Numiera Therapeutics Announces Orphan Drug Designation and Matching Funds from the State of Colorado to Advance Innovative Brain Cancer Treatment

Numiera Therapeutics, an Innosphere client company and pharmaceutical pioneer in small-molecule drugs for oncology, is proud to announce two major milestones: its lead candidate has received Orphan Drug Designation from the FDA for treating malignant gliomas, and the company has been awarded competitive 2:1 matching funds from the State of Colorado’s Office of Economic Development and International Trade (OEDIT).

The Orphan Drug Designation provides Numiera with a number of incentives, including seven years of post-approval market exclusivity, tax credits, and fee waivers. This designation significantly bolsters the company’s efforts to bring an innovative treatment for brain tumors to clinical trials and to market. The competitively-awarded 2:1 matching funds from OEDIT further underscore the transformative potential of Numiera’s approach to cancer therapy and support the company’s path into clinical development.

Targeting the Engines of Cancer Cells
Numiera is revolutionizing cancer treatment by targeting fatty acid metabolism in cancer cells. Unlike traditional approaches that focus on glucose metabolism, Numiera’s research has uncovered a critical vulnerability in cancer cells that rely on fatty acid oxidation for energy production. By inhibiting the carnitine palmitoyl transferase (CPT1) pathway, Numiera’s lead candidate aims to “stall the engines” of cancer cells, slowing tumor growth and enhancing patient outcomes.

“Our approach represents a paradigm shift in neuro-oncology. By targeting how these cancer cells generate energy through fatty acid oxidation, we are not only addressing an unmet need for glioblastoma patients but also paving the way for broader applications in the field of oncology,” said Dr. Izi Stoll, Co-Founder and CEO of Numiera Therapeutics.

A Promising Path Forward
Numiera Therapeutics has built a strong foundation, including independently-replicated preclinical efficacy data and a comprehensive pharmacology-toxicology dataset for its lead candidate. The company has also filed a patent on a small-molecule combination product to expand its therapeutic pipeline.

“Our goal is clear: to move this science into the clinic and give hope to patients who currently have limited treatment options,” said Dr. Josh Pan, Co-Founder of Numiera Therapeutics and Chief Business Development Officer at Landmark BioVentures. “With the orphan drug designation and investment from the State of Colorado, we are well-positioned to take the next step toward clinical trials.”

Upcoming Opportunities at JPM Life Sciences Investor Conference
Numiera Therapeutics will be attending the annual life sciences investor conference in San Francisco, January 12-16, 2025. The company invites potential investors and partners to connect and learn more about its groundbreaking work in oncology.

For more information, please contact Numiera Therapeutics at [email protected].