IMV Inc. (Nasdaq: IMV) (TSX: IMV), a clinical-stage
biopharmaceutical company (the “Company” or “IMV”), today provided
updates on the development of DPX-COVID-19, a vaccine candidate
against the novel coronavirus, and on the Company’s business and
clinical operations amid the COVID-19 pandemic.
“As the COVID-19 pandemic continues to spread, we have taken all
necessary measures to prioritize the health and safety of our
employees, patients, investigators and each of their families. In
parallel, we remain committed to serving the unmet needs of
patients, both through our efforts to potentially develop a
prophylactic vaccine to curb this novel coronavirus and across our
ongoing clinical studies with DPX-Survivac in advanced-stage cancer
patients,” said Frederic Ors, Chief Executive Officer of IMV. “We
are committed to progressing the development of our DPX-COVID-19
vaccine candidate working expeditiously with our partners to
advance human clinical studies as fast as possible.”
Update on IMV’s Development of DPX-COVID-19
On Wednesday, March 18, 2020, IMV announced in a press release
plans to develop of a DPX-based vaccine for COVID-19 in
collaboration with well-respected experts. Since the genomic and
proteomic sequences of the novel coronavirus (SARS-Cov2) were made
available, the Company has made significant progress as
follows:
- 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.
- 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.
Update on IMV’s Business and Clinical Operations
IMV prioritizes the health and safety of its employees and their
families, and of the patients, investigators and healthcare
professionals involved in clinical studies of DPX candidates.
Business Operations:
In line with public health interventions recommended to impede
the spread of COVID-19, IMV has implemented policies to protect its
team: Health Canada hygiene measures were enforced on premises; the
Company suspended all corporate travel outside Canada and between
corporate offices in Québec and Dartmouth; and the Company’s IT
infrastructure has been revised to support employees working from
home.
With its COVID-19 development activities and its ongoing
clinical trials, IMV is considered as an essential health and
community service provider and is making all efforts to comply with
the classification requirements of Nova Scotia and Quebec.
The Company has taken additional action to maximize social
distancing, including reviewing individual lab schedules on a
weekly basis to ensure the continuity of activities in the lab and
assessing activities to require the minimum number of people who
can perform the activity safely and with appropriate quality.
Clinical Operations:
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 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.
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.
About the DPX Platform
DPX is the Company’s proprietary lipid-based delivery platform
with no aqueous component in the final formulation. The DPX
platform can be formulated with peptide antigens. Its unique “no
release” mechanism of action allows antigen presenting cells (APCs)
to be attracted to the injection site, facilitating a robust and
sustained immune response within lymph nodes. Fully synthetic, easy
to manufacture; each product is stored in dry form and
reconstituted in lipids for injection, providing an extended shelf
life and simple handling and administration in the clinic. More
details about the DPX mechanism of action here:
https://imv-inc.com/platform.
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 (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-activating immunotherapy
that combines the utility of the platform with a target: survivin.
IMV is currently assessing DPX-Survivac in advanced ovarian cancer,
as well as in a combination therapy in multiple clinical studies
with Merck’s Keytruda®. Connect at www.imv-inc.com .
Cautionary Language Regarding 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 progress in developing a DPX-based vaccine candidate
against COVID-19, the Company’s belief that the DPX-based platform
creates the opportunity for production of a COVID-19 vaccine, the
Company’s belief in the potential efficacy of its DPX-based vaccine
against COVID-19, the anticipated timing of the Company’s
preclinical assays, studies and clinical trials related to its
DPX-based vaccine against COVID-19 and the expected impact of
COVID-19 on the Company’s other clinical studies and trials and its
operations generally. 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 preclinical assays, studies and
clinical trials, the receipt of all regulatory approvals by the
Company to commence and then continue clinical studies and trials,
and, if successful, the commercialization of its proposed vaccine
candidate related to COVID-19, the Company’s ability to raise
sufficient capital, including potentially through grant awards
available in Canada, to fund such clinical studies and trials 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, the ability for the Company to accurately assess and
anticipate the impact of COVID-19 on the Company’s other clinical
studies and trials and operations generally 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/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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200330005157/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: Delphine Davan, Director, Communications,
IMV M: (514) 968-1046 E: ddavan@imv-inc.com
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