Bavarian Nordic has evidence its COVID-19 vaccine may hold up against omicron. With a midphase trial finding antibody titers were boosted to levels associated with a high level of protection, the biopharma is pushing ahead with plans to move into a phase 3 study.
Copenhagen-based Bavarian Nordic shared top-line data from the phase 2 trial of its capsid-virus-like particle vaccine candidate ABNCoV2 late last year, linking the jab to an up to 40-fold boost in antibodies against ancestral SARS-CoV-2 when given as a booster. A subsequent data drop revealed the lower, 50-μg dose triggered similar antibody levels to the 100-μg dose.
Now, Bavarian Nordic has shared a glimpse at how the vaccine may fare against omicron, the variant that has swept the world since the company began the phase 2 trial. Omicron neutralizing antibody titers were lower than for other variants, including beta and delta, but still hit levels associated with a high level of protection.
“We now have demonstrated a large range of immune responses against different variants of concern, including omicron. This encourages us to continue to rapidly initiate our phase 3 study and subsequently submit this vaccine for licensure,” Bavarian Nordic CEO Paul Chaplin said in a statement.
Bavarian Nordic plans to start the 4,000-subject phase 3 clinical trial soon to evaluate the effect of giving ABNCoV2 as a booster. Participants will receive either 100 μg ABNCoV2 or an mRNA vaccine to show whether the investigational candidate is noninferior to a licensed product.
The Danish government has stepped up to support development of the vaccine, agreeing to provide up to 800 million Danish kroner ($114 million). Most of the cash is contingent on Bavarian Nordic reaching milestones related to phase 3 development and the upscaling of manufacturing for commercial production.