Southlake, Texas—OncoNano Medicine, Inc., a clinical-stage biotechnology innovator, has announced the presentation of its ongoing Phase 1/1b clinical trial at the forthcoming 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. This event is scheduled to take place in Chicago, Illinois from May 31 to June 4, 2024. OncoNano will reveal a Trials in Progress poster elucidating the objectives and design of their ONM-501 study, which evaluates the dual-activating STING agonist, ONM-501.
Study Focus and Objectives
The ON-5001 study, a multicenter, open label, non-randomized trial, aims to explore the safety, tolerability, and optimal dosing of ONM-501. This dual-activating STING (Stimulator of Interferon Genes) agonist is being tested both as a monotherapy and in conjunction with cemiplimab (Libtayo®) in patients with advanced solid tumors and lymphomas. The trial identifier is NCT06022029.
ASCO Presentation Details
- Title: A phase 1 dose-escalation and expansion study of an intratumorally administered dual STING agonist (ONM-501) alone and in combination with cemiplimab in patients with advanced solid tumors and lymphomas.
- Presenter: Dr. Julia Foldi, Assistant Professor of Medicine, Oncology at the University of Pittsburgh Medical Center.
- Session: Developmental Therapeutics—Immunotherapy
- Poster: Poster Board #160a; Abstract TPS2693
- Date/Time: June 1, 2024; 9:00 AM-12:00 PM CDT
About ONM-501
ONM-501 is a next-generation STING agonist currently in Phase 1 development targeting solid tumors. STING activation triggers a robust type-1 interferon response essential for both innate and adaptive immune activation against infections and potentially cancer. ONM-501 is composed of a pH-sensitive polymer, PC7A, loaded with a cGAMP payload that induces sustained STING activation.
In preclinical trials, ONM-501 demonstrated promising results by maturing dendritic cells and priming cytotoxic T cells, effectively exhibiting antitumor efficacy. The ongoing Phase 1 trial, conducted in the USA with plans to expand to Australia in the second half of 2024, investigates the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ONM-501 as a standalone therapy and in combination with cemiplimab in patients with advanced solid tumors and lymphomas. More information can be found on clinicaltrials.gov under the identifier NCT06022029.
About OncoNano Medicine
OncoNano Medicine, Inc. is advancing cancer treatment through its proprietary nanotechnology platform. The ON-BOARD™ polymeric micelle platform is engineered to utilize pH as a universal tumor target, enabling precise delivery of anti-cancer payloads directly to tumor sites. OncoNano is leveraging this platform to enhance pharmacokinetics and pharmacodynamics across a spectrum of payloads, from small molecules to large biologics, thereby facilitating localized tumor targeting. This innovation is fostering the development of a diverse oncology pipeline aimed at addressing significant unmet medical needs.
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