Cullinan Therapeutics Receives Approval to Initiate its Global Phase 1 Clinical Trial for the Treatment of Systemic Lupus Erythematosus

Cullinan Therapeutics, Inc. received Human Research Ethics Committee (HREC) approval in Australia to initiate its global Phase 1 clinical trial to evaluate CLN-978, its CD19xCD3 bispecific T cell engager, for the treatment of systemic lupus erythematosus (SLE).

SLE affects approximately 430,000 individuals globally.¹ Currently available treatments do not routinely induce treatment-free remission, with most patients requiring lifelong immune suppression to treat symptoms without modifying the course of disease. CLN-978 is a novel CD19 bispecific T cell engager designed to deliver T cell-directed potency with off-the-shelf access and convenient dosing.

“We are pleased to receive this first approval to initiate our global study of CLN-978 in SLE in Australia,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “We have been focused on rapidly executing our global clinical development strategy for autoimmune diseases, and today’s approval is an important step to treat patients around the world living with SLE. Our investigational candidate, CLN-978, combines the optimal target (CD19) and modality (T cell engager) for a highly differentiated, potentially best-in-class program​. We look forward to working with all our sites, investigators, and patients as we continue to expeditiously progress development of CLN-978 in Australia and beyond.”

On September 16, Cullinan Therapeutics announced the submission of an Investigational New Drug Application to the U.S. Food and Drug Administration for this study.

CLN-978 is a novel, highly potent, half-life extended CD19xCD3 bispecific T cell engager construct. CLN-978 potently 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 expressing very low CD19 levels. A human serum albumin (HSA)-binding domain increases the serum half-life of CLN-978 and, with subcutaneous delivery, permits more patient-friendly dosing and potentially reduced toxicity. 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 HSA. 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 therapeutic option for patients with autoimmune diseases such as SLE and rheumatoid arthritis.

SLE is a chronic, heterogeneous autoimmune disease in which the immune system attacks a patient’s own tissues. The most common manifestations of SLE include skin rashes, arthritis, swelling in the feet, and around the eyes, extreme fatigue, and low fevers. Lupus nephritis (LN) is a kidney disease and the most common severe manifestation of SLE. Approximately 40% of patients with SLE develop LN, which has a 10-year 30% mortality rate. SLE is more prevalent in women, people of color, and women of childbearing age. SLE affects approximately 430,000 individuals globally.¹ Currently available treatments do not routinely induce treatment-free remission, and most patients require lifelong immune suppression that treats symptoms without modifying the course of disease.

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. For more information, visit https://cullinantherapeutics.com/.