Bavarian Nordic Provides Update on its Universal RSV Vaccine
(Thomson Reuters ONE) -
* 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 (5x10(8)) and low (1x10(8)) 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 (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
Company Announcement no. 27 / 2017
2017-27-en:
http://hugin.info/100065/R/2135893/817341.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
Unternehmensinformation / Kurzprofil:
Datum: 21.09.2017 - 10:13 Uhr
Sprache: Deutsch
News-ID 560784
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contact information:
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Kategorie:
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