Therapyx, Inc. receives an NIH SBIR Phase IIb grant in the amount of $2.8 million to advance its mucosal immunization platform

Buffalo, New York-August 11th, 2020 Therapyx is pleased to announce a new three year SBIR Phase IIb award to continue the development of NGoXIM, the world’s first prophylactic vaccine intended to enhance specific adaptive immune responses that provide lasting, protective immunity against infection with N. gonorrhoeae. NGoXIM is an encapsulated interleukin-12 (IL-12) plus bacterial outer membrane vesicles (OMV) specifically formulated for mucosal delivery.  The award, entitled “Experimental Gonococcal Vaccine” was made from The National Institute of Allergy and Infectious Diseases of the National Institutes of Health to Dr. Michael Russell, Ph.D., Chief Science Officer and Dr. Dominick L. Auci, MBA, Ph.D., VP for R&D at Therapyx.  NGoXIM is being developed by Therapyx in collaboration with Intravacc, a leading not-for-profit R&D organization with unique capabilities and infrastructure aimed at the optimization of vaccines, vaccine processes and vaccine technologies.  With a team of 150 professionals, Intravacc is located at Utrecht Science Park Bilthoven in the Netherlands

Gonorrhea is the second most frequent reportable bacterial infectious disease in the US with a reported incidence of >300,000 cases per annum. Because of under-reporting and symptomatic treatment, the real incidence is believed to be more than twice that number.  No effective gonorrhea vaccine is currently available and the disease is known to be acquired repeatedly with apparently no development of protective immunity resulting from previous infection. The CDC has listed antibiotic-resistant N. gonorrhoeae as one of the top three pathogens presenting “an immediate public health threat that requires urgent and aggressive action”.

“We are thrilled with this new award” said Dr. Dominick L. Auci,“and are eager to continue development of this prototype mucosal vaccine. The use of our encapsulated IL-12 product, specifically formulated for mucosal administration, along with Intravacc’s proprietary, specially engineered gonococcal OMVs, represents an adjuvant-antigen combination specifically engineered for mucosal immunization. We have already shown that vaccination with NGoXIM induces potent and lasting anti-bacterial activity in primates, demonstrating not only proof-of-principle for the NGoXIM product, but also for the mucosal vaccine platform in general. This rapidly adaptable platform for mucosal vaccine engineering and development has vast potential in many challenging areas of infectious diseases, including influenza and COVID-19. This new award will allow us to refine our mucosal vaccine platform and fully optimize NGoXIM in non-human primates. It will also allow us to respond to FDA guidance and perform required toxicology. Importantly, the work will substantially de-risk the product, making it more attractive to potential partners.”

Therapyx also continues the development of its other products, PCX12 and GneX12TM towards clinical trials, and has a deep pipeline of discovery stage products, including ATRAXIMTM, FAPXILand TPX-EGCG.  Some of these products may be eligible for orphan status as well as 505(b)(2) accelerated development pathway.

CAUTIONARY STATEMENT: Therapyx is developing a proprietary drug delivery system based on the encapsulation of highly potent protein therapeutics into micro-particles that engineer slow, controlled, local release of drug substances while preserving bioactivity, reduced toxicity and shelf-stability. Its lead products PCX12, GneX12, NGoXIM, and ATRAXIM are aimed at mucosal infections and immune mediated inflammatory diseases. For more information on Therapyx, contact the Company’s website at This press release contains 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. The actual results may differ materially from those contained in this press release.

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