Immunovaccine Announces Regulatory Clearance for Phase 2 Clinical Trial Evaluating DPX-Survivac in Combination with Merck’s...
November 08 2017 - 6:05AM
Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), a clinical stage
vaccine and immuno-oncology company, today announced that Health
Canada has granted Sunnybrook Research Institute regulatory
clearance to begin recruiting patients for its Phase 2 clinical
study of a triple-combination immunotherapy in patients with
measurable or recurrent diffuse large B-cell lymphoma (DLBCL). This
trial, announced initially in May 2017, is designed to evaluate the
safety and efficacy of Immunovaccine’s lead product candidate,
DPX-Survivac, along with Merck’s pembrolizumab and low-dose
cyclophosphamide in this patient population.
“With clearance received from Health Canada, we
hope to quickly begin the important work of evaluating a critically
needed therapy for those who suffer from DLBCL – a fast-growing
form of lymphoma that can spread to nearly every organ of the
body,” said Frederic Ors, Chief Executive Officer at Immunovaccine.
“Despite promising results observed in the treatment of DLBCL with
cutting-edge monotherapies like checkpoint inhibitors, a
significant number of patients still do not respond to treatment.i
It is our goal to increase the types of patients who are able to
respond to these therapies via synergistic combinations that can
activate and direct T cell responses. Through complementary
mechanisms of action, we believe the combination of DPX-Survivac
and pembrolizumab could amplify T cell production and infiltration
to help realize the desired immune response in a broader range of
patients with this type of cancer.”
Primary investigator Neil Berinstein, MD,
Affiliate Scientist, Sunnybrook Research Institute, Professor of
Medicine/Immunology, University of Toronto, is leading the
non-randomized, open-label study, which is expected to enroll 25
evaluable participants at several centers in Canada. Researchers
conducting the study will test the novel immunotherapy combination
in patients whose DLBCL expresses survivin, a tumor antigen highly
expressed in 60 percent of DLBCL patients.
The study’s primary objective is to document a
minimal objective response rate. Secondary objectives include
measuring tumor regression and documenting durations of response.
In addition, researchers will perform analyses to assess
circulating tumor infiltrating T cell immune responses and
potential biomarkers of immune and clinical response.
DLBCL is the most common type of non-Hodgkin
lymphoma (NHL) in the United States and worldwide, accounting for
up to one-third of patients with newly diagnosed NHL in the United
States.
About DPX-SurvivacDPX-Survivac
consists of survivin-based peptide antigens formulated in the
Company’s proprietary DepoVax™ delivery platform. DPX-Survivac is
thought to work by eliciting a cytotoxic T cell immune response
against cells presenting survivin peptides. Survivin, recognized by
the National Cancer Institute (NCI) as a promising tumor-associated
antigen, is broadly over-expressed in most cancer types, and plays
an essential role in antagonizing cell death, supporting
tumor-associated angiogenesis, and promoting resistance to
anti-cancer therapies. Immunovaccine has identified over 15 cancer
indications in which the over-expression of survivin can be
targeted by DPX-Survivac. DPX-Survivac received Fast Track
designation from the U.S. Food & Drug Administration (FDA) as
maintenance therapy in advanced ovarian cancer, as well as orphan
drug designation status from the U.S. FDA and the European
Medicines Agency (EMA) in the ovarian cancer indication.
About Immunovaccine
Immunovaccine Inc. is a clinical-stage biopharmaceutical
company dedicated to making immunotherapy more effective, more
broadly applicable, and more widely available to people facing
cancer and infectious diseases. Immunovaccine develops T
cell-activating cancer immunotherapies and infectious disease
vaccines based on DepoVax, the Company’s patented platform that
provides controlled and prolonged exposure of antigens and adjuvant
to the immune system. Immunovaccine has advanced two T
cell activation therapies for cancer through Phase 1 human clinical
trials and is currently conducting a Phase 1b study
with Incyte Corporation and a phase 2 study with Merck
assessing lead cancer therapy, DPX-Survivac, as a combination
therapy in ovarian cancer. The Corporation is also exploring
additional applications of DepoVax, including DPX-RSV, an
innovative vaccine candidate for respiratory syncytial virus (RSV),
which has recently completed a Phase 1 clinical
trial. Immunovaccine also has ongoing clinical projects
to assess the potential of DepoVax to address malaria and the Zika
virus. Connect at www.imvaccine.com.
Immunovaccine Forward-Looking
StatementsThis 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 forward-looking statements in this press
release except as required by law.
Contacts for Immunovaccine:
MEDIA Mike Beyer, Sam Brown
Inc.T: (312) 961-2502 E: mikebeyer@sambrown.com
INVESTOR RELATIONSPierre Labbé, Chief
Financial OfficerT: (902) 492-1819 E:
info@imvaccine.com
Patti Bank, Managing Director, Westwicke
PartnersO: (415) 513-1284T: (415) 515-4572 E:
patti.bank@westwicke.com
_____________________
i 1. Chi Young Ok and Ken H. Young, Checkpoint inhibitors in
hematological malignancies, Journal of Hematology and
Oncology (2017). 10.1186/s13045-017-0474-3
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