IMV to Host Conference Call & Webcast to Report Updated Results from DeCidE1, its Ongoing Phase 2 Study of DPX-Survivac in Pa...
February 20 2020 - 6:05AM
Business Wire
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage
biopharmaceutical company pioneering a novel class of
immunotherapies, today announced that company management will host
a conference call & webcast to report topline results from
DeCidE1, an ongoing Phase 2 study evaluating its lead compound,
DPX-Survivac, in patients with advanced recurrent ovarian cancer,
on Tuesday, February 25, 2020 at 8:00 am EST.
IMV aims to make immunotherapy more effective, more broadly
applicable, and more widely available to people facing cancer.
Patients with advanced, recurrent ovarian cancer have limited
treatment options. The five-year survival rate for women with
advanced disease is less than 30%1.
In 2020, the standard of care for recurrent cancer is
single-agent chemotherapy, which elicits a response rate of ~12%
with limited duration of benefit and severe adverse effects. There
is a significant need for more effective and better-tolerated
therapies in recurrent ovarian cancer.
Conference Call & Webcast Information
Financial analysts are invited to join the conference call by
dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600
(International).
All interested parties are able to register and access the live
audio webcast by clicking the link available under the Investors
section of the company’s website: “Events, Webcasts &
Presentations”.
The webcast will be recorded
and available on the IMV website for 30 days following the call.
About the DeCidE1 Study
“DeCidE1” is a Phase 2 multicenter, randomized, open-label study
to evaluate the safety and effectiveness of DPX-Survivac with
intermittent low dose cyclophosphamide. This phase 2 arm enrolled
22 patients with recurrent, advanced platinum-sensitive and
–resistant ovarian cancer. Patients received two subcutaneous
injections of DPX-Survivac three weeks apart and every eight weeks
thereafter, and intermittent low dose CPA, one week on, and one
week off for up to one year. Paired tumor biopsies were performed
prior to treatment and on treatment.
Primary endpoints of this study are overall response rate,
disease control rate and safety. Secondary endpoints include cell
mediated immunity, immune cell infiltration in paired biopsy
samples, duration of response, time to progression, overall
survival and biomarker analyses.
About DPX-Survivac
DPX-Survivac is the lead candidate in IMV’s new class of
targeted immunotherapies designed to elicit antigen-specific
functional, robust and sustained de novo T cell response. IMV
believes this mechanism of action (MOA) is key to generating
durable solid tumor regressions. DPX-Survivac consists of five
unique HLA-restricted survivin peptides formulated in IMV’s
proprietary DPX drug delivery platform and known to induce a
cytotoxic CD8+ T cell response against survivin expressing cancer
cells.
Survivin, recognized by the National Cancer Institute (NCI) as a
promising tumor-associated antigen, is broadly over-expressed in
most cancer types and plays an essential role in antagonizing cell
death, supporting tumor-associated angiogenesis and promoting
resistance to chemotherapies. IMV has identified over 20 cancer
indications in which survivin can be targeted by DPX-Survivac.
Company has recently published data with DPX-Survivac (as single
regimen or in combination with Merck’s Keytruda®) at the American
Society of Hematology annual meeting in December 2019 (see poster)
and at the ASCO-SITC symposium in February 2020 (see poster).
DPX-Survivac has received Fast Track designation from the U.S.
Food and Drug Administration (FDA) as maintenance therapy in
advanced ovarian cancer, as well as orphan drug designation status
from the U.S. FDA and the European Medicines Agency (EMA) in the
ovarian cancer indication.
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. 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 a combination therapy in multiple clinical studies with
Merck’s Keytruda®. 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 FDA potentially granting accelerated regulatory approval of
DPX-Survivac. 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 design and completion of clinical trials
and the receipt and timely 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.
1J Clin Oncol. 2014 May 1;32(13):1302-8. doi:
10.1200/JCO.2013.51.4489. Epub 2014 Mar 17
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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, SternIR 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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