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

On September 6, 2023 OncoNano Medicine, Inc. reported 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 (Press release, OncoNano Medicine, SEP 6, 2023, View Source [SID1234634947]).

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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."