VAXXINITY, is a U.S. based (HQ in NY) spinout of the UBI (United Biomedical Inc.) group of companies, founded in 1985.
History
Successful sero-diagnostic and vaccine franchises with a legacy of firsts:
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First approved synthetic peptide-based blood screening diagnostic (HIV, 1989)
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First synthetic peptide vaccine for infectious diseases (Foot and mouth disease, 2007) and (Porcine respiratory and reproductive syndrome in field trial)
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First synthetic vaccine against a self-antigen (Anti_LHRH, 2014 for immunocastration in pigs)
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First vaccine (Alzheimer’s Disease and Parkinson’s Disease) to elicit antibody levels proven to cross blood-brain barrier (2020)
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More than 100 million diagnostic tests and more than 5 billion vaccine doses delivered.
Whats Unique About the VAXXINITY Vaccine as opposed to other incumbents?
A MULTITOPE PEPTIDE-BASED VACCINE (MPV) AGAINST COVID-19*
While other manufacturers utilize inactive SARS-CoV-2 vaccines, or unproven technologies (e.g., mRNA, DNA, lipid nanoparticles, subunit proteins or vector-based vaccines), that typically target only one structural protein of the virus (e.g., Spike, S), VAXXINITY is uniquely different.
VAXXINITY specifically designed its vaccine to allow for the inclusion and presentation of multiple epitopes to elicit both B-cell (antibody) and T-cell (cellular) responses without enhancing COVID-19 disease. Of the 17 non-traditional killed SARS-CoV-2 vaccines currently in clinical and full development, almost all focus solely on the S protein. While this is a rational target, a single protein may not raise a sufficient or broad enough immune response. The VAXXINITY vaccine is designed to target a critical antigen from the S protein (Receptor Binding Domain, RBD) thought to be necessary for viral attachment to human cells plus additional viral epitopes (from other viral structural proteins) designed to promote B-cell and CD8+ T-cell memory responses.
Furthermore, the VAXXINITY vaccine is completely synthetic, carrying no biohazard risk. There is absolutely no virus of any kind used in the manufacturing of the VAXXINITY vaccine.
Strong Scientific Basis
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First Multitope Peptide-Based Vaccine (MPV) against Covid-19
Proven track record of success in developing other vaccines
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Proven track record of successfully licensed 20 vaccines/drugs including vaccines against Ebola, Dengue and smallpox for pandemics
Manufacturing scale up and logistics capabilities solved
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No dependency on the cold chain, thereby easing transporting and logistical nuances
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Existing FDA, EMA, and Japan approved manufacturing facilities
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Partnership with maersk to ensure logistics
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Conventional cold chain only required (2-8 degrees Celcius). Does not need additional investments for new infrastructure
PRECLINICAL STUDIES SHOW HIGH NEUTRALIZING TITERS
Our preliminary, preclinical studies suggest that our vaccine will lead to high immunogenicity and will produce neutralizing titers against the live virus. The data demonstrates that the VAXXINITY vaccine generates anti-S1-RBD titers of >1,000,000 as measured by ELISA, and neutralizing titers (100% neutralization of >8,120) in Cytopathic Effect (CPE) assays.
PLATFORM ELICITED IMMUNOGENICITY IN ELDERLY PATIENTS
In other contexts, the platform as previously shown high immunogenicity in elderly patients. Data from human clinical trials in elderly patients using the UBI vaccine platform, including the UBI Alzheimer's vaccine, has demonstrated a high level of response (in >98% of those tested).
SAFETY
Ensuring the public's safety and establishing worldwide protection is the main priority from a global perspective. VAXXINITY, the vaccine, developed and is produced on the UBI vaccine platform that has been successfully used in other contexts. This platform was designed to produce safe and efficacious vaccines that prevent viral infection. This platform will be used to develop and produce the VAXXINITY Covid-19 vaccine to achieve a favorable risk benefit profile based on clinical studies.
The UBI vaccine platform has been utilized in four human clinical trials with up to 3 years of repeated dosing and has demonstrated safety and tolerability. The platform is both adaptable and controllable, designed to produce highly engineered vaccines with minimal off-target effect.
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