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Media Release
Immunovaccine and NCIC Clinical Trials Group
To Collaborate on Phase II Study of DPX-Survivac
NCIC CTG to Sponsor Randomized Trial
With Approximately 250 Ovarian Cancer Patients
Halifax, Nova Scotia; July 15, 2013 – Immunovaccine Inc. (“Immunovaccine” or the
“Company”) (TSX-V: IMV), a clinical stage vaccine company, today announced that Canada’s
NCIC Clinical Trials Group (NCIC CTG) will sponsor and conduct a randomized Phase II study
of Immunovaccine’s cancer vaccine, DPX-Survivac, in patients with advanced ovarian cancer.
The study is designed to assess whether IMV’s vaccine therapy can delay or prevent cancer
recurrence.
The Phase II trial is a randomized, blinded, placebo-controlled study with DPX-Survivac in
combination with low dose oral cyclophosphamide as an immune modulator. The study will
enroll approximately 250 patients with ovarian cancer at an estimated 20 clinical centers. The
NCIC CTG is a Canadian-based academic clinical trials cooperative group conducting large
multi-center clinical trials across Canada and internationally.
Patients in the trial will have undergone surgery and standard post-operative chemotherapy.
Patients will be randomized to two groups, one receiving the combination vaccine therapy and
another receiving a placebo vaccine and cyclophosphamide. Immune responses and diseaserelated biomarkers including CA125 will be measured for correlative analyses. The results may
guide further development of DPX-Survivac.
“NCIC CTG’s decision to become actively involved in the development of our cancer vaccine
validates the approach we have been pursuing for the therapy of ovarian cancer,” said John
Trizzino, CEO of Immunovaccine. “Directing the bulk of the resources required to complete this
study to NCIC CTG will help us realize our ultimate goal, to bring advanced science to patients
in need.”
Earlier this year, Immunovaccine published positive results from the Company’s Phase I clinical
trial of DPX-Survivac. The data showed that all 18 patients who had received DPX-Survivac in
combination with cyclophosphamide produced targeted immune responses and that the majority
of patients in one cohort of the study were strong responders who presented sustained
circulating specific T cells (CD8 T cells) in their blood.
The presence of circulating CD8 T cells is thought to be critical in treating cancer because they
are implicated in identifying and eradicating residual cancer cells. Controlling or eliminating
these escaped cells may be one way of delaying or preventing recurrence of the cancer.
The Phase I trial demonstrated that the vaccine had no systemic side effects or dose-limiting
toxicities.
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DPX-Survivac is among a class of immunotherapeutic treatments that have attracted
widespread interest in recent months. Bristol-Myers Squibb Company and Merck & Co Inc. both
announced in May that immunotherapeutic drugs they are developing can dramatically influence
the course of disease in cancer patients. (View announcements: BMS and Merck.)
As the incidence of cancer rises world-wide, researchers have been seeking ways to reprogram
a patient’s own immune system to fight the disease and prolong life. The results of the BristolMyers and Merck trials provide a leap forward in immunotherapy. DPX-Survivac is an
immunotherapeutic that is intended to teach the immune system to recognize and kill cells
displaying the survivin signature. Survivin is present in many different types of cancer, including
breast, colon and melanoma among others.
Ovarian cancer accounts for more deaths than any other gynecologic cancer. Symptoms do not
occur until it is in the later stages of the disease, reducing the chance for successful treatment
and remission. It kills more than 100,000 women annually around the world. Improved surgical
techniques have helped to reduce the rate of recurrence according to some studies, but the
average life expectancy of newly diagnosed ovarian cancer patients is less than 4 years.
The agreement between NCIC CTG and Immunovaccine will provide a framework for the NCIC
CTG to sponsor the randomized Phase II trial and assume responsibility for conducting the trial
in accordance with good clinical practice. The Company is in discussion with potential codevelopment partners to support the NCIC CTG-sponsored trial.
“The NCIC CTG is recognized for its effectiveness in conducting large international clinical
trials,” Trizzino said. “By working with the NCIC CTG, we are able to advance our breakthrough
science in an efficient and cost effective manner.”
The trial is expected to get underway in 2014 with results in 2017.
About the NCIC Clinical Trials Group
The NCIC Clinical Trials Group (NCIC CTG) is a cancer clinical trials cooperative group that
conducts Phase I-III trials testing anti-cancer and supportive therapies across Canada and
internationally. It is a national research program of the Canadian Cancer Society. The NCIC
CTG's Central Office is located at Queen's University in Kingston, Ontario, Canada. The Group
is committed to assessing all modalities of therapy for a spectrum of cancer types. More than 60
member institutions, from major cancer centres to community hospitals, enroll patients in NCIC
Clinical Trials Group studies. Connect at http://www.ctg.queensu.ca/
About DPX-Survivac
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™
adjuvanting platform. Survivin has been recognized by the National Cancer Institute (NCI) as a
promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer
specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian
cancer, including breast, colon and lung cancers. Survivin plays an essential role in
antagonizing apoptosis, supporting tumor-associated angiogenesis, and promoting resistance to
various anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is
found in a higher percentage of tumors than other TAA’s.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T-cell immune response
against cells presenting survivin peptides on HLA class I molecules. This targeted therapy
attempts to use the immune system to actively and specifically search for and destroy tumor
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cells. Survivin-specific T cells have been shown to target and kill survivin-expressing cancer
cells while sparing normal cells.
About DepoVax™
DepoVax™ is a patented formulation that provides controlled and prolonged exposure of
antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained
immune response with the capability for single-dose effectiveness. The DepoVax™ platform
possesses impressive flexibility, allowing it to work with a broad range of target antigens in
various therapeutic applications. The technology is also commercially scalable, with potential
for years of stability and ease of use in the clinic.
About Immunovaccine
Immunovaccine Inc. applies its novel adjuvanting platform to the development of vaccines for
cancer therapy, infectious diseases and animal health. The Company’s DepoVax™ platform is a
patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant
to the immune system. Immunovaccine has advanced two DepoVax™-based cancer vaccines
into Phase I human clinical trials. The Company is also advancing a broad infectious diseases
pipeline including vaccines in such indications as malaria, respiratory syncytial virus (RSV) and
anthrax. In addition to the Company’s human health vaccine strategy, it continues to capture
value from animal health vaccine applications. Immunovaccine has key partnerships in the
animal health sector including an agreement with Zoetis (formerly Pfizer Animal Health).
Connect at www.imvaccine.com.
This press release contains forward-looking information under applicable securities law. All information
that addresses activities or developments that we expect to occur in the future is forward-looking
information. Forward-looking statements are based on the estimates and opinions of management on the
date the statements are made. However, they should not be regarded as a representation that any of the
plans will be achieved. Actual results may differ materially from those set forth in this press release due to
risks affecting the company, including access to capital, the successful completion of clinical trials and
receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forwardlooking statements in this press release.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this
release.
-30Contacts:
Dr. Marc Mansour, Chief Science Officer, Immunovaccine, Inc.
T: (902) 492-1819 E: [email protected]
Tim Brons, Vida Strategic Partners (media)
T: (415) 675-7402 E : [email protected]
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