Bavarian Nordic Initiates Trial of CV301 in Combination with Nivolumab in Patients with Lung Cancer
(Thomson Reuters ONE) -
* Study is exploring potential benefits of combining a cancer vaccine and PD-
1 checkpoint inhibitor
COPENHAGEN, Denmark, December 29, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) today announced the initiation of a clinical trial combining its
proprietary cancer immunotherapy candidate, CV301, with the anti-PD-1 drug,
OPDIVO® (nivolumab) from Bristol-Myers Squibb. The study is enrolling patients
with non-small cell lung cancer (NSCLC) who have failed prior therapy.
The trial will begin with a Phase 1 safety component, enrolling up to 40
patients; the Phase 2 portion of the study will enroll 120 patients who will be
randomized to receive either nivolumab (monotherapy) or a combination of CV301
and nivolumab. The study will enroll patients from up to 20 clinical sites
throughout the United States. Detailed information on the trial can be found at
http://clinicaltrials.gov/ct2/show/NCT02840994.
The rationale for this combination approach is for the vaccine to generate a
tumor specific T cell response and allow the checkpoint inhibitor to maintain
that immune effect by preventing the tumor from turning that response off.
While the primary endpoint of the study is overall survival, numerous secondary
endpoints including response rate, progression free survival and duration of
response will be evaluated and offer the potential for an early efficacy signal,
prior to an overall survival endpoint.
"We are pleased to announce the initiation of this study, which marks the entry
for Bavarian Nordic into lung cancer. While CV301 has shown the ability to
generate immune responses to tumor-associated antigens in a variety of cancers,
this study is the first seeking proof-of-concept for a promising combination
approach and we look forward to the results as well as to advance CV301 as
combination therapy in additional indications over the next years," said Paul
Chaplin, President & CEO of Bavarian Nordic.
About CV301
CV301 is an immunotherapy candidate which is being developed under a CRADA with
the National Cancer Institute (NCI).
CV301 targets two tumor-associated antigens, CEA and MUC-1, which are over-
expressed in multiple solid tumors, including lung, bladder and colorectal
cancer. Similar to PROSTVAC®, CV301 uses a prime/boost dosing schedule. CV301
incorporates a modified version of vaccinia (MVA-BN, a proprietary technology of
Bavarian Nordic) as a priming dose, followed by multiple fowlpox boosts, and
encodes the TRICOM costimulatory molecules.
A precursor version of CV301 has been tested in six NCI-sponsored clinical
trials in various cancers, and a Phase 2 study in bladder cancer is currently
ongoing. More than 300 patients have been treated with the product candidate.
About OPDIVO (nivolumab)
Marketed by Bristol-Myers Squibb, OPDIVO is an immune checkpoint inhibitor
(anti-PD-1 therapy) approved for treatment of patients with advanced NSCLC in
the second line setting, among other indications. OPDIVO has demonstrated
superior overall survival across histologies, versus chemotherapy, in two
pivotal Phase 3 trials in patients with advanced NSCLC.
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 (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
2016-12-29-en:
http://hugin.info/100065/R/2068019/776573.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: 29.12.2016 - 13:00 Uhr
Sprache: Deutsch
News-ID 515181
Anzahl Zeichen: 6511
contact information:
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