(Salt Lake City, February 12, 2025) – GlycoMira Therapeutics announced that the Food and Drug Administration has accepted the Company’s Investigational New Drug filing, (IND) to commence first-in-human Phase 1a Clinical Trials of its novel first-in-class anti tumor therapeutic. In pre-clinical studies, GlycoMira’s lead compound, GM-1111, has been shown to significantly improve the effectiveness of radiation in reducing tumor volume, along with protecting healthy tissue from radiation-induced damage in head and neck squamous cell carcinoma models. Other pre-clinical studies suggest that GM-1111 is effective in inhibiting tumor growth in

colorectal, renal, breast, and lung cancer models.

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The Company will soon begin Phase 1a clinical investigations of GM-1111 in combination with radiation for the treatment of head and neck cancers and the mitigation of radiation-induced oral mucositis. According to Allied Market Research 2021, the global head and neck cancer treatment market is predicted to reach $2.99B by 2030. American Cancer Society 2023 Cancer Facts and Figures Annual Report indicates that more than 70,000 new cases occur annually in the US. There is a high incidence of re-occurrence, and over 80% of patients will develop severe oral mucositis during treatment, a complication arising from the standard of care that

substantially degrades quality of life and compromises treatment and prognosis.

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Commenting on the FDA’s letter of authorization, William P. Tew, PhD, the Company’s CEO stated, “Moving to clinical investigation is a major step forward in our drug development program. In the last few decades, therapeutic strategies that target the specific molecules responsible for the initiation or amplification of cancer progression have shown great success. As such, the concept of multi-target drugs has emerged as a promising therapeutic strategy for the treatment of many cancers. Our lead asset, GM-1111, is unique among oncology therapeutics in its multi-modal activity. Pre-clinical studies indicate that GM-1111 inhibits multiple molecular factors in the tumor micro-environment that contribute to the development and growth of solid tumors, as well as treatment-resistant cancers. Simultaneous action against these molecular and cellular components will ultimately lead to the improved therapeutic efficacy and outcomes for patients. GM-1111 has the potential to establish a new paradigm for in the treatment of solid tumors.”

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About GlycoMira Therapeutics:

GlycoMira Therapeutics is a Salt Lake City based clinical biopharmaceutical company focused on the development of innovative immune-modulating and anti-inflammatory therapeutics for oncology applications. GlycoMira's technology is exclusively licensed from the University of Utah. To date, GlycoMira has received over $10M in NIH awards to support the development of GM-1111 for unmet medical needs