The National Institutes of Health (NIH) has agreed to fund development of a nasally administered gonorrhea vaccine. Intravacc secured the financial support, landing a $14.6 million contract as it works to move its NGoXIM candidate into a phase 1 trial.
Dutch biotech Intravacc developed NGoXIM using its outer membrane vesicle (OMV) platform. OMVs are spherical particles with immune-stimulating properties. Designing OMVs with immunogenic peptides or proteins stimulates adaptive immunity. In the case of NGoXIM, Intravacc has combined its gonococcal OMVs with sustained-release microspheres containing recombinant human IL-12.
Intravacc has run preclinical proof-of-concept studies of the intranasal vaccine, generating evidence of efficacy in animals and of a potent, lasting and cross-protective immune response. The biotech will now develop a complete production process to support good manufacturing practice vaccine batches.
Delivery of clinical trial materials is one of the tasks standing between Intravacc and the start of a phase 1 trial in healthy adults. The other core task is to gather nonclinical toxicity data. Intravacc wants to test both safety and efficacy in the phase 1 trial. Therapyx is providing the IL-12 microspheres.
The NIH said the contract “may support formulation and manufacture of the individual vaccine components, as well as stability testing, nonclinical immunogenicity and efficacy testing in animal models, IND enabling GLP toxicology, submission of an IND and clinical safety and efficacy evaluation.” The contract cost for 2022 is $2 million. The NIH lists October 2023 as the end date for the project.