First in-vivo T cell therapy to demonstrate
clinical activity in hard-to-treat solid tumor
79% of evaluable patients achieved disease
control on target lesions; 53% experienced tumor regressions
37% achieved durable clinical benefit lasting ≥
6 months; including four partial regressions so far, overall
response rate not yet reached as six patients remain on
treatment
Treatment well-tolerated with limited side
effects observed
IMV to host a conference call and webcast
today, February 25, 2020 at 8:00 a.m. EST; data also to be featured
at KOL symposium on Thursday, February 27, 2020
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage
biopharmaceutical company pioneering a novel class of
immunotherapies, today reported updated results from DeCidE1, an
ongoing Phase 2 study of its lead candidate, DPX-Survivac, in
patients with advanced recurrent ovarian cancer. The new results
show that DPX-Survivac immunotherapy is active and well-tolerated
in patients with advanced ovarian cancer.
“Today’s update marks a pivotal milestone for IMV and, we
believe, is a breakthrough for targeted T cell immunotherapies, as
these results demonstrate for the first time activity in a solid
tumor which is among the hardest to treat” said Frederic Ors,
President and Chief Executive Officer at IMV. “We were pleased to
achieve the primary objectives of our DeCidE1 study, showing
DPX-Survivac was active, durable and well-tolerated in advanced
ovarian cancer. With these results in hand, we plan to engage with
the US Food and Drug Administration (FDA) on the design of a
potential pivotal trial in ovarian cancer that might support an
accelerated pathway.”
Mr. Ors continued, “Notably, these results also continue to
validate the unique mechanism of our DPX platform and the relevance
of survivin as a cancer target, as we await updated Phase 2 data
from two additional studies of DPX-Survivac in the first half of
this year.”
“We are highly encouraged by the data from DeCidE1, which shows
that DPX-Survivac immunotherapy was well-tolerated and achieved
sustained clinical activity in advanced and recurrent ovarian
cancer. This is a particularly significant observation in heavily
pre-treated patients, for whom remain tremendous unmet need and
limited options beyond single-agent chemotherapy, which generates
responses in just 12% of patients with short duration and severe
adverse effects,” said Joanne Schindler, M.D., D.V.M., Chief
Medical Officer at IMV. “These results demonstrate DPX-Survivac’s
clinical potential as a well-tolerated and, possibly, more
effective treatment than currently available therapies. We believe
this outcome places DPX-Survivac at the forefront of a new paradigm
in the treatment of ovarian cancer and other solid tumors, as a
targeted T cell therapy that can achieve durable responses while
maintaining quality of life.”
Updated Results from DeCidE1
All 22 patients with advanced recurrent ovarian cancer enrolled
in this arm of the study were heavily pre-treated, with the median
number of prior therapies greater than three.
As of February 24, 2020, 19 patients were evaluable for efficacy
with six patients (31%) still receiving treatment. Key preliminary
findings are outlined below:
- 15 patients (79%) achieved disease control, defined as Stable
Disease (SD) or Partial Response (PR) on target lesions
- Tumor shrinkage of target lesions was observed in 10 patients
(53%)
- Durable clinical benefits lasting ≥6 months were observed in
seven patients (37%) so far:
- Four of these seven patients (21% of evaluable patients)
achieved PR with tumor regression >30% on target lesions
- Three stable diseases were ongoing for > 6 months (range
7-9) including -29.5% and -12% tumor regressions
- Median duration not reached yet, with five of these seven (71%)
patients still on treatment at > 6 months (range 7-10)
- Analysis of Baseline Tumor Burden (BTB) showed durable clinical
benefits across a broad range of BTB (1.5-7.7 cm) with a higher
number of patients achieving benefits in BTB < 5 cm as
previously observed in other arms of the study:
- Six out 11 with BTB < 5 cm (55%) achieved clinical benefits
lasting > 6 months
- Durable clinical benefits include platinum resistant and
refractory patients who previously received PARP inhibitors and
bevacizumab
- Treatment was well-tolerated, with most adverse events being
Grade 1-2 reactions at the injection site
Clinical Development Plans for DPX-Survivac in Advanced
Recurrent Ovarian Cancer and other cancer indications
IMV plans to take these results to the U.S. Food and Drug
Administration (FDA) for a Type B meeting, to align on the design
of a Phase 2b study with potential to support registration under
accelerated approval in this indication.
In parallel, the Company will continue to evaluate DPX-Survivac
in other tumor types. Currently, there are two actively accruing
Phase 2 studies of DPX-Survivac in combination with Merck’s
Keytruda®: SPiReL, an investigator-sponsored study in
recurrent/refractory diffuse large B-cell lymphoma (r/r DLBCL) and
a basket study across five solid tumor indications. Updated data
are expected from both studies in the first half of 2020.
Conference Call and Webcast Information
IMV will host a conference call and webcast on Tuesday, February
25, 2020 at 8:00 a.m. EST to discuss the DPX-Survivac clinical
results.
Financial analysts are invited to join the conference call by
dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600
(International). Other interested parties will be able to access
the live audio webcast at this link.
The Company also plans to review portions of the data at its
upcoming Key Opinion Leader Symposium on Thursday, February 27,
2020 at 8:30 a.m. EST.
Both webcasts will be recorded and available on IMV website for
30 days following under "Events, Webcasts & Presentations."
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 (CPA). This phase 2 arm
enrolled 22 patients with recurrent, advanced platinum-sensitive
and –resistant ovarian cancer. Patients received 2 subcutaneous
injections of DPX-Survivac 3 weeks apart and every eight weeks
thereafter, and intermittent low dose CPA one week on and one week
off for up to 1 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.
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 in 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 and the timing of expected results from other
DPX-Survivac’s studies with other tumor types. 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 and studies,
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/20200225005324/en/
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, Stern IR 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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