IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology
corporation, today announced results of ongoing research to further
explore the novel mechanism of action (MOA) of its DPX-RSV vaccine
candidate for respiratory syncytial virus (RSV).
New data from a preclinical study highlighted the effects of two
potential approaches to preventing RSV, comparing a single dose
bovine version of DPX-RSV to a two-dose conventional
investigational bovine RSV vaccine. Researchers found that IMV’s
vaccine candidate yielded strong antigen-specific immune responses
and a protective effect on disease pathology. The degree of
protection was comparable between the two vaccine candidates.
“While we remain focused on advancing our immuno-oncology
clinical program, it is our intention to partner our DPX technology
in other applications, including infectious diseases,” said
Frederic Ors, Chief Executive Officer, IMV Inc. “We are pleased to
see additional single-dose data supporting our differentiated
approach to addressing RSV, and we believe that demonstrations of
this unique MOA will further bolster our business development
efforts to progress this asset.”
Conventional RSV vaccine candidates target either the F or G
proteins of the virus, providing protection by neutralizing the RSV
virus. Clinical measures of efficacy focus on the amount of
neutralizing antibodies in the bloodstream.i,[ii] DPX-RSV works
differently; it targets the SH viral ectodomain of the RSV virus,
and, instead of neutralizing the virus, it enables the immune
system to recognize and destroy infected cells. Because there are
no neutralizing antibodies resulting from the DPX-RSV MOA, a
different clinical assessment is required to determine the vaccine
candidate’s protective effect.
In this study, researchers compared the effects of both the IMV
and conventional RSV vaccine approaches among bovines with known
RSV infections (The bovine animal model is considered an optimal
model of RSV infection.)iii,[iv] Researchers administered one dose
of DPX-bRSV to one cohort; the second received two doses of a
subunit RSV bovine vaccine. Researchers measured immune response
with an antibody titer test, and assessed disease pathology with a
lung lesion score and other clinical parameters (such as body
temperature changes).
They found SH antibodies in 14 of the 15 subjects that received
DPX-bRSV, and the improvements observed in disease pathology were
comparable between the two cohorts. These were the first bovine
animal health data to directly correlate the vaccine-induced immune
response against IMV’s novel RSV target - the SH viral protein–
with measures of disease protection.
“We engaged in these studies to demonstrate that the unique
immune response induced by DPX-RSV could provide protection against
RSV infections,” said Marianne Stanford, PhD, Vice President,
Research, IMV Inc. “We believe that the key takeaway is that these
results underscore the viability of a novel MOA in providing
benefit compared to traditional approaches. Our earlier Phase 1
clinical study of DPX-RSV provided impressive immunogenicity
results and a tolerable safety profile. These additional data help
to connect the dots of that immune response to its impact on
disease pathology.”
IMV is also collaborating on additional studies to further
demonstrate the validity of DPX-RSV’s novel MOA. These include an
academic collaboration to assess the levels of SH-specific
antibodies present in the elderly population following RSV
infections, and an ongoing collaboration with an undisclosed
partner on the development of a SHe human monoclonal antibody.
IMV and its research partners plan to present complete data for
these ongoing studies at an upcoming scientific conference or
publish the results in a peer-reviewed scientific journal.
About RSV
Respiratory syncytial virus (RSV) is a common virus that infects
the lungs and breathing passages. While it usually leads to mild,
cold-like symptoms, it can be severe in elderly adults, infants,
and individual with compromised immune systems. It is second only
to influenza as the most commonly identified cause of viral
pneumonia in older persons. Globally, it is estimated that 64
million cases of RSV infection occur annually in all age
groups, with 160,000 deaths. There is no vaccine currently
available to prevent RSV.
About DPX-RSV
DPX-RSV is IMV’s prophylactic, small B-cell epitope peptide
vaccine candidate designed specifically to address the unmet
medical needs in respiratory syncytial virus (RSV). DPX-RSV targets
the SH antigen of RSV, which may provide additional immunogenic
benefit over traditional approaches for high-risk populations,
including infants and the elderly.v Scientists from VIB and Ghent
University (Belgium) demonstrated the protective potential of the
ectodomain of the small hydrophobic (SH) protein of RSV as a
vaccine antigen.vi In addition, the concentrated dosage enabled by
the DPX delivery system may help mitigate injection site
point-of-pain, which has been a limitation for other potential
treatments. IMV reported Phase 1 data for DPX-RSV at the 12-month
time point, in which 100 percent of healthy older adult volunteers
who responded to vaccine achieved a sustained antigen-specific
immune response that remained at peak one year post-vaccination.
IMV holds exclusive worldwide license on applications that target
the SH ectodomain antigen in RSV from VIB and Ghent University.
About IMV
IMV Inc., formerly Immunovaccine 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 combination therapy in multiple clinical studies
with Incyte and 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.
Contacts for
IMV:MEDIA Mike Beyer, Sam
Brown Inc.T: +312.961.2502 E: MikeBeyer@sambrown.com
INVESTOR RELATIONSPierre Labbé, Chief
Financial OfficerT: (902) 492-1819 E: info@imv-inc.com
Patti Bank, Managing Director, Westwicke
PartnersO: (415) 513-1284T: (415) 515-4572 E:
patti.bank@westwicke.com
i RSV Vaccine and mAb Snapshot. (2018, September) Retrieved from
URL:
https://www.path.org/resources/rsv-vaccine-and-mab-snapshot
ii Mazur NI, Higgins D., Nunes MC., Melero JA., Langedijk AC.,
Horsley N., . . . Respiratory Syncytial Virus Network (ReSViNET)
Foundation. “The respiratory syncytial virus vaccine landscape:
lessons from the graveyard and promising candidates.” Lancet Infect
Dis. 2018 Jun 18. doi: 10.1016/S1473-3099(18)30292-5.
Retrieved via URL: http://www.ncbi.nlm.nih.gov/pubmed/29914800
iii Taylor G. “Animal models of respiratory syncytial virus
infection.” Vaccine 2017 Jan 11;35(3):469-480. doi:
10.1016/j.vaccine.2016.11.054. Retrieved via URL:
http://www.ncbi.nlm.nih.gov/pubmed/27908639
iv Taylor, G. “Bovine model of respiratory syncytial virus
infection.” Current Topics in Microbiology and Immunology.
2013;372:327-45. doi: 10.1007/978-3-642-38919-1_16. Retrieved via
URL: http://www.ncbi.nlm.nih.gov/pubmed/24362697
v Schepens, Bert, Michael Schotsaert, and Xavier Saelens. “Small
Hydrophobic Protein of Respiratory Syncytial Virus as a Novel
Vaccine Antigen.” Immunotherapy 7.3 (2015): 203-06. DOI:
10.2217/IMT.15.11
vi MS. Schepens et al, EMBO Mol Med 2014 6:1436-1454
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