UB-612 Vaccine Description
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.
Vaxxinity announced on February 11, 2022, two articles on the UB-612 homologous booster results and binding and neutralizing activity of antibodies against multiple variants. These findings include, but are not limited to, three doses of UB-612 elicited neutralizing antibody titers of GMT VNT50 of 335 against the Omicron variant of SARS-CoV-2, over 3-fold higher than reported after three doses of an approved mRNA vaccine; the receptor-binding domain (RBD)- and spike (S) protein-binding IgG antibodies after booster immunization with UB-612 produced high cross-reactivity against multiple SARS-CoV-2 variants, including Alpha, Beta, Delta, Gamma and Omicron, similar to or higher than those of approved vaccines and boosters; and the RBD-binding antibodies against the Wuhan strain reported for several authorized vaccines are predictive of UB-612 vaccine efficacy against COVID-19 at approximately 95% after three doses.
Vaxxinity announced on September 12, 2022, that it had initiated a rolling submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for conditional marketing authorization as a heterologous boost to authorized primary series vaccines. And on October 24, 2022, the Company confirmed it initiated a rolling submission to the Therapeutic Goods Administration in Australia for provisional approval of its UB-612 COVID-19 vaccine as a heterologous boost after being granted provisional determination in September 2022.
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.
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 per year (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 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. 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 symptoms of the disease, 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.
October 24, 2022 - Vaxxinity, Inc. announced that enrollment is complete for its global Phase 3 pivotal trial evaluating UB-612 as a heterologous booster vaccine to mRNA, adeno-vectored, and inactivated primary series vaccinations. The company remains on track to report topline data in the fourth quarter of 2022.
September 12, 2022 - “Authorizations by stringent regulatory authorities such as the MHRA could open the pathway for UB-612 to reach countries with high unmet needs,” said Mei Mei Hu, CEO of Vaxxinity. “Additionally, this (pending) authorization is a pathway to grant WHO emergency use listing, which would provide another option for getting UB-612 to countries through the COVAX program.”
March 28, 2022 - Vaxxinity, Inc. announced that it has begun dosing participants in Phase 3 pivotal trial of UB-612, the Company's next-generation COVID-19 booster candidate. Vaxxinity expects to deliver a topline readout of the study in the second half of 2022.
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 times higher titers of neutralizing antibodies against the Omicron variant than reported by an approved mRNA vaccine.
June 27, 2021 - Taiwan News reported United Biomedical, Inc. released the midterm study report for the phase II clinical trials of its COVID-19 vaccine UB-612, which showed strong performances in terms of safety and efficacy with no trial participants experiencing serious adverse reactions. UBI stated it plans to complete the current phase II trial in the second half of November 2021. According to CNA reporting, it will also speed up the phase III clinical trial involving 11,000 participants in India.
June 21, 2021 - Vaxxinity announced a purchase order for its COVID-19 vaccine, UB-612, with the Government of Paraguay, contingent upon issuance of an Emergency Use Authorization (EUA) by the Taiwanese Food and Drug Administration, which will trigger a EUA in Paraguay. The order was signed on June 16 in Asunción by Dr. Julio Borba, Paraguay Minister of Health and Social Welfare, and Jon Harrison, Vaxxinity Chief Strategy Officer. Ambassador José Han, Taiwan's Ambassador to Paraguay.
June 14, 2021 - Vaxxinity is developing a novel coronavirus vaccine using synthetic proteins, which can also help treat neurodegenerative diseases like Alzheimer's and Parkinson's, reported the Financial Times. Mei Mei Hu, CEO of Vaxxinity, was quoted as saying to FT: "Commercialising Covid means not only proving one aspect, one modality of our platform for infectious diseases but also being able to fuel the development of other programs of that technology platform."
June 4, 2021 - Reuters reported Erik Prince is involved with this company.
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 - The media reported that Aurobindo Pharma 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 diseases 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. In addition, 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 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
UB-612 is currently being assessed in 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 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.
