate to severe SLE. Secondary objectives include examining pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity. Jeffrey Jones, MD, MBA, Chief Medical Officer at Cullinan Therapeutics, expressed the company's enthusiasm about moving forward with the clinical trial in the U.S. He highlighted the significant unmet medical need in SLE treatment, as current therapies often fail to control disease activity fully and prevent long-term organ damage. CLN-978, a bispecific T cell engager targeting CD19, offers a unique approach with the potential for potent T cell redirecting therapy, combined with the convenience of off-the-shelf access and subcutaneous administration.

Earlier in September, the company received clearance to initiate its global clinical trial in Australia (NCT06613360).

CLN-978 is a novel and highly potent bispecific T cell engager that binds with high affinity to CD19 on B cells and CD3 on T cells, facilitating the destruction of B cells expressing CD19. It is engineered to target B cells effectively, even those with low CD19 levels, and is designed to be small in size to enhance its binding properties. Additionally, the molecule includes a single-domain antibody binding to human serum albumin, which extends its serum half-life. CLN-978 was developed internally by Cullinan and is a wholly-owned asset of the company. It has the potential to provide an easy-to-administer, off-the-shelf treatment option for autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis.

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease where the immune system mistakenly attacks the body's own tissues. Common symptoms include skin rashes, arthritis, swelling, fatigue, and low fevers. Lupus nephritis (LN), a severe manifestation of SLE, affects the kidneys and occurs in about 40% of SLE patients, carrying a 30% mortality rate over ten years. SLE affects between 160,000 to 320,000 people in the U.S. and approximately 3.4 million individuals globally. It is more common in women and people of color and typically occurs between the ages of 15 and 45, though it can also develop in children or later in life. Current treatments often require lifelong immune suppression and do not generally induce treatment-free remission.

Cullinan Therapeutics, Inc. is committed to developing innovative therapies for autoimmune diseases and cancer. The company has built a diverse portfolio of clinical-stage assets aimed at inhibiting key disease drivers or harnessing the immune system to eradicate diseased cells. By applying rigorous criteria to advance only the most promising candidates, Cullinan aims to bring transformative therapies to patients swiftly and effectively.