Data From First Dosing Cohort Show a 70% Disease
Control Rate – Including 30% of Patients with Partial Responses –
and Demonstrate a Tolerable Safety Profile
Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), a clinical stage
immuno-oncology company, today announced positive top-line clinical
data from its ongoing Phase 1b trial evaluating the safety and
efficacy of Immunovaccine’s lead immuno-oncology candidate,
DPX-Survivac, in combination with Incyte’s IDO1 enzyme inhibitor
epacadostat, and low-dose cyclophosphamide in patients with
advanced ovarian cancer. Immunovaccine is conducting the trial in a
collaboration with Incyte Corporation.
Initial results from ten evaluable patients in the DPX-Survivac
plus 100 mg epacadostat dosing cohort demonstrate a disease control
rate of 70%, including partial responses (PR, defined as ≥30%
decrease in tumor lesion size) in 30% of the patients (three out of
ten). To date, the combination also exhibited a well-tolerated
safety profile, with the majority of adverse events (AEs) reported
as Grade 1 and Grade 2, and only one potential treatment-related
AE.
“Individuals with recurrent ovarian cancer, in particular, have
not yet benefited from immunotherapy treatment breakthroughs in the
way that those with other hard-to-treat cancers have,” said
Frederic Ors, Chief Executive Officer of Immunovaccine. “We believe
that these clinical results reported thus far for this combination
immunotherapy in this patient population are promising. We are
excited by the potential of DPX-Survivac to increase the number of
individuals who may benefit from novel combination immunotherapies,
and look forward to our continued work with Incyte and our other
partners to increase the treatment options for such patients.”
Blood tests indicated that the majority of treated patients
exhibited targeted T cell activation. Tumor biopsies and analyses
thus far have supported the reported mechanism of action (MOA) of
this immunotherapy combination, with DPX-Survivac triggering T cell
infiltration into the tumor. This T cell activation was also
correlated with tumor regression.
“These first data from this trial are consistent with our prior
clinical findings, which indicated that DPX-Survivac could deliver
best-in-class T cell activation,” continued Mr. Ors. “We believe
that these results support the theory that our T cell activation
can lead to tumor regressions, which is critical for advancing
immunotherapy treatments for many types of cancer.”
About the Phase 1b TrialThe Phase 1b trial is a
single-arm, non-randomized, open label, uncontrolled, safety and
efficacy study for patients with advanced, platinum-sensitive and
resistant ovarian cancer. Investigators completed enrollment of ten
evaluable patients for the study’s first dosing cohort, which
consists of 100 mg epacadostat twice daily (BID), DPX-Survivac, and
low-dose cyclophosphamide.
In the first dosing cohort, investigators observed:
- A 30% overall response rate, with three out of ten PRs
- Two of the patients exhibiting PRs have completed one year of
treatment with responses ongoing at 12 and 14 months,
respectively
- Four patients (40%) had stable disease
- Two of the patients exhibiting stable disease are still
enrolled in the trial, with one of those patients showing a 21%
tumor reduction
- A 70% disease control rate (defined as the total number of
patients achieving complete response, partial response, and stable
disease)
At the time of data cut-off, there were also preliminary data on
the first three evaluable patients in the second dosing cohort
evaluating the combination of 300 mg BID epacadostat, DPX-Survivac,
and low-dose cyclophosphamide. From the first three evaluable
patients, two showed stable disease, with one patient showing tumor
regression of approximately 25%. The second dosing cohort is
ongoing and is expected to enroll 16 to 40 patients in total.
Immunovaccine expects to provide a clinical update on the second
dosing cohort in the first half of 2018 and investigators are also
planning to submit the study findings for scientific
publication.
“The activation of T cells is the hallmark of DPX-Survivac’s
mechanism of action, and, we believe, this initial data shows, for
the first time, a significant number of tumor regressions in a
combination therapy clinical trial centered on T cell activation
technology,” said Mr. Ors. “We are of the opinion that these data
provide clinical proof-of-concept that significantly de-risks our
development strategy for both our partners and shareholders, while
potentially bringing future benefits to patients in need. We are
looking forward to building on this solid foundation to accelerate
the Company’s growth.”
Conference Call and Webcast
InformationImmunovaccine will host a webcast and
conference call to provide an overview of this data. The call can
be accessed by dialing (844) 461-9932 (U.S. and Canada) or (636)
812-6632 (International) with the conference ID# 3558749. You can
access the live audio webcast and presentation via this link, or by
pasting this URL in your browser:
https://edge.media-server.com/m6/p/9u4kwnce.
About Ovarian CancerAccording 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-SurvivacDPX-Survivac consists of
survivin-based peptide antigens formulated in Immunovaccine’s
proprietary DepoVax™ delivery platform. DPX-Survivac is thought 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.
Immunovaccine 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 ImmunovaccineImmunovaccine 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. Immunovaccine develops T cell-activating cancer
immunotherapies and other vaccine candidates based on DepoVax™, the
Company’s patented platform that provides controlled and prolonged
exposure of antigens and adjuvant to the immune system.
Immunovaccine has advanced two T cell-activating therapies for
cancer through Phase 1 human clinical trials and is currently
conducting a Phase 1b study with Incyte Corporation assessing lead
cancer therapy, DPX-Survivac, as a combination therapy in ovarian
cancer. The Company is also exploring additional applications of
DepoVax, including DPX-RSV, an innovative vaccine candidate for
respiratory syncytial virus (RSV), which has recently completed a
Phase 1 clinical trial. Immunovaccine also has ongoing clinical
projects to assess the potential of DepoVax to address malaria and
the Zika virus. Connect at www.imvaccine.com.
Immunovaccine 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 them will be achieved. Actual results
may differ materially from those set forth in this press release
due to risks affecting the Company, including access to capital,
the completion of clinical trials and receipt of all regulatory
approvals. Immunovaccine Inc. assumes no responsibility to update
forward-looking statements in this press release except as required
by law.
Contacts for Immunovaccine:
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@imvaccine.com
Patti Bank, Managing Director, Westwicke
PartnersO: (415) 513-1284T: (415) 515-4572 E:
patti.bank@westwicke.com
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