The National Institutes of Health awards a new grant in the amount of $3 million to Therapyx to continue its development of FAPXIL, a first-in-class oral immune therapy for Familial Adenomatous Polyposis

Buffalo, New York- September 7th, 2023. Therapyx is pleased to announce a new SBIR Phase IIb award to continue the development of FAPXILTM, a first-in-class immune therapy for the treatment of familial adenomatous polyposis (FAP). FAPXIL contains the key immune regulatory cytokine interleukin 10, formulated for oral delivery and sustained release in the gut. The award, entitled “IL-10NanoCap for Therapy of Familial Adenomatous Polyposis,” was made by The National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health to Dr. Dominick L. Auci, MBA, Ph.D., VP for R&D at Therapyx. FAP is an autosomal dominant disease, manifests equally in both sexes, and affects up to 50,000 Americans, making it eligible for orphan status. There is no cure.

FAPXIL’s putative immune mechanism of action, the neutralization of disease-causing regulatory T cells, would make it a first-in-class immune therapy with potential applications in other diseases. “This award” said Dr. Dominick L. Auci, “will facilitate our continued development of FAPXIL, a new product aimed at an orphan indication and an unmet medical need. While we are committed to advancing our pipeline, continued new product development underscores the vast potential of our patented ExStaM platform”. The three-year award, in the amount of $1,000,000 per year, will fund technology transfer, drug product manufacturing and toxicology studies recommended by the FDA.

Therapyx continues the development of its other products, PCX12TM. GneX12 TM and NGoXIMTM towards the clinic. The company also has a deep pipeline of discovery-stage products. Moreover, certain products are likely to be eligible for FDA orphan drug designation, as well as 505(b)(2) accelerated regulatory development pathway.

Therapyx is developing a proprietary drug delivery system called ExStaM, based on mild encapsulation of highly potent protein therapeutics into nano/microparticles. The system preserves bioactivity and achieves controlled tissue specific release, reduced toxicity, and shelf-stability. Therapyx’s lead products are aimed at cancer, mucosal infections and immune mediated inflammatory diseases. For more information on Therapyx, Inc. vist the Company’s website at

CAUTIONARY STATEMENT: This press release may contain forward-looking statements concerning the potential and prospects of the Company’s drug discovery program and its drug candidates. Any statement describing a goal, expectation, intention or belief of the Company is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the ability to obtain regulatory approval; the Company’s future capital needs and ability to obtain additional funding; the ability of the Company to protect its intellectual property rights and to not infringe the intellectual property rights of others; the development of competitive products by other companies; and other risks detailed from time to time in the Company’s filings and press releases. Actual results may differ materially from those suggested in this press release.

Share This Article
footer bubble icon

Let's Talk

Interested? Let’s change the future of pharmaceuticals together.

Contact Us