The National Institutes of Health Awards a grant in the amount of $3,000,000 to TherapyX, Inc.
Buffalo, New York- June 20, 2017. TherapyX is pleased to announce a SBIR Phase IIb award to continue development of TreXTAMTM it’s first-in-class immune therapy for the treatment of inflammatory bowel disease (IBD) and potentially systemic lupus erythematosus (SLE). TreXTAMTM is a combination of particulate transforming growth factor beta 1 (TGFb) and all-trans retinoic acid (ATRA) formulated for oral delivery. The award entitled “Delivery of Nanoencapsulated TGFbeta and ATRA for the Treatment of IBD” was made from The National Institute of Allergy and Infectious Diseases of the National Institutes of Health to Dr. Dominick L. Auci, MBA, Ph.D., VP for R&D at TherapyX. It will fund additional IND-enabling formulation studies as well as rodent and non-human primate efficacy and GLP toxicology studies recommended by the FDA at our last pre-IND meeting
“We are thrilled with this new award” said Dr. Dominick L. Auci, Vice President for Research and Development. “and excited about continuing development of TreXTAMTM. Its putative mechanism of action, the induction, activation and stabilization of regulatory T cells, would make it a first-in-class immune therapy for IBD with potential applications in autoimmune diseases such as SLE. This new award will allow us to adequately respond to previous FDA guidance and enable first-in-man phase I/II clinical studies. Importantly, the work will substantially de-risk the product, making it more attractive to potential partners.”
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 ATRAXIMTM, FAPXIL and TPX-ECGC 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 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 NGoXIMTM and TreXTAMTM are aimed at mucosal infections and immune mediated inflammatory diseases, respectively. For more information on TherapyX, Inc. contact the Company’s website at therapyxinc.com
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.