7/9 (77.8%) evaluable subjects exhibited
clinical benefit, including three complete responses and two
partial responses
Reproducible survivin-specific T cell responses
and favorable safety profile observed in all seven subjects that
achieved clinical benefit on treatment
Top-line results from SPiReL study & launch
of an IMV-sponsored study in r/r DLBCL are planned in 2020
IMV will host a conference call and webcast on
Monday, December 9, 2019 at 8:00am EST
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage
biopharmaceutical company pioneering a novel class of
immunotherapies, today announced that updated results from SPiReL,
an ongoing Phase 2 investigator-sponsored study of DPX-Survivac in
combination with pembrolizumab in patients with
recurrent/refractory diffuse large B-cell lymphoma (r/r DLBCL),
were presented in a poster session at the 61st American Society of
Hematology (ASH) Annual Meeting in Orlando, FL. The poster, which
included additional data collected between the abstract submission
and the presentation, continued to demonstrate a favorable
therapeutic profile and treatment-associated clinical benefit in
r/r DLBCL patients who received the DPX-Survivac combination
regimen.
“These updated data show encouraging clinical activity in
patients treated with a DPX-Survivac combination regimen for
recurrent/refractory diffuse large B-cell lymphoma,” said Neil
Berinstein, MD, FFCPC, ABIM, hematologist at Sunnybrook Health
Sciences Centre and lead investigator for the clinical trial. “In
contrast, both to standard-of-care treatments and other
immunotherapeutic approaches in development, to observe this
clinical benefit alongside a favorable safety profile highlights
DPX-Survivac’s potential to reach this patient population in dire
need of better treatment options.”
“These results demonstrate a robust response in evaluable
patients who received the combination regimen including
DPX-Survivac, which continues to exhibit a promising therapeutic
profile for patients with hard-to-treat cancers,” said Joanne
Schindler, M.D., D.V.M., Chief Medical Officer of IMV. “These data
further validate DPX-Survivac’s novel mechanism, extending
previously documented results in solid cancers now to
survivin-expressing hematologic malignancies, and support the
hypothesis that our lead candidate works well in combination with
checkpoint inhibitors. We believe this represents a potentially
meaningful alternative to more toxic chemotherapy regimens; and,
with this foundation, we look forward to topline results from this
study as we prepare to launch an IMV-sponsored study in r/r DLBCL
in 2020.”
Updated Clinical Data from the SPiReL Study
In the poster presentation at ASH, Dr. Berinstein reported
updated clinical results from the ongoing Phase 2 SPiReL study.
Highlights of this preliminary data are outlined below:
- 7/9 (77.8%) evaluable subjects exhibited clinical benefit,
including three (33.3%) complete responses and two (22.2%) partial
responses;
- Reproducible survivin-specific T cell responses observed in all
subjects that achieved clinical responses on treatment;
- One subject, who received three prior lines of systemic
therapies and failed autologous stem cell transplant, reached a
complete response at the first on-study scan following treatment
with the DPX-Survivac combination regimen and remains free of
disease recurrence after completing the study; and
- Clinical benefits and favorable toxicity profile observed in a
heterogenous population of r/r DLBCL patients, including patients
of advanced age and/or with comorbidities, who are more susceptible
to adverse effects and more difficult to treat.
As of December 1, 2019, 17 subjects have been enrolled in the
study.
Conference Call Information:
IMV will host a conference call and webcast on Monday, December
9, 2019 at 8:00 a.m. EST to discuss the DPX-Survivac clinical
results presented at ASH.
Financial analysts are invited to join the conference call by
dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600
(International) using the conference ID number: 8796370. Other
interested parties will be able to access the live audio webcast at
this link: http://bit.ly/IMV_ASH19.
The webcast will be recorded and available on the IMV website
for 30 days following the call. The poster and the webcast will
available on the Investors section of the company’s website, under
“Events, Webcasts & Presentations”.
About the SPiReL Study
“SPiReL” is a Phase 2 non-randomized, open label, efficacy and
safety study. Eligible subjects have persistent or
recurrent/refractory DLBCL, confirmed expression of survivin and
are not eligible for curative therapy. Study treatment includes
administering two doses of 0.5 mL of DPX-Survivac 3 weeks apart
followed by up to six 0.1 mL doses every 8 weeks. Intermittent low
dose cyclophosphamide is administered orally at 50 mg twice daily
for 7 days followed by 7 days off. Pembrolizumab 200 mg is
administered every 3 weeks. Study participants continue active
therapy for up to one year or until disease progression, whichever
occurs first.
The primary objective of this study is to document the response
rate to this treatment combination using modified Cheson criteria.
Secondary objectives include duration of response and safety.
Exploratory endpoints include T cell response, tumor immune cell
infiltration, and gene expression analysis.
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 CD8+ T cell generation. 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 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
a single regimen, 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. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191208005044/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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