- Launched development program for a DPX-based vaccine candidate
against COVID-19
- Reported updated Phase 2 data from DeCidE1 study in advanced
ovarian cancer; These encouraging results support DPX-Survivac
being amongst the first in vivo T cell therapy to demonstrate
meaningful clinical activity in a hard-to-treat solid tumor with
37% (7/19) evaluable subjects achieving durable clinical benefit
lasting ≥ 6 months
- Updated Phase 2 data from SPiReL study evaluating DPX-Survivac
as a combination therapy in r/r DLBCL presented at ASH 2019, where
78% (7/9) evaluable subjects exhibited clinical benefit, including
three complete responses and two partial responses. One subject,
who received three prior lines of systemic therapies and failed
autologous stem cell transplant, reached a complete response at the
first on-study scan following treatment with the DPX-Survivac
combination regimen and remained free of disease recurrence after
completing the study
- Demonstrated, through our trials, DPX-Survivac’s ability to
elicit sustained clinical activity in both solid and hematologic
tumors with a favorable tolerability and safety profile
- Implemented, in the context of the COVID-19 pandemic, measures
to ensure the continuity of its business and clinical
activities
- Management to host conference call and webcast tomorrow at 8:00
a.m. ET
IMV Inc. (the “Company” or “IMV”) (TSX:IMV; NASDAQ:IMV), a
clinical-stage biopharmaceutical company pioneering a novel class
of immunotherapies, today announced its financial and operational
results for the fourth quarter and full year ended December 31,
2019.
“We have made significant progress this past year at IMV, with
multiple encouraging readouts from clinical and translational
studies of our lead candidate, DPX-Survivac. Taken together, these
data not only provide important validation of our platform’s novel
mechanism and survivin as a target antigen, but also demonstrate
its ability to elicit sustained clinical activity in both solid and
hematologic tumors,” said Frederic Ors, Chief Executive Officer of
IMV. “In particular, the recent results from DeCidE1, our ongoing
Phase 2 study in advanced ovarian cancer, show DPX-Survivac’s
potential to deliver improved outcomes over standard-of-care
chemotherapy across key measures in a heavily pre-treated solid
tumor population while also providing for excellent benefits and
being well tolerated by patients during treatment.”
Mr. Ors continued, “More recently, the 2019 novel coronavirus
(COVID-19) pandemic has significantly impacted businesses across
all sectors and the healthcare industry is not spared. In this
context, we implemented a continuity plan for our current business
and clinical operations following the FDA guidance. Vaccines
against infectious disease have been a core part of IMV’s heritage
across the DPX platform technology, and we have decided to launch
the development of a DPX-based vaccine against COVID-19.”
“Even in these challenging times, we expect to keep a forward
momentum with planned updates from ongoing Phase 2 studies. Looking
ahead, as we hope to accumulate proof-of-concept in multiple
hard-to-treat indications, we plan to engage with the U.S. Food and
Drug Administration (FDA) on the design of potential pivotal trials
in support of an accelerated pathway for DPX-Survivac in advanced
ovarian cancer and r/r DLBCL."
Development of the DPX-COVID-19 vaccine
candidate
On Wednesday, March 18, 2020, IMV announced in a press release
plans to develop of a DPX-based vaccine candidate for COVID-19 in
collaboration with experts in the field. Earlier today, we
announced an update on our progress:
- The Company has used sequences of the virus and
immunoinformatics to predict and identify several hundred epitopes,
of which 23 were selected for their biological relevance to the
virus and potential to generate neutralizing antibodies against
SARS-CoV-2;
- Based on this analysis, IMV has begun manufacturing peptide
candidates targeting these epitopes as well as planning with IMV’s
suppliers and contract manufacturers to prepare for the cGMP batch
required to support a clinical study in humans;
- In collaboration with Gary Kobinger, Ph.D., Director of the
Research Centre on Infectious Diseases at the University Laval in
Quebec City, preclinical assays in animal models are also planned
in April through May of this year to validate the safety and
potency of the vaccine candidate before initiating the human
clinical study;
- In collaboration with Joanne Langley, M.D. at the Canadian
Center for Vaccinology (CCfV) and the Canadian Immunization
Research Network (CIRN) the design of a Phase 1 clinical study in
48 healthy subjects has been completed and clinical sites
identified in both Nova Scotia and Quebec;
- IMV has initiated discussions with Health Canada in preparation
for a Clinical Trial Application (CTA). A meeting is being
scheduled in the week of April 20, 2020 with the goal to initiate
the clinical study in the summer of 2020; and
- The company has submitted several grant applications in Canada
in an effort to help support its clinical program.
