• Ongoing Phase 1/1b Clinical Trial Evaluating ONM-501, a Dual-activating STING Agonist, Alone and In Combination with Cemiplimab in Solid Tumors

SOUTHLAKE, Texas–(BUSINESS WIRE)–OncoNano Medicine, Inc. (“OncoNano”), a clinical-stage biotechnology company pioneering the development of polymeric micelles encapsulating anti-cancer payloads, today announced that it will present a Trials in Progress poster at the upcoming 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, Illinois, May 31st–June 4th, 2024.

The poster will highlight the study objectives and design of the ongoing ON-5001 study, a phase 1/1b, multicenter, open label, non-randomized dose escalation and dose expansion to examine the safety, tolerability and optimal dosing of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist, as a monotherapy and in combination with cemiplimab (Libtayo®) in patients with advanced solid tumors and lymphomas (NCT06022029).

Details for the ASCO Annual Meeting Trials in Progress poster presentation are as follows:

Presentation Overview:

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: Julia Foldi, M.D., Ph.D., Assistant Professor of Medicine, Oncology, 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

Once presented the poster will be made available on the OncoNano website at Publications — OncoNano (www.onconano.com/publication).

About ONM-501

ONM-501 is a next generation dual-activating STING (STimulator of INterferon Genes) agonist currently in phase 1 development for the treatment of solid tumors. STING activation mediates a multifaceted type-1 interferon response that is critical in the activation of innate and adaptive immunity against infection and, potentially, cancer. ONM-501 is a pH-sensitive polymer, PC7A, carrying a cyclic guanosine monophosphate–adenosine monophosphate (cGAMP) payload, that together induce prolonged STING activation. In preclinical models, when delivered to the tumor microenvironment, ONM-501 produces dendritic cell maturation and cytotoxic T cells priming, while demonstrating antitumor efficacy. ONM-501 is currently being evaluated in a phase 1, multicenter, open label, non-randomized dose escalation and dose expansion trial to examine the safety, pharmacokinetics, pharmacodynamics, and early activity of ONM-501 as a monotherapy and in combination with an anti-PD-1 checkpoint inhibitor, cemiplimab, in patients with advanced solid tumors and lymphomas. The trial is open in the United States and planned to open in Australia in 2H2024; visit clinicaltrials.gov (NCT06022029) for more details. ONM-501 development has been supported in part by a grant from the Cancer Prevention and Research Institute of Texas.

About OncoNano Medicine

OncoNano Medicine, Inc. is a clinical-stage biotechnology company working to transform cancer therapeutics with its proprietary nanotechnology platform. OncoNano’s ON-BOARD™ polymeric micelle platform is designed to leverage a universal tumor target, namely pH, to precisely deliver anti-cancer payloads to the tumor microenvironment. Our product candidates are designed to improve the pharmacokinetic and pharmacodynamic properties of various payloads from small molecules to large biologics through encapsulation and localized tumor targeting. OncoNano is utilizing ON-BOARD™ to generate a robust oncology pipeline to support novel therapeutic development for patients with high unmet medical needs. Learn more about our platform and pipeline at www.OncoNano.com.


LA Communications

Lauren Arnold