Intravacc has been awarded a contract with base and options that may total US$14.6 million for the development of a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG).
The contract has been awarded by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH),
Gonorrhea is a sexually transmitted disease caused by the NG bacterium. Intravacc will develop a prophylactic vaccine based on its proprietary outer membrane vesicles (OMV) platform technology.
The NG vaccine, NGoXIM, is based on gonococcal OMVs combined with sustained-release microspheres containing recombinant human IL-12, and will be administered intranasally. Proof-of-concept studies with NGoXIM have already shown the vaccine to be effective in animal models. The studies induced a potent, lasting, and cross-protective immune response.
Intravacc will work towards a non-clinical toxicity (TOX) and clinical trial material batch to execute a phase I study in healthy adults, investigating the safety of the vaccine and generating efficacy data. The IL-12 containing microspheres called GneX12 will be developed and produced by U.S. company Therapyx Inc.
Gonorrhea is the second most common bacterial infectious disease in the U.S., with a reported incidence of more than 300,000 cases per year. However, the true incidence is believed to be more than double the reported incidence.
Currently there is no effective gonorrhea vaccine available, and the disease is known to be contracted repeatedly without apparently developing protective immunity. In addition, antibiotic resistance is increasingly common for this bacterium. Gonorrhea is on the WHO high-priority list of antimicrobial resistant bacteria.
Jan Groen, Intravacc’s CEO, said: “Together with our sub-contractor Therapyx, we are honored that NIH and NIAID have awarded us this contract, allowing both of us to demonstrate the safety and tolerability of our intranasal gonorrhea vaccine candidate, NGoXIM (Avacc 11).”
Intravacc’s OMV platform technology
For the development of vaccines, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) – spherical particles with intrinsic immune-stimulating properties. The OMVs can be designed with immunogenic peptides and/or proteins that stimulate effective adaptive immunity. The OMV carrier has been optimized to induce a more effective immune response against these newly introduced antigens.
Intravacc has also developed genetic tools to increase the yield of the OMVs, reduce the toxicity and achieve the desired antigenic composition. Intravacc’s OMV platform is scalable and allows rapid and efficient modification of the antigen composition, either through genetic modification of the bacterial host or by associating antigens with stored OMVs.