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
DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–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
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
- One subject has received DPX-Survivac for more than 21 months so
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.
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.
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.
Andrea Cohen, Sam Brown Inc.
E: [email protected]
Marc Jasmin, IMV Senior Director, Investor Relations
O: (902) 492-1819 ext :1042
E: [email protected]