Cullinan Therapeutics presented preclinical data for CLN-978, a novel CD19xCD3 bispecific T cell engager, demonstrating potential for B cell depletion across multiple autoimmune diseases like rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus.

Cullinan Therapeutics will participate in a fireside chat at the Stifel 2025 Virtual Immunology and Inflammation Forum, presenting insights into their clinical-stage therapeutic assets targeting autoimmune diseases and cancer.

Cullinan Therapeutics announced ongoing clinical trials for CLN-978 and velinotamig in autoimmune diseases, shared zipalertinib oncology results, and appointed two new board members while maintaining a strong cash position of $510.9 million.

Cullinan Therapeutics received approval from the European Medicines Agency to initiate a Phase 1 trial of its bispecific CD19 T cell engager CLN-978 in patients with rheumatoid arthritis. The trial will be conducted at research institutions in Germany and Italy, and CLN-978 is also being studied for systemic lupus erythematosus.

Cullinan Therapeutics reported progress in its pipeline, including initial clinical data for CLN-978 in Systemic Lupus Erythematosus expected in Q4 2025 and positive results from the pivotal Phase 2b study of zipalertinib. The company ended 2024 with $606.9 million in cash, providing runway into 2028.

Cullinan Therapeutics will present new preclinical data for its CD19-directed T cell engager CLN-978 at the ACR Convergence 2024 conference. The data show CLN-978 induced similar T cell activation, target B cell depletion, and cytokine production in cells from patients with SLE or RA as compared to healthy volunteers, suggesting a broad therapeutic potential. Cullinan plans to initiate a global Phase 1b study of CLN-978 in patients with moderate to severe SLE.

Amgen's rocatinlimab outperformed placebo in an atopic dermatitis trial, but the data fell short of market leader Dupixent's results, raising concerns about its competitiveness. Uplizna, Amgen's treatment for myasthenia gravis, showed promising results in a Phase 3 trial, with potential advantages like less frequent dosing.

Cullinan Therapeutics presented positive updated data from its pivotal Phase 2b study of zipalertinib in patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations who progressed on prior amivantamab treatment. The data showed a consistent objective response rate of 40% and a manageable safety profile.

Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment

CAMBRIDGE, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that Nadim Ahmed, Chief Executive Officer and Jeffrey Jones, MD, MBA, Chief Medical Officer, will participate in a fireside chat at the TD Cowen 5th Annual Oncology Innovation Summit: Insights for ASCO & EHA, being held virtually on May 28 and 29, 2024.

Preliminary data from CLN-619 in combination with checkpoint inhibitor pembrolizumab show objective responses in patients with tumor types that are typically unresponsive to pembrolizumab, such as non-small cell lung cancer (NSCLC) with oncogenic mutations

Combination and monotherapy solid tumor dose escalation data for CLN-619 to be presented in a poster session at ASCO 2024 Annual Meeting