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2017-09-21 10:13 CEST
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Bavarian Nordic Provides Update on its Universal RSV Vaccine

  • Preliminary 6 Month Phase 2 Data continue to Demonstrate a Broad and Durable Immune Response against RSV 
  • Updated Clinical Plans to Develop and Initiate a Human Challenge Study in 2018

COPENHAGEN, Denmark, September 21, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced initial 6 month follow-up data from the Phase 2 trial of MVA-BN® RSV, a universal vaccine candidate designed to induce protective immune responses against both subtypes (A & B) of the respiratory syncytial virus (RSV). The randomized, placebo-controlled trial, evaluated the safety, tolerability and immunogenicity of the recombinant vaccine in 421 healthy adults aged 55 and older.

The subjects were enrolled into four active arms of the study, which examined the effects of both a high (5x108) and low (1x108) dose, administered as either one or two vaccinations (day 0, 28) and compared to a placebo arm. At 6 month follow up, a persistent antibody response against multiple RSV targets can still be observed. 

Also announced today are the Company's updated clinical plans for the RSV vaccine, which will now include a human challenge study. Anticipated to initiate recruitment in the second half of 2018 the placebo-controlled study will explore the protective effects of MVA-BN RSV. Bavarian Nordic intends to use evidence from the challenge study to assist in the planning and design of late phase RSV studies as well as demonstrating early evidence regarding efficacy of MVA-BN RSV in preventing disease in healthy volunteers subsequently exposed to live RSV.

Bavarian Nordic will partner with a global CRO to develop a novel and differentiated approach to the RSV challenge model. Previous attempts at RSV challenge studies have historically been seen as lacking in sufficient measurable outcomes, which may be associated with the relatively low virulence of the virus administered to volunteers. The CRO has developed a new primary isolate of RSV which, in infectivity assays, has demonstrated  a degree of virulence and pathogenicity more commonly associated with circulating, wild-type strains. This new model will potentially allow Bavarian Nordic to more accurately assess the protective benefits of its vaccine when confronted with a virulent RSV infection.

"We are very happy to report this data, once again demonstrating the durability of our vaccine for up to 6 months," said Paul Chaplin, President and CEO of Bavarian Nordic, "Announcing the development of a more virulent RSV human challenge model creates the potential to gain efficacy data of our RSV vaccine prior to initiating the pivotal Phase 3. The global CRO is an ideal partner and a leader in the field having previously been successful in developing a virulent influenza challenge model."

About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases, based on the Company's live virus vaccine platform. Through long-standing collaborations, including a collaboration with the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for infectious diseases, including the non-replicating smallpox vaccine, IMVAMUNE®, which is stockpiled for emergency use by the United States and other governments. The vaccine is approved in the European Union (under the trade name IMVANEX®) and in Canada. Bavarian Nordic and its strategic partner Janssen are developing an Ebola vaccine regimen, and therapeutic vaccines for HPV, HBV and HIV. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies, including PROSTVAC®, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC. 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. 27 / 2017

2017-27-en
Sep 21, 2017

HUG#2135893