Full Press Release Details
Cullinan Therapeutics Receives Approval to Initiate its Global Phase 1 Clinical Trial of CLN-978 for the Treatment of Systemic Lupus Erythematosus
Phase 1 clinical trial is designed to assess the safety, pharmacokinetics and initial clinical activity of CLN-978 for patients with systemic lupus erythematosus
The trial will be conducted in multiple sites in Australia as well as other countries around the world
CAMBRIDGE, Mass., September 17, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today 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.
About Systemic Lupus Erythematosus (SLE)
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.
About Cullinan Therapeutics
Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company's beliefs and expectations regarding: our preclinical and clinical developments plans and timelines, the clinical and
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[1] GlobalData estimates. Includes U.S., EU5 (United Kingdom, Germany, France, Spain, Italy), Japan, Australia.