Combination Immunotherapy Continues to Show
Tolerable Safety Profile and Promising Activity With Second Dosing
Cohort Showing 6 of the First 8 Evaluable Participants Exhibiting
Stable Disease at First CT Scan
IMV Inc. (Nasdaq:IMV) (TSX:IMV), a clinical stage immuno-oncology
corporation, today announced that investigators shared new positive
data in an oral presentation for its DeCidE1 (DPX-Survivac with low
dose CyclophosphamIDe and Epacadostat) clinical study at the 2018
American Society for Clinical Oncology (ASCO) annual meeting. These
data from the ongoing Phase 1b/2 trial evaluated the safety and
efficacy of the combination of IMV’s lead candidate DPX-Survivac
and low dose cyclophosphamide, with Incyte’s IDO1 enzyme inhibitor
epacadostat, in patients with advanced recurrent ovarian cancer.
During the presentation, Oliver Dorigo, M.D., Ph.D., Associate
Professor of Obstetrics and Gynecology (Oncology), Stanford
University Medical Center, provided an update on the clinical
benefits from the first 18 evaluable participants among 26 enrolled
(including 10 from 100mg epacadostat dosing cohort and 8 from 300mg
epacadostat cohort), as well as blood sample and tumor biopsy
analyses from the study’s first dosing cohort. IMV is
conducting the Phase 1b/2 trial in an ongoing collaboration
with Incyte Corporation.
”We continue to be impressed by the safety and efficacy signals
we see from this clinical trial, especially in this heavily
pre-treated patient population with advanced ovarian disease and
very limited treatment options,” said Frederic Ors, Chief Executive
Officer, IMV Inc. “We designed DPX-Survivac to program immune cells
in vivo in order to heighten and sustain anti-cancer T cell
responses. Thus, we are especially pleased to be able to
demonstrate, for the first time, a clear correlation between
partial regressions and T cell infiltration in the tumors. Ovarian
cancer represents one of the highest unmet medical needs in today’s
cancer treatment landscape, and we are committed to advancing this
program as quickly and safely as possible.”
Updated Clinical Response and Safety Data for
DeCidE1At the time of data cut-off, 39 patients
were enrolled (including 25 new participants in the 300mg cohort
with 8 evaluable from day 56 first CT scan). Data from the first 18
evaluable patients across both dosing cohorts showed:
- 7 tumor regressions, including 4 Partial Responses (PR)
reported so far (PR, defined as ≥30% decrease in tumor lesion
size);
- Study participants were generally tolerating treatments well,
with no related significant adverse events (SAEs) reported.
Data from the first 8 evaluable participants in the 300mg
epacadostat dosing cohort at first CT scan included:
- 6 patients demonstrated stable disease (SD) at day 56, with 4
of these SDs still on trial at data cut-off;
- 2 patients with tumor regressions observed so far, including
one PR with a tumor regression ongoing for more than 9 months.
IMV plans to report updated results on these patients and others
enrolled in the trial when data from at least 16 evaluable
participants in the second dosing cohort are available.
Researchers also analyzed patient data to study the
combination’s mechanism of action (MOA). They examined blood
samples and tumor biopsies for the 10 evaluable patients treated in
the first dosing cohort. These data showed:
- Survivin-specific T cell responses detected in 100% (10/10) of
patients
- Increase in T cell infiltration post treatment in 37% (3/8) of
the analyzable tumor biopsies based on two complementary testing
methodologies (RNA sequencing and immunohistochemistry)
- 2 of the 3 patients with T cell infiltration showed PRs with
significant and durable tumor regressions lasting more than one
year.
- The third patient with T cell infiltration exhibited
Progressive Disease (PD) with evidence of down regulation of the
major histocompatibility (MHC) presentation pathway and significant
increases in suppressive markers, both indicative of mechanisms of
resistance.
