IMV Announces Clinical Update for DPX-Survivac Program in Ovarian Cancer Following Positive Feedback from U.S. FDA
January 29 2019 - 7:05AM
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology
corporation, today announced updates on its clinical program for
its lead investigational treatment, DPX-Survivac, as a potential
monotherapy in advanced recurrent ovarian cancer. In December 2018,
IMV met with the U.S. Food and Drug Administration (FDA) in a Type
B meeting to discuss the results-to-date of its DECIDE1 clinical
trial and ongoing development plan, as well as to obtain agency
guidance on a potential accelerated regulatory pathway for
DPX-Survivac as a T cell immunotherapy for the treatment of
advanced ovarian cancer in patients with progressing disease.
“This FDA meeting was an important milestone for the
DPX-Survivac program, and we are very pleased to be aligned with
the agency on key aspects of our clinical development plan,” said
Frederic Ors, Chief Executive Officer at IMV. “We believe that,
with no currently approved immunotherapy options available, ovarian
cancer remains a serious unmet medical need. We look forward to
advancing our ongoing phase 2 DECIDE study in order to potentially
expedite DPX-Survivac development as a possible first-in-class T
cell immunotherapy treatment for patients with advanced ovarian
cancer.”
FDA Meeting Highlights
The purpose of IMV’s Type B meeting with the FDA was to request
feedback on the design of the clinical program for DPX-Survivac.
This program includes the ongoing DECIDE phase 2 clinical study and
a potential future registration trial for accelerated approval in a
subset of ovarian cancer patients.
The FDA reviewed the Company's proposed clinical development
plan and acknowledged the potential for accelerated approvals in
advanced ovarian cancer based on objective response rate (ORR)
according to RECIST 1.1 criteria with reported median duration of
response (DOR). In addition, the FDA provided important guidance on
clinical design considerations for different lines of therapy and
platinum-sensitive and -resistant patient populations.
In addition, IMV submitted a protocol amendment for a predictive
enrichment approach to the phase 2 DECIDE trial, and further
discussed those details with the FDA during the Type B meeting. The
phase 2 primary endpoint, based on objective response rate (ORR)
per RECIST 1.1 criteria, is intended to confirm the high response
rate and duration of clinical benefits observed in previously
announced results in a patient population defined by a clinical
biomarker based on baseline tumor burden (BTB).
Multiple clinical sites are now open for enrollment in the
DECIDE phase 2 trial. Subject to phase 2 results, IMV plans to
schedule a follow-up meeting with FDA to finalize the design of a
potential pivotal trial based on ORR and DOR.
About the DECIDE Phase 2 Trial Cohort
The DECIDE (DPX-Survivac with low dose intermittent
cyclophosphamide) phase 2 study is an open label safety and
efficacy study for individuals with advanced platinum-sensitive and
-resistant ovarian cancer with sum of base line target lesions per
RECIST criteria less than 5 cm. Primary and secondary endpoints
include:
- Safety profile,
- ORR and DOR using RECIST 1.1 criteria,
- Induction of systemic survivin-specific T cells in the blood,
and
- Induction of T cell infiltration into tumors.
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 as a monotherapy in
advanced ovarian cancer, as well as a combination therapy in
multiple clinical studies in collaboration with 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. 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.
Contacts for IMV:
MEDIA Andrea Cohen, Sam Brown
Inc.T: (917) 209-7163 E: AndreaCohen@sambrown.com
INVESTOR RELATIONSMarc Jasmin, IMV
Senior Director, Investor RelationsT: (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
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