IMV Inc. Presents New Positive Data from Phase 2 Monotherapy Arm of Its Decide1 Trial in Advanced Ovarian Cancer & Continued ...
June 01 2019 - 1:15PM
Business Wire
Tumor regressions demonstrate potential for
DPX-Survivac immunotherapy in hard-to-treat solid tumors
Data correlations of survivin specific T cell
levels and durable clinical benefit continue to link novel
mechanism of action of DPX-Survivac with anti-cancer activity
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage
immuno-oncology corporation, today announced that investigators
shared new positive data for its DeCidE1 (DPX-Survivac with low
dose Cyclophosphamide and Epacadostat) clinical trial at the 2019
American Society for Clinical Oncology (ASCO) Annual Meeting.
These new data are from the ongoing Phase 1b/2 trial evaluating
the safety and efficacy of IMV’s lead candidate DPX-Survivac and
intermittent low-dose cyclophosphamide (CPA), with and without
Incyte’s IDO1 enzyme inhibitor epacadostat, in patients with
advanced recurrent ovarian cancer. New data from evaluable patients
from the phase 2 monotherapy arm of the trial indicated the
potential for DPX-Survivac to impact solid tumor growth in hard to
treat ovarian cancer patients. Longer-term follow-up from the phase
1b portion of the trial continued to demonstrate that the levels of
survivin-specific T cells in the blood of patients – a measure of
DPX-Survivac’s novel mechanism of action (MOA) – correlated with
durable clinical benefits.
Updated Clinical Data for DeCidE1
In a poster presentation, Janos L. Tanyi, M.D., Ph.D., Assistant
Professor of Obstetrics and Gynecology at the Hospital of the
University of Pennsylvania, provided an update on the clinical
results from the first patients enrolled in the phase 2 monotherapy
cohort. Researchers have enrolled 19 of 28 participants to
date:
- Of seven patients evaluable at data
cut-off in the monotherapy arm, five showed signs of treatment
benefits, including reduction of target lesions in two patients,
while two patients progressed.
- Within the group of four patients with
low tumor burden – a potential predictor of response – three showed
stable diseases including two reductions in tumor burden continuing
the positive trend seen in earlier results.
- All subjects evaluable for T cell
responses (five of five) showed survivin specific T cell activation
in the blood, four of five showed a robust response. IHC analysis
for tumor infiltration is ongoing
- Treatments have been well
tolerated.
“We believe that immunotherapy can and should be an integral
part of treatment options for hard-to-treat cancers, including
solid tumor indications like ovarian cancer in which patients
continue to maintain an urgent need for better outcomes,” said
Frederic Ors, Chief Executive Officer, IMV Inc. “We continue to
accumulate evidence of DPX-Survivac’s clinical activity in these
patients and are encouraged by the multiple tumor shrinkages and
long-lasting responses we have seen to date.”
The data also highlighted long-lasting responders from the phase
1b portion of the study with key takeaways as follows:
- Prolonged duration of clinical benefits
reaching up to more than two years, surpassing the progression-free
survival to previous treatments, including platinum-based
chemotherapy.
- Long-lasting clinical benefits and high
levels of survivin specific T cells are associated with long-term
treatment;
- One subject has received DPX-Survivac
for more than 21 months so far. This finding is the longest
duration of treatment for DPX-Survivac on record to date.
- It is supportive of DPX Survivac’s
ability to maintain high levels of survivin-specific T cells in the
blood over a prolonged period of time.
About the DeCidE1 Phase 1b/2 Trial
The DeCidE1 study is an open label, uncontrolled phase 1b/2
trial to assess the safety and efficacy of DPX-Survivac and
cyclophosphamide with and without epacadostat in individuals with
advanced, platinum-sensitive and resistant ovarian cancer. IMV
completed enrollment of 53 subjects in the phase 1b cohort in
December 2018. Following positive top line data, IMV amended the
phase 2 protocol to stop enrollment in the combination arm with
epacadostat and evaluate DPX-Survivac monotherapy with CPA in
patients with lower tumor burden. As of the May 27, 2019 data
cut-off date, 12 subjects have been enrolled in the phase 2
randomized portion of the trial and 7 subjects have been enrolled
so far in the monotherapy population with lower baseline tumour
burden.
The amended phase 2 cohort of the DECIDE1 trial is targeting
enrollment of at least 16 subjects in the population with a lower
baseline tumor burden. Enrollment is ongoing at multiple sites in
the U.S. and Canada.
About DPX-Survivac
DPX-Survivac is the lead candidate in IMV’s new class of
immunotherapies that programs targeted T cells in vivo. It has
demonstrated the potential for industry-leading targeted,
persistent, and durable T cell activation. IMV believes this
mechanism of action (MOA) is key to generating durable solid tumor
regressions. DPX-Survivac consists of survivin-based peptides
formulated in IMV’s proprietary DPX drug delivery platform.
DPX-Survivac is designed to work by eliciting a cytotoxic T cell
immune response against cancer cells presenting survivin peptides
on their surface.
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 anti-cancer therapies. IMV has identified over 15
cancer indications in which the over-expression of survivin can be
targeted by DPX-Survivac.
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. It is currently being evaluated in
multiple Phase 1b/2 clinical trials.
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 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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190601005030/en/
Media:Andrea Cohen, Sam Brown Inc.O: (917)
209-7163E: andreacohen@sambrown.comInvestor
Relations:Marc Jasmin, IMV Senior Director, Investor Relations
and CommunicationsO: (902) 492-1819 ext :1042M: (514) 617-9481E:
mjasmin@imv-inc.com
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