“We know how important T cells are to controlling gynecological
cancers, particularly in advanced ovarian disease, where it has
been estimated that less than 20 percent of patients are responsive
to monotherapies like checkpoint inhibitors,” said Gabriela Nicola
Rosu, M.D., Chief Medical Officer at IMV Inc. “IMV’s approach to
program T cells in vivo is showing promising results that have been
able to connect the dots between T cell infiltration and tumor
response in these patients, many of whom have rapidly growing
tumors. We believe this data is an important milestone toward our
goal of significantly increasing the number of individuals able to
benefit from immunotherapy treatments.”
ASCO Presentation DetailsSession
Title: Engaging the Immune System in Ovarian
CancerLocation: S406Abstract
Number: 5510Title: “Clinical data from
the DeCidE1 trial: Assessing the first combination of DPX-Survivac,
low dose cyclophosphamide (CPA), and epacadostat (INCB024360) in
subjects with stage IIc-IV recurrent epithelial ovarian
cancer.”Presentation Date and Time: Sunday, June
3, 2018, 9:57 a.m. - 10:09 a.m. CTPresenter: Dr.
Oliver Dorigo, DeCidE1 Clinical Investigator and Lead Author
Conference Call and Webcast Information
IMV will host a webcast and conference call to provide an
overview of its ASCO presentation:
- Date: Sunday, June 3, 2018
- Time: 5:30 p.m. CT
- Title: ASCO 2018 Presentation of Phase 1b/2
Combination Clinical Trial Results in Advanced Ovarian Cancer
- Access: The conference line is (844) 461-9932
(U.S. and Canada) or (636) 812-6632 (International), and the
conference ID# is 3089163.
- Webcast: A live audio webcast and presentation
is available via this link, or by pasting this URL in an
internet browser: https://edge.media-server.com/m6/p/3xhqbfbx
About the DeCidE1 Phase 1b/2 Trial The Phase
1b/2 trial is an open label, uncontrolled, safety and efficacy
study for individuals with advanced, platinum-sensitive and
resistant ovarian cancer. The Phase 1b portion has two dosing
cohorts:
- The first with 100mg of epacadostat twice daily (BID), with
DPX-Survivac and low dose cyclophosphamide,
- The second with 300mg of epacadostat BID in combination with
DPX-Survivac and low dose cyclophosphamide.
Investigators have completed enrollment of the first dosing
cohort. At the time of data cut off, 25 patients are enrolled in
the second dosing regimen, and investigators expect to continue
enrollment until at least 16 evaluable patients are available.
The Phase 1b arm primary endpoints are to determine:
- The safety profile of the combination regimen,
- Induction of systemic survivin specific T cells in the
blood,
- Induction of T cell infiltration into tumors.
Secondary endpoints include objective response rate (ORR) using
modified RECIST v1.1 criteria; duration of response based on
modified RECIST criteria; time to progression (TTP); and overall
survival (OS.)
IMV announced positive top line data from the first dosing
cohort in December 2017. The Company also recently announced that
it would expand this clinical program with Incyte to include a
Phase 2 component. The Phase 2 arm will assess the safety and
efficacy of DPX-Survivac and cyclophosphamide with and without
epacadostat in individuals with advanced recurrent ovarian cancer.
In accordance with regulatory guidelines for combination trials,
the goal of the Phase 2 component is to evaluate the clinical
contribution of each investigational drug in the combination
regimen.
About Ovarian Cancer According to
the American Cancer Society (ACS), ovarian cancer ranks
fifth in cancer deaths among women, accounting for more deaths than
any other cancer of the female reproductive system. Often diagnosed
in its advanced stages, about 21,290 women received a new diagnosis
of ovarian cancer in 2015; approximately 14,180 women would die
from the disease, according to ACS estimates.
Ovarian cancer has a significant impact globally as
well. The World Cancer Research Fund reports that ovarian
cancer is the seventh most common cancer in women worldwide (18
most common cancer overall), with 239,000 new cases diagnosed in
2012.
About DPX-Survivac 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 received Fast Track
designation from the U.S. Food & 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 IMVIMV 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 conducting three clinical studies with Incyte and
Merck assessing DPX-Survivac as a combination therapy in ovarian
cancer and diffuse large B-cell lymphoma. Connect
at www.imv-inc.com.
IMV Forward-Looking StatementsThis 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.
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
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