UB-612 Vaccine 2023
Vaxxinity UB-612 multitope subunit protein/peptide-based 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. Vaxxinity's UB-612 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. In addition, the UB-612 vaccine candidate is entirely synthetic, carrying no biohazard risk. UB-612 is designed to promote B-cell and CD8+ T-cell memory responses.
The Vaxxinity platform has been shown to elicit robust antibody responses in non-Covid-19 related subjects, including older adults, safely and consistently across repeat dosing over three years or more. In addition, antibody levels are recalled to their initial peak following each boost, regardless of the time interval since the last dose. At the same time, the Company is developing a second COVID-19 candidate, UB-612A, with a new formulation using different adjuvants.
On December 2, 2022, Vaxxinity announced the next-generation UB-612 COVID-19 vaccine, when administered as a single heterologous booster dose, elicited strong neutralizing antibodies against SARS-CoV-2 when compared head-to-head to three globally authorized platforms: mRNA (Pfizer-BioNTech’s BNT162b2), adenovirus vector (AstraZeneca’s ChAdOx1-S), and inactivated virus (Sinopharm’s BIBP), when administered as homologous boosters, confirming success in meeting the primary and key secondary immunogenicity endpoints of its pivotal global Phase 3 trial. And UB-612 elicits superior neutralizing antibody titers and seroconversion rates against both Wuhan and Omicron BA.5 variants compared to adenovirus vector (ChAdOx1-S) and inactivated (BIBP) vaccines.
On May 9, 2023, the Company announced it expects to complete the Phase 3 trial of UB-612 in the second half of 2023 and to obtain additional data about UB-612’s safety, tolerability, and antibody titer half-life.
Vaxxinity is a newly formed entity (April 2021) merging United Neuroscience and COVAXX, both spinouts of the United Biomedical Group. COVAXX is at 1717 Main Street, Suite 3388, Dallas, TX 75201. Mei Mei Hu, CEO of COVAXX, was appointed CEO of Vaxxinity as of June 2021. Vaxxinity's synthetic peptide-based vaccine platform is the epitome of manufacturability, producing over 500 million doses of its Foot and Mouth Disease vaccine annually (and over 4.5 billion doses delivered to date).
UB-612 Availability
Vaxxinity expects to submit the final sections of its marketing application to the MHRA and the TGA in 1H 2023 for conditional/provisional approval in the UK and Australia.
UB-612 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."
On February 8, 2021, COVAXX 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."
Aurobindo Pharma Limited and COVAXX (Vaxxinity) entered 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. Vaxxinity (COVAXX) previously 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, the largest clinical diagnostic Company in Brazil, to conduct Phase 2/3 clinical trials and distribute vaccines within Brazil.
UB-612 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. Vaxxinity's Alzheimer's drug, which uses similar technology, encourages the body to clear misfolded proteins called amyloid plaques from the brain because genetic analysis has linked them to disease symptoms, reported the FT on June 12, 2021.
UB-612 Vaccine News For 2020 - 2022
December 2, 2022 - Vaxxinity Announces Positive Topline Pivotal Phase 3 COVID-19 Booster Data for UB-612. UB-612 elicited a strong immune response following primary immunization with globally approved vaccines from Pfizer-BioNTech, AstraZeneca, and Sinopharm in a head-to-head study against those vaccines as homologous boosters. UB-612 is unique because it’s designed to activate both the B- and T-cell arms of the immune system.
February 11, 2022 - Vaxxinity, Inc. announced results from studies demonstrating the ability of UB-612, its COVID-19 vaccine candidate, to elicit a broad immune response against multiple variants of concern, and specifically more than three times higher titers of neutralizing antibodies against the Omicron variant of SARS-CoV-2 than an approved mRNA vaccine with boosters. UB-612 elicits >3 three times higher titers of neutralizing antibodies against the Omicron variant than reported by an approved mRNA vaccine.
April 1, 2021 - Dallas-based COVAXX and United Neuroscience announced their vaccine development efforts consolidated 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 8, 2021 - COVAXX announced positive interim Phase 1 data from its open-label COVID-19 clinical trial conducted in Taiwan.
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 agency.
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.
UB-612 COVID-19 Vaccine Clinical Trials
UB-612 is currently being assessed in the Phase 3 pivotal trial as a booster vaccine for subjects who have received primary immunization with mRNA, adenovirus vector, or inactivated virus vaccines. Vaxxinity reiterates its plan to have a topline readout of the Phase 3 trial in the fourth quarter of 2022.
COVAXX stated that 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 AurobinIn addition, COVAXX has an agreement with Diagnosticos da America SA (DASA S.A.), Brazil's largest clinical diagnostic Company, to conduct Phase 2/3 clinical trials and distribute vaccines within Brazil.