Vaccines to Democratize Health
COVAXX was founded in March 2020 to defeat COVID-19. We spun out of United Biomedical, a vaccine company with a >30-year history and 5 billion vaccine doses sold. Our proprietary synthetic peptide platform has allowed us to innovate the first multitope peptide-based vaccine for COVID-19: UB-612.
Mission: Our belief is that immunity to COVID-19 should be accessible to all. COVID-19 has not discriminated, and neither should our response. We are working with partners around the world to ensure access to our vaccine in countries of all economic means.
Production: COVAXX’s synthetic peptide platform allows for rapid scaling of vaccine production. Combining our in-house production capacity with that of several manufacturing partners around the world, COVAXX expects to produce 500 million to 1 billion doses of UB-612 by the end of 2021, which will be distributed to countries of all economic means.
Clinical development: COVAXX began clinical development of UB-612 in a 60-subject Phase 1 study in September 2020. Interim data from that study suggests the vaccine to be well tolerated, with no significant safety observations to date. Subjects developed an antibody response similar to that of patients who have recovered from COVID-19. The antibodies have demonstrated the ability to neutralize the virus in vitro. Furthermore, we have observed evidence of a T-cell response against SARS-CoV-2, a key part of our vaccine’s design that allows the long term memory arm of the immune system to recognize and stop the virus.
In the coming months we will begin Phase 2 and 3 trials of UB-612 in India, Brazil, Taiwan, and the United States. efficacy against SARS-CoV-2 disease. COVAXX expects to achieve its first emergency use authorization (EUA) for the These trials will enroll thousands of subjects with the aim of demonstrating the vaccine’s safety, tolerability and UB-612 vaccine in mid-2021.
COVAXX is developing the world’s first multitope peptide-based vaccine against SARS-CoV-2 to make immunity to COVID-19 accessible to all. This vaccine, UB-612, is specifically designed to allow for the inclusion and presentation of multiple epitopes (portions mimicking the SARS-CoV-2 virus) to target both B-cell (antibody) and T-cell (cellular) against SARS-CoV-2.
Of multiple SARS-CoV-2 vaccines currently in clinical development, almost all focus solely on the Spike protein. While this is a rational target, a single protein may not raise a sufficient or broad enough immune response. UB-612 is designed to target a critical antigen from the Spike protein, the 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.
What makes UB-612 different?
Safety & tolerability
Interim Ph1 data suggests a well tolerated vaccine with no significant safety issues observed to date.
• No serious adverse events or adverse events
of special interest
• Minimal local/systemic adverse events after 1st and 2nd dose
• Potential for high adherence to 2nd dose in real world use, translating to successful national campaigns
Rapid Adaptation to Mutation
Because we make our vaccines from synthetic peptides, we can swap target epitopes and amino acid sequences with relative ease. This means we can respond rapidly as needed to changes in the SARS-CoV-2 virus. In fact, we successfully achieved such a response to a mutation in foot-and-mouth disease virus with our sister company’s animal health vaccine.
Logistics & scalability
• 2-8⁰C storage and distribution means no special cold-chain requirements, existing vaccine infrastructure could be used for distribution, even in resource-limited settings
• Partnership with Maersk secures reliable global shipping and delivery
• COVAXX, through its sister companies in the United Biomedical Group, has already scaled production to 500 million doses/year, and through both internal expansion and a network of global partnerships we will increase that capacity to up to 1 billion doses/year by the end of 2021
• 5 billion doses commercialized to date based on platform technology
The COVAXX vaccine platform has been shown to elicit robust antibody responses in subjects, including older adults, safely and consistently across repeat dosing over 3 years or more1. Antibody levels are recalled to their initial peak following each boost, regardless of the time interval since the last dose. This will remain especially important in an environment where the field has not yet determined the durability of immunity from COVID-19 vaccines, and where we may face a seasonal recurrence of COVID-19, as we see annually with influenza.
1 Based on observations from Phase 2a Long Term Extension study of UB-311 in mild-to-moderate Alzheimer’s disease (NCT03531710)