New Phase 2 Clinical Trial Results Continue to Demonstrate Potential Clinical Benefit of IMV’s DPX-Survivac in Combination ...
12 June 2019 - 9:05PM
Business Wire
Complete radiologic responses linked to T cell
activity observed in two of first six evaluable patients
IMV to host investor conference call and
webcast on June 12, 2019 at 8:00 am ET
IMV Inc. (Nasdaq:IMV; TSX:IMV), a clinical stage immuno-oncology
corporation, today announced updated data from the ongoing
investigator-sponsored SPiReL Phase 2 clinical trial assessing
IMV’s lead candidate, DPX-Survivac, in combination with
intermittent low dose cyclophosphamide and Merck’s checkpoint
inhibitor Keytruda® (pembrolizumab). The trial is designed to
evaluate the safety and efficacy of the combination immunotherapy
in patients with persistent or recurrent/refractory diffuse large
B-cell lymphoma (DLBCL).
At the first “on treatment” assessment, five of the first six
patients demonstrated clinical benefit, including four patients
with tumor regressions. Two patients reached a complete
radiological response, one a partial response, and two had stable
disease while on study. In addition, the combination continued to
demonstrate an acceptable safety profile.
“We are highly encouraged by the level of activity that we are
observing with the combination of DPX-Survivac and Keytruda in
these patients with DLBCL,” said Frederic Ors, IMV’s Chief
Executive Officer. “We believe that the clinical benefits the
SPiReL trial has yielded thus far, and the data linking this
antitumor activity with the T cell responses, support
DPX-Survivac’s novel mechanism of action and our combination
immunotherapy approach. We will continue working with our partners
to advance this clinical study towards improving the lives of
patients with difficult-to-treat cancers who need better treatment
options.”
Updated SPiReL Data Highlights:
At the time of data cut-off for this analysis, 11 patients were
enrolled in the trial. Efficacy data from the first six evaluable
patients are based on modified Cheson criteriai:
- Two patients achieved a complete
radiological response
- These patients have shown the best
survivin specific T cell responses to DPX-Survivac among the
analyzed samples
- One patient with a Complete Response
(CR) has completed the one-year study period
- One patient achieved a Partial Response
(PR) at first “on treatment” scan
- Two patients have reached stable
disease
- Each of these patients has remained
progression free for six and eight months while on treatment
- One patient with bulky disease
progressed at first scan
- Two subjects are not evaluable, coming
off trial at day 7 and day 28
- The treatment combination appears to be
well-tolerated with only 2 serious adverse events related to
treatment (low white blood count and low neutrophil count)
- Radiological results from three
additional patients are pending
The ICML abstract was published on June 12, 2019 via the 15-ICML
ABSTRACT BOOK, a supplement to Hematological Oncology with first
author Neil Berinstein, MD, FRCPC, ABIM Haematologist at the Odette
Cancer Centre, Sunnybrook Health Sciences Centre and Affiliate
Scientist at Sunnybrook Research Institute. Dr. Berinstein will be
available at the ICML conference to discuss the results.
IMV will host a conference call and webcast to discuss the
SPIREL results today, Wednesday, June 12, 2019, at 8:00 a.m. ET.
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: 9685423. Other interested
parties will be able to access the live audio webcast at this link:
https://ir.imv-inc.com/events-and-presentations. The webcast will
be recorded and made available on the IMV website for 30 days
following the call.
About DLBCL
Diffuse large B-cell lymphoma (DLBCL) is the most frequent type
of malignant lymphoma worldwide and accounts for approximately one
third of all non-Hodgkin lymphomas. In the United States, it is
estimated that nearly 25,000 new cases of DLBCL will be diagnosed
in 2019. As many as 30% of all patients with DLBCL who either fail
to respond to or show a relapse to initial therapies are
reported to have a poor outcome and require more therapeutic
options.
About the SPiReL Study
SPiReL (DPX-Survivac with Low Dose
Cyclophosphamide administered with Pembrolizumab in
Patients with persistent or Recurrent/refractory Diffuse Large B-Cell Lymphoma) is a Phase 2
non-randomized, multi-centre, open-label study. Primary
Investigator Dr. Neil Berinstein is leading the trial, which is
expected to enroll 25 evaluable participants whose recurrent DLBCL
expresses survivin, a tumor antigen expressed in of the majority of
DLBCL tumors. 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, investigators will perform analyses to
assess circulating antigen specific immune responses and changes in
tumor-infiltrating T cell immune responses within the tumor
microenvironment. They also plan to assess potential biomarkers of
immune and clinical response.
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
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 anti-cancer
therapies. IMV has identified over 15 cancer indications in
which the over-expression of survivin can be targeted by
DPX-Survivac.
The U.S. Food and Drug Administration (FDA) has
provided Fast Track designation to DPX-Survivac as
maintenance therapy in advanced ovarian cancer. In addition, the
FDA and European Medicines Agency (EMA) have granted orphan
drug designation status in the ovarian cancer indication.
Investigators are currently evaluating DPX-Survivac in multiple
Phase 2 clinical trials.
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. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190612005255/en/
For IMV Inc:Media:Andrea Cohen, Sam Brown
Inc.O: (917) 209-7163E: andreacohen@sambrown.com
Investor Relations:Marc Jasmin, IMV Senior Director,
Investor Relations and CommunicationsO: (902) 492-1819 ext :1042M:
(514) 617-9481E: mjasmin@imv-inc.com
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