Vaxxinity announces Phase 3 COVID-19 booster data for UB-612

Vaxxinity (VAXX) announced that its 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 platform vaccines administered as homologous boosters, confirming success in meeting the primary and key secondary immunogenicity endpoints of its pivotal global Phase 3 trial. When delivered as a heterologous booster in three separate substudies in populations previously vaccinated with Pfizer-BioNTech’s BNT162b2, AstraZeneca’s (AZN) ChAdOx1-S, or Sinopharm’s (SHTDF) BIBP, UB-612 was shown to generate neutralizing antibody titers 28 days after administration that were: Statistically non-inferior to, and directionally higher than, BNT162b2: 1.04 GMR against Wuhan, 1.11 GMR against Omicron BA.5; Statistically superior to ChAdOx1-S: 1.92-fold higher geometric mean titers against Wuhan with UB-612, 2.85-fold higher against Omicron BA.5; Statistically superior to BIBP: 5.77-fold higher geometric mean titers against Wuhan with UB-612, 5.93-fold higher against Omicron BA.5. Vaxxinity intends to complete rolling submissions with the Medicines and Healthcare products Regulatory Agency in the United Kingdom, and the Therapeutic Goods Administration in Australia, to support potential conditional and provisional marketing authorizations, respectively, of UB-612 in the first half of 2023. Topline data from the Phase 3 trial also indicate that seroconversion rates at day 29 of UB-612 were statistically non-inferior to and directionally higher than BNT162b2, statistically superior to ChAdOx1-S, with 1.9-fold higher SCR against Wuhan and 2.0-fold higher SCR against Omicron BA.5, and statistically superior to BIBP, with 8.3-fold higher SCR against Wuhan and 5.8-fold higher SCR against Omicron BA.5. Preliminary safety data show that UB-612 continues to be generally well tolerated; no serious adverse events were reported. The study is ongoing, and the long-term safety profile continues to be evaluated. The Phase 3 international, randomized, active-controlled platform trial compares the safety and immunogenicity of a booster dose of UB-612 in people who have received primary immunizations with BNT162b2, ChAdOx1-S, or BIBP head-to-head against those of a homologous boost.