Bavarian Nordic Obtains Rights to New Cancer Vaccine Product Candidates
05 October 2011
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Includes rights to immunotherapy product candidate for
multiple cancer indications; data from ongoing NCI-sponsored Phase
2 study in breast cancer expected in first half of 2012.
Kvistgård, Denmark, October 5, 2011 - Bavarian
Nordic A/S (OMX: BAVA) today announced that its BN
ImmunoTherapeutics subsidiary has entered into an expanded
strategic partnership with the National Cancer Institute (NCI).
Under the licensing and Cooperative Research and Development
Agreements (CRADA), the NCI and Bavarian Nordic will jointly
develop new off-the-shelf product candidates for the treatment of
multiple cancers and a new technology platform based on NCI's
cancer vaccine technology.
Through the expanded collaboration with the NCI and license with
the National Institutes of Health (NIH), the Company has obtained
certain rights to CVAC-301 (formerly developed as PANVAC), an
off-the-shelf, cancer immunotherapy product candidate. CVAC-301
originates from the same poxvirus technology platform as
PROSTVAC®, the Company's lead product candidate licensed from
the NIH in 2008 and also being developed in collaboration with NCI
under a CRADA.
"This agreement marks a major step forward for Bavarian Nordic
as the product candidate and technology platform significantly
expand our cancer vaccine portfolio and enhances our position as a
leader in recombinant immunotherapies for the treatment and
prevention of life-threatening diseases," said Reiner Laus,
President of the Cancer Vaccine Division. "As already shown with
PROSTVAC® in prostate cancer and CVAC-301 in other cancer
indications, this technology platform holds great promise in the
future treatment of patients with several types of cancers who
today face a limited number of treatment alternatives. Also, we are
strengthening our ties with the National Cancer Institute - a world
leader in cancer research, and we look forward to collaborating
with the experienced staff at NCI on the development of new cancer
vaccines for the benefit of even more cancer patients."
While PROSTVAC® incorporates a single antigen overexpressed
in prostate cancer (PSA), CVAC-301 incorporates two antigens (CEA
and MUC-1) that are overexpressed in other major cancers, including
breast, lung, and ovarian, which makes CVAC-301 potentially
applicable in various cancers. CVAC-301 is currently the subject of
an NCI-sponsored, randomized Phase 2 study of docetaxel alone or in
combination with CVAC-301 in metastatic breast cancer with data
expected in the first half of 2012.
Under the agreement the Company will manufacture additional
vaccine constructs for the NCI. As part of this collaborative
effort, NCI will fund and conduct certain preclinical and clinical
studies to evaluate the product candidates alone and in combination
with other modalities. The funding can include Phase 3 studies.
The licensing cost of CVAC-301 does not affect the company's
expectations for the financial results for 2011. In addition, due
to CVAC-301's advanced stage of development and broader
applicability beyond HER2+ breast cancer, the company expects to
reassess earlier-stage pipeline programs, such as MVA-BN®
HER2, following the completion of ongoing studies.
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 CVAC-301 and PROSTVAC®
Both PROSTVAC® and CVAC-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
CVAC-301 can be found on the Company's website: /cvac-301
Conference call
A conference call will be held today, 5 October 2011 at 6 p.m.
CET (12 p.m. EST) with Anders Hedegaard, President & CEO,
Reiner Laus, CEO of BN ImmunoTherapeutics Inc. and Rolf Sass
Sørensen, Vice President Investor Relations &
Communications. The conference call will begin with a presentation
of CVAC-301 and the expanded NCI collaboration, followed by a
Q&A session. Dial-in numbers for the conference call are: UK:
+44 (0)20 7162 0077. USA: +1 334 323 6201. The accompanying
presentation is available on the company's website: /cvac-301.
Contact:
Anders Hedegaard, President & CEO.
Phone: +45 23 20 30 64