IMV Inc. Announces Phase 2 Basket Trial in Collaboration with Merck to Evaluate DPX-Survivac in Combination with KEYTRUDA® A...
September 11 2018 - 7:05AM
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology
corporation, today announced that it has expanded its clinical
program with a Phase 2 basket trial evaluating its lead candidate,
DPX-Survivac, in combination with low dose cyclophosphamide and
Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients
with select advanced or recurrent solid tumors.
“The clinical data from our recent ASCO meeting presentation
demonstrated for the first time the unique potential of
DPX-Survivac to generate solid tumor regressions in ovarian
cancer,” said Frederic Ors, Chief Executive Officer, IMV Inc. “We
are delighted to expand our clinical program and collaboration with
Merck across multiple cancer indications, and look forward to
investigating the potential added benefit of combining DPX-Survivac
and KEYTRUDA®.”
The open-label, multicenter, Phase 2 basket study will evaluate
the safety and efficacy of the immunotherapeutic combination agents
in patients with bladder, liver (hepatocellular carcinoma),
ovarian, or non-small cell lung (NSCLC) cancers as well as tumors
shown to be positive for the microsatellite instability high
(MSI-H) biomarker. Investigators plan to enroll more than 200
patients across five indications at multiple medical centers in
Canada and the United States. IMV expects to initiate trial
enrollment in the 4th quarter of 2018.
“With this new study evaluating the combination of IMV and Merck
immunotherapies, our goal is to expand the patient impact and
market potential of our lead candidate across a broad range of
cancers,” said Joseph Sullivan, Senior Vice President, Business
Development, IMV Inc. “The Merck team has significant experience in
the field, and we are very enthusiastic about exploring this
combination with them in multiple solid tumor indications.”
The American Society of Clinical Oncology (ASCO) defines a
basket clinical study as a trial that investigates the effects of a
drug regimen in multiple tumor types that share a common molecular
target, regardless of where the disease originated.
This is the third clinical trial evaluating the combination of
DPX-Survivac, low dose cyclophosphamide, and pembrolizumab in
advanced recurrent cancers. Two ongoing investigator-sponsored
Phase 2 trials are evaluating this combination in patients with
advanced ovarian cancer and diffuse large B-cell lymphoma
(DLBCL).
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA.
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 against cancer. IMV
believes this MOA is key to generating durable regressions in solid
tumors. DPX-Survivac consists of survivin-based peptide antigens
formulated in IMV’s proprietary DPX drug delivery platform.
DPX-Survivac is believed to work by eliciting a prolonged cytotoxic
T cell attack on cancer 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 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. 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 Christy Curran,
Sam Brown Inc.T: +1 615-414-8668 E:
ChristyCurran@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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