Majority of 23 peptide epitopes selected by IMV
demonstrated robust antibody responses in an animal model after
first and second dose in DPX formulation without any additional
adjuvant
DPX-COVID-19 to utilize multi-target approach,
to optimize immune response against virus’ weaknesses, enhance
efficacy at preventing infection and reduce potential for immune
escape
Phase 1 clinical study of DPX-COVID-19 is
scheduled during summer 2020
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage
biopharmaceutical company pioneering a novel class of cancer
immunotherapies and vaccines against infectious diseases, today
announced positive preclinical results demonstrating robust
immunogenic and antibody responses from the majority of peptide
epitopes. Based on these data, the Company has selected multiple
peptide epitopes to be formulated within its DPX platform to form a
vaccine candidate against the novel coronavirus, DPX-COVID-19.
“These preclinical data are highly encouraging, showing that
peptides formulated within the DPX platform have induced early and
strong immunogenic response in an animal model. Notably, the
antibody responses observed were equivalent or superior to levels
achieved with DPX-RSV, which delivered a robust and sustained
immune response in a Phase 1 study,” said Marianne Stanford, Ph.D.,
Vice President Research and Development at IMV. “Based on these
results, our team has down selected a combination of peptides that
have demonstrated immunogenicity and target several areas of the
virus mechanism of entry in a non-overlapping fashion. DPX-COVID-19
is designed to focus the immune response on the weaknesses for the
virus, to potentially increase its efficacy at preventing the
infection and to efficiently inhibit virus entry into cells,
thereby reducing the potential for immune escape, even in case of a
mutation.”
“These results reflect the promise and versatility of our DPX
platform technology, which has enabled our team to develop a new
targeted vaccine candidate just two months after launching into
development. Moreover, as we have shown across our clinical studies
to date, our unique, targeted approach has elicited favorable
results in sensitive populations, including older adult and
immunocompromised patients who are most susceptible to this virus,”
said Frederic Ors, President and CEO at IMV. “We are working
closely with our collaborators to advance DPX-COVID-19 with urgency
and remain on track to launch a Phase 1 clinical study in summer
2020.”
IMV and its collaborators have rapidly advanced a DPX-based
vaccine for COVID-19, since announcing plans in March. The Company
used sequences of the virus and immunoinformatics to predict and
identify several hundred epitopes, of which 23 were selected for
validation in preclinical studies based on their biological
relevance to the virus and potential to generate neutralizing
antibodies against SARS-CoV-2. Preclinical studies have been
ongoing since the beginning of April, with the goal to validate and
down select the most promising peptide candidates targeting
weaknesses of the virus.
In preclinical animal models, IMV evaluated all 23 peptides
formulated within the DPX platform. The majority of peptide
epitopes tested generated targeted antibody responses after the
first and second dose, without requiring an adjuvant. Based on
these results, IMV has selected an optimal combination of peptides
based on the best antibody responses for each of the key mechanisms
for attachment, fusion and entry of SARS-CoV-2 into human cells.
The antibody responses observed were equivalent or superior to a
DPX-based peptide epitope vaccine (DPX-RSV) used as a reference to
evaluate the level of immunogenicity in these preclinical studies.
DPX-RSV is a vaccine candidate against respiratory syncytial virus
(RSV), another RNA respiratory virus, and has demonstrated high
functional antibody titers (up to 100-fold increase over placebo
maintained for at least 421 days1) in a Phase 1 clinical study in
older adults (age 50-64).
Further vaccination-challenge preclinical assays in animal
models are currently performed and IMV intends to publish results
of preclinical studies in a peer-reviewed scientific journal in the
coming weeks.
In April, IMV conducted a pre-Clinical Trial Application (CTA)
meeting with Health Canada and is finalizing a design for a Phase 1
clinical study of DPX-COVID-19. The randomized, placebo-controlled
study is expected to enroll approximately 84 healthy subjects in
two age strata and to assess two different doses of DPX-COVID-19.
The Company is on track to initiate this study in the summer of
2020.
About DPX-COVID-19
DPX-COVID-19 is IMV’s vaccine candidate against the novel strain
of coronavirus that is causing the current pandemic. It is a
DPX-based formulation of multiple peptides of the SARS-CoV-2 that
generated early and strong immune responses during the preclinical
assays in animal models. A first-in-human Phase 1 clinical study is
scheduled to initiate during summer 2020. Fully synthetic,
DPX-COVID-19 has the potential for fast and large-scale
manufacturing to supply a significant number of doses rapidly
compared to more conventional vaccines. For more information, visit
www.imv-inc.com
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 cancer-targeted
immunotherapies and vaccines 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.
IMV is also developing a DPX-based vaccine to fight against
COVID-19. Visit www.imv-inc.com and connect with us on Twitter and
LinkedIn.
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 potential benefits of a DPX-based vaccine
against COVID-19 as compared to other potential vaccines, the
anticipated timing of the Company’s preclinical assays, studies and
clinical trials and the release of any results therefrom 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.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.
1 https://pubmed.ncbi.nlm.nih.gov/29617814/
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version on businesswire.com: https://www.businesswire.com/news/home/20200521005173/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 of Communications, IMV O: (902)
492-1819 E: ddavan@imv-inc.com
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