Immunovaccine Announces Initiation of Patient Dosing in Investigator-Sponsored Phase 2 Clinical Trial of Its Lead Candidate ...
March 28 2018 - 7:05AM
Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), a clinical stage
immuno-oncology company, today announced that the first patient has
been treated in a Phase 2 Study combining DPX-Survivac with Low
Dose Cyclophosphamide administered with Pembrolizumab in Patients
with persistent or recurrent/refractory Diffuse Large B-Cell
Lymphoma (DLBCL). Sunnybrook Research Institute is sponsoring the
study, which is assessing the safety and efficacy of
Immunovaccine’s novel T cell activating therapy, DPX-Survivac, in
combination with Merck’s anti-PD-1 drug, Pembrolizumab, and
low-dose cyclophosphamide in this patient population.
“We are very pleased to have this triple combination clinical
trial underway for these patients. These types of advanced
lymphomas remain difficult-to-treat, and have not benefitted from
recent advances in breakthrough monotherapies in the same way other
forms of the disease have,” said Frederic Ors, Immunovaccine’s
Chief Executive Officer. “We designed DPX-Survivac in large part to
boost the rates of other novel immuno-modulating agents, and
continue to see clinical data that support this goal in other
cancer types. We look forward to working with our partners at
Sunnybrook Research Institute and Merck Canada to further this
endeavor.”
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.
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 whose
DLBCL expresses survivin, a tumor antigen highly expressed in 60
percent of DLBCL patients.
The study’s primary objective is to document the objective
response rate. Secondary objectives include measuring tumor
regression and documenting durations of response. In addition,
researchers will perform analyses to assess circulating antigen
specific immune responses and changes in tumor infiltrating T cell
immune responses within the tumor microenvironment. Potential
biomarkers of immune and clinical response will be identified.
“We are pleased to be able to assess this novel combination
immunotherapy in patients with advanced DLBCL,” said Dr.
Berinstein. “Despite recent breakthroughs, this is an unmet medical
need and this approach may have relevance to many other cancers.
Working with Immunovaccine’s candidate DPX-Survivac gives us the
opportunity to assess whether these patients may experience
enhanced anti-cancer activity with novel combination
treatments.”
Immunovaccine announced regulatory clearance for this trial at
the end of 2017. This trial is supported in part by a
research grant from the Investigator-Initiated Studies Program of
Merck Canada Inc. and Immunovaccine.
This investigator-sponsored DLBCL trial also marks the second
Phase 2 study evaluating anti-cancer activity of Immunovaccine’s
lead candidate, DPX Survivac, in combination with Merck’s
pembrolizumab and cyclophosphamide. The other Phase 2 trial is
evaluating the triple combination immunotherapy in patients with
advanced ovarian cancer.
About DPX-SurvivacDPX-Survivac consists of
survivin-based peptide antigens formulated in the Company’s
patented 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 ImmunovaccineImmunovaccine Inc. is a
clinical-stage biopharmaceutical corporation 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 Corporation’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 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 its platform 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
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