IMV will continue to provide updates on the development of
DPX-COVID-19, and is working on a dedicated DPX-COVID-19 page on
its website.
DPX-Survivac Clinical Program
Updates
Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian
Cancer
DeCidE1 is a Phase 2 multicenter, randomized, open-label study
to evaluate the safety and efficacy of DPX-Survivac with
intermittent low dose cyclophosphamide (CPA). This phase 2 arm
enrolled 22 patients with recurrent, advanced platinum-sensitive
and/or resistant ovarian cancer.
In February 2020, IMV reported interim data from this study,
demonstrating amongst others:
- 15/19 (79%) evaluable subjects demonstrated disease control,
including 10 tumor regressions (53%);
- 7/19 subjects (37%) achieved clinical benefit with
partial/stable responses lasting > 6 months; and
- Treatment was well-tolerated with majority of adverse events
being grade 1-2 reactions at the injection site.
At the time of the data cutoff, six (31%) patients remained on
therapy. Five (26%) of these patients were still on treatment at
> 6 months. Additional data available here.
Phase 2 SPiReL Study in r/r DLBCL
SPiReL is an investigator-initiated Phase 2 study evaluating
DPX-Survivac and CPA in combination with Keytruda® (pembrolizumab)
in r/r DLBCL.
In December 2019, updated clinical results were reported in a
poster presentation at the American Society of Hematology (ASH)
annual meeting in Orlando, FL. Highlights of the data included:
- 7/9 (77.8%) evaluable subjects exhibited clinical benefit,
including three (33.3%) complete responses and two (22.2%) partial
responses;
- Reproducible survivin-specific T cell responses observed in all
subjects that achieved clinical responses on treatment;
- One subject, who received three prior lines of systemic
therapies and failed autologous stem cell transplant, reached a
complete response at the first on-study scan following treatment
with the DPX-Survivac combination regimen and remained free of
disease recurrence after completing the study; and
- Clinical benefits and favorable toxicity profile observed in a
heterogenous population of r/r DLBCL patients, including patients
of advanced age and/or with comorbidities, who are more susceptible
to adverse effects and more difficult to treat.
The study remains ongoing, with preliminary topline results
expected in 2020.
Phase 2 Basket Trial in Multiple Advanced Metastatic Solid
Tumors
The Basket Trial is an open label, multi-center Phase 2 study,
evaluating the safety and efficacy of DPX-Survivac and CPA in
combination with Keytruda® across five cohorts of patients with
bladder cancer, liver cancer (hepatocellular carcinoma), ovarian
cancer (with and without CPA), NSCLC and tumors shown to be
positive for the microsatellite instability high (MSI-H)
biomarker.
As of March 24, 2020, a total of 82 patients were enrolled
across all five indications out of a maximum target number of 184
patients.
In the context of the COVID-19 pandemic, IMV expects to report
preliminary topline clinical results on several of the solid tumor
indications later in 2020.
Clinical Translational Studies
In November 2019, IMV presented translational data from the
DeCidE1 clinical study at the 34th Annual Meeting of the Society
for the Immunotherapy of Cancer (SITC) in National Harbor, MD. The
data validate DPX-Survivac’s underlying mechanism of action and are
available here.
In February 2020, Dr. Oliver Dorigo, MD, Ph.D. presented, on
behalf of IMV, translational data supporting DPX-Survivac’s
mechanism of action at the ASCO-SITC Clinical Immuno-Oncology
Symposium in Orlando, FL. The data included samples collected from
three Phase 1 and/or Phase 2 studies evaluating DPX-Survivac alone
or in a combination regimen in patients with advanced,
platinum-sensitive or resistant ovarian cancer and are available
here.
