UTR Therapeutics Inc Announces IND submission to the US FDA for a First-in-Human Clinical Trial of an mRNA destabilizing drug targeting c-MYC driven cancers

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NEW YORK, May 08, 2025 (GLOBE NEWSWIRE) — UTR Therapeutics Inc (UTRx Inc.), a drug development biotech company based in New York City, USA is pleased to announce a new milestone, the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for UTRxM1-18, a novel therapeutic approach for targeting c-MYC driven cancers. This milestone, driven by our innovative platform 3’UTR engineering technology, precisely targets specific transcripts and degrades them. This technology supports our vision of changing how we treat and live beyond cancer.

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UTRxM1-18 harnesses UTR’s proprietary Ultra-Targeted RNA platform to degrade disease-causing transcripts with ultra-high precision and specificity. Pioneered by Dr. Chidiebere Awah MD, PhD, our CEO and Principal Investigator, UTRxM1-18 targets oncogenic c-MYC by recognizing specific motifs and switching the ribosome machinery from a translational to a degradation program utilizing molecular machinery only present in tumor cells. This results in high fidelity targeting of c-MYC driven tumor cells but with excellent safety and tolerability in normal healthy cells both in-vitro and in-vivo. Our first-in-human Phase 1 trial is slated for 2026, pending FDA approval.

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c-MYC is over-expressed in more than 75% of human cancers, however prior attempts to target c-MYC have been hindered in part due to off-target effects. UTRxM1-18 overcomes these limitations by relying on molecular machinery not found in normal healthy cells. In the upcoming human trial, UTRxM1-18 will be used to target c-MYC driven tumors including triple negative breast cancer, pancreatic cancer, colorectal cancer and ovarian cancer. In animal studies, UTRxM1-18 showed robust dose-dependent efficacy in targeting human-derived tumors from each of these cancer subtypes with no dose-limiting toxicities even at the highest doses tested.

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“This IND submission is a seismic leap forward and offers patients an option where there are none,” said Dr. Awah. “Our technology’s unique ability to therapeutically degrade mRNA transcripts redefines what’s possible in biotech. We’re not just innovating—we’re rewriting the future of cancer and disease,” said Dr David T Asuzu MD, PhD, MPH, Chief Medical Officer (Adult Cancers), UTRx Inc. “The validation data supports the technological abilities of engineering mRNA stability elements on the 3’UTR of oncogenes for therapeutic use,” said Dr. Kevin Struhl PhD, co-inventor of the technology and advisor to UTRx Inc, and Professor of Biological Chemistry and Molecular Pharmacology at Harvard University.

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UTRx Inc. is thrilled to share this milestone of IND submission with both our institutional and retail investors. We welcome connections with external partners in our quest for bringing transformative medicines through clinical development. Explore opportunities to support our mission, including unique investment vehicles for retail investors. Contact us to learn how you can contribute to our vision and share our promising future.