Bavarian Nordic announced the signing of an agreement with AdaptVac, a joint venture established by ExpreS2ion Biotechnologies and NextGen Vaccines spun out of the University of Copenhagen, to license AdaptVac’s proprietary capsid virus-like particle (cVLP) technology for coronaviruses, including the COVID-19 indication.

The parties signed ahead of agreement in May and have now concluded a license agreement that provides Bavarian Nordic the global commercialization rights to the COVID-19 vaccine. Under the terms of the agreement, Bavarian Nordic will make an upfront payment of EUR 4 million to AdaptVac, in addition to potential future development and sales milestones and tiered royalties.

Last month, encouraging preclinical data for the vaccine candidate was reported, demonstrating the induction of very high levels of neutralizing antibodies against SARS-CoV-2, compared to published preclinical data from other COVID-19 vaccines in development. Based on these data, the first clinical study of the vaccine is planned to be initiated during the fourth quarter of 2020, with data expected to become available early in 2021. The Phase 1/2a study is supported by a Horizon 2020 EU grant awarded to the PREVENT-nCoV consortium, which, in addition to AdaptVac and ExpreS2ion Biotechnologies, represents various European universities.

Bavarian Nordic will assume responsibility for further clinical development, manufacturing and commercialization and have plans to gain regulatory approvals within the next 12-18 months. These plans are dependent on external funding, which the Company is in the process of seeking from various initiatives established to rapidly advance COVID-19 vaccines.

The agreement has no impact on Bavarian Nordic’s financial guidance for 2020.

Paul Chaplin, President & CEO of Bavarian Nordic said: “We are very pleased to have signed the agreement with AdaptVac, allowing us to support and rapidly advance this highly promising COVID-19 vaccine candidate. We continue to believe this vaccine candidate can address the WHO requirements to be safe and effective in all populations and induce a rapid protection after a single vaccination.”

AdaptVac is a joint venture between ExpreS2ion Biotechnologies and NextGen Vaccines, owned by the inventors of the novel proprietary and ground-breaking viral capsid-like virus particle (CLP) platform technology spun out from the University of Copenhagen. The Company aims to accelerate the development of highly efficient therapeutic and prophylactic vaccines within high-value segments of oncology, infectious diseases and immunological disorders. Granting of the core patent in the U.S. has expanded AdaptVac’s patent protection to include their entire pipeline of vaccines and immunotherapies in development.

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacture and commercialization of life-saving vaccines. They are a global leader in smallpox vaccines and have been a long-term supplier to the U.S. Strategic National Stockpile of a non-replicating smallpox vaccine, which has been approved by the FDA.