Bavarian Nordic to Present Data Combining Its Cancer Immunotherapies With Immune Checkpoint Inhibitors at the 2014 ASCO Annua...
15 Mai 2014 - 8:06AM
Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today two
papers featuring the combination of the Company's proprietary
cancer immunotherapy candidate MVA-BN(r)-HER-2 together with immune
checkpoint inhibitors will be presented as posters, including a
highlight posters discussion session, during the 2014 ASCO Annual
Meeting in Chicago, IL from May 30 to June 3. A third poster
featuring the Company's lead cancer immunotherapy candidate
PROSTVAC(r) provides new evidence elucidating the mechanism of
action of PROSTVAC for prostate cancer.
"The results will show what we and others have hypothesized,
namely that the development of robust anti-cancer immune responses
is augmented and accelerated when the foundational benefit from our
active immunotherapy is coupled with immune checkpoint inhibitors,"
said James B. Breitmeyer, President of Bavarian Nordic's Cancer
Immunotherapy Division. "By design, the checkpoint inhibitors
remove inhibitions from the immune system, but sometimes an initial
immune stimulation is still required. Our active immunotherapy
stimulates the immune system to target the cancer, and the
checkpoint inhibitors amplify that response. The data from the
presented work help to elucidate the survival effect seen in
published human studies of prostate cancer with our lead candidate,
PROSTVAC, combined with ipilimumab, which we hope to replicate in
future combination clinical trials."
Abstract titles and summary:
"Anti-tumor efficacy of poxvirus-based active immunotherapy
alone and in combination with sub-therapeutic dosing with immune
checkpoint inhibitors"
General Poster Session, Developmental Therapeutics:
Immunotherapy, Sunday, June 1, 2014 from 8:00 AM to 11:45 AM CDT.
The abstract can be seen at the ASCO Annual Meeting website:
http://abstracts.asco.org/144/AbstView_144_130074.html.
- Anti-tumor efficacy was significantly improved when Bavarian
Nordic's poxvirus-based active immunotherapy was combined with one
or two immune checkpoint inhibitors in both primary and metastatic
preclinical tumor models.
- Complete tumor regression resulted from combining MVA-BN-HER2
immunotherapy with anti-PD-1 plus anti-LAG-3 antibodies.
- The doses of anti-PD-1 plus anti-LAG-3 could be reduced by 90%
while retaining anti-tumor efficacy if the iCPIs were given in
combination with MVA-BN-HER2 active immunotherapy.
- The authors conclude that combination therapy of reduced-dose
iCPIs with poxvirus-based active immunotherapy could potentially
offer improved clinical benefit, safety and tolerability over iCPI
therapy alone.
"Magnitude and quality of tumor-infiltrating T cell response
upon poxvirus-based active immunotherapy alone and in combination
with CTLA-4 immune checkpoint inhibition"
Poster Highlights Session, Developmental Therapeutics:
Immunotherapy, Monday, June 2, 2014 from 1:15 PM to 4:15 PM CDT.
The abstract can be seen at the ASCO Annual Meeting website:
http://abstracts.asco.org/144/AbstView_144_130077.html.
- Combining MVA-BN-HER2 immunotherapy with CTLA-4 blockade in
preclinical therapeutic tumor models demonstrated significantly
improved efficacy for median overall survival (p<0.001).
- MVA-BN-HER2 administration was accompanied by a 30 fold
increase in tumor infiltrating, antigen-specific CD8 T cells (CD8
TILs) compared to no treatment, which was further augmented to
90-fold in combination with anti-CTLA-4.
- The authors conclude that poxvirus-based immunotherapy induces
a robust, functional tumor-infiltrating T cell response that is
augmented significantly in combination with CTLA-4 immune
checkpoint inhibition, and that leads to improved survival in
nonclinical models.
"PROSTVAC, PSA-targeted Immunotherapy - New Evidence for
Mechanism of Action"
General Poster Session, Developmental Therapeutics:
Immunotherapy, Sunday, June 1, 2014 from 8:00 AM to 11:45 AM CDT.
The abstract can be seen at the ASCO Annual Meeting website:
http://abstracts.asco.org/144/AbstView_144_134733.html.
- Patients administered PROSTVAC immunotherapy showed evidence of
significant enhancement of PSA-specific T cell responses compared
to subjects administered placebo viral vectors.
- Increased numbers and improved quality of activated
PSA-specific T cells were observed with the PROSTVAC prime and
boost regimen compared to single vector regimens in preclinical
models.
- The authors conclude that PROSTVAC immunotherapy elicits broad,
highly functional T cell immunity to PSA, which then expands to
include immune responses against endogenous tumor antigens not
targeted by the immunotherapy, via antigen
spreading.
Bavarian Nordic will also be present at the conference with an
exhibit, booth #2004 where attendees can learn more about PROSTVAC
and the PROSPECT clinical trial - a global, randomized,
double-blind, placebo-controlled Phase 3 study of PROSTVAC in men
with asymptomatic and minimally symptomatic metastatic,
castration-resistant prostate cancer.
Bavarian Nordic will also host a PROSTVAC update and investor
and analyst reception on Saturday, May 31, 2014 in Chicago, IL at 5
PM CDT. Confirmed speakers and panelists include Philip Kantoff,
M.D. (Dana-Farber Cancer Institute), James L. Gulley, M.D., Ph.D.
(NCI), Ravi A. Madan, M.D. (NCI), Larry Fong, M.D. (UCSF), Winald
Gerritsen, M.D., Ph.D. (Radboud University Medical Centre Nijmegen)
and James B. Breitmeyer, M.D., Ph.D. (Bavarian Nordic). For
registration and more information on this event, visit
http://www.bavarian-nordic.com/asco2014.
About Bavarian Nordic
Bavarian Nordic is an international biotechnology company
developing and manufacturing novel cancer immunotherapies and
vaccines for infectious diseases. Lead product candidates are
PROSTVAC(r), an immunotherapy product candidate for advanced
prostate cancer that is the subject of an ongoing pivotal Phase 3
clinical trial, and IMVAMUNE(r), a non-replicating smallpox vaccine
candidate in Phase 3 development, which is being developed and
supplied for emergency use to the U.S. Strategic National Stockpile
under a contract with the U.S. Government. The vaccine is approved
in Canada under the trade name IMVAMUNE and in the European Union
under the trade name IMVANEX(r).
Bavarian Nordic's shares are listed on NASDAQ OMX Copenhagen
under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The
company has a sponsored Level 1 ADR program listed in the US (OTC)
under the symbol BVNRY.
For more information, 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.
Rolf Sass
Soerensen, Vice President Investor Relations (EU). Phone +45 61 77
47 43 Seth
Lewis, Vice President Investor Relations (US). Phone + 1
978-298-5654
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