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OncoNano and Regeneron Enter into Clinical Trial Supply Agreement for Use of Libtayo® (cemiplimab) in ONM-501 Study

Libtayo to be used in the Phase 1b segment of the ONM-501 trial

SOUTHLAKE, Texas – September 6, 2023 – OncoNano Medicine, Inc. today announced a clinical trial supply agreement with Regeneron for the use of Libtayo® (cemiplimab), a PD-1 inhibitor, in the combination stage of the first human trial of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist and lead therapeutic development candidate.

The ONM-501 first-in-human trial (NCT06022029) is a multicenter Phase 1a/b dose escalation and dose expansion study of intratumoral ONM-501 as monotherapy and in combination with Libtayo in patients with advanced solid tumors and lymphomas. OncoNano is the sponsor of the clinical trial, and Regeneron will supply cemiplimab.

“We believe that our ONM-501 program, which leverages cyclic dinucleotide activation and polyvalent binding to STING to generate both a burst and a sustained immune response, has the potential to show an improved clinical profile as compared to earlier experimental STING agonists,” said Kartik Krishnan, M.D., Ph.D., Chief Medical Officer of OncoNano Medicine. “We are thrilled to collaborate with a leading company such as Regeneron as we continue working toward our mission of delivering targeted therapeutics to cancer patients.”

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

OncoNano’s lead development candidate is pegsitacianine, a novel fluorescent nanoprobe using the ON-BOARD platform, 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. ONM-501, OncoNano’s second development program, is a next generation STING (STimulator of INterferon Genes) agonist that is advancing towards a first in human trial in the first half of 2023. Pegsitacianine and ONM-501 have been supported by grants received from the Cancer Prevention Research Institute of Texas. Learn more at

MacDougall Advisors
Lauren Arnold