Taiwan’s Ministry of Health and Welfare granted conditional approval for Phase 2 clinical trials
COVAXX has begun enrollment of the expected 3,850 subjects, including adolescents, adults, and seniors.
COVAXX is in production for the first 100 million doses, and subsequently over 500 million doses this year
DALLAS, TX (Feb. 2, 2021) – COVAXX, a U.S. biotechnology company and subsidiary of United Biomedical, Inc. (UBI), has announced that the Taiwan 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 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.”
Lou Reese, executive chairman of COVAXX, added, “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 cost-effective, scalable and proven science-based solution. Starting this Phase 2 clinical trial, we are closer to doing that.”
Globally, COVAXX has established a partnership with the University of Nebraska Medical Center (UNMC), home of the highly respected 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, a leading 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.
UB-612 Fact Sheet:www.covaxx.com/vaccine
About COVAXX. COVAXX is a subsidiary of United Biomedical Inc (UBI), founded in 1985. The company is a scientific trailblazer creating technological firsts, including the manufacture and commercialization of more than 100 million antibody blood tests, and 5 billion vaccine doses against infectious diseases in animal health. With proprietary access to UBI’s core technology platforms, COVAXX can develop and commercialize high precision antibody tests and a promising COVID-19 vaccine that together would form a unique Differentiating Infected from Vaccinated Individuals (DIVI) system.
COVAXX (not to be confused with single “x” COVAX) is developing UB-612, the first multitope peptide-based vaccine designed to activate both B and T-cell arms of the immune system to fight against SARS-CoV-2.
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 vaccine around the world.