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OncoNano Medicine Announces Pre-Clinical Data for Dual-Activating STING agonist at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

ONM-501 shown to be promising immuno-therapeutic candidate for clinical evaluation in solid tumors

SOUTHLAKE, Texas – November 10, 2022 – OncoNano Medicine, Inc. today announced the presentation of data on its pre-clinical candidate ONM-501 at the 37th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in Boston, Massachusetts. 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.

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.”

Presentation Overview

Title: ONM-501, a Polyvalent STING Agonist, Exhibits Anti-Tumor Efficacy with Increased Tumor T-Cell Infiltration in Mice and is Well Tolerated in Rats and Non-Human Primates
Date: November 10 – 11, 2022
Time: 9:00 am – 9:00 pm EST
Location: Poster Hall, Boston Convention and Exhibition Center, Boston, MA

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 immune- 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 ONBOARD platform, that is currently under study in Phase 2 clinical trials as a real-time surgical imaging agent for use in multiple cancer surgeries. 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


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