UB-612 COVID-19 Vaccine Description
The UB-612 vaccine candidate is specifically designed to allow for the inclusion and presentation of multiple epitopes to elicit both B-cell (antibody) and T-cell (cellular) responses without enhancing COVID-19 disease.
The COVAXX vaccine is designed to target a critical antigen from the S protein (Receptor Binding Domain, RBD) thought to be necessary for viral attachment to human cells plus additional viral epitopes (from other viral structural proteins) designed to promote B-cell and CD8+ T-cell memory responses.
The UB-612 vaccine candidate is completely synthetic, carrying no biohazard risk. There is no virus of any kind used in the manufacturing of the COVAXX vaccine.
COVAXX uses high precision, multi-antigen peptide platform approach to develop a SARS-CoV-2 vaccine, UB-612: the first multitope peptide-based vaccine COVID-19. The platform has been used successfully to develop a vaccine for hand, foot, and mouth disease and has previously been shown to be safe and well-tolerated in four human clinical trials.
On January 8, 2021, COVAXX Co-Founder and CEO Mei Mei Hu stated in a press release: “We have been studying the new South African mutation, and we believe it is a significant threat to public health. As a result, we are not only testing UB-612 against these variants but have also begun early testing and design of a second vaccine candidate that addresses both the UK and the South African variant and the potential to be a single-dose vaccine for primary immunization.”
Subject to regulatory approval, COVAXX is planning to supply up to 500 million doses globally in 2021.
COVAXX is a United Biomedical Inc (UBI) subsidiary, founded in 1985, with headquarters in New York. COVAXX’s synthetic peptide-based vaccine platform is the epitome of manufacturability, producing over 500 million doses of its Foot and Mouth Disease vaccine per year (and over 4.5 billion doses delivered to date).
UB-612 COVID-19 Vaccine Indication
The UB-612 vaccine candidate is indicated to prevent COVID-19.
UB-612 COVID-19 Vaccine News
January 8, 2021 - COVAXX announced that the company has initiated preclinical work on a second vaccine candidate to address the latest mutations of the SARS-CoV-2 responsible for COVID-19, and specifically the South African mutation. The South African variant is named 501Y.V2 because it contains the same mutation, N501Y, from the UK variant. There is no clear evidence that both variants are associated with more severe disease or worse outcomes.
December 24, 2020 - COVAXX announced an exclusive agreement with Aurobindo Pharma to expand its global development and commercialization of UB-612 to India and the United Nations Children's Fund (UNICEF) agency. Under the signed license agreement, Aurobindo Pharma has obtained the exclusive rights to commercialize in India and UNICEF and non-exclusive rights in other select emerging and developing markets. COVAXX will supply the bulk product, and Aurobindo will manufacture the finished doses at its facilities in Hyderabad, India.
November 25, 2020 - COVAXX, a U.S. company developing a multitope peptide-based vaccine to fight COVID-19, announced 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, the largest clinical diagnostic company in Brazil, to conduct Phase 2/3 clinical trials and distribute vaccines within Brazil.
September 28, 2020 - COVAXX announced 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 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.
UB-612 COVID-19 Vaccine Clinical Trial
COVAXX stated on January 8, 2021, it is completing Phase 1 clinical trials of its first COVID-19 vaccine candidate, UB-612, in Taiwan and will begin Phase 2-3 clinical trials in Asia, Latin America. In the USA, COVAXX has an agreement with the University of Nebraska Medical Center, home of the National Pandemic Center, to conduct trials in the U.S. In Brazil, COVAXX is partnered with Diagnosticos da America, SA (DASA), the largest medical logistics company in Latin America.
Clinical Trial NCT04545749: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine. Last Update Posted: September 29, 2020.
This is a phase I, open-label, dose-escalation clinical study to evaluate the safety, tolerability, and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy adults aged 20 to 55 years old.
Estimated Study Completion Date: August 31, 2021.