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OncoNano Medicine Begins Phase 1 Trial of ONM-501 in Advanced Solid Tumors and Lymphomas

Tuesday, November 28, 2023

OncoNano Medicine, Inc. has announced the initiation of its Phase 1 clinical trial at the University of Pittsburgh Medical Center (UPMC) for ONM-501, a polyvalent STING agonist designed for immuno-oncology applications and formulated with OMNI™, the company's core immune activating polymer technology.

The Phase 1 trial (NCT06022029) is a multicenter study involving dose escalation and expansion, focusing on patients with advanced solid tumors and lymphomas. ONM-501, featuring dual STING activation, utilizes polymers in micelle construction to bind and activate STING in conjunction with the payload crucial for activation—a synthetic version of the endogenous ligand cGAMP. The trial will include combinatorial dose escalation and expansion cohorts, with ONM-501 administered in combination with Regeneron’s Libtayo® (cemiplimab-rwlc), an anti-PD-1 monoclonal antibody. OncoNano and Regeneron have established a clinical trial supply agreement for this joint study.

Dr. Kartik Krishnan, President & Head of R&D for OncoNano Medicine, expressed enthusiasm about this development, stating, "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." He further highlighted that the initiation of the first human trial for ONM-501 brings them closer to providing cancer patients with a differentiated and targeted therapeutic approach.



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