The following are brief descriptions of each of our vaccines in development. Request a confidential follow-up meeting for more details and other supportive data.
We are pioneering a prophylactic quadrivalent vaccine to combat hand, foot, and mouth disease (HFMD), which is primarily caused by four enteroviruses: EV71, CVA16, CVA10, and CVA6. This innovative cell-based vaccine combines four inactivated vaccines after virus culture on our cellular platform technology. Leveraging the time-tested Cell-Vacc platform, three of the viruses are grown on Intravacc's cGMP-grade Vero cells, which have a rich history in viral vaccine development since 1987. The fourth enterovirus is cultured on a cGMP-grade HEK293 cell line. Promising pre-clinical studies reveal virus-neutralizing titers and protective responses against all viruses in animal models.
A vaccine concept aimed at improving the effectiveness and duration of protection against pertussis, or whooping cough. Avacc 3 may enhance the efficacy of primary acellular pertussis (acP) vaccinations and potentially replace acP or whole cell pertussis (wcP) components in multivalent vaccines for infants. Produced on Intravacc's safe OMV platform, Avacc 3 offers both intranasal and parental administration options, increased immunogenicity, self-adjuvanticity, genetic detoxification, and extended stability. In preclinical testing, vaccinated mice challenged with Bordetella pertussis were protected against bacterial colonization of airways.
Avacc 5 is an innovative inactivated-virus vaccine designed to prevent enterovirus D68 infection, which is associated with acute flaccid myelitis. Built on our well-established Cell-Vacc platform, Avacc 5 is being developed toward phase I clinical trials with support from the U.S. National Institutes of Health. Immunogenicity studies have demonstrated its effectiveness in inducing virus-neutralizing antibodies, even without the need for an adjuvant. Additionally, it provides cross-protection against other EV D68 viruses from different clades. A phase I clinical study with this new vaccine candidate is foreseen to start in 2025.
Avacc 10 is an intranasal vaccine designed as a booster vaccine to prevent COVID-19. Building on our OMV-Vacc technology, it combines Outer Membrane Vesicles (OMV) from Neisseria meningitidis with stabilized SARS-CoV-2 spike proteins. The intranasal administration of Avacc 10 triggers the mucosal system, leading to the production of both immunoglobulin A (IgA) and IgG, which enhances both local and systemic immunity. Preclinical studies showed that Avacc 10 vaccination in mice induced high levels of IgG and IgA, and the antibodies were capable of cross-neutralizing various SARS-CoV-2 variants. In hamsters, it provided 100% protection against lung lesions and delayed transmission. Toxicology studies in rabbits confirmed its safety and immunogenicity. Avacc 10 is currently being tested in a phase I clinical study in healthy volunteers.
Avacc 11 is an intranasal vaccine designed to induce robust local and systemic immunity against N. gonorrhoeae infection. It incorporates Outer Membrane Vesicles (OMV) from N. gonorrhoeae to stimulate the production of immunoglobulins A and G (IgA, IgG) from airway mucosal cells. Co-administered sustained-release microspheres containing human interleukin-12 (IL-12) counteract immune suppression typically seen in N. gonorrhoeae infection. Avacc 11 utilizes our OMV-Vacc platform known for its efficiency in prophylactic vaccines against various infections. Preclinical studies, including trials in mice and non-human primates, demonstrated the efficacy of Avacc 11 in clearing N. gonorrhoeae infection. NIH/NIAID has awarded Intravacc a contract to develop Avacc 11 up to phase I clinical trial.
Another vaccine designed to combat gonorrhea, Avacc 12 uses a heterologous Outer Membrane Vesicle (OMV) from N. meningitidis in which several meningococcal antigens are replaced for their gonococcal counterparts. Based on evidence demonstrating the protective potential of N. meningitidis OMVs against gonorrhea, Avacc 12 taps into this mechanism for defense. Employing our OMV-Vacc platform, which has demonstrated efficacy in bacterial and viral infections, the vaccine combines the safe and naturally secreted bacterial vesicles from engineered N. meningitidis bacteria expressing N. gonorrhoeae antigens. Preclinical studies in mice have shown that Avacc 12 elicits a robust IgG response, demonstrating its pre-clinical utility.
A nonavalent vaccine that targets Porin A of N. meningitidis serogroup B. The vaccine builds on the OMV-Vacc platform and has shown efficacy in protecting against meningococcal B disease. The proprietary vaccine technology is currently licensed by CDBIO for the Chinese market. For licensing options in other regions, please get in touch with us.
In collaboration with the German Center for Neurodegenerative Diseases (DZNE), we have developed a therapeutic vaccine targeting poly-GA repeats in ALS patients with C9orf72 mutations. This vaccine candidate was developed on the Con-Vacc platform, offering optimized antigen design, conjugation methods, and antigen characterization. With a €2.5-million grant from the European Union, DZNE and Intravacc will advance the vaccine toward a toxicology study. In mouse models, the vaccine reduces poly-GA aggregates, inflammation, and neuronal damage, offering hope for ALS treatment.
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