Immunovaccine and Incyte Expand Clinical Collaboration Evaluating Combination Immunotherapies in Advanced Recurrent Ovarian C...
April 24 2018 - 7:05AM
Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), a clinical stage
immuno-oncology company, today announced that it has entered into
an agreement with Incyte Corporation to expand their ongoing
clinical trial collaboration. The Companies plan to add a Phase 2
component to their ongoing Phase 1b combination study evaluating
the safety and efficacy of Immunovaccine’s lead candidate,
DXP-Survivac, in combination with Incyte’s IDO1 enzyme inhibitor
epacadostat and low dose cyclophosphamide in advanced ovarian
cancer patients.
The Phase 2 component will be a randomized, open label, efficacy
study that will include up to 32 additional evaluable subjects. It
will evaluate DPX-Survivac and low dose cyclophosphamide with, or
without, epacadostat in patients with advanced recurrent ovarian
cancer. In accordance with regulatory guidelines for combination
trials, the goal of this portion of the program is to evaluate the
clinical contribution of each investigational drug in the
combination regimen.
“We were encouraged by the topline data we shared last December
from the first dosing cohort of our trial, especially in this
hard-to-treat population of ovarian cancer patients,” said Frederic
Ors, Chief Executive Officer at Immunovaccine. “We believe that
these results further support the hypothesis that the unique
mechanism of action underscoring our T cell activation technology
can trigger tumor regressions, even in patients who typically don’t
respond well to current monotherapies. We are pleased to expand our
collaboration with Incyte, and build on the initial demonstration
of this combination in ovarian cancer.”
The Phase 2 arm of the study will be conducted under an
amendment to the existing collaboration, in which Immunovaccine and
Incyte are co-funding the trial.
Immunovaccine and Incyte previously reported positive topline
data from the first dosing cohort of the Phase 1b portion of the
study. Those results showed that the combination of 100mg of
epacadostat, in combination with DPX-Survivac and low dose
cyclophosphamide, showed a 70 percent disease control rate –
including 30 percent of patients (three out of ten) experiencing
partial responses in tumor regression – and demonstrated a
tolerable safety profile. Immunovaccine expects to provide a
clinical update on the Phase 1b program in the first half of
2018.
About DPX-Survivac DPX-Survivac consists of
survivin-based peptide antigens formulated in Immunovaccine’s
proprietary immune-activating delivery technology. 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 and 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 other serious
diseases. Immunovaccine develops T cell-activating cancer
immunotherapies based on the Company’s proprietary drug delivery
platform. This patented technology provides controlled and
prolonged exposure to a broad range of immunogenic stimuli.
Immunovaccine has advanced two T cell-activating therapies for
cancer through Phase 1 human clinical trials and is currently
conducting a Phase 1b study with Incyte Corporation assessing its
lead cancer therapy, DPX-Survivac, as a combination therapy in
ovarian cancer. The Company is also exploring additional
applications of its platform, 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 Statements 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 them 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 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 RELATIONS Pierre Labbé, Chief
Financial Officer T: (902) 492-1819 E: info@imvaccine.com
Patti Bank, Managing Director, Westwicke
Partners O: (415) 513-1284 T: (415) 515-4572
E: patti.bank@westwicke.com
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