Pharma Focus America

Actym Therapeutics Receives Regulatory Approval for Phase 1 Clinical Trial of ACTM-838, its Lead Program, in Patients with Solid Tumors

Friday, May 31, 2024

Actym Therapeutics has attained approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, marking a significant leap forward for its lead drug candidate, ACTM-838. This achievement allows the company to commence a Phase 1 clinical trial, focusing on evaluating the safety, tolerability, and initial effectiveness of ACTM-838.

ACTM-838 is a pioneering treatment based on Actym's proprietary S. Typhimurium-Attenuated Cancer Therapy (STACT™) platform. This platform aims to address the challenge of the immunosuppressive tumor microenvironment (TME) by delivering immunomodulatory payloads directly to tumor-resident antigen-presenting cells (APCs).

Dr. Jason J. Luke, an expert in immunotherapy for solid tumors, emphasizes the potential of Actym's approach in overcoming barriers posed by the TME. He highlights the innovative combination of ACTM-838's payload delivery, including engineered IL-15plex and STING, which has demonstrated promising results in preclinical studies.

Tom Smart, CEO of Actym, expresses enthusiasm for the progression of their lead clinical program and anticipates further exploration of the STACT™ platform's potential in collaboration with pharmaceutical partners.

The Phase 1 trial, designated as NCT06336148, will enroll patients with advanced solid tumors, offering a new treatment option for those who have exhausted other therapeutic avenues.

The STACT™ platform represents a versatile approach, allowing targeted delivery of various therapeutic payloads to the TME. ACTM-838, as the first clinical asset utilizing this platform, holds promise in enhancing anti-tumor immunity through its unique mechanism of action.

Engineered to thrive in the tumor microenvironment, ACTM-838 selectively delivers immune-modulatory payloads to APCs, activating both innate and adaptive immune responses. This comprehensive approach aims to transform the immunosuppressive TME into an anti-tumor environment, fostering durable immune-mediated tumor regression.

Overall, the Phase 1 clinical trial of ACTM-838 seeks to establish its safety profile, validate payload delivery, and demonstrate proof-of-mechanism, paving the way for further development in treating solid tumors.



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