A $14.6 million contract for its jointly developed gonorrhea vaccine and a partnership with CEPI to advance coronavirus vaccines make a busy week for Intravacc.
Dutch firm, Intravacc, and microparticulate immune therapeutics firm Therapyxpartnered in August 2020 to develop NGoXIM, a prophylactic vaccine that treats gonorrhea.
This week, the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the firms a contract with base and options that could potentially total to $14.6 million in funding. Intravacc says this contract allows both companies to demonstrate the safety and efficacy of NGoXIM.
According to Intravacc, NGoXIM is based on its outer membrane vesicles (OMV) platform technology. The OMVs are used in combination with sustained-release microspheres, which contain recombinant human IL-12 and are administered intranasally.
Therapyx is responsible for developing and producing the IL-12 containing microspheres called GneX12.
“OMVs are spherical buddings of the outer membrane that are released spontaneously by many Gram-negative bacteria during growth. They present a range of surface antigens in a native conformation and have natural properties like immunogenicity, self-adjuvation and uptake by immune cells. This means that OMVs are a good basis for vaccines against pathogenic bacteria,” a spokesperson for Intravacc told us.
“In the past twenty years, Intravacc has optimized its OMV platform to make it safe and effective for use in humans. The OMVs for the gonorrhea vaccine are derived from genetically modified Ng bacteria.”
Intravacc says that it will create a complete manufacturing process for NGoXIM in order to generate vaccine batches under the required Good Manufacturing Practices (GMP). Additionally, the firm claims it will push towards a non-clinical toxicity (TOX) and clinical trial material to conduct a Phase I study in healthy humans to investigate the efficacy and safety of the vaccine.
In the same week
In March 2021, the Coalition for Epidemic Preparedness Innovations (CEPI) announced up to $200 million in funding to be allocated to various companies developing vaccines that provide protection against SARS-CoV-2 and betacoronaviruses .
Under the terms of this deal, CEPI will give Intravacc up to $4.8 million in seed funding to develop a betacoronavirus vaccine candidate, which can be administered intranasally. The funding itself will support the testing of Intravaac’s subunit vaccine, Avacc 101.
Avacc 101 is also based on its OMV platform, which it claims could be quickly adapted to support outbreaks of disease caused by new betacoronavirus variants and strains, as well as protecting “pre-emergent” variants from animals before infecting the human population.
In March 2021, the firm started a concept design for a so-called ‘Multi-Purpose Vaccine Production Plant’ in response to COVID-19 located at Utrecht Science Park, Bilthoven.
Intravacc says that intranasal administration could possibly create mucosal immunity that is required to block viral infection and, therefore, reduce person-to-person transmission.
The spokesperson for Intravacc told us that one of the advantages of intranasal vaccines is that it “causes a local response in the mucosal tissue in the nose (mainly the induction of IgA antibodies), as well as a systemic immune response (IgG antibodies). A vaccine that is injected into the muscle only causes a systemic immune response.”
They continued: “An intranasal vaccine also causes an immune response in other mucosal tissues, like the genital tract. The genital tract is the place where the gonorrhea bacteria infect humans. By vaccinating intranasally you can thus make sure that there is an immune response at the site where the Gonorrhea bacterium infects thereby preventing infection.”