Bavarian Nordic (OMX:BAVA) has dosed the first subject in a Phase 3 clinical study of the COVID-19 vaccine candidate ABNCoV2.
The study will test whether ABNCoV2 is non-inferior to Comirnaty from Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) in terms of neutralizing antibodies it produces against the original strain of SARS-CoV-2. Secondary endpoints in the study will assess how the vaccine stacks up against other variants of concern.
In May, Bavarian Nordic announced that a Phase 2 study found that ABNCoV2 induced a solid boost in neutralizing antibodies against the original omicron strain.
The non-adjuvanted ABNCoV2 vaccine candidate uses a virus-like particles (VLP) platform.
Copenhagen, Denmark–based Bavarian Nordic has become best known recently for its monkeypox and smallpox vaccine. Known as Jynneos in the U.S., the monkeypox vaccine is named Imvanex in Europe and Imvamune in Canada.
Bavarian Nordic’s product portfolio includes vaccines for rabies, tick-borne encephalitis and Ebola. Bavarian Nordic licensed the Ebola vaccine to Janssen.
Its pipeline includes vaccine candidates for smallpox, respiratory syncytial virus and immuno-oncology.
The Phase 3 study of its COVID-19 booster will enroll roughly previously vaccinated 4,000 adults.
The study will break participants into two groups, with the first receiving a 100 µg booster dose of ABNCoV2. The second group will receive a 30 µg adult booster dose of the original version of Comirnaty.
The active controlled portion of the study will be based in Denmark and Belgium.
The company is also enrolling subjects in the U.S. to test the safety and tolerability of the vaccine candidate.
Eyeing 2023 approval, Bavarian Nordic anticipates initial results from the studies by the end of 2022.
In earlier clinical trials, ABNCoV2 boosted neutralizing antibodies against SARS-CoV-2 variants of concern.
BAVA shares were flat in trading today.
Bavarian Nordic has received financial support from the Danish Ministry of Health.