SilverV
Announcing topline data from a Phase 3 trial, Vaxxinity, Inc. (NASDAQ:VAXX) said Friday that its protein-based COVID-19 vaccine candidate UB-612 generated a better immune response as a booster compared to those from AstraZeneca (AZN) and Sinopharm Group (OTCPK:SHTDF) (OTCPK:SHTDY).
However, its response to BNT162b2, the messenger-RNA-based COVID-19 vaccine developed by Pfizer (PFE) and BioNTech (BNTX), was non-inferior, the company said.
The Phase 3 trial, co-funded by Coalition for Epidemic Preparedness Innovations (CEPI), involved 944 participants aged 16 years and older in the U.S., Panama, and the Philippines.
The pivotal trial was designed to evaluate a booster dose of UB-612 in those who received primary immunizations with BNT162b2 and AstraZeneca’s (AZN) vector-based shot ChAdOx1-S, or Sinopharm’s (OTCPK:SHTDF) inactivated virus vaccine BIBP.
Their safety and immunogenicity data were compared with results from those who received a homologous boost.
According to the company, the trial achieved the primary endpoint indicating neutralizing antibody titers 28 days after administration of UB-612 as a heterologous booster in three sub-studies.
The neutralizing antibody titers for UB-612 were statistically superior to both ChAdOx1-S and BIBP against the Wuhan strain and Omicron BA.5 of COVID on Day 28. Meanwhile, the experimental vaccine led to statistically non-inferior and directionally higher antibody titers than BNT162b2 at Day 28.
The trial also met key secondary immunogenicity endpoints indicating statistically superior seroconversion rates for UB-612 against both Wuhan and Omicron BA.5 variants compared to ChAdOx1-S and BIBP vaccines.
Early safety data indicated no serious adverse events, and the trial is ongoing to generate a long-term safety profile.
Vaxxinity (VAXX) expects to conclude the trial in H1 2023 and complete the ongoing rolling submissions in the U.K. and Australia in H1 2023, seeking conditional and provisional marketing authorizations for UB-612, respectively.
“Given these Phase 3 topline results, and UB-612’s generally lower cost structure and ease of distribution, we believe UB-612 has the potential to serve as an optimal choice for boosting,” Vaxxinity (VAXX) Chief Executive Mei Mei Hu remarked.
