IMV Inc. Launches Plans to Advance Clinical Development of a Vaccine Candidate Against COVID-19
18 March 2020 - 10:05PM
Business Wire
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage
biopharmaceutical company (the “Company” or “IMV”), today announced
that it is advancing the clinical development of a DPX-based
vaccine candidate against COVID-19. Vaccines against infectious
disease have been a core part of IMV’s heritage across its DPX
platform technology.
The goal of this development program will be to establish the
clinical safety and immunogenicity of a vaccine candidate based on
the Company’s DPX delivery technology and incorporating peptides
targeting novel epitopes from the coronavirus strain. The Company
believes that this peptide-based approach, combined with the
portability of the DPX platform, offers the potential for
accelerated development and rapid, large-scale production of a
vaccine.
The Company intends to develop its vaccine candidate
DPX-COVID-19 in collaboration with lead investigators for the phase
1 clinical study: Joanne Langley, M.D. and Scott Halperin, M.D., of
the Canadian Center for Vaccinology (CCfV) at Dalhousie University,
the Izaak Walton Killam Health Center and the Nova Scotia Health
Authority and the Canadian Immunization Research Network (CIRN);
along with Dr. Gary Kobinger, Ph.D., Director of the Research
Centre on Infectious Diseases at the University Laval in Quebec
City and Global Urgent and Advanced Research and Development
(GUARD) in Canada. The investigators will assist with preclinical
and clinical evaluation and with further development strategy in
collaboration with the Canadian government and others.
“As lead investigator on the Phase 1 study of DPX-RSV
(Respiratory Syncytial Virus), I witnessed the unique potential of
IMV’s epitope-based vaccine approach. I was particularly impressed
by the persistence of immunogenicity at one year in an older adult
population, suggesting that it is possible with this type of
approach, to create an immune response that lasts for an extended
period of time” said Dr. Langley. “I believe this collaboration
creates the possibility of an accelerated path to clinical
development of a vaccine to prevent COVID-19, and underscores the
importance of public-private partnerships to tackle this
epidemic.”
“We appreciate the urgent need to find solutions to the growing
pandemic. Across our many clinical studies, we have observed DPX
technology to elicit a robust immune response with a sustained
effect, including in sensitive populations. We believe this
technology offers a meaningful solution as a potential vaccine,
especially in older adults and those with pre-existing conditions
who are most at risk to this virus and generally more difficult to
vaccinate effectively,” said Frederic Ors, Chief Executive Officer
of the Company. “Additionally, we are pleased to be collaborating
on this project with Dr. Langley, Dr. Halperin and Dr. Kobinger,
who are leading voices in immunization and infectious disease and
share our commitment to public health.”
Third-party research in related coronaviruses has identified the
benefit of humoral and cellular (B and T cell) immune responses for
protection and resolution of infection, and the Company believes
the body of data it has produced to date supports its DPX platform
for peptide-based induction of B cells and T cells. The Company is
now designing a vaccine candidate against COVID-19 based on
third-party immunological studies of SARS-CoV and third-party
sequencing data available for SARS-CoV-2 with the goal of selecting
potentially immunogenic epitopes within the virus that induce
neutralizing antibody responses and protective T cell
responses.
Through the Company’s other clinical studies, the Company
believes its DPX technology has demonstrated a favorable safety
profile and immunogenicity in both cancer and infectious disease
settings, with sustained effect and potential for single-dose
effectiveness as a prophylactic vaccine. Over 200 patients have
been dosed with DPX-based immunotherapies and data from these
studies suggest treatment is well-tolerated, including in heavily
pre-treated cancer patients with advanced-stage disease. The
Company has also applied this technology for the prevention of
respiratory syncytial virus (RSV), the second-leading cause of
respiratory illness in infants, the elderly and the
immunosuppressed. The Company reported its Phase 1 data[1] from its
clinical candidate, DPX-RSV, which demonstrated a favorable safety
profile and immunogenicity in older adults (age 50-64), as well as
preclinical data from research-stage candidates aimed at other
infectious diseases, including malaria and anthrax.
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 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 and the
Company’s anticipated 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/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.
1: Langley et Al, 2019, Journal of Infectious Diseases
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version on businesswire.com: https://www.businesswire.com/news/home/20200318005125/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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