IMV Inc. Announces Initial Data from the Ongoing Phase 2B VITALIZE Trial in Patients with r/r DLBCL
December 15 2022 - 7:05AM
Business Wire
Complete responses were observed in patients
who received at least three previous lines of treatment (including
CAR-T's)
Recent clinical data add to the growing
enthusiasm for the therapeutic potential of cancer vaccines in
combination with checkpoint inhibitors
Oral presentation of the clinical data at the
Immuno-Oncology 360° conference in February 2023
IMV Inc. (Nasdaq: IMV; TSX: IMV) (“IMV” or the “Company”), a
clinical-stage biopharmaceutical company developing a portfolio of
immune-educating therapies based on its novel DPX® platform to
treat solid and hematologic cancers, today announced positive
initial patient data from the VITALIZE Phase 2B trial evaluating
its lead DPX product, MVP-S, in combination with pembrolizumab in
patients with relapsed, refractory Diffuse Large B Cell Lymphoma
(“r/r DLBCL”) who received at least three previous lines of
treatment. Detailed results will be presented in a podium
presentation at the Immuno-Oncology 360° conference to be held in
New York City on February 7-10, 2023.
“The initial clinical data from the VITALIZE trial are
encouraging and the accelerating recruitment in this study reflects
a growing interest for this therapeutic combination in DLBCL,” said
Dr. Matthew Matasar, Chief of Blood Disorders at Rutgers Cancer
Institute of New Jersey and RWJBarnabas Health, and primary
investigator of the VITALIZE trial. He added: “We find it
remarkable that we have seen complete responses in this trial in
patients that were refractory to prior cellular therapy and other
advanced therapies.”
“Positive initial results for the VITALIZE trial are an
important development milestone for MVP-S” said Andrew Hall, CEO of
IMV “Alongside other compelling cancer vaccine data announced this
week, these data on MVP-S highlight renewed interest in the
potential for cancer vaccines as a therapeutic class.”
Andrew Hall added “A well-tolerated, easy-to-administer therapy,
such as MVP-S, that provides durable clinical benefit is meaningful
for patients who have already been subject to aggressive, toxic
treatment regimens. Clinical activity in a highly refractory
patient population may represent a path to registration in
DLBCL.”
About the VITALIZE Study
The VITALIZE Phase 2B trial is a randomized, parallel group,
Simon two-stage study designed to assess IMV’s lead candidate,
MVP-S, in combination with pembrolizumab with or without
cyclophosphamide. Across the arms of this study, the combination
will be evaluated in up to 102 subjects with r/r DLBCL who have
received at least two prior lines of systemic therapy and who are
ineligible or have failed autologous stem cell transplant (ASCT) or
CAR-T therapy.
The primary endpoint is Objective Response Rate (ORR), centrally
evaluated per Lugano (2014) and measured by the number of subjects
per arm achieving a best clinical response of Partial or Complete
Response (PR+CR) during the 2-year treatment period. All subjects
will be evaluated for their baseline PD-L1 expression. Exploratory
endpoints include evaluation of cell-mediated immune response,
tumor immune cell infiltration, and other biomarker analyses.
About IMV
IMV Inc. is a clinical-stage immuno-oncology company advancing a
portfolio of therapies based on the Company’s immune-educating
platform, DPX®. Through a differentiated mechanism of action, the
DPX platform delivers instruction to the immune system to generate
a specific, robust, and persistent immune response. IMV’s lead
candidate, maveropepimut-S (MVP-S), delivers antigenic peptides
from survivin, a well-recognized cancer antigen commonly
overexpressed in advanced cancers. MVP-S also delivers an innate
immune activator and a universal CD4 T cell helper peptide. These
elements foster maturation of antigen presenting cells as well as
robust activation of CD8 T cell effector and memory function. MVP-S
treatment has been well tolerated and has demonstrated defined
clinical benefit in multiple cancer indications as well as the
activation of a targeted and sustained, survivin-specific
anti-tumor immune response. MVP-S is currently being evaluated in
clinical trials for hematologic and solid cancers, including
Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder
and breast cancers. IMV is also developing a second immunotherapy
leveraging the DPX immune delivery platform, DPX-SurMAGE. This
dual-targeted immunotherapy combines antigenic peptides for both
the survivin and MAGE-A9 cancer proteins to elicit immune responses
to these two distinct cancer antigens simultaneously. A Phase 1
clinical trial in bladder cancer, using MVP-S or DPX-SurMAGE, was
initiated in early 2022. For more information, visit
www.imv-inc.com and connect with us on Twitter and LinkedIn.
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 use such
word as “will”, “may”, “potential”, “believe”, “expect”,
“continue”, “anticipate” and other similar terminology.
Forward-looking statements are based on the estimates and opinions
of management on the date the statements are made. In this press
release, such forward-looking statements include, but are not
limited to, statements regarding the potential impact of the
VITALIZE study and the anticipated date detailed results from its
Phase 2B trial will be presented, the Company’s ability to advance
its development strategy, and the prospects for its lead
immunotherapy and its other pipeline of immunotherapy candidates.
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, those related to the detailed results when
presented being at least consistent with the initial results from
the VITALIZE Phase 2B trial, the Company’s priorities with MVP-S
and its DPX delivery platform, the potential for its delivery
platform and the anticipated timing of enrollment and results for
its clinical trial programs and studies as 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/20221215005319/en/
Investor Relations & Media Delphine Davan
Senior Director, Communications and Investor Relations
IMV Inc. O: (902) 492.1819 ext: 1049 E:
ddavan@imv-inc.com
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