IMV Inc. (“IMV” or the “Corporation”) (Nasdaq: IMV; TSX: IMV), a
clinical stage immuno-oncology company, today issued the following
statement regarding recent market activity.
In recent weeks, shares of IMV Inc. have come under unwarranted market
pressure and the management team believes it is prudent to provide a
mid-quarter update on the health of the business and the Company’s
upcoming Q2 clinical milestones.
“From a financial and clinical results standpoint, IMV has recently
achieved noteworthy milestones and, based on clinical results observed
thus far, our long term outlook remains unchanged and very promising,”
said Frederic
Ors, Chief Executive Officer. “We have strengthened our balance
sheet and expanded our shareholder base through a recent equity offering
completed with Wells Fargo as lead underwriter. In addition, IMV has
also reported promising clinical results from the phase 2 cohort of the
DECIDE clinical study, which we believe confirm the potential activity
of DPX-Survivac as monotherapy.”
Phase 2 Cohort of the DECIDE Clinical Study in Ovarian Cancer
As reported earlier this year, IMV’s latest clinical results update
indicated that six patients receiving DPX-Survivac monotherapy with
intermittent low-dose cyclophosphamide (mCPA) reached the first CT scan
assessment and key related findings were as follows:
-
83% of the subjects (5 of 6) showed stable disease (SD), including two
tumor regressions;
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80% (4 of 5) of those with stable disease were in subjects with a
lower baseline tumor burden (BTB) of less than 5 centimeters, which
also included the two tumor regressions.
In earlier stages of this trial, durable clinical responses occurred
after 140 days. As of March 25, 2019, these responses had endured 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. The amended phase 2
cohort of the DECIDE trial focuses on patients with low tumor burden
(less than 5 centimeters targeting the enrollment of at least 16
additional patients at numerous sites in the U.S. and Canada.
Phase 2 Study in Combination with KEYTRUDA® in Relapsed/Refractory
DLBCL (SPIREL)
As of April 5, 2019, ten patients have been enrolled and treated across
four different clinical sites in Canada. Additional patients are being
screened and IMV expects to report updated clinical data at about the
same time than the bi-annual International
Conference on Malignant Lymphoma, which will be held in
Lugano Switzerland starting June 18, 2019.
Phase 2 Basket Trial in Combination with KEYTRUDA® in Multiple Solid
Tumors
Screening and enrollment of patients is ongoing at multiple clinical
sites across the U.S. and Canada for five cohorts of 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.
The first patients have been dosed in the ovarian and lung cancer
cohorts and IMV expects to report preliminary clinical results on
several of the solid tumor indications before the end of 2019.
The following table indicates IMV expected milestones between now and
the first half of 2020 as at the date of this release.
Milestones
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Key dates
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Initiation of Basket trial in 5 solid tumor indications
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September 2018 x
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First preliminary Phase 2 clinical results with Merck Keytruda in
DLBCL
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September 2018 x
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Phase 1b/2 clinical results in Ovarian with Incyte
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December 2018 x
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Meeting with FDA on Ovarian cancer program
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December 2018 x
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Dosing of first patient in Basket trial
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March 2019 x
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Phase 2 monotherapy results in Ovarian - ASCO
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June 2019
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Phase 1/1b monotherapy long term follow-up - ASCO
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June 2019
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Phase 2 clinical results with Merck Keytruda in DLBCL - ICML
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June 2019
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Preliminary clinical results Basket trial in 5 indications
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H2 2019
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Potential registration trial in Ovarian and/or DLBCL for FDA accelerated/breakthrough
designation
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H2 2019
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Top line clinical results for Basket trial
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H1 2020
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Meeting with FDA on potential accelerated registration trial from
Basket trial
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H1 2020
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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. 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. 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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