COVAXX announces advanced purchase commitments of more than 140 million doses of its UB-612 vaccine, totaling over $2.8 billion, to deliver vaccines in multiple countries, including Brazil, Ecuador and Peru. These public and private commitments follow the start of human trials in Taiwan and the September agreement with Diagnosticos da America SA (Dasa S.A.), the largest clinical diagnostic company in Brazil, to conduct Phase 2/3 clinical trials and distribute vaccines within Brazil.
“In parallel with the expedited clinical development of UB-612, we are working to help countries with the greatest unmet needs customize their plans for vaccine studies, supply and distribution,” said Mei Mei Hu, co-founder and CEO of COVAXX. “The realistic view of vaccine production is that we will need a wide range of vaccine options utilizing different technologies to meet worldwide demand. As much as vaccines matter, vaccinations matter more. To be administered effectively, vaccines need to demonstrate easy and affordable distribution, durability of response with the capability to further extend it with effective boosts, as well as the ability to adapt to a potential mutation in the virus while building on the first vaccines made available.”
COVAXX (not to be confused with single “x” COVAX) is currently completing Phase 1 clinical trials of UB-612 in Taiwan and has an agreement with the University of Nebraska Medical Center (UNMC), home of the National Pandemic Center, to also conduct trials in the U.S. Last month, COVAXX announced a global logistics partnership with Maersk, the world’s largest shipping and integrated logistics provider, that creates a framework for all transportation and supply chain services that will be needed to deliver COVAXX’s UB-612 around the world.
“We applaud the progress of other vaccine developers, but recognize the global requirement for billions of doses,” said Dr. Peter H. Diamandis, COVAXX’s co-founder and vice-chairman. “Our vaccine has the following key attributes that make it potentially best in class: First, it is boostable. COVID-19 is not ‘one and done’ and populations will likely require boosters to protect against the virus. UB-612 technology has been shown to effectively boost repeatedly and without any side effects. Second, the vaccine is stable at 2-8C and can be delivered via existing distribution infrastrucure and normal refrigeration; Third, from preliminary data, UB-612 has observed minimal reactogenicity (i.e. no fevers, chills or systemic issues). While clinical efficacy data will be available during the next few months, we believe COVAXX is a best-in-class vaccine that is affordable and accessible for all earthlings.”
“The reality of vaccine manufacturing is that some vaccines will be available earlier than others, though in limited quantities and most likely available in the countries in which they are manufactured, as well as countries with a robust infrastructure and the financial ability to handle the complex cold-chain distribution,” said Lou Reese, COVAXX’s co-founder and executive chairman. “COVAXX is specifically focused on disrupting this traditional method. Our vaccine will be distributed globally, and our primary focus is on supplying emerging markets.”
UB-612 is a multitope vaccine designed to activate both B and T-cell arms of the immune system. UB-612 consists of the Spike protein S1 subunit Receptor Binding Domain (RBD) genetically fused to a single chain Fc domain of human IgG1 (S1-RBD-sFc), combined with proprietary peptides representing T helper (Th) and cytotoxic T-cell (CTL) epitopes on S2 subunit, Membrane and Nucleocapsid structural protein components of SARS-CoV-2. These Th and CTL peptides are selected based on their predicted binding to human MHC I and II, which would allow for the induction of memory recall and T-cell activation and effector functions. The vaccine candidate is formulated with CpG1 and aluminum phosphate (AdjuPhos®) to induce a Th1 prone response.
To date, preclinical studies in guinea pigs, rats and mice have shown that the UB-612 vaccine candidate generated extremely high titers of neutralizing antibodies with S1-RBD:hACE2 inhibition activities, as well as a balanced Th1/Th2 response toward the Th1 polarity.