87.5% of evaluable subjects exhibited clinical
benefit, including 2 complete responses and 3 partial responses
All patients tested were positive for survivin
and blood analysis shows strong survivin-specific T cell responses
correlated with clinical responses
The final conference poster presentation will
include additional data collected between the abstract submission
and the presentation itself
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage
biopharmaceutical company pioneering a novel class of
immunotherapies, today announced that updated results from SPiRel,
a Phase 2 study of the Company’s lead program, DPX-Survivac, as a
combination therapy in patients with recurrent/refractory diffuse
large B-cell lymphoma (DLBCL), will be featured in a poster session
at the 61st American Society of Hematology (ASH) Annual Meeting,
being held December 7-10, 2019 in Orlando, FL.
Poster Presentation Details:
Poster Title: Combination of DPX-Survivac, Low Dose
Cyclophosphamide, and Pembrolizumab in Recurrent/Refractory DLBCL:
The SPiReL Study
Presenter: Neil Berinstein, MD, FRCPC, ABIM,
Haematologist at the Sunnybrook Health Sciences Centre, Toronto,
ON.
Publication Number: 3236
Session Name: 704. Immunotherapies: poster II
Date and Time: December 8, 2019, 6:00 p.m. – 8:00 p.m.
EDT
Location: Orange County Convention Center, Hall B
The American Society of Hematology has published the official
abstracts on its meeting website in advance of the ASH Annual
Meeting.
The final conference poster presentation will include additional
data collected between the abstract submission on June 27, 2019 and
the presentation itself. The poster will be available under Events,
Webcasts and Presentations in the investors section of IMV’s
website on the day of presentation.
About the SPiReL study
“SPiReL” is a Phase 2 non-randomized, open label, efficacy and
safety study. Eligible subjects have recurrent/refractory DLBCL,
confirmed expression of survivin are 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. Enrollment is ongoing
with a goal of up to 25 subjects in this multi-center study.
At the time of data cut-off for the abstract on June 27, 2019,
23 subjects have been screened and 12 have been enrolled.
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 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. 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/20191106005479/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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