IMV Inc. Reaches Multiple Milestones in Advanced Ovarian Cancer Clinical Trial
August 09 2018 - 7:05AM
- Enrollment Completed for Phase 1b Cohorts
- First Dosing Occurred in Phase 2 Portion of the Program
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage
immuno-oncology corporation, today announced that it has reached
two important milestones in its ongoing clinical trial
collaboration with Incyte Corporation. Investigators have completed
enrollment for both Phase 1b dosing cohorts and have treated the
first patient in the Phase 2 component of the combination trial,
which is evaluating the safety and efficacy of IMV’s lead
candidate, DPX-Survivac, and low dose cyclophosphamide with and
without epacadostat in patients with advanced ovarian cancer.
“Completion of the Phase 1b enrollment and initiation of the
Phase 2 component of our clinical program are key milestones in our
goal to accelerate the clinical evaluation and path to market of
our novel immuno-therapy,” said Frederic Ors, IMV’s Chief
Executive Officer. “We are very pleased to be able to continue to
make substantial progress for advanced ovarian cancer patients who
have such a high unmet medical need.”
Investigators have completed enrollment in the Phase 1b cohorts
of the study, with a total of 50 patients across the two dosing
groups. The Phase 1b study is evaluating the safety and efficacy of
combining DPX-Survivac, 100 mg or 300 mg of epacadostat, and low
dose cyclophosphamide in individuals with advanced,
platinum-sensitive and resistant ovarian cancer.
Investigators plan to enroll up to 32 evaluable patients in the
Phase 2 cohort, which 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 component of
the program is to evaluate the clinical contribution of each
investigational drug in the combination regimen.
Investigators recently announced positive preliminary data from
the Phase 1b dosing arms in an oral presentation at the 2018
meeting of the American Society of Clinical Oncology (ASCO). IMV
expects to release topline data from the Phase 1b arms of the study
by the end of 2018.
About DPX-Survivac
DPX-Survivac is the lead candidate in IMV’s new class of
immunotherapies that programs targeted T cells in vivo. It has
demonstrated the potential for industry-leading targeted,
persistent, and durable T cell activation. IMV believes this MOA is
key to generating durable solid tumor regressions. DPX-Survivac
consists of survivin-based peptide antigens formulated in IMV’s
proprietary DPX drug development platform. DPX-Survivac is believed
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. IMV has identified over 15 cancer indications in
which the over-expression of survivin can be targeted by
DPX-Survivac.
DPX-Survivac has 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 FDA and the European
Medicines Agency (EMA) in the ovarian cancer indication. It is
currently being evaluated in multiple Phase 1b/2 clinical
trials.
About IMV
IMV Inc., formerly 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. IMV is pioneering
a new class of immunotherapies based on the Company’s proprietary
drug delivery platform. This patented technology leverages a novel
mechanism of action that enables the programming of immune cells in
vivo, which are aimed at generating powerful new synthetic
therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a
T cell-activating immunotherapy that combines the utility of the
platform with a target: survivin. IMV is currently assessing
DPX-Survivac as a combination therapy in multiple clinical studies
with Incyte and Merck. Connect at www.imv-inc.com.
IMV 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 the plans will be achieved. Actual
results may differ materially from those set forth in this press
release due to risks affecting the Corporation, including access to
capital, the successful completion of clinical trials and receipt
of all regulatory approvals. IMV Inc. assumes no responsibility to
update forward-looking statements in this press release except as
required by law.
Contacts for
IMV: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@imv-inc.com
Patti Bank, Managing Director, Westwicke
PartnersO: (415) 513-1284T: (415) 515-4572 E:
patti.bank@westwicke.com
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