Initial Phase 2 Data From an IMV Clinical Study Continues to Demonstrate DPX-Survivac’s Prior Trend as a Potential Monother...
March 26 2019 - 6:05AM
Business Wire
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage
immuno-oncology corporation, today announced preliminary data from
the phase 2 cohort of the DECIDE clinical study. Six patients
receiving DPX-Survivac monotherapy with intermittent low-dose
cyclophosphamide (mCPA) have reached the first CT scan assessment
with key related findings as follows:
- 83% of the subjects (5 of 6) show
stable disease (SD), including two tumor regressions
- 80% (4 of 5) with stable disease are in
subjects with a lower baseline tumor burden (BTB), which also
includes the two tumor regressions
“This initial phase 2 data confirms the earlier trends we saw in
the phase 1b portion of the study,” said Frederic Ors, Chief
Executive Officer. “It supports the potential of DPX-Survivac as a
monotherapy and the use of our patient selection strategy. We are
encouraged by these early initial results and are committed to
advancing this program quickly with the goal of providing an
additional treatment option to patients with advanced ovarian
cancer.”
Importantly, in earlier stages of this trial, durable clinical
responses occurred after 140 days, and have now lasted for 20
months or more. Additional data at the 140 day mark of this cohort
will be available by the end of the first half of 2019.
This amended phase 2 study evaluates the safety and efficacy of
DPX-Survivac monotherapy with mCPA in patients with advanced
recurrent ovarian cancer. As of the March 25, 2019 data cut-off
date, 13 patients have been enrolled in the phase 2 portion of the
trial in addition to the 53 enrolled in the phase 1b cohort. Five
patients were randomized into the DPX-Survivac monotherapy cohort.
Seven patients had been randomized into DPX-Survivac/mCPA in
combination with epacadostat before the phase 2 protocol was
amended to stop enrollment in the combination arm. One of the
patients in the combination arm elected to switch to the
monotherapy arm of the trial. Positive data from the phase 1b
portion of the trial led IMV to amend the study to monotherapy in
patients with lower tumor burden.
The amended phase 2 cohort of the DECIDE trial is targeting an
enrollment of at least additional 16 patients in the population
with a lower tumor burden. Enrollment is ongoing at multiple sites
in the U.S. and Canada.
About IMV
IMV 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 monotherapy in
advanced ovarian cancer, as well as a combination therapy in
multiple clinical studies with 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. In the press release, such forward-looking
statements include, but are not limited to, statements regarding
the FDA potentially granting accelerated regulatory
approval of DPX-Survivac. 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 design and completion of clinical trials
and the receipt and timely receipt of all regulatory
approvals. IMV Inc. assumes no responsibility to update
forward-looking statements in this press release except as required
by law. These forward-looking statements involve known and unknown
risks and uncertainties and those risks and uncertainties include,
but are not limited to, our ability to access capital, the
successful and timely completion of clinical trials, the receipt of
all regulatory approvals and other risks detailed from time to time
in our ongoing quarterly filings and annual information form
Investors are cautioned not to rely on these forward-looking
statements and are encouraged to read IMV’s continuous disclosure
documents, including its current annual information form, as well
as its audited annual consolidated financial statements which are
available on SEDAR at www.sedar.com and on EDGAR
at www.sec.gov/edgar.
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version on businesswire.com: https://www.businesswire.com/news/home/20190326005278/en/
MEDIAAndrea Cohen, Sam Brown Inc.O: (917) 209-7163
E: andreacohen@sambrown.com
INVESTOR RELATIONSMarc Jasmin, IMV Senior
Director, Investor Relations and CommunicationsO: (902) 492-1819
ext: 1042M: (514) 917-9481 E: mjasmin@imv-inc.com
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