Operational Highlights:
- Update on IMV’s clinical operation following the COVID-19
pandemic: It is anticipated that the COVID-19 pandemic crisis
will impact ongoing trial activities across the industry due to the
pressure placed on the healthcare system as well as governmental
and institutional restrictions. IMV’s clinical team is working
closely with each clinical site and our CRO on a contingency plan
to ensure that patient safety and the integrity of data is
maintained. IMV is following the FDA guidance issued for the
COVID-19 pandemic: “FDA Guidance on Conduct of Clinical Trials of
Medical Products during COVID-19 Pandemic Guidance for Industry,
Investigators, and Institutional Review Boards". Additionally, the
team continues to monitor updated institutional, regional and
national guidance to fully comply with applicable guidelines as
they are issued. It is noted that some clinical sites have paused
or slowed enrollment in clinical trials, while other sites, less
impacted, are continuing activities as planned. The overall
enrollment rate may decrease, but clinical activities are
continuing, and patients are encouraged to comply with directives
from public health officials and, subject to such compliance, to
attend visits as planned or to discuss alternatives with their
physician. The current activities performed at central labs to
assess the eligibility of patients and the management of clinical
samples is not impacted, and IMV is working with the vendors to
ensure continuity of activities. Finally, drug supply is not
expected to be impacted at this time. As added precaution, IMV is
working on a contingency plan to ensure proper provisioning of
drugs to all clinical sites in the event of future transportation
or other constraints.
- Appointment of Joanne Schindler, M.D., D.V.M. as Chief
Medical Officer: Dr. Schindler joined IMV in November 2019 and
has over 15 years of experience in the biopharmaceutical industry,
primarily in early-stage oncology drug development. Most recently,
she served as Vice President, Clinical Development at H3
Biomedicine, and will oversee IMV’s clinical development
efforts.
- Research collaboration with Navidea Biopharmaceuticals:
In November 2019, IMV entered into a preclinical research
collaboration with Navidea to explore the potential combinatory
effect of DPX-based immunotherapies with Navidea’s activated
macrophage-targeting therapeutics. IMV and Navidea will jointly
conduct research throughout the duration of the study.
Upcoming Milestones:
Over the course of upcoming quarters, the Company expects to
deliver the following milestones:
- Top line Phase 2 clinical results update in the DLBCL
combination trial in 2020
- Updated Phase 2 clinical results for Basket trial in 2Q20
- Potential initiation of Phase 1 clinical trial for DPX-COVID-19
during the summer of 2020
Overview of Year-End 2019 Financial Results
Research and development expenses increased by $6,044,000 for
the year ended December 31, 2019, compared to 2018. These increases
are mainly due to expenses related to the ongoing basket trial,
pre-clinical development of DPX-SurMAGE for bladder cancer and
personnel costs due to an increase in headcount. The increase is
also attributable to manufacturing activities to support the
increased clinical activity, which included purchasing raw
materials and contract manufacturing organization costs.
General and administrative expenses increased by $897,000 for
the year ended December 31, 2019 compared to 2018. This increase is
mainly due to personnel costs as a result of increased head count,
investor relations activities, a full year of increased insurance
premiums and regulatory fees following the Nasdaq listing in
mid-2018, and a full year of increased rent, lease interest
accretion, and utilities following the move to its new Dartmouth
facility in mid-2018.
The net loss and comprehensive loss of $27,365,000 ($0.55 per
share) the year ended December 31, 2019 was $5,430,000 higher than
the net loss and comprehensive loss for the year ended December 31,
2018.
At December 31, 2019, the Corporation had cash and cash
equivalents of $14,066,000 and working capital of $13,199,000,
compared with $14,895,000 and $12,247,000, respectively at December
31, 2018. For the year ended December 31, 2019, IMV's cash burn
rate, defined as net loss for the period adjusted for operations
not involving cash (interest on lease obligation, depreciation,
accretion of long-term debt, stock-based compensation and DSU
compensation), was $25.5 million. IMV expects research and
development expenditures to increase over time due to the
continuing development of product candidates and other clinical,
preclinical, and regulatory activities.
As of March 30, 2020, the number of issued and outstanding
common shares was 51,028,180 and a total of 1,959,452 stock options
and deferred share units were outstanding.
The Corporation's audited annual consolidated results of
operations, financial condition and cash flows for the year ended
December 31, 2019 and the related management's discussion and
analysis (MD&A) are available on SEDAR at www.sedar.com and on
EDGAR at www.sec.gov/edgar.
Conference Call and Webcast Information
Management will host conference call and webcast tomorrow, March
31, 2020 at 8:00 a.m. ET. Financial analysts are invited to join
the conference call by dialing (866) 211-3204 (U.S. and Canada) or
(647) 689-6600 (international) using the conference ID# 7482187
Other interested parties will be able to access the live audio
webcast at this link:
https://ir.imv-inc.com/events-and-presentations.
