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Bavarian Nordic

COVID-19

ABNCoV2

  • ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate
  • Phase 2 data demonstrated durable and broad antibody responses against variants of concern
  • Phase 3 ongoing with read-out in 2023

ABNCoV2 is a virus-like particle (VLP)-based vaccine candidate in development as a universal booster vaccine for COVID-19. The goal is to create a longerlasting vaccine protection with broader efficacy that obviates the need for continuously adapting to new variants of the SARS-CoV-2 virus. We have licensed the vaccine candidate from AdaptVac.

We have concluded the Phase 2 clinical development of ABNCoV2 with results confirming the vaccine candidate’s ability to boost neutralizing antibodies to levels reported to be highly efficacious against SARS-CoV-2, both when used for primary vaccination and when used as a booster in subjects previously vaccinated with mRNA- or adenovirus-based vaccines.

In September 2022, we initiated a double-blind, controlled Phase 3 clinical trial of ABNCoV2 in 4,000 adult subjects who either previously completed primary vaccination or have already received one booster dose of a licensed COVID-19 vaccine. One cohort is evaluating the safety and tolerability of the vaccine in 3,000 subjects receiving a single 100 µg dose of ABNCoV2 (US sites). A second cohort of 1,000 subjects, who are randomized to receive either a single 100 µg dose of ABNCoV2, or a single 30 µg adult booster dose of Comirnaty (Denmark and Belgium sites) The primary endpoint of the trial is to assess non-inferiority of ABNCoV2 compared to Comirnaty® in terms of neutralizing antibodies against the SARS-CoV-2 (Wuhan wild type). Other variants of concern will be assessed as secondary endpoints. Initial trial results are expected in mid-2023.

The Phase 3 development of ABNCoV2 is largely funded through an agreement with the Danish State.