DALLAS– COVAXX, a U.S. company developing UB-612, a multitope protein/synthetic peptide-based vaccine to fight COVID-19, today announced positive interim Phase 1 data from its open-label COVID-19 clinical trial conducted in Taiwan. This study, which evaluated the safety, tolerability, and immunogenicity of UB-612, showed that the vaccine was generally well-tolerated and elicited robust antibody responses comparable to those seen in human convalescent sera.
UB-612 was well-tolerated and had a reassuring safety profile
Overall, the vaccine was well-tolerated and very few solicited and unsolicited adverse events (AEs) were observed. Minimal local or systemic AEs were observed after dose 1 and 2, with no increase in reactogenicity after the second dose. Almost all AEs were mild (Grade 1) and of <2-day duration and no Serious AEs (SAEs) were observed. The trial is ongoing and all participants are being followed up to day 196.
UB-612 induced neutralizing antibodies in 100% of participants
All subjects developed neutralizing antibodies after two doses of the vaccine. At the 100 ug dose level, anti-S1-RBD and viral neutralizing antibody responses compared favorably to responses observed in hospitalized patients who had recovered from COVID-19.
Favorable product profile
UB-612 is stable at temperature 2°C to 8°C, allowing for successful cold chain management with existing infrastructure.
The vaccine candidate is designed to mimic a natural infection to activate both antibody (B-cell) and cellular (T-cell) arms of the immune system to generate protective neutralizing antibodies and cytotoxic T-cells against SARS-CoV-2. The UBI technology platform has been successful in commercializing vaccines for infectious disease in animal health and is currently in clinical trials for other indications.
“These results are very promising,” said Gray Heppner, MD, FACP, FASTMH, Chief Medical Officer of COVAXX. ”We are encouraged by the data and are accelerating our Phase 2/3 program to deploy a safe and effective vaccine candidate to combat this pandemic.”
COVAXX is currently in Phase 2 clinical trials of UB-612 in Taiwan with a grant from Taiwan’s Ministry of Health and Welfare, and will soon begin Phase 2/3 trials in India in partnership with Aurobindo. COVAXX has an 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. COVAXX also 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. COVAXX has advance purchase commitments and agreements for its UB-612 vaccine to deliver doses across multiple countries including low income countries.
