COPENHAGEN, Denmark, September 29, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the presentation of data from a Phase 1 study of its novel, broad spectrum RSV (respiratory syncytial virus) vaccine candidate, MVA-BN RSV ® . The Phase 1 was a dose ranging study which enrolled 63 volunteers, including the elderly.
The presentation, entitled " A randomized, single-blind, placebo-controlled Phase 1 trial to evaluate the safety, tolerability, and immunogenicity of the recombinant MVA-BN RSV ® vaccine in healthy adult subjects " will take place today at the 10th International Respiratory Syncytial Virus Symposium in Patagonia, Argentina.
As was previously reported, MVA-BN RSV was well tolerated, with no unexpected or serious adverse reactions. A significant boost in antibodies and T cells against RSV was measured in all groups following vaccination including antibodies against both RSV subtypes, A&B. Also of note was the production of IgA, a specialized antibody that is transported from the blood to the mucosal surfaces (e.g. nose, throat, lungs) potentially allowing for protection against RSV at the point of infection/inflammation. Based on these data, a Phase 2 study in 400 subjects will begin this fall.
A link to the abstract can be found on the conference website, www.rsv16.org , and a copy of the slide presentation will be available on the company's website, www.bavarian-nordic.com under Investors > Events & Presentations.
Respiratory syncytial virus, or RSV, is the most common cause of bronchiolitis and pneumonia in infants and a significant cause of respiratory illness in older adults, resulting in a high number of hospitalizations. RSV infections are responsible each year for a similar number of deaths as the flu in children up to age 14, as well as in the elderly population. It is estimated that more than 64 million people are infected globally each year, yet unlike the flu, there is no vaccine to prevent RSV, presenting a large unmet medical need and market opportunity.
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 Janssen are developing an Ebola vaccine regimen, which was 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 .
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.
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Last updated on: 30/09/2016
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