On November 27, 2023 OncoNano Medicine, Inc. reported 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 (Press release, OncoNano Medicine, NOV 27, 2023, View Source [SID1234637975]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."