Cullinan Therapeutics Approved for Global Phase 1 Trial of CLN-978 in Lupus

Cullinan Therapeutics, Inc. has received approval from the Human Research Ethics Committee (HREC) in Australia to commence a Phase 1 clinical trial testing CLN-978 for systemic lupus erythematosus (SLE). This trial aims to evaluate the safety, pharmacokinetics, and initial clinical activity of CLN-978. The study will be conducted in multiple locations in Australia and other countries worldwide.

Systemic lupus erythematosus is a chronic autoimmune disease affecting approximately 430,000 people globally. The condition leads the immune system to attack the body’s own tissues, resulting in symptoms such as skin rashes, arthritis, swelling, extreme fatigue, and low fevers. One of the severe manifestations of SLE is lupus nephritis, a kidney disease that affects around 40% of SLE patients and has a significant mortality rate. Current treatments for SLE often require lifelong immune suppression and do not typically lead to treatment-free remission.

CLN-978 is a novel CD19 bispecific T cell engager. It is designed to deliver T cell-directed potency with convenient dosing and off-the-shelf access. This therapeutic candidate aims to efficiently target B cells expressing low levels of CD19 due to its high-affinity binding properties. Additionally, the inclusion of a human serum albumin (HSA)-binding domain extends its serum half-life, allowing for subcutaneous delivery and potentially reducing toxicity. CLN-978 has been developed internally by Cullinan Therapeutics and holds the promise of offering a more convenient therapy for patients with autoimmune diseases such as SLE and rheumatoid arthritis.

Jeffrey Jones, MD, MBA, Chief Medical Officer of Cullinan Therapeutics, expressed satisfaction with the approval to begin the global study, particularly in Australia. He emphasized the company's commitment to rapidly advancing its global clinical development strategy for autoimmune diseases and noted the significance of this approval in aiding patients with SLE worldwide. Jones highlighted the optimal targeting (CD19) and modality (T cell engager) of CLN-978, positioning it as a potentially best-in-class therapy. He also underscored the company's eagerness to collaborate with sites, investigators, and patients to advance the development of CLN-978.

The announcement of HREC approval in Australia follows Cullinan Therapeutics' submission of an Investigational New Drug Application to the U.S. Food and Drug Administration for the same study. This step is part of their broader strategy to develop transformative therapeutics targeting autoimmune diseases and cancer.

Cullinan Therapeutics is known for its innovative approach in creating new standards of care for patients. The company's portfolio includes various clinical-stage assets aimed at inhibiting disease drivers or leveraging the immune system to eradicate diseased cells. Their focus spans both autoimmune diseases and cancer, with a strong foundation in oncology, immunology, and translational medicine. By emphasizing rigorous criteria and innovative thinking, Cullinan aims to bring new therapeutic solutions to patients swiftly and effectively.