Actym Therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to start a Phase 1 clinical trial of its lead drug candidate, ACTM-838.
BERKELEY, Calif., May 30, 2024 /PRNewswire/ -- Actym Therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to start a Phase 1 clinical trial of its lead drug candidate, ACTM-838. The open-label monotherapy dose escalation study is designed to evaluate the safety, tolerability, payload delivery, and preliminary anti-tumor activity of escalating doses of ACTM-838, which represents the first drug candidate based on the company’s proprietary S. Typhimurium-Attenuated Cancer Therapy (STACT™) platform to reach the clinic. ACTM-838 delivers immunomodulatory payloads, engineered IL-15plex (IL-15/ IL-15Ra) and STING, specifically to tumor-resident phagocytic antigen-presenting cells (APCs) in the tumor microenvironment (TME). “The immunosuppressive TME is a key challenge in the treatment of solid tumors, limiting the efficacy of many potentially effective anticancer drugs. Actym Therapeutics has developed an innovative technology to specifically deliver and express constitutively active STING in tumor-resident myeloid cells using a systemically administered therapy. IL-15plex expression adds complementary activity on B, T, and NK cells, achieving durable anti-tumor immunity,” said Jason J. Luke, MD, FACP, a leading international physician-scientist specializing in the clinical development of immunotherapies for solid tumors. “Actym’s approach to modulating the TME has a unique potential to overcome these immunological barriers. Their lead candidate, ACTM-838, was shown to be safe and effective in preclinical studies and is now ready to enter the clinic.” “The IND clearance for ACTM-838 is a major milestone for Actym and potentially a significant step forward in harnessing the power of immunotherapy to treat patients with solid tumors more effectively,” said Tom Smart, CEO of Actym. “It is terrific to see the vision and impressive work pioneered by Actym’s founders translated into a promising clinical-stage asset. As we advance our lead clinical program, we also look forward to further expanding the potential applications of our STACT™ biological platform by developing new product candidates in-house and in collaboration with pharmaceutical companies.” The Phase 1 (NCT06336148) open-label monotherapy dose escalation study with ACTM-838 will be conducted at clinical sites in the United States and Australia and will enroll patients with advanced solid tumors who have failed prior lines of therapy and have no clinically beneficial treatment options. About STACT™ Biological Platform About ACTM-838 Engineered to be auxotrophic for adenosine metabolites, ACTM-838 localizes to the TME where it survives and proliferates in the adenosine-rich tumor milieu. It is phagocytosed by APCs and delivers IL-15-plex and eSTING transgenes to these cells that subsequently express the proteins in the local TME. Phagocytosis of the accumulated STACT chassis in the TME initiates activation of innate immunity. Local expression of eSTING further stimulates the innate immune system by triggering type I interferon (IFN) pathways and other cytokines. This switches the immunosuppressive TME from a pro-tumor Th2/M2 TME to an anti-tumor Th1/M1 and activated NK immune phenotype, priming a new T cell response. Locally expressed IL-15-plex additionally supports the activation and viability of NK and B cells as well as existing and newly primed T cells. Through this multifaceted mechanism, ACTM-838 engages both innate and adaptive immunity to generate a comprehensive, robust, and durable anti-tumor immune response in the body. The Phase 1 clinical study of ACTM-838 is designed to establish safety, payload delivery, and proof-of-mechanism of the STACTÔ biological platform and ACTM-838 in humans. About Actym Therapeutics Contacts Media Requests for Actym View original content to download multimedia:https://www.prnewswire.com/news-releases/actym-therapeutics-announces-ind-clearance-for-phase-1-clinical-trial-investigating-lead-program-actm-838-in-patients-with-solid-tumors-302159288.html SOURCE Actym Therapeutics Inc. |