Bavarian Nordic Announces Presentation of Phase 1 Data for its RSV Vaccine at International RSV Symposium
(Thomson Reuters ONE) -
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.
About RSV
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
(at)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
Press Release
2016-09-29-en:
http://hugin.info/100065/R/2045513/764160.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Bavarian Nordic A/S via GlobeNewswire
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Bereitgestellt von Benutzer: hugin
Datum: 29.09.2016 - 15:00 Uhr
Sprache: Deutsch
News-ID 497914
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