Therapyx and Intravacc partner to develop the world’s first prophylactic vaccine against Gonorrhea.

Buffalo, New York-October 10, 2018. Therapyx is pleased to announce that it has entered into a strategic partnership with Netherlands-based Intravacc for the co-development of NGoXIMTM, the world’s first prophylactic vaccine against infection with Neisseria gonorrhoeae. This new vaccine is intended to enhance specific adaptive immune responses that provide lasting, protective immunity against N. gonorrhoeae. NGoXIMTM is a combination of a sustained-release formulation of interleukin 12 (GneX12TM) and bacterial outer membrane vesicles (OMV) formulated for mucosal delivery.

No effective gonorrhea vaccine is currently available and the disease is known to be acquired repeatedly with apparently no development of protective immunity 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.” A recent WHO technical consultation on vaccines against sexually transmitted infections (2017) called for renewed efforts to develop a vaccine against gonorrhea. This partnership effort is a direct response to that call.

Under the terms of the partnership agreement, Therapyx will focus efforts on IND-enabling efficacy and toxicology studies in primates while Intravacc will be responsible for the discovery and development of OMVs with improved immunogenic properties and reduced toxicity. Financial terms were not disclosed.

“We are thrilled to partner with Intravacc” said Dr. Dominick L. Auci, Vice President for Research and Development at Therapyx. “They bring over 100 years of expertise in vaccines including novel OMV technology to this important project. We couldn’t be working with a more experienced, innovative and dedicated team”.

“We are delighted to be working with Therapyx” said Mr. Nico Oudendijk, General Director of Intravacc. “The IL-12 technology they bring into the project is key to develop an efficacious vaccine against this disease.”

About Intravacc: Intravacc, based in Bilthoven, the Netherlands, is an established R&D organization with more than 100 years’ experience in the development and optimization of vaccines, vaccine processes and vaccine technologies. Intravacc has state-of-the-art research and production facilities and its aim is to substantially reduce development risks and costs of new vaccines inorder to contribute to global health and equity in access to vaccines worldwide.

About Therapyx: Therapyx, Inc. is developing a proprietary drug delivery system based on mild encapsulation of highly potent protein therapeutics into biodegradable particles that preserve bioactivity, achieving controlled tissue specific release, reduced toxicity and shelf-stability.  Its lead products, TreXTAMTM and NGoXIMTM (formerly TGFbNanoCap and GVAX12, respectively) are aimed at mucosal infections and immune mediated inflammatory diseases, respectively. The company also has a deep pipeline of discovery stage products, including PCX12TM, FAPXILTM and TPX-EGCG that will soon progress into development.  Certain aforementioned products may be eligible for orphan status, as well as 505(b)(2) accelerated development pathway.

For more information on Intravacc, contact the company’s web site atwww.intravacc.nl/

For more information on Therapyx, Inc., contact the Company’s website at www.therapyxinc.com

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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