IMV Inc. Issues Statement on Recent Market Activity And Provides Corporate Update
16 April 2019 - 11:31PM
Business Wire
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;
- 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
Key dates Initiation of Basket trial in
5 solid tumor indications
September 2018 x
First preliminary Phase 2 clinical results with Merck Keytruda in
DLBCL
September 2018 x
Phase 1b/2 clinical results in Ovarian with Incyte
December 2018 x
Meeting with FDA on Ovarian cancer program
December 2018 x
Dosing of first patient in Basket trial
March 2019 x
Phase 2 monotherapy results in Ovarian - ASCO June 2019 Phase 1/1b
monotherapy long term follow-up - ASCO June 2019 Phase 2 clinical
results with Merck Keytruda in DLBCL - ICML June 2019 Preliminary
clinical results Basket trial in 5 indications H2 2019
Potential registration trial in Ovarian
and/or DLBCL for FDAaccelerated/breakthrough designation
H2 2019 Top line clinical results for Basket trial H1 2020 Meeting
with FDA on potential accelerated registration trial from Basket
trial H1 2020
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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version on businesswire.com: https://www.businesswire.com/news/home/20190416005655/en/
INVESTOR RELATIONS :Marc Jasmin, Senior Director,
Investor Relations and CommunicationsO: (902) 492-1819 ext :
1042M: (514) 917-9481 E: mjasmin@imv-inc.comMEDIA:Andrea
Cohen, Sam Brown Inc.O: (917) 209-7163
E: andreacohen@sambrown.com
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