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 Intravacc, a global leader in translational research and development of viral and bacterial vaccines, has partnered with American, Buffalo, NY, based Therapyx, to further develop and optimize the world’s first prophylactic vaccine against gonorrhea, NGoXIM. For this Therapyx received a $ 2.8 million Phase IIB grant in the US and has chosen to partner with Intravacc for its unique capabilities and infrastructure for the optimization of vaccines, vaccine processes and vaccine technologies.

NGoXIM is a microsphere vaccine with encapsulated interleukin-12 (IL-12) and outer bacterial membrane vesicles from Neisseria gonorrhoeae, developed with Intravacc’s OMV platform. This vaccine therefore consists of a combination of adjuvant and antigen, specifically designed for mucosal immunization. Vaccination with NGoXIM has been shown to induce potent and persistent antibacterial activity in primates. In this collaboration, the parties will focus on enhancing and optimizing the specific adaptive immune response in non-human primates as a prelude to testing in humans. This should ultimately lead to a vaccine that provides lasting protection against infection with the Neisseria gonorrhoeae bacteria.

Gonorrhea

Gonorrhea is the second most common bacterial infectious disease in the US, with a reported incidence of more than 300,000 cases per year. The Neisseria gonorrhoeae bacteria, a gram-negative aerobic 0.6–1.0 µm bacteria, is the cause of this sexually transmitted disease. Due to under-reporting and asymptomatic disease course, the true incidence is believed to be more than double. There is currently no effective gonorrhea vaccine available and the disease is known to be contracted repeatedly without apparently developing protective immunity as a result of previous infection. In addition, antibiotic resistance is increasingly common for this bacterium. The US-based Center for Disease Control and Prevention has listed antibiotic resistant N. gonorrhoeae as one of the top three pathogens that “pose an immediate threat to public health that must be urgently and aggressively addressed”.

 Dr. Jan Groen, Intravacc’s CEO, comments:

“We are proud to partner with Therapyx in the further optimization and development of the world’s first gonorrhea vaccine. Vaccination with the candidate vaccine inducing a potent and lasting antibacterial activity in primates, not only shows the proof-of-principle for NGoXIM, but also the potency of the mucosal vaccine platform in general. This rapidly adaptable platform for the engineering and development of mucosal vaccines has enormous potential for challenging respiratory viral infections, including influenza and COVID-19, among others. With our unique infrastructure and pilot plant for the optimization of vaccines, vaccine processes and vaccine technologies, we can contribute to accelerated further development of this promising vaccine, for which there is a great worldwide medical need.”