IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology
corporation, today announced details of the initial data from an
ongoing investigator-sponsored Phase 2 clinical trial. In the
study, investigators are evaluating IMV’s lead candidate,
DPX-Survivac, in combination with low dose cyclophosphamide and
Merck’s checkpoint inhibitor Keytruda® (pembrolizumab), in patients
with persistent or recurrent/refractory diffuse large B-cell
lymphoma (DLBCL).
The preliminary data included assessment of safety and clinical
activity (based on modified Cheson criteriai) for the first four
evaluable patients who have completed their first CT scan after the
start of treatment. The data showed that:
- Two of the first four evaluable participants showed tumor
regressions at the first on-treatment CT scan.
- The first enrolled participant demonstrated a tumor regression
of 48% at first on-treatment scan;
- The second participant demonstrated a partial response (PR) via
a tumor regression of 66% at first on-treatment scan.
- Preliminary data from the third participant demonstrated stable
disease.
- The other participant had early disease progression less than
two months following treatment initiation and was discontinued from
the study.
- The combination therapy appears to demonstrate an acceptable
safety profile, with no serious adverse events reported to
date.
“These data have provided IMV’s first clinical data for
DPX-Survivac in combination with Merck’s Keytruda, and we are
encouraged by these early signs of clinical activity in DLBCL,”
said Frederic Ors, IMV’s Chief Executive Officer. “Our clinical
results in ovarian cancer have consistently showed that our
proprietary T cell technology has the capacity to generate
regressions in solid tumors. One of IMV’s key objectives is to
provide patients with more effective treatment options by expanding
our clinical program to include other hard-to-treat cancer
indications. While these data are preliminary, we are pleased to
see the promising initial activity in a blood cancer, where
checkpoints inhibitors alone have thus far shown modest anti-cancer
activity.” ii
Primary Investigator Neil Berinstein, MD, Affiliate
Scientist, Sunnybrook Research Institute, Professor of
Medicine/Immunology, University of Toronto, is leading the
non-randomized, open-label study. The trial is expected to enroll
25 evaluable participants whose DLBCL expresses survivin, a tumor
antigen expressed in approximately 60 percent of DLBCL
patients.
Sunnybrook Health Sciences Centre clinicians have, to date,
enrolled four patients. Investigators have also started screening
and recruiting patients at two additional sites: Ottawa Hospital
Research Institute and the Research Institute of the McGill
University Health Centre.
The study’s primary endpoint is to document the objective
response rate. Secondary objectives include measuring tumor
regression, and documenting the toxicity profile and durations of
response. In addition, researchers will perform analyses to assess
circulating antigen specific immune responses and changes in
tumor-infiltrating T cell immune responses within the tumor
microenvironment. Investigators also plan to assess potential
biomarkers of immune and clinical response.
IMV announced initiation of patient dosing for this
trial earlier this year. This trial is supported in part by a
research grant from the Investigator-Initiated Studies Program of
Merck Canada Inc. and IMV.
This trial is one of the two Phase 2 studies evaluating the
anti-cancer activity of IMV’s lead candidate, DPX Survivac, in
combination with Merck’s pembrolizumab and low dose
cyclophosphamide. The other ongoing trial is evaluating
the triple combination immunotherapy in patients with advanced
ovarian cancer.
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 MOA is
key to generating durable solid tumor regressions. DPX-Survivac
consists of survivin-based peptide antigens formulated in IMV’s
proprietary DPX drug development platform. DPX-Survivac is believed
to work by eliciting a cytotoxic T cell immune response against
cells presenting survivin peptides.
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., formerly Immunovaccine 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 combination therapy in multiple clinical studies
with Incyte and 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.
Contacts for
IMV:MEDIA Mike Beyer, Sam
Brown Inc.T: (312) 961-2502 E: mikebeyer@sambrown.com
INVESTOR RELATIONSPierre Labbé, Chief
Financial OfficerT: (902) 492-1819 E: info@imv-inc.com
Patti Bank, Managing Director, Westwicke
PartnersO: (415) 513-1284T: (415) 515-4572 E:
patti.bank@westwicke.com
____________________________
i Cheson, B.D.,, Pfistner, B., Juweid, M.E., Gascoyne, R.D.,
Specht, L., Horning, S.J., . . . and Diehl, V. (2007). Revised
Response Criteria for Malignant Lymphoma. Journal of Clinical
Oncology, 25(5) DOI: 10.1200/JCO.2006.09.2403
ii
http://clinicaltrials.gov/ct2/show/results/NCT02038933?sect=X70156&view=results#outcome1
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