Phase III trial of UB 612 as booster meets endpoints in COVID-19.- Vaxxinity
Vaxxinity announced today 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 III trial.
When delivered as a heterologous booster in three separate substudies in populations previously vaccinated with Pfizer-BioNTech’s BNT162b2, AstraZeneca’s ChAdOx1-S, or Sinopharm’s 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 (95% CI: 0.89, 1.21; p=0.6147), 1.11 GMR against Omicron BA.5 (95% CI: 0.94, 1.31; p=0.2171). Statistically superior to ChAdOx1-S: 1.92-fold higher geometric mean titers against Wuhan with UB-612 (GMR=1.92; CI: 1.44, 2.56; p<0.0001), 2.85-fold higher against omicron ba.5 (gmr="2.85;" ci: 2.00, 4.05; p><0.0001). statistically superior to bibp: 5.77-fold higher geometric mean titers against wuhan with ub-612 (gmr="5.77;" ci: 4.62, 7.20; p><0.0001), 5.93-fold higher against omicron ba.5 (gmr="5.93;" ci: 4.60, 7.65; p><0.0001).></0.0001).></0.0001),></0.0001).></0.0001),>
Topline data from the Phase III trial also indicate that seroconversion rates at day 29 (SCR, defined as an at least 4-fold increase of neutralizing antibody titers from baseline) 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 (23.6% absolute difference, p=0.0009) and 2.0-fold higher SCR against Omicron BA.5 (29.2% absolute difference, p<0.0001), and statistically superior to bibp, with 8.3-fold higher scr against wuhan (56.8% absolute difference, p><0.0001) and 5.8-fold higher scr against omicron ba.5 (58.0% absolute difference, p><0.0001). 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.></0.0001).></0.0001)></0.0001),>
Vaxxinity intends to complete rolling submissions with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, and the Therapeutic Goods Administration (TGA) in Australia, to support potential conditional and provisional marketing authorizations, respectively, of UB-612 in the first half of 2023. Vaxxinity expects that achieving authorizations in these high income countries will open up the door to authorizations in low and middle income countries and to the WHO’s Emergency Use Listing (EUL), both of which align with Vaxxinity’s mission of democratizing health across the globe.
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