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 UB-612 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, says the company. The UB-612 vaccine candidate is completely synthetic, carrying no biohazard risk.
Of multiple SARS-CoV-2 vaccines currently in clinical development, almost all focus solely on the Spike protein. While this is a rational target, a single protein may not raise a sufficient or broad enough immune response. UB-612 is designed to target a critical antigen from the Spike protein, the 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.
Aurobindo Pharma Limited and COVAXX, a US-based company, entered into an Exclusive License Agreement to develop, commercialize and manufacture UB-612, the first Multitope Peptide-based Vaccine to fight COVID-19, for India and the United Nations Children’s Fund agency.
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 is currently conducting a Phase 1 clinical trial for the vaccine candidate. COVAXX uses high precision, multi-antigen peptide platform approach to develop the 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.
COVAXX is based at 1717 Main Street, Suite 3388, Dallas, TX 75201.
UB-612 COVID-19 Vaccine History
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. Still, we 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 plans to supply up to 500 million doses globally in 2021.
On February 8, 2021, COVAXX’s announced its COVID-19 Vaccine, UB-612, Induced Neutralizing Antibodies in 100% of Participants During Phase 1 Clinical Trial. “These results are very promising,” said Gray Heppner, M.D., 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 a wholly-owned subsidiary of Vaxxinity., founded in 1985. 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 is temperature stable at normal 2-8C and does not need to be stored in an ultra-low temperature cold chain.
UB-612 COVID-19 Vaccine News
April 1, 2021 - Dallas-based COVAXX and United Neuroscience announced the consolidation of their vaccine development efforts under the newly formed holding company, Vaxxinity, Inc. The U.S. corporation is based in Dallas, Texas, with operations in Asia, Europe, Latin America, and the United States. COVAXX and United Neuroscience are now wholly-owned subsidiaries of Vaxxinity.
February 19, 2021 - Media reported Aurobindo Pharma has said it expects to submit clinical trial data of its COVID-19 vaccine UB-612 by July 2021. Aurbindo has sought permission from Indian drug regulator CDSCO to conduct a Phase-2/3 trial of India's vaccine candidate. However, the Subject Expert Committee of CDSCO, which reviewed Aurbindo's proposal, recommended that the firm submit the Phase II/III clinical trial protocol approved by Brazil's regulatory authority.
February 8, 2021 - COVAXX 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 doses 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 until 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.
February 2, 2021 - Dallas-based COVAXX announced that the Taiwan Ministry of Health and Welfare, on January 29, 2021, 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 the world’s first multitope peptide-based vaccine against COVID-19, using its high precision, commercially proven, and scalable vaccine platform.
January 8, 2021 - COVAXX announced that the company had initiated preclinical work on a second vaccine candidate to address the latest mutations of the SARS-CoV-2 responsible for COVID-19, 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 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 Trials
COVAXX stated on February 8, 2021, 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.
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.
The Phase 2 clinical trial is a multi-center, placebo-controlled, randomized, observer-blind study to explore further 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 to complete 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 subject enrollment.