The National Institutes of Health Awards a new grant in the amount of $2.91 million to Therapyx

Buffalo, New York- May 1st, 2020.  Therapyx is pleased to announce a new SBIR Phase IIb award to continue the development of GneX12TM, a first-in-class immune therapy to induce protection against re-infection with Neisseria Gonorrhoeae. GneX12 is meant to be given in conjunction with standard of care antibiotic treatment, or as a fail-safe treatment for disease caused by drug resistant Neisseria gonorrhoeae.  Gnex12 is the key immune regulatory cytokine interleukin 12 formulated for sustained release mucosal delivery. The award, entitled “Therapy and Prophylaxis for Genital Tract Infection” 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.  Gonorrhea is the second most frequent reportable 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.  As N. gonorrhoeae is becoming multiple-drug-resistant, there are serious concerns that it could become untreatable.  CDC has listed drug-resistant N. gonorrhoeae as “an immediate public health threat that requires urgent and aggressive action”, and WHO has called for “the creation and development of new therapeutic options”. This project is a direct response to that call.

The three-year award, in the amount of approximately $1,000,000 per year, will fund pivotal formulation studies as well as toxicology studies recommended by the FDA in our previous Type C meeting.  “This award” said Dr. Dominick L. Auci, Vice President for Research and Development“allows us to accelerate development of GneX12TM  through IND-enabling toxicology studies in rodents and non-human primates as we prepare the product for entry into human clinical trials.”

Therapyx also continues the development of its other products, PCX12TM. TreXTAMTM and NGoXIMTM towards the clinic. The company also has a deep pipeline of discovery stage products, including TPX-ECGC.  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 microparticles that preserves bioactivity, achieves controlled tissue specific release, reduced toxicity and shelf-stability.  Its lead products are aimed at cancer, mucosal infections and immune mediated inflammatory diseases. For more information on Therapyx, Inc. contact 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.

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