Tumor
regressions and partial responses observed in subjects with
ovarian, non-small cell lung and bladder cancer
Treatment
well-tolerated, with no related Grade 3-4 or immune-related adverse
events
IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage
immuno-oncology company, today presented preliminary results from
its ongoing Phase 2 basket trial, evaluating DPX-Survivac in
combination with Merck’s Keytruda® (pembrolizumab) and intermittent
low dose cyclophosphamide (CPA) in patients with advanced and
metastatic solid tumors. The data were presented during the
Immunotherapy of Cancer poster session at the European Society for
Medical Oncology (ESMO) 2019 Congress, being held September 27 –
October 1, 2019, in Barcelona, Spain.
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“We are encouraged by the initial response observed from these
preliminary data, which feature a safety profile consistent with
observations across other studies of DPX-Survivac as well as
promising signs of clinical activity. Importantly, these results
expand our clinical dataset into four additional hard-to-treat
solid tumor indications, as we continue to explore the broad
potential of our targeted T cell therapy in more than 20 solid and
hematological tumor types that express survivin,” said Frederic
Ors, IMV’s Chief Executive Officer. “Later this year, we anticipate
additional data from ongoing studies of DPX-Survivac in our lead
indications – including topline results from DeCidE1, a Phase 2
study evaluating DPX-Survivac in ovarian cancer, and updated
results from SPiRel, a Phase 2 study evaluating DPX-Survivac in
combination with Keytruda in r/r DLBCL – both of which have
demonstrated this program’s potential to safely generate a durable
clinical response.”
Preliminary Results from the Phase 2 Basket Trial
At the time of cut-off, 23 patients were enrolled across all
five patient cohorts. This includes 19 patients across all cohorts
who received DPX-Survivac in combination with pembrolizumab with
CPA, and four patients from the ovarian cancer cohort receiving
DPX-Survivac with only pembrolizumab:
- Preliminary results from the first on-study scan showed tumor
reduction in patients with ovarian cancer (with and without CPA),
non-small cell lung cancer (NSCLC) and bladder cancer;
- Partial responses observed at first scan in two subjects
(bladder cancer, ovarian cancer); 19/23 subjects are still active
on study treatment.
- T cell infiltration observed in biopsy samples from subjects
who achieved tumor reduction on treatment;
- Eight ovarian cancer patients were enrolled in the study,
randomized 1:1 to treatment with and without CPA. Tumor control and
tumor reductions were observed in both groups; and
- Safety evaluation on all evaluable patients demonstrated that
treatment was well-tolerated, with no related Grade 3-4 or
immune-related adverse events (AEs) reported.
The poster is available on the Investors section of the
company’s website, under “Events, Webcasts & Presentations” at
www.imv-inc.com.
About the Phase 2 Basket Trial
IMV’s Phase 2 basket trial is an open label, multi-center study,
evaluating DPX-Survivac across five cohorts of patients with
bladder cancer, liver cancer (hepatocellular carcinoma), ovarian
cancer (with and without CPA), NSCLC and tumors shown to be
positive for the microsatellite instability high (MSI-H)
biomarker.
Subjects will receive DPX-Survivac (SC: 2 x 0.25 mL every three
weeks, followed by up to 11 x 0.1 mL every nine weeks), in
combination with pembrolizumab (IV: 200 mg every 3 weeks cycle) and
CPA (oral: 50 mg BID on alternating weeks) across five cohorts of
patients with bladder cancer, liver cancer (hepatocellular
carcinoma), ovarian cancer, NSCLC and tumors shown to be positive
for the microsatellite instability high (MSI-H) biomarker. The
study is designed to assess primary endpoints of safety and
objective response rate (ORR), with multiple secondary and
exploratory measures.
The study included a safety lead-in, which included 20 patients
from all five cohorts. The five cohorts are now expanded to recruit
additional subjects following a Simon two stage design. Enrollment
in the ovarian cancer cohort will be randomized 1:1 into two arms
with and without CPA. All other cohorts will utilize a single-arm
design and administer treatment with the triple combination. As of
Sept. 27th, 2019, 28 patients are enrolled (50 were screened). IMV
expects to enroll 184 patients across clinical sites in the U.S.
and Canada.
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 chemotheratherapies. 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.
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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
Mrs. Delphine Davan, Director of Communications, IMV M:
(514) 968 1046 E: ddavan@imv-inc.com
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