Bavarian Nordic Announces First Subject Dosed with MVA-BN® Filo in a Phase 1 Study Investigating a New Prime-Boost Regimen of Ebola Candidate Vaccines
(Thomson Reuters ONE) -
* First human trial investigating MVA-BN® Filo as an Ebola vaccine
* MVA-BN Filo is being investigated as a booster in an ongoing Phase study 1
of the cAd3-EBO Z vaccine being developed by GSK and the U.S. National
Institutes of Health (NIH)
KVISTGAARD, Denmark, December 4, 2014 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) announced today that the first subject has been dosed with MVA-BN Filo in
a Phase 1 safety and immunogenicity trial, evaluating a heterologous prime-boost
regimen of Ebola candidate vaccines. The trial, sponsored by the University of
Oxford, is assessing the monovalent cAd3-EBO Z vaccine co-developed by GSK and
the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of
the National Institutes of Health (NIH), and Bavarian Nordic's multivalent MVA-
¬BN Filo vaccine, designed to protect against Ebola Zaire, Ebola Sudan and
Marburg virus.
Recent preclinical research has shown that by employing an MVA-based booster
dose, the vaccine may offer a more robust and durable immune response. The
investigators hope to be able to replicate these findings in clinical studies
and have therefore chosen to include Bavarian Nordic's MVA-BN Filo vaccine in
the study for a heterologous boost.
The study is enrolling 60 healthy adults in three cohorts receiving different
doses of the cAd3-EBO Z vaccine. Half of the subjects in each cohort will
furthermore receive a booster dose of the MVA-BN Filo vaccine. Primary objective
is the assessment of safety and tolerability; secondary objective is the
assessment of cellular and humoral immune responses. Preliminary results from
the study are anticipated in the first half of 2015. More information on the
trial can be found at http://clinicaltrials.gov/ct2/show/NCT02240875.
Both the cAd3-EBO Z vaccine and the MVA-BN Filo vaccine have been developed in
collaboration with NIAID. In partnership with Bavarian Nordic and Crucell
Holland B.V., one of the Janssen Pharmaceutical Companies of Johnson & Johnson,
NIAID furthermore investigated a prime-boost regimen of Bavarian Nordic's MVA-BN
Filo and Janssen's AdVac® technology. Based on promising preclinical results,
Bavarian Nordic and Janssen recently entered into a collaboration to develop and
manufacture large quantities of this vaccine regimen, which is planned to enter
clinical trials shortly.
"In support of the various clinical trials currently underway to fast-track the
development of urgently needed vaccines against Ebola, we are pleased that these
studies may confirm the role of a heterologous prime boost regimen incorporating
the MVA-BN vaccine platform technology," said Paul Chaplin, President and Chief
Executive Officer of Bavarian Nordic. "We are also making progress in our
collaboration with Janssen as part of their commitment to accelerate and expand
the production of its Ebola vaccine regimen. Manufacturing of our MVA-BN Filo
vaccine is well underway and the first trial in humans of this prime-boost
vaccine regimen will soon open for enrollment."
Contacts
Rolf Sass Sørensen, Vice President Investor Relations (EU). Phone
+45 61 77 47 43
Seth Lewis, Vice President Investor Relations (US). Phone + 1 978-298-5654
About Bavarian Nordic
Bavarian Nordic is an international biotechnology company developing and
manufacturing novel cancer immunotherapies and vaccines for infectious diseases.
Lead product candidates are PROSTVAC®, an immunotherapy product candidate for
advanced prostate cancer that is the subject of an ongoing pivotal Phase 3
clinical trial, and IMVAMUNE®, a non-replicating smallpox vaccine candidate in
Phase 3 development, which is being developed and supplied for emergency use to
the U.S. Strategic National Stockpile under a contract with the U.S. Government.
The vaccine is approved in Canada under the trade name IMVAMUNE and in the
European Union under the trade name IMVANEX. Bavarian Nordic's shares are listed
on NASDAQ OMX Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg:
BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC)
under the symbol BVNRY. For more information, visit www.bavarian-nordic.com.
About MVA-BN®
MVA-BN (Modified Vaccinia Ankara - Bavarian Nordic) is a proprietary and
patented vaccine platform technology of Bavarian Nordic. MVA-BN is a robust and
adaptable platform suitable for addressing a wide variety of infectious
diseases, including biological threats.
In addition to developing MVA-BN as a safer smallpox vaccine (approved in the EU
and Canada) essential to protecting the immune-compromised population, Bavarian
Nordic has conducted more than a dozen preclinical and clinical studies of
recombinant MVA-BN-based vaccines. More than 7,500 individuals, nearly 1,000 of
whom are immunocompromised, have been vaccinated with MVA-BN-based vaccines,
showing the platform displays high immunogenicity and a favorable safety
profile.
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. 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.
201432uk:
http://hugin.info/100065/R/1877031/661607.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via GlobeNewswire
[HUG#1877031]
Unternehmensinformation / Kurzprofil:
Datum: 04.12.2014 - 07:31 Uhr
Sprache: Deutsch
News-ID 357174
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