Bavarian Nordic takes COVID-19 booster shot into Phase 3 trials
ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by Denmark's AdaptVac (spun out from the University of Copenhagen) using its proprietary capsid virus like particle (cVLP) technology.
Bavarian Nordic gained the global commercialization rights to the vaccine in 2020 with a €4m ($3.97m) upfront payment to AdaptVac, assuming the responsibility for further clinical development towards licensure.
A Phase 2 trial has already confirmed the ability of ABNCoV2 to 'significantly boost' antibody titers (also previously demonstrated in preclinical and Phase 1 clinical trials), and also confirmed the potential of ABNCoV2 to boost antibody titers against SARS-CoV2 variants of concern.
Now, the double-blind, controlled Phase 3 clinical trial will enroll approximately 4,000 adult subjects who have already completed primary vaccination as well as those who have received one booster dose of a licensed COVID-19 vaccine.
An active controlled group will be conducted in Denmark and Belgium and will start enrollment later this fall: receiving either a 100 µg dose of ABNCoV2 or a 30 µg adult booster dose of Pfizer/BioNTech’s Comirnaty
A second group, situated in the US, will evaluate the safety and tolerability of the vaccine in subjects receiving a 100 µg dose of ABNCoV2.
The trial will assess non-inferiority of ABNCoV2 compared to Comirnaty in terms of neutralizing antibodies against the SARS-CoV-2 (Wuhan wild type) as the primary endpoint, and other variants of concern as secondary endpoints
Initial trial results are expected towards the end of 2022, with the aim of obtaining approval of the vaccine in 2023.
Paul Chaplin, President and CEO of the Danish vaccine specialist, said: “Advancing ABNCoV2 into Phase 3 trials represents another significant step in the progression of our pipeline this year, and not least an important contribution to the development of a universal COVID-19 booster vaccine.
"In clinical trials to-date, ABNCoV2 has shown potential to boost neutralizing antibodies against SARS-CoV-2, including variants of concern, to levels associated with a high degree of protection. We hope that the Phase 3 trial will confirm these strong results, thus unleashing the potential of ABNCoV2 as a differentiated approach without the need for adaptation”.
The Phase 3 development of ABNCoV2 is partly funded through an agreement with the Danish State.
Bavarian Nordic’s pipeline also includes MVA-BN RSV, a vaccine for Respiratory Syncytial Virus, which is in Phase 3 trials; as well as a novel immuno-oncology candidate using the company’s MVA-BN tech (which is in Phase 1/2 trial).