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OncoNano Medicine Announces First Patient Dosed in Phase 1 Study Evaluating ONM-501 in Patients with Advanced Solid Tumors and Lymphomas

Dual-activating STING agonist formulated with OMNI™, the company’s core immune activating polymer technology.

SOUTHLAKE, Texas – November 27, 2023 – OncoNano Medicine, Inc. today announced that the first patient has been dosed at University of Pittsburgh Medical Center (UPMC) in its Phase 1 clinical trial evaluating ONM-501, a dual-activating polyvalent STING (STimulator of INterferon Genes) agonist for immuno-oncology applications formulated with OMNI™, the company’s core immune activating polymer technology.

The ONM-501 trial (NCT06022029) is a multicenter Phase 1, dose escalation and dose expansion study in patients with advanced solid tumors and lymphomas. ONM-501 features dual STING activation, with the polymers used to construct the micelles binding to and activating STING alongside the payload critical to activation. This is the synthetic version of the endogenous ligand cGAMP. During the combinatorial dose escalation and expansion cohort segments of the trial, ONM-501 will be dosed in combination with Regeneron’s Libtayo® (cemiplimab-rwlc), an anti-PD-1 monoclonal antibody. OncoNano and Regeneron have entered into a clinical trial supply agreement for this ONM-501 study.

“This marks an exciting milestone in the development of ONM-501 as preclinical data support an enduring activation of STING with the potential for an improved clinical profile compared to earlier experimental cyclic dinucleotide STING agonists,” said Kartik Krishnan, M.D., Ph.D., President & Head of R&D for OncoNano Medicine. “The initiation of our first human trial for ONM-501 brings us one step closer to providing cancer patients with our differentiated approach to targeted therapeutics.”

About OncoNano Medicine
OncoNano Medicine is developing a new class of cancer products that utilize principles of molecular cooperativity in their design to exploit pH as a biomarker to diagnose and treat solid tumors with high specificity. Our polymeric micelles are designed to efficiently deliver oncology payloads to the tumor microenvironment for an enhanced therapeutic index. Our product candidates and interventions are designed to help patients across the continuum of cancer care and include solid tumor therapeutics, a platform of immuno-oncology therapeutics that activate and guide the body’s immune system to target cancer, and agents for real-time image guided surgery.

ONM-501, OncoNano’s first therapeutic program, is a next generation dual-activating STING (STimulator of INterferon Genes) agonist. OncoNano’s second therapeutic development program is ONM-412, the highly potent pro-inflammatory cytokine, interleukin-12 (IL-12), encapsulated in the ON-BOARD™ polymeric micelle system. Additionally, the ON-BOARD™ platform has been used for pegsitacianine, a novel fluorescent nanoprobe that is being studied as a real-time surgical imaging agent for use in multiple cancer surgeries and is advancing towards a pivotal clinical trial to aid in tumor detection of peritoneal carcinomatosis. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas (CPRIT). Learn more at

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