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
DARTMOUTH, Nova Scotia–(BUSINESS WIRE)–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
-
These patients have shown the best survivin specific T cell
-
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
-
Each of these patients has remained progression free for six and
- 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.
Contacts
For IMV Inc:
Media:
Andrea Cohen, Sam Brown Inc.
O:
(917) 209-7163
E: andreacohen@sambrown.com
Investor Relations:
Marc Jasmin, IMV Senior Director,
Investor Relations and Communications
O: (902) 492-1819 ext :1042
M:
(514) 617-9481
E: mjasmin@imv-inc.com