Bavarian Nordic's Immunotherapy Product Candidate CV-301 Shows Promise in Breast and Ovarian Cancer
(Thomson Reuters ONE) -
Data update from ongoing NCI-sponsored Phase 2 study in breast cancer expected
in first half of 2012.
Kvistgård, Denmark, November 8, 2011 - Bavarian Nordic A/S (OMX: BAVA) today
announced that encouraging clinical trial results with CV-301 in patients with
metastatic breast or ovarian cancer were published in Clinical Cancer Research,
a peer-reviewed journal of the American Association for Cancer Research. Through
an expanded collaboration with the National Cancer Institute (NCI) and license
with the National Institutes of Health (NIH), the Company obtained rights to CV-
301, an off-the-shelf cancer immunotherapy product candidate for multiple
cancers, in October 2011.
The NCI-funded study enrolled 26 heavily pretreated patients with metastatic
breast or ovarian cancer and assigned them to monthly vaccinations with CV-301.
Among the 12 patients with breast cancer, median time to progression (TTP) was
2.5 months and median overall survival (OS) was 13.7 months. One breast cancer
patient had a complete response and remains on study for 37 months or more. For
the 14 patients with ovarian cancer, median TTP was 2 months and median OS was
15 months. Treatment with CV-301 was well tolerated, with mild injection-site
reactions representing the most common side effect.
"Approval of the first active immunotherapy for cancer by the U.S. Food and Drug
Administration provided definitive proof-of-concept for this class of agents and
further demonstrated that overall survival, rather than time to progression or
tumor shrinkage, may be a more relevant clinical endpoint in evaluating the
effects of immunotherapies," said Reiner Laus, President of the Cancer Vaccine
Division. "The sustained benefit seen in some patients receiving CV-301 provides
additional insight into the potential of this therapeutic vaccine and we look
forward to results from an ongoing randomized Phase 2 study of CV-301 in
patients with metastatic breast cancer."
CV-301 originates from the same poxvirus technology platform as PROSTVAC(®), the
Company's lead product candidate. While PROSTVAC(®) incorporates a single
antigen overexpressed in prostate cancer (PSA), CV-301 incorporates two antigens
(CEA and MUC-1) that are overexpressed in other major cancers, including breast,
lung, and ovarian, which makes CV-301 potentially applicable in various cancers.
CV-301 is currently the subject of an NCI-sponsored, randomized Phase 2 study of
docetaxel (chemotherapy) alone or in combination with CV-301 in metastatic
breast cancer.
Asger Aamund
Chairman of the Board
Contact
Anders Hedegaard, President & CEO. Phone +45 23 20 30 64
About Poxviruses and Immunotherapy
Although increased expression of tumor associated antigens, such as PSA, CEA,
and MUC-1, is associated with advanced disease these antigens do not
sufficiently activate the immune system to attack cancer cells. To overcome this
poor responsiveness, recombinant poxvirus vectors, including vaccinia, fowlpox
and modified vaccinia Ankara (MVA), can be genetically engineered to express one
or more tumor-associated antigens to greatly enhance the immune system's ability
to recognize and destroy cancer cells bearing any of the targeted antigens.
About CV-301 and PROSTVAC(®)
Both PROSTVAC(®) and CV-301 are prime-boost vaccines, sequentially combining two
different poxviruses (vaccinia and fowlpox). Collectively, these two product
candidates have been the subject of over 30 clinical trials in more than 1,000
patients with prostate, breast, lung, colorectal, gastric, pancreatic, ovarian,
and other cancers. These extensive clinical studies suggest a favorable safety
and tolerability profile for poxvirus-based vaccines along with immunologic
responses directed against the relevant tumor-associated antigens.
Further information and a list of scientific publications on CV-301 can be found
on the Company's website:http://www.bavarian-nordic.com/cv-301
About Bavarian Nordic
Bavarian Nordic is a vaccine-focused biotechnology company developing and
producing novel vaccines for the treatment and prevention of life-threatening
diseases with a large unmet medical need. The company's pipeline targets cancer
and infectious diseases, and includes ten development programmes. Two programmes
are under preparation for Phase 3: PROSTVAC(®), a therapeutic vaccine for
advanced prostate cancer is being developed under a collaboration agreement with
the National Cancer Institute, and IMVAMUNE(®), a third-generation smallpox
vaccine is being developed under a contract with the U.S. Government. For more
information please visit www.bavarian-nordic.com.
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.
201130uk:
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Source: Bavarian Nordic A/S via Thomson Reuters ONE
[HUG#1561890]
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Datum: 08.11.2011 - 19:00 Uhr
Sprache: Deutsch
News-ID 85417
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