The National Institutes of Health awards a grant in the amount of $1,793,879 to Therapyx, Inc.
Buffalo, NY-March 14, 2017 Therapyx is pleased to announce a new SBIR Phase II award to continue development of NGoXIMTM, a completely novel prophylactic vaccine against genital tract infections including Gonorrhea. The award entitled “Experimental Gonococcal Vaccine” will fund preclinical studies and manufacturing scale-up of the company’s current vaccine formulation. NGoXIMTM is a prophylactic vaccine product aimed at preventing infections, and is in addition to and separate from the company’s GneX12TM product, aimed at therapeutic intervention. The NIH SBIR award, from the Institute of Allergy and Infectious Disease to Dr. Yingru Liu Ph.D., aims at optimization, scale-up, pharmacology and toxicology studies in preparation for an exploratory meeting with the United States Food and Drug Administration (FDA).
“We are delighted with this new award” said Dr. Dominick L. Auci, Vice President for Research and Development. “and excited about continuing development of NGoXIMTM. We have already established that NGoXIMTM induces durable Th1-driven adaptive immune responses that protect against genital tract infection. This new award will allow us to optimize schedule, explore alternate routes and elucidate the basis of protective immunity, something that has never been observed before. Importantly, we will now be able to continue development work and seek guidance from the FDA regarding specific work that will enable first-in-man phase I clinical studies, which we hope to initiate in the not-too-distant future.”
Therapyx also continues the development of it other products, TreXTAMTM and PCX12TM towards clinical studies.
Therapyx, Inc. is developing a proprietary drug delivery system based on mild encapsulation of highly potent protein therapeutics into microparticles that preserves bioactivity, achieves controlled tissue specific release, reduced toxicity and shelf-stability. Its two lead products NGoXIMTM and TreXTAMTM are aimed at mucosal infections and inflammatory diseases, respectively. For more information on Therapyx, Inc. contact the Company’s website at www.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.