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Cullinan Therapeutics

Cullinan Therapeutics

Cullinan Therapeutics, Inc., a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced the upcoming presentation of preclinical data for CLN-978, a novel CD19xCD3 bispecific T cell engager, at American College of Rheumatology (ACR) Convergence 2024, taking place in Washington, D.C. from November 14-19, 2024.

“These preclinical data show that CLN-978 is a highly potent T cell engager that leads to deep B cell depletion, supporting the broad development of CLN-978 as a potential new therapeutic option for patients with autoimmune diseases,” said Jeffrey Jones, MD, MBA, Chief Medical Officer, Cullinan Therapeutics. “We look forward to continued collaboration with investigators and the patient community as we initiate our global Phase 1 clinical trial of CLN-978 in systemic lupus erythematosus and deliver on our mission to bring new standards of care to patients.”

The details of the presentation include:
Title: CLN-978, a CD19-directed T Cell Engager (TCE), Leads to Rapid and Deep B Cell Depletion and Has Broad Potential for Development in Autoimmune Diseases
Presenting Author: Stephen Wax, MD, PhD, Vice President, Clinical Development, Cullinan Therapeutics
Poster Number: 0003
Session Type: Poster Session A
Session Date and Time: November 16, 2024, 10:30 AM-12:30 PM Eastern Time
Session Title: B Cell Biology & Targets in Autoimmune & Inflammatory Disease Poster

On October 15, Cullinan Therapeutics announced U.S. Food and Drug Administration clearance of an Investigational New Drug Application for its global Phase 1 clinical trial to evaluate CLN-978 for the treatment of SLE to proceed in the U.S. Cullinan previously announced Human Research Ethics Committee (HREC) approval to initiate the global clinical trial in Australia (NCT06613360).

About CLN-978
CLN-978 is a novel, highly potent CD19xCD3 bispecific T cell engager. CLN-978 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, including those with very low CD19 levels. Small in molecular size (65 kDa), 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 human serum albumin to extend serum half-life. 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, subcutaneously delivered therapeutic option for patients with autoimmune diseases such as SLE and rheumatoid arthritis.

About Systemic Lupus Erythematosus
Systemic lupus erythematosus (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.1,2 The prevalence of SLE in the US is estimated at 160,000 to 320,000 cases and SLE affects approximately 3.4 million individuals globally.3,4 SLE is more prevalent in women and people of color. It occurs most often in people between the ages of 15 and 45 years, but can occur in childhood or later in life as well. 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.

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