EDMONTON, May 24, 2017 /CNW/ - OncoQuest Inc.
("OncoQuest"), a privately held, biopharmaceutical company focused
on the development and commercialization of immunotherapeutic
products for the treatment of cancer, today announced the
presentation of initial safety and efficacy data from the company's
multicenter, randomized Phase 2 study in patients with newly
diagnosed advanced ovarian cancer at the upcoming 2017 ASCO
(American Society of Clinical Oncology) Meeting in Chicago, Illinois, USA.
Date and
Time:
|
Saturday, June 3,
2017, 1:15 p.m. – 4:45 p.m. CDT
|
Abstract
Number:
|
5536
|
Location:
|
Hall
A
|
Poster
Board:
|
Board
#358
|
Session:
|
Gynecologic
Cancer
|
"We are pleased to share these initial results from our phase 2
study evaluating our lead drug, oregovomab, an anti-CA125 murine
monoclonal antibody in scheduled combination with standard of care
chemotherapy (carboplatin and paclitaxel) compared to standard of
care alone in ovarian cancer patients in the front-line or initial
treatment setting," said Dr. Madi
Madiyalakan, CEO of OncoQuest.
The study enrolled 97 patients (95 patients evaluable) