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OncoNano Medicine Announces Positive Preclinical Data for ONM-501 at AACR Virtual Conference on Tumor Immunology and Immunotherapy

SOUTHLAKE, Texas – October 8, 2021OncoNano Medicine, Inc. announced positive results from its preclinical study of ONM-501, a novel dual-activating polyvalent STING agonist for immuno-oncology applications. The data, presented at The American Association for Cancer Research (AACR) Virtual Conference on Tumor Immunology and Immunotherapy, demonstrate strong efficacy in multiple tumor models.

“We are excited by the positive preclinical results for ONM-501 recently presented at AACR. STING plays a crucial role in mediating our innate immune systems but has consistently been a challenging pathway to target,” said Martin Driscoll, Chief Executive Officer of OncoNano Medicine, Inc. “We are encouraged by the constellation of preclinical data that demonstrates ONM-501 could have a clinical profile differentiated from earlier generation cyclic dinucleotide STING agonist compounds. The novel ONM-501 formulation consisting of our STING activating pH-sensitive micelle loaded with an endogenous agonist has demonstrated a capability to produce a dual and prolonged activation of STING while recruiting a robust adaptive immune response to the tumor microenvironment. We look forward to continuing our IND-enabling activities as we advance ONM-501 to first in human trials.”

Presentation Overview
TITLE: ONM-501 ― A synthetic polyvalent STING agonist for cancer immunotherapy

PRESENTER: Qingtai Su, Ph.D., Senior Scientist, OncoNano Medicine, Inc.

ONM-501 demonstrated antitumor efficacy in six different syngeneic mouse models from different tissues of origin (MC38, 4T1, TC-1, B16-F10, CT26 and A20). The animals were treated intratumorally with ONM-501 as a monotherapy or in combination with PD-1 blockade. The findings indicate that ONM-501 demonstrated:

  • Strong antitumor efficacy across all tumor models tested as a mono or combo therapy
  • Significantly improved efficacy with increased complete response in several modelswhen combined with PD-1 blockade
  • Successful combination of a novel, proprietary STING activating micelle with theendogenous cGAMP potentially offers a synergistic immunotherapy strategy against cancer

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, 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


Lauren Arnold