On November 10, 2022 OncoNano Medicine, Inc. reported the presentation of data on its pre-clinical candidate ONM-501 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in Boston, Massachusetts (Press release, OncoNano Medicine, NOV 10, 2022, View Source [SID1234623774]). ONM-501, OncoNano’s lead therapeutic program in development, is a dual-activating STING (Stimulator of Interferon Genes) agonist advancing towards a first in human trial planned to be initiated in the first half of 2023.
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Previously published data has demonstrated the differentiated mechanism of ONM-501 with dual "burst" and "sustained" STING activation, enhanced cytosolic delivery and tumor retention through encapsulation of an endogenous STING agonist – cGAMP with OnocoNano’s proprietary STING-activating OMNI polymeric micelles. These two mechanisms operate in concert to activate STING and potentiate this activation, providing potent anti-tumor efficacy as a monotherapy and in combination with anti-PD1 in multiple preclinical mouse models with both "hot" and "cold" tumor microenvironments. In vivo PD analysis confirmed STING activation, enhanced tumor lymphocyte infiltration, and tumor PD-L1 upregulation by ONM-501, and demonstrated the target-engagement activity of ONM-501 in multiple species, and high tolerability in rodents and non-human primates, making it a promising therapeutic candidate for clinical evaluation.
"The results presented here confirm many of our hypotheses regarding the potential of ONM-501 to provide a robust therapeutic index of immune activating STING activity that may be differentiated from other STING agonists. This is why we are so buoyed by the continued positive preclinical results for ONM-501, underscoring its potential as a monotherapy and in combination with anti-PD1 in multiple ‘hot’ and ‘cold’ murine syngeneic tumor models," said Kartik Krishnan, MD, PhD, Chief Medical Officer at OncoNano. "We look forward to bringing ONM-501 to the clinic in 2023 as we continue on our mission to deliver critical new treatments to patients in need."