HAUPPAUGE, NY (September 28, 2020) -- COVAXX announced today the first healthy adult volunteers were safely dosed in the company's Phase 1, open-label, dose-escalation study of the UB-612 vaccine candidate for COVID-19 in Taiwan. The study is partly supported by a grant from the Ministry of Health and Welfare in Taiwan of up to 430M (NTD) or approximately $15M (USD). This clinical trial expands the international collaborations of COVAXX after the recently announced agreements with Dasa, the largest diagnostic medicine company in Brazil and Latin America, and with The University of Nebraska Medical Center to conduct large scale human efficacy clinical trials in Brazil and the United States, respectively.
"Administering the initial dose of our vaccine candidate to the first participants not only marks the start of this Phase 1 clinical trial but also represents a significant step forward in the global fight against COVID-19," said Mei Mei Hu, co-Chief Executive Officer of COVAXX.
The Phase 1 open-label trial is designed to evaluate the safety, tolerability, and immunogenicity of UB-612, a multitope peptide-based vaccine candidate against COVID-19 based on a commercially proven platform that allows for the cost-effective production of vaccines at scale. The design of the vaccine components provides the additional advantage of utilizing existing cold-chain storage and distribution channels as it does not require additional infrastructure such as -80⁰C freezers or liquid nitrogen tanks to store materials at temperatures beyond -80⁰C
The trial is currently enrolling 60 healthy male and female adults, from 20-55 years of age, in three groups of 20 subjects. Each subject will receive ascending dose levels of UB-612 in two intramuscular injections spaced 28 days apart. The dose groups will be staggered so that safety can be rapidly assessed before ascending to the next dose level. Since UB-612 is designed to elicit both functional antibodies (B cells) and cellular immune responses (T cells), a wide array of immunological tests will be performed to demonstrate its protective activity. The most important neutralization titer analysis of the data will be performed by Laboratory of Molecular Virology and Viral Immunology at Academia Sinica, the most prestigious research institute in Taiwan, under the leadership of Dr. Yi-Ling Lin along with other esteemed clinical and biomedical laboratories globally.
"The results of this clinical study, which will be evaluated through interim analyses, will enable COVAXX to select an appropriate dose and rapidly progress to a Phase 2/3 clinical trial," said Farshad Guirakhoo, Chief Scientific Officer at COVAXX. "Our innovative vaccine platform approach is imperative to tackle one of the world's most important scientific challenges of our time. Producing a safe and effective COVID-19 vaccine within the next 12 to 18 months is not only a challenge but it also requires new levels of collaborations across healthcare industries and governments worldwide. Today we have reached an important milestone in our fight against COVID-19."
About UB-612. 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.
