Bavarian Nordic Announces Initiation of Phase 2 Combination Trial of PROSTVAC and Ipilimumab in Patients with Localized Prostate Cancer
(Thomson Reuters ONE) -
* Trial is being conducted as part of clinical collaboration with Bristol-
Myers Squibb
COPENHAGEN, Denmark, October 10, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) today announced the initiation of a Phase 2 clinical trial of its
prostate cancer immunotherapy candidate, PROSTVAC (rilimogene), in combination
treatment with ipilimumab (Yervoy(®)), an immune checkpoint inhibitor from
Bristol-Myers Squibb, as neoadjuvant therapy in 75 patients with localized
prostate cancer.
Patients will be randomized into three cohorts of 25 each to receive either
PROSTVAC or ipilimumab or a combination of both. The primary endpoint of the
study is to evaluate CD3+ T cell immune responses and secondary measures include
immunologic infiltration, circulating effector T cells and regulatory T cells.
The principal investigator of the study is Lawrence Fong, MD, Professor,
Department of Medicine (Hematology/Oncology), University of California, San
Francisco (UCSF) and UCSF is also sponsor of the study. More information on the
trial can be found at http://clinicaltrials.gov/ct2/show/NCT02506114
"Checkpoint inhibitors continue to show impressive benefit for a number of
cancers," said Dr. Fong. "As we continue to explore the potential for benefit in
a broader group of patients, we are looking toward combinations of therapies
that may have the ability to enhance the clinical activity we have seen to date
in certain cancers. Combining a cancer vaccine which specifically targets
antigens against prostate cancer and has shown an ability to stimulate the
body's T cell immune response, with a checkpoint inhibitor may enhance efficacy
in attacking tumors. We look forward to evaluating this further in the trial."
The combination of PROSTVAC and ipilimumab was previously investigated in an
NCI-sponsored Phase 1 trial in patients with metastatic castration-resistant
prostate cancer, indicating improved survival for the treatment regimen when
compared to the predicted survival (J Clin Oncol 33, 2015 (suppl 7; abstr
172)). This improved effect is believed to be due to PROSTVAC's ability to
stimulate an anti-prostate cancer immune response combined with the ability of
checkpoint inhibitors to make the anti-cancer immune response more effective.
"We are pleased to expand the scope of PROSTVAC trials into combinations with
immunotherapies that have complementary mechanisms of action. Based on
previously reported data from the combination treatment of PROSTVAC and
ipilimumab, we believe this combination may generate synergistic effects which
could improve the long-term outcome for the patients," said Paul Chaplin,
President & Chief Executive Officer of Bavarian Nordic.
This is the first trial conducted under the clinical collaboration with Bristol-
Myers Squibb which was entered in 2015 upon signing of an option and license
agreement for PROSTVAC. A second trial is planned in order to investigate the
combination treatment of PROSTVAC, ipilimumab and nivolumab (Opdivo(®)), the
latter also a checkpoint inhibitor product from Bristol-Myers Squibb's immuno-
oncology portfolio.
About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec, or "rilimogene") is a
prostate specific antigen (PSA)-targeted immunotherapy candidate designed to
enhance or stimulate the body's immune response, specifically T cells that will
home to and kill prostate cancer cells, altering the course of the disease and
improving overall survival (OS) of patients with prostate cancer. A robust data
package has been established that includes 16 ongoing or completed clinical
studies, comprising more than 1,800 patients of which more than 1,100 patients
have been actively treated with PROSTVAC, which has been generally well-
tolerated. A randomized, placebo-controlled Phase 2 trial demonstrated the
potential of PROSTVAC to extend the median overall survival by 8.5 months in
patients with advanced prostate cancer. These results led to the initiation of
the PROSPECT pivotal Phase 3 clinical trial study in 1,297 patients, which has
completed enrollment and top-line data are anticipated in 2017.
PROSTVAC is being developed in collaboration with the National Cancer Institute
under a Cooperative Research and Development Agreement.
Latest review article:
PROSTVAC(®) targeted immunotherapy candidate for prostate cancer
ND Shore, Immunotherapy. 2014;6(3):235-47
More information available at http://www.bavarian-
nordic.com/pipeline/prostvac.aspx.
About ipilimumab
Ipilimumab (Yervoy(®)) is an immune checkpoint inhibitor developed and marketed
by Bristol-Myers Squibb. It is approved by the FDA for the treatment of
melanoma.
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
Press Release
2016-10-10-en:
http://hugin.info/100065/R/2047808/765568.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: 10.10.2016 - 13:00 Uhr
Sprache: Deutsch
News-ID 499573
Anzahl Zeichen: 8250
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