On April 10, 2024 OncoNano Medicine, Inc. reported a late-breaking poster detailing the preclinical efficacy and safety of muONM-412, an ON-BOARD nanoparticle-encapsulated murine interleukin-12 fusion protein (IL-12Fc), and in vitro characterization of ONM-412, encapsulating human IL-12Fc, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 in San Diego, California (Press release, OncoNano Medicine, APR 10, 2024, View Source [SID1234641985]).
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Despite its potent pleiotropic and well-established anti-cancer effects, the clinical application of IL-12 has been hindered by significant adverse toxicities. OncoNano developed ON-BOARD, an ultra-pH sensitive nanoparticle platform, to shield payloads from systemic exposure and target solid tumors by responding to the highly acidic tumor microenvironment. Encapsulation of payloads like IL-12 by ON-BOARD may provide the opportunity to improve the therapeutic index of a variety of anti-cancer therapies.
"As part of the study presented at AACR (Free AACR Whitepaper), the preclinical safety and activity of muONM-412 were evaluated with the data demonstrating it significantly improved tolerability over unencapsulated IL-12Fc while showing potent antitumor efficacy in mice. Findings also reveal that ONM-412 illustrates favorable stability and pH-responsive IL-12 bioactivity in vitro," said Tian Zhao, Ph.D., Vice President of Research and Development for OncoNano Medicine. "We believe our ON-BOARD ultra-pH sensitive micelle technology can transform the targeted delivery of oncology therapeutics and look forward to continuing the development of new treatments for patients with cancer."
muONM-412 key findings:
Exhibited improved tolerability in vivo compared to unencapsulated IL-12Fc through the observation of reduced body weight loss, absence of liver toxicity and lower plasma IFNy levels.
Induced tumor immune remodeling, with increased infiltration by IFNγ+ and GzmB+ CD8 T and NK cells.
Strong dose-responsive anti-tumor efficacy shown in MC38 tumor-bearing animals.
ONM-412 key findings:
Demonstrated high encapsulation efficiency (>85%) in uniformly distributed particles (Dh<50nm) with 12-month on-going shelf-life stability.
Rapid and complete recovery of IL-12 bioactivity shown <10 minutes after acid-activation.
Confirmed pH-specific release in vitro with a >100-fold activation window between the acid-activated and intact formulations by a HEK reporter assay and an IFNγ induction assay.
Presentation Overview:
TITLE: Preclinical characterization of ONM-412, an ultra-pH sensitive nanoparticle encapsulated IL-12 fusion protein
PRESENTER: Jason Miller, Ph.D., Associate Director, Research Pipeline Development, OncoNano Medicine
Link to the poster may be found on the OncoNano Medicine website at: News – OncoNano Medicine.