Bavarian Nordic Announces Additional Positive Data from a Phase 2 Study of its Universal RSV Vaccine

Presence of antibodies in nasal mucosa suggest vaccine-induced immune protection at source of infection IgA antibodies against RSV observed in both serum and mucosa of vaccinated individuals

COPENHAGEN, Denmark, March  6, 2018 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced additional positive data from its 421 patient, Phase 2 study investigating the safety and immune effects of its universal RSV vaccine, MVA-BN RSV in an older adult population.

In a planned follow-up analysis, nasal swabs demonstrated, on average, an approximately 1.5-fold increase in IgA antibodies over baseline levels, with peak increases seen in the weeks immediately following vaccination. The boosting effect was more pronounced in individuals with a lower baseline mucosal IgA at the time of vaccination. This observation suggests that the vaccine has the desired effect of boosting memory responses against RSV in patients with a poor underlying immunity.

Previous published studies have shown that in RSV human challenge studies, the presence of IgA antibodies in the mucosa is highly correlated with immune protection in subjects who do not develop symptoms of RSV[1]. In those studies, the level of IgA expression seen was similar to the levels of expression detected post-vaccination with MVA-BN RSV.

The presence of mucosal IgA in vaccinated subjects is a truly encouraging, demonstrating that our vaccine is performing as intended. The ability to fight off a severe RSV infection wanes as individuals get older. Observing a booster effect in this elderly population gives us additional confidence that protection against RSV may be possible in this at-risk population using our vaccine. With a mortality rate on par with influenza, the need for an RSV vaccine remains significant, said Paul Chaplin, President and CEO of Bavarian Nordic. 

MVA-BN RSV has been specifically designed to mimic a natural RSV infection, and can boost the body's memory response against RSV. The vaccine has been shown to elicit T-cells and humoral antibodies against each of the 5 targets encoded in the vaccine, as well as the whole virus. Previously reported data demonstrated that the vaccine induced sustained protection levels for up to 6 months, the duration of an RSV season, against all 5 encoded targets when compared to a placebo.

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development of innovative and safe therapies against cancer and infectious diseases. Using our live virus vaccine platform technology, MVA-BN®, we have created a diverse portfolio of proprietary and partnered product candidates intended to improve the health and quality of life for children and adults. We supply our IMVAMUNE® non-replicating smallpox vaccine to the U.S. Strategic National Stockpile and other government stockpiles. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Registration studies are currently underway in the U.S. In addition to our long-standing collaboration with the U.S. government on the development of IMVAMUNE® and other medical countermeasures, our infectious disease pipeline comprises a proprietary RSV program as well as vaccine candidates for Ebola, HPV, HBV and HIV, which are developed through a strategic partnership with Janssen. Additionally, in collaboration with the National Cancer Institute, we have developed a portfolio of active cancer immunotherapies, designed to alter the disease course by eliciting a robust and broad anti-cancer immune response while maintaining a favorable risk-benefit profile. Through multiple industry collaborations, we seek to explore the potential synergies of combining our immunotherapies with other immune-modulating agents, e.g. checkpoint inhibitors. For more information visit www.bavarian-nordic.com or follow us on Twitter @bavariannordic.

Forward-looking statements
This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are outside of our control, that could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements concerning our plans, objectives, goals, future events, performance and/or other information that is not historical information. All such forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements which may accompany the forward-looking statements. We undertake no obligation to publicly update or revise forward-looking statements to reflect subsequent events or circumstances after the date made, except as required by law.

Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43

Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271

Company Announcement no. 05 / 2018

[1] Habibi M, Agnieszka J, Markis S, et. al. American Journal of Respiratory and Critical Care Medicine Volume 191 Number 9

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Source: Bavarian Nordic A/S via Globenewswire

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