Updated Phase 1 Data Show Bavarian Nordic’s Vaccine Candidate Induces a Broad and Durable Immune Response against RSV

  • Antibody levels maintained against multiple targets 6 months post vaccination
  • Additional T cell data confirms broad activity against all 5 RSV targets included in the vaccine

COPENHAGEN, Denmark, February 23, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced 6 month follow-up data from the Phase 1 trial of MVA-BN® RSV, its novel, broad spectrum vaccine against respiratory syncytial virus (RSV). The randomized, placebo-controlled trial, evaluated the safety, tolerability and immunogenicity of the recombinant vaccine in 63 healthy adults, including an elderly group of individuals and positive top line results were reported in May 2016.

The 6 month (30 weeks) analysis revealed that the antibody response induced by the vaccine candidate remained at similar levels previously reported, demonstrating that MVA-BN RSV induced a durable immune response lasting at least 6 months; a period spanning a normal RSV season. Specifically:

  • neutralizing antibodies against both RSV subtypes A & B remained at similar levels previously reported for 8 weeks post the vaccination
  • blood IgG and IgA, the later a specialized antibody that is transported from blood to mucosal surfaces (e.g. throat, lungs etc.) remained elevated at the levels previously reported for 6-8 weeks post the initial vaccination.

Additionally, T cell responses have now been measured for all RSV proteins included in the vaccine. There was a 3-4 fold increase in the T cell response in the elderly volunteers to the RSV Matrix (M) protein and the surface glycoprotein (G) from RSV subtype B. Therefore, MVA-BN RSV has now induced a strong (3-5 fold) booster response to all five RSV proteins included in the vaccine (Fusion [F], G [from both subtype A & B], nucleocapsid [N] and M).

 "These data are another important step in the development of an effective RSV vaccine, as we have shown this vaccine, based on our potent MVA platform, is able to induce a durable immune response spanning at least a whole RSV season. We are highly encouraged that our vaccine candidate has induced a robust and broad immune response against 5 RSV proteins, which remains a clearly differentiated approach to prior RSV vaccines based on using only a single RSV protein," said Paul Chaplin, President and CEO of Bavarian Nordic.

An ongoing Phase 2 trial is evaluating the safety and immunogenicity of 2 different doses, with or without a booster at day 28, of MVA-BN RSV in 400 healthy subjects aged 55 or older. Top-line results from the randomized, placebo controlled study are anticipated in mid-2017 and will provide essential information for subsequent, larger efficacy studies.

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 partner Janssen are developing an Ebola vaccine regimen, which has been fast-tracked, with the backing of worldwide health authorities, and a vaccine for the prevention and treatment of HPV. 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. 04 / 2017

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