Biology:UB-612

From HandWiki

UB-612 is a COVID-19 vaccine candidate developed by United Biomedical Asia (zh), and Vaxxinity, Inc.[1] It is a peptide vaccine.[2][3]

It is composed of SARS-CoV-2 S1-RBD protein and synthetic peptides representing T cell (Th and CTL) epitopes on the nucleocapsid, spike and membrane proteins. The multitope composition is differentiated from other solely spike-protein based vaccines. By recognition against epitopes on Spike (S1-RBD and S2) and non-Spike (N and M) structure proteins, UB-612 provides B-cell and T-cell memory immunity and offers a potential as a universal vaccine to fend off the Omicron variant and new emerging variants of concern.[4][5] Vaxxinity began seeking regulatory approval for UB-612 for use as a booster vaccine in the United Kingdom and Australia in 2022.[6][7]

Technology

UB-612 is a peptide vaccine incorporating multiple epitopes, including the spike protein receptor binding domain as well as other virus structural proteins.[1][3] The spike protein peptide is fused to an Fc domain of single-chain IgG1, and the other six peptides are derived from highly conserved sequences from the spike, nucleocapsid, and membrane proteins of SARS-CoV-1 and SARS-CoV-2. It also contains a proprietary UBITh1 peptide derived from the measles virus fusion protein, CpG oligonucleotides, and aluminum phosphate adjuvant to improve the immune response. It is produced in CHO cells.[2]

Clinical trials

In September 2020, phase I clinical trials of UB-612 started in Taiwan.[8] and in January 2021, phase II clinical trials began in Taiwan.[9] In February 2021, phase II/III clinical trials began.[10] Results from clinical trials showing positive safety and efficacy data were published in May 2022,[4] and in May-June 2023.[11][12]

In March 2022, Vaxxinity started an international phase III clinical trial of UB-612 as a heterologous booster vaccine against three approved platforms: mRNA, adenovirus vector, and inactivated virus.[13] The company announced positive topline data of the trial in December 2022[14] and positive results were published in January 2024.[15] A Phase III international trial[16] conducted from March to September 2023, found that UB‑612, given as a heterologous third‑dose booster after primary vaccines, met non‑inferiority versus homologous boosters, outperformed ChAdOx1 and Sinopharm BIBP COVID-19 vaccines on neutralizing antibody responses (including Omicron subvariants), showed durability comparable to Pfizer–BioNTech COVID-19 vaccine through 12 months, and had a similar safety profile.[17]

Controversy

In June 2021, a report revealed that the UB-612 vaccine was developed in part by the US-based Covaxx, a for-profit venture initiated by Blackwater founder Erik Prince. In a series of text messages to Paul Behrends, the close associate recruited for the Covaxx project, Prince described the profit-making possibilities of selling the COVID-19 vaccines. At the time, Covaxx had not yet provided any data from the clinical trials on safety or efficacy it conducted in Taiwan. The responsibility of creating distribution networks was assigned to an Abu Dhabi-based entity, which was mentioned as "Windward Capital" on the Covaxx letterhead but was actually Windward Holdings. The firm's sole shareholder, who handled "professional, scientific and technical activities", was Erik Prince. In March 2021, Covaxx raised $1.35 billion in a private placement.[18]

References

  1. ↑ 1.0 1.1 "Taiwan's second domestic COVID vaccine's midterm performance in phase II trials inferior to local competitor: experts". Taiwan News. 27 June 2021. https://www.taiwannews.com.tw/en/news/4233956. 
  2. ↑ 2.0 2.1 "SARS-CoV-2 Vaccines Based on the Spike Glycoprotein and Implications of New Viral Variants". Frontiers in Immunology 12. 2021-07-12. doi:10.3389/fimmu.2021.701501. PMID 34322129. 
  3. ↑ 3.0 3.1 "COVID-19 Vaccine" (in en-US). https://vaxxinity.com/covid-19-vaccine/. 
  4. ↑ 4.0 4.1 "A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants". The Journal of Clinical Investigation 132 (10). May 2022. doi:10.1172/JCI157707. PMID 35316221. 
  5. ↑ "High Neutralizing Antibody Levels Against Severe Acute Respiratory Syndrome Coronavirus 2 Omicron BA.1 and BA.2 After UB-612 Vaccine Booster". The Journal of Infectious Diseases 226 (8): 1401–1406. October 2022. doi:10.1093/infdis/jiac241. PMID 35723969. 
  6. ↑ "Vaxxinity moves HQ, jobs to Florida's Space Coast from Texas". American City Business Journals. 9 February 2023. https://www.bizjournals.com/orlando/news/2023/02/09/vaxxinity-florida-space-coast-hq.html. 
  7. ↑ "Phase 3 Trial of Vaxxinity's COVID-19 Vaccine as a Heterologous Booster Advances". 2 November 2022. https://www.contagionlive.com/view/phase-3-trial-of-vaxxinity-s-covid-19-vaccine-as-a-heterologous-booster-advances. 
  8. ↑ Clinical trial number NCT04545749 for "A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine" at ClinicalTrials.gov
  9. ↑ Clinical trial number NCT04683224 for "A Study to Evaluate the Safety, Immunogenicity, and Efficacy of UB-612 COVID-19 Vaccine" at ClinicalTrials.gov
  10. ↑ Clinical trial number NCT04773067 for "A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers" at ClinicalTrials.gov
  11. ↑ "Toward a pan-SARS-CoV-2 vaccine targeting conserved epitopes on spike and non-spike proteins for potent, broad and durable immune responses". PLOS Pathogens 19 (4). April 2023. doi:10.1371/journal.ppat.1010870. PMID 37079651. 
  12. ↑ Wang CY, Kuo BS, Lee YH, Ho YH, Pan YH, Yang YT, Chang HC, Fu LF, Peng WJ (June 2023). "Targeting Multiple Conserved T-Cell Epitopes for Protection against COVID-19 Moderate-Severe Disease by a Pan-Sarbecovirus Vaccine". medRxiv 10.1101/2023.06.28.23291948.
  13. ↑ Clinical trial number NCT05293665 for "Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine" at ClinicalTrials.gov
  14. ↑ "Vaxxinity's Phase III Covid-19 booster trial meets endpoints". 5 December 2022. https://www.clinicaltrialsarena.com/news/vaxxinity-covid-booster-trial/. 
  15. ↑ "UB-612 pan-SARS-CoV-2 T cell immunity-promoting vaccine protects against COVID-19 moderate-severe disease". iScience 27 (2). February 2024. doi:10.1016/j.isci.2024.108887. PMID 38318376. Bibcode: 2024iSci...27j8887W. 
  16. ↑ Clinical trial number NCT05293665 for "Platform Trial to Compare Homologous Boost of Authorized COVID-19 Vaccines and Heterologous Boost With UB-612 Vaccine" at ClinicalTrials.gov
  17. ↑ "Safety and immunogenicity of UB-612 heterologous booster in adults primed with mRNA, adenovirus, or inactivated COVID-19 vaccines: a randomized, active-controlled, Phase 3 trial". eClinicalMedicine 86. August 2025. doi:10.1016/j.eclinm.2025.103349. PMID 40727012. 
  18. ↑ "Blackwater founder Prince takes role in COVID vaccine venture". 4 June 2021. https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-blackwater-founder-prince-takes-role-covid-vaccine-venture-2021-06-04/. 



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