National Institute of Diabetes and Digestive and Kidney Diseases awards $2,073,687 SBIR FastTrack grant to Therapyx, Inc.
Buffalo, New York- March 7th, 2019. Therapyx is pleased to announce a new SBIR FastTrack award to develop FAPXILTM, a first-in-class immune therapy for the treatment of familial adenomatous polyposis (FAP). FAPXILTM is 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 from 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. It manifests equally in both sexes, and affects up to 50,000 Americans making it eligible for orphan status. There is no cure. Its putative immune mechanism of action, the neutralization of disease causing pathogenic T-cells, would make it a first-in-class immune therapy with potential applications in other diseases as well.
The phase 1 segment of the award, in the amount, $388,880, will fund pivotal formulation studies as well as rodent efficacy work. The second phase, expected to exceed $1,685,000 will fund GMP manufacturing and GLP toxicology studies as recommended by the FDA. “This new award” said Dr. Dominick L. Auci, Vice President for Research and Development. “begins our development of FAPXILTM, a new product aimed at an orphan indication and an un-med medical need. We look forward to completing phase 1 early in 2020 and beginning work on phase 2 by Q3, 2020. While we are committed to advancing our pipeline, continued new product development underscores the vast potential of our patented EXStaM platform”.
Therapyx also continues the development of it other products, NGoXIMTM and GneX12TM towards clinical trials. The company has a deep pipeline of discovery stage products, including PCX12TM, and TPX-EGCG that will soon progress into development. 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 that preserves bioactivity, achieves controlled tissue specific release, reduced toxicity and shelf-stability. Its lead products TreXTAMTM and GneX12TM are aimed at immune mediated inflammatory diseases and mucosal infections, respectively. For more information on Therapyx, Inc. contact the Company’s website at therapyxinc.com
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