Forkhead BioTherapeutics

Forkhead BioTherapeutics, Inc. is a biotechnology firm focused on developing a regenerative oral therapy for insulin-dependent diabetes. Founded in 2017 by Charles Queenan III, Hua Viola Lin, and Domenico Accili, the company's scientific basis is anchored in research licensed from Columbia University, stemming from discoveries made by Dr. Accili. The company's primary objective is to address the significant market of patients requiring daily insulin management.

The core of Forkhead's strategy revolves around an oral agent, named the Foxin™ pill, designed to induce cell conversion within the patient's own body. This therapeutic approach targets the suppression of the FOXO1 protein, a transcription factor, in specific enteroendocrine cells located in the gut. The intended outcome is to transform these gut cells into functional, glucose-responsive, insulin-producing cells, thereby restoring the body's natural ability to manage glucose metabolism. This method seeks to harness the intrinsic plasticity of these cells to create a self-sustaining source of insulin, potentially replacing the need for external insulin injections. The business model appears centered on the successful clinical development and eventual commercialization of this novel drug candidate.

Prior to founding Forkhead, CEO Charles Queenan III accumulated extensive experience in the life sciences sector, including leadership roles at the JDRF, the Diabetes Investment Fund LLC, and as the founder of a strategic consultancy for life science organizations. This background in diabetes-focused investment and research funding provides relevant experience for guiding the company's strategic direction. The company secured multiple rounds of funding, including seed rounds and grants from entities like the National Institutes of Health (NIH) Small Business Innovation Research (SBIR) program, Viva Biotech, and Kaitai Capital Management. While PitchBook and Tracxn list the company as "Out of Business" or "deadpooled" as of late 2024, the company's website remains active, and it holds a portfolio of active patents, primarily focused in the United States.

Keywords: regenerative medicine, diabetes treatment, insulin-dependent diabetes, oral therapeutic, cell conversion, FOXO1 inhibition, gut cells, insulin production, glucose metabolism, Columbia University, Charles Queenan, Hua Viola Lin, Domenico Accili, Foxin pill, biotechnology, metabolic disease, cell therapy, drug discovery, preclinical, small molecule drug