Cullinan Therapeutics Announces Preclinical Data for CLN-978, a CD19-directed T Cell Engager, to be Presented at ACR Convergence 2024

Core Viewpoint - Cullinan Therapeutics is advancing the clinical development of CLN-978, a novel CD19xCD3 T cell engager, for the treatment of autoimmune diseases, particularly systemic lupus erythematosus (SLE) [1][4]. Group 1: CLN-978 Preclinical Data - New in vitro preclinical data indicate that CLN-978 induces similar T cell activation, target B cell depletion, and cytokine production in human peripheral blood mononuclear cells from SLE and rheumatoid arthritis patients compared to healthy volunteers [2]. - The studies suggest that the previously observed cytokine window in B-NHL model systems is expected to be preserved in SLE and RA patients, indicating a broad therapeutic index [3]. Group 2: Clinical Development Plan - The U.S. FDA has cleared an Investigational New Drug Application for a global Phase 1 clinical trial of CLN-978 in patients with moderate to severe SLE, with Human Research Ethics Committee approval also obtained in Australia [5]. - The trial will enroll patients with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater, who have had an inadequate response to at least two treatments [6]. - The primary objective of the study is to evaluate the safety of CLN-978, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity, with initial clinical data expected in Q4 2025 [7]. Group 3: Investor Engagement - Cullinan will host an in-person investor event on November 16, 2024, where management will discuss the company's developments and engage with analysts and institutional investors [8]. Group 4: About CLN-978 - CLN-978 is a highly potent bispecific T cell engager designed to efficiently target B cells, including those with low CD19 levels, and can be delivered subcutaneously, offering off-the-shelf convenience [9]. Group 5: About Systemic Lupus Erythematosus - Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting approximately 160,000 to 320,000 cases in the U.S. and around 3.4 million individuals globally, with significant morbidity and mortality associated with its severe manifestations [10]. Group 6: About Cullinan Therapeutics - Cullinan Therapeutics is focused on creating new standards of care for patients through a diversified portfolio of clinical-stage assets targeting autoimmune diseases and cancer, leveraging deep expertise in oncology and immunology [11].