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Bavarian Nordic A/S

First topic vaccinated in Phase 3 medical trial evaluating potential of the VLP-based candidate, ABNCoV2 as a booster COVID-19 vaccine

Trial will assess non-inferiority of ABNCoV2 in comparison with Comirnaty® by way of neutralizing antibodies towards the SARS-CoV-2 (Wuhan wild sort) as the first endpoint, and different variants of concern as secondary endpoints

COPENHAGEN, Denmark, September 2, 2022 – Bavarian Nordic A/S (OMX: BAVA) introduced immediately the dosing of the primary topic within the Phase 3 medical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate.

The double-blind, managed Phase 3 medical trial will enroll roughly 4,000 grownup topics who both beforehand accomplished major vaccination or have already acquired one booster dose of a licensed COVID-19 vaccine. The trial consists of two teams. An energetic managed group will probably be performed in Denmark and Belgium and can begin enrollment later this fall. Subjects on this group will probably be randomized to obtain both a single 100 µg dose of ABNCoV2, or a single 30 µg grownup booster dose of Comirnaty. The second group, which has now began enrollment within the U.S., will consider the protection and tolerability of the vaccine in topics receiving a single 100 µg dose of ABNCoV2.

Initial trial outcomes are anticipated in direction of the top of 2022, which is able to permit for a rolling submission to the regulatory authorities, aiming to acquire approval of the vaccine in 2023.

Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, mentioned: “Advancing ABNCoV2 into Phase 3 trials represents one other important step within the development of our pipeline this 12 months, and never least an vital contribution to the event of a common COVID-19 booster vaccine. In medical trials to-date, ABNCoV2 has proven potential to spice up neutralizing antibodies towards SARS-CoV-2, together with variants of concern, to ranges related to a excessive diploma of safety. We hope that the Phase 3 trial will verify these robust outcomes, thus unleashing the potential of ABNCoV2 as a differentiated method with out the necessity for adaptation”.

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The Phase 3 growth of ABNCoV2 is partly funded via an settlement with the Danish State.

About ABNCoV2
ABNCoV2 is a next-generation COVID-19 vaccine candidate, initially developed by AdaptVac, Denmark, utilizing their proprietary capsid virus like particle (cVLP) expertise. Bavarian Nordic has licensed the worldwide commercialization rights to the vaccine and has assumed the accountability for additional medical growth in direction of licensure.

ABNCoV2 has proven to be extremely immunogenic in related preclinical fashions inducing a sturdy and extremely protecting response from a COVID-19 problem. Results from a Phase 2 trial has confirmed the power of ABNCoV2 to considerably increase antibody titers as beforehand demonstrated in preclinical and Phase 1 medical trials, and in addition verify the potential of ABNCoV2 to spice up antibody titers towards SARS-CoV2 variants of concern.

About Bavarian Nordic
Bavarian Nordic is a totally built-in vaccines firm centered on the event, manufacturing and commercialization of life-saving vaccines. We are a world chief in smallpox vaccines and have been a long-term provider to the U.S. Government of a non-replicating smallpox vaccine, which has been accepted by the FDA, additionally for the safety towards monkeypox. The vaccine can also be accepted in Europe and Canada. Our business product portfolio moreover comprises market-leading vaccines towards rabies and tick-borne encephalitis. Using our reside virus vaccine platform expertise, MVA-BN®, we’ve got created a various portfolio of proprietary and partnered product candidates designed to avoid wasting and enhance lives by unlocking the ability of the immune system, together with an Ebola vaccine, which is licensed to the Janssen Pharmaceutical Companies of Johnson & Johnson. We are additionally dedicated to the event of a subsequent era COVID-19 vaccine. For extra data go to www.bavarian-nordic.com.

Forward-looking statements
This announcement consists of forward-looking statements that contain dangers, uncertainties and different components, lots of that are exterior of our management, that would trigger precise outcomes to vary materially from the outcomes mentioned within the forward-looking statements. Forward-looking statements embrace statements regarding our plans, goals, targets, future occasions, efficiency and/or different data that’s not historic data. All such forward-looking statements are expressly certified by these cautionary statements and every other cautionary statements which can accompany the forward-looking statements. We undertake no obligation to publicly replace or revise forward-looking statements to replicate subsequent occasions or circumstances after the date made, besides as required by legislation.

Contacts
Europe: Rolf Sass Sørensen, Vice President Investor Relations, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600

Company Announcement no. 33 / 2022

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By Seth A. Dunbar

Seth Dunbar leads clinical research study operations and quality & compliance. He is experienced working with teams to help drug sponsors better leverage eSource data. With 10+ years of experience Seth brings expertise developing eClinical services that integrate data and technology to help companies optimise study execution.

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