COVAXX Announces Phase 2 Clinical Trials of UB-612 Vaccine Candidate against COVID-19

COVAXX has announced that the Taiwan, China Ministry of Health and Welfare on January 29, granted conditional approval to begin Phase 2 trials of UB-612, its vaccine candidate to address the pandemic caused by SARS-CoV-2. COVAXX is developing world's first multitope peptide-based vaccine against COVID-19, using its high precision, commercially proven and scalable vaccine platform.

The Phase 2 clinical trial is a multi-center, placebo-controlled, randomized, observer-blind study to further explore the immunogenicity, safety, and tolerability of the UB-612 vaccine in three distinctive cohorts: adolescents (12 to 18 years old), adults (19 to 64 years old), and seniors (65 years and older). The first subject of the Phase 2 trials was enrolled last week, with the goal of completing enrollment and administration of the first doses of UB-612 in all subjects in one month. The total number of subjects to be enrolled is 3,850. The clinical trial is set to be launched simultaneously in 11 medical centers and hospitals in Taiwan, China Region of China to accelerate the process of subject enrollment.

"This next step in the clinical development of our vaccine candidate marks a major milestone for COVAXX and for supplying the world, which is in critical need for effective vaccines to fight the COVID-19 pandemic," said Mei Mei Hu, CEO of COVAXX. "Our multitope vaccine has shown promising results from preclinical studies and Phase 1 safety trials, eliciting high titers of specific neutralizing antibodies as well as T-cell responses against multiple viral structural proteins which were recognized by COVID-19 patients who successfully controlled their SARS-CoV-2 infection."

"COVID-19 is not 'one and done' and people will likely require boosters to protect against the virus, which is possible with UB-612. More importantly, the vaccine needs to be accessible and affordable to everyone, globally. With UB-612. we want to democratize getting vaccinated and tackle the global COVID-19 pandemic using a cost-effective, scalable and proven science-based solution. Starting this Phase 2 clinical trial, we are closer to doing that," Lou Reese, Executive Chairman of COVAXX, said.

Globally, COVAXX has established a partnership with the University of Nebraska Medical Center (UNMC), home of the Global Center for Health Security, to conduct clinical trials in the United States, and 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 has also announced a collaboration with Aurobindo Pharma, an Indian pharmaceutical company, to assist in the clinical testing, manufacturing and distribution of the UB-612 vaccine within India and to UNICEF, which is leading a global distribution network.

UB-612 is temperature stable at normal 2-8C and does not need to be stored in an ultra-low temperature cold chain. COVAXX is in production for the first 100 million doses, and will deliver over 500 million doses this year.