The National Institutes of Health awards a new grant in the amount of $3 million to Therapyx to continue the development of GneX12, a first-in-class immune therapy to induce protection against reinfection with Neisseria Gonorrhoeae

Buffalo, New York – September 12th, 2023.  Therapyx is pleased to announce a new SBIR award to continue the development of GneX12TM, a first-in-class immune therapy to induce protection against reinfection with Neisseria Gonorrhoeae. GneX12 is designed to be given in conjunction with standard of care antibiotic treatments, or as a fail-safe treatment for disease caused by drug resistant N. Gonorrhoeae.  Gnex12 contains the key immune regulatory cytokine interleukin 12, formulated for sustained release in the mucosa. The coveted new Commercialization Readiness Pilot Program 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 more than 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. The CDC has listed drug-resistant N. gonorrhoeae as “an immediate public health threat that requires urgent and aggressive action” and the 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 $1,000,000 per year, will fund pivotal GMP manufacturing work as well as toxicology studies recommended by the FDA. “This award” said Dr. Dominick L. Auci“ promotes the continued development of GneX12 and includes IND-enabling studies. The work will accelerate the advancement of the product to initial human clinical trials.”

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