Bavarian Nordic has provided an update on the Phase 3 development of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.
The upcoming Phase 3 trial has been redesigned to include a licensed mRNA-based vaccine (Comirnaty) in the comparator arm of the study, to potentially support the primary objective of the study and demonstrate that the neutralizing antibodies induced by ABNCoV2 are non-inferior to the levels stimulated by the licensed mRNA-based vaccine.
The addition of the comparator vaccine for clinical trial use has now been made possible in cooperation with regulatory authorities and vaccine manufacturers, and enables Bavarian Nordic to conduct a double-blind, controlled Phase 3 trial.
The Phase 3 trial
The Phase 3 trial will enroll approximately 4,000 adult subjects who either previously completed primary vaccination or have already received one booster dose of a licensed COVID-19 vaccine. The trial consists of two groups, which will run in parallel. The active, controlled group will enroll 1,000 subjects who will be randomized to receive either a single 100 µg dose of ABNCoV2 or a single 30 µg adult booster dose of Comirnaty. The other group will evaluate the safety and tolerability of the vaccine in 3,000 subjects who will receive a single 100 µg dose of ABNCoV2.
“Based on the new design, the Phase 3 trial will now start enrolling in August 2022, but the overall timelines for trial remain unaffected.”
Based on the new design, the Phase 3 trial will now start enrolling in August 2022, but the overall timelines for trial remain unaffected. Thus, the Company still anticipates the initial data read-out before the end of 2022, which will allow for a rolling submission to the regulatory authorities, aiming to obtain approval of the vaccine in 2023.
“We are pleased to be able to run the Phase 3 trial of ABNCoV2 as a double-blind, controlled study, which provides us with a more robust foundation for the regulatory process towards approval. With its differentiated approach, we believe that ABNCoV2 could provide several advantages over the current licensed COVID-19 vaccines and look forward to initiating the study and presenting the first Phase 3 data for this universal booster vaccine candidate later this year,” says Paul Chaplin, President and CEO of Bavarian Nordic.
ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac, Denmark using their capsid virus like particle (cVLP) technology. Bavarian Nordic has licensed the global commercialization rights to the vaccine and has assumed the responsibility for further clinical development towards licensure.
ABNCoV2 has shown to be highly immunogenic in relevant preclinical models inducing a durable and highly protective response from a COVID-19 challenge. Results from a Phase 2 trial has confirmed the ability of ABNCoV2 to significantly boost antibody titers as previously demonstrated in preclinical and Phase 1 clinical trials, and also confirm the potential of ABNCoV2 to boost antibody titers against SARS-CoV2 variants of concern.
The Phase 3 development of ABNCoV2 is being funded through an agreement with the Danish State.