Bavarian Nordic Announces Collaboration to Evaluate CV301 and Tecentriq in Bladder Cancer

Bavarian Nordic Announces Collaboration to Evaluate CV301 and Tecentriq in Bladder Cancer

ID: 529443

(Thomson Reuters ONE) -


* Collaboration is the second to evaluate a combination of CV301 with a
checkpoint inhibitor

COPENHAGEN, Denmark, March 10, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) today announced an agreement with F. Hoffmann-La Roche Ltd  (Roche)
whereby Roche has agreed to supply their PD-L1 blocking antibody Tecentriq(®)
(atezolizumab) for a clinical study combining Bavarian Nordic's cancer vaccine,
CV301, and Tecentriq  in patients with urothelial carcinoma, or bladder cancer.

Bavarian Nordic plans to conduct a phase 2 study in patients with locally
advanced or metastatic urothelial carcinoma (mUC) who have disease progression
during or following platinum-containing chemotherapy or have disease progression
within 12 months of neoadjuvant or adjuvant treatment with platinum-containing
chemotherapy, a patient population where Tecentriq has accelerated approval in
the U.S. CV301 is designed to generate a T cell response to both CEA and MUC1,
two tumor antigens that are highly over expressed in bladder cancers. This study
will evaluate the hypothesis that combining a checkpoint inhibitor with a cancer
vaccine such as CV301 could be synergistic by enhancing the immune response seen
in this patient population to date. The study is anticipated to initiate around
the end of 2017.

"In keeping with our strategy to expand the potential of CV301, we are extremely
pleased to enter into this collaboration with Roche. This represents our second
collaboration in the advancement of CV301 as combination therapy in multiple
cancers. We look forward to the initiation of this study and to explore the
potential synergy of our programs for the benefit of patients with bladder
cancer," said Paul Chaplin, President and CEO of Bavarian Nordic.

Under the terms of the agreement, Roche has committed to supplying Tecentriq to
Bavarian Nordic during the phase 2 trial. Bavarian Nordic will be responsible




for conducting the clinical trial, and both companies will share data from the
trial. Bavarian Nordic continues to retain all commercial rights to CV301.

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 MUC1, 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. In December 2016, the MAGNI-lung-01 study was initiated. This Phase
1b/2 study evaluates the combination of CV301 and OPDIVO(®) (nivolumab) from
Bristol-Myers Squibb in patients with non-small cell lung cancer.

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

Company Announcement no. 5 / 2017

2017-05-en:
http://hugin.info/100065/R/2086814/787441.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: 10.03.2017 - 09:54 Uhr
Sprache: Deutsch
News-ID 529443
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