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 and
vaccines based on the Company’s proprietary drug delivery platform
(DPX). 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-targeted immunotherapy that combines the utility of the
platform with a target: survivin. IMV is currently assessing
DPX-Survivac targeted therapy 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 Company’s intention to develop a DPX-based vaccine candidate
against COVID-19, the Company’s belief that the DPX-based platform
creates the opportunity for accelerated development and rapid,
large-scale production of a COVID-19 vaccine, the Company’s belief
in the potential efficacy of its DPX-based vaccine against
COVID-19, the Company’s belief in the benefits of the third-party
research and studies in related coronavirus and SARS studies and
third-party sequencing data and their applicability to the
Company’s DPX platform and a DPX platform related vaccine, the
expected milestone completion dates and the Company’s anticipated
results and expected timing of such results from its DPX cancer and
infectious disease studies. Such statements 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 and uncertainties affecting the Company and
its products. The Company 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, the Company’s ability to develop a
DPX-based vaccine candidate against the COVID-19 through the
successful and timely completion of clinical trials and studies,
the receipt of all regulatory approvals by the Company to commence
and then continue clinical studies, and, if successful, the
commercialization of its proposed vaccine candidate related to
COVID-19, the Company’s ability to raise sufficient capital to fund
such clinical trials and studies and the production of any COVID-19
vaccine, the ultimate applicability of any third-party research and
studies in related coronavirus and SARS studies and sequencing, the
Company’s ability to enter into agreements with the proposed lead
investigators to assist in the clinical development on its vaccine
candidate related to COVID-19, the Company’s ability to collaborate
with governmental authorities with respect to such clinical
development, the coverage and applicability of the Company’s
intellectual property rights to any vaccine candidate related to
COVID-19, the ability of the Company to manufacture any vaccine
candidate related to COVID-19 rapidly and at scale and other risks
detailed from time to time in the Company’s ongoing filings and in
its annual information form filed with the Canadian regulatory
authorities on SEDAR as www.sedar.com and with the United States
Securities and Exchange Commission on EDGAR at www.sec.gov/edgar.
Investors are cautioned not to rely on these forward-looking
statements and are encouraged to read the Company’s continuous
disclosure documents which are available on SEDAR and on EDGAR.
IMV INC.
Consolidated Statements of Loss and
Comprehensive Loss
(In thousands of Canadian dollars, except
shares and per share amounts)
Years ended
December 31,
2019
2018
$
$
Revenue
Subcontract revenue
59
82
Interest Income
509
401
Total revenue
568
483
Expenses
Research and development
18,986
12,852
General and administrative
10,140
9,243
Government assistance
(2,432)
(1,062)
Accreted interest
1,239
1,385
Total operating expenses
27,933
22,418
Net loss and comprehensive loss
(27,365)
(21,935)
Basic and diluted loss per
share
(0.55)
(0.50)
Weighted-average shares outstanding
49,653,578
43,766,951
IMV INC.
Consolidated Statements of Financial
Position
(In thousands of Canadian dollars, except
shares and per share amounts)
December 31,
December 31,
2019
2018
Assets
Current assets
Cash and cash equivalents
$
14,066
$
14,895
Accounts receivable
845
1,337
Prepaid expenses
3,032
2,699
Investment tax credits receivable
1,661
1,111
Total current assets
19,604
20,042
Property and equipment
2,830
2,883
Total assets
$
22,434
$
22,925
Liabilities and Equity
Current liabilities
Accounts payable and accrued
liabilities
$
6,157
$
7,575
Amounts due to directors
60
49
Current portion of long-term debt
88
81
Current portion of lease obligations
100
90
Total current liabilities
6,405
7,795
Lease obligation
1,208
1,308
Deferred share units
–
1,436
Long-term debt
8,373
8,069
Total liabilities
15,986
18,608
Equity
6,448
4,317
Total liabilities and equity
$
22,434
$
22,925
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200330005730/en/
Investor Relations Marc Jasmin, Senior Director,
Investor Relations, IMV O: (902) 492-1819, ext: 1042 M: (514)
617-9481 E: mjasmin@imv-inc.com
Josh Rappaport, Director, Stern IR O: (212) 362-1200 E:
josh.rappaport@sternir.com
Media Mrs. Delphine Davan, Director, Communications,
IMV M: (514) 968-1046 E: ddavan@imv-inc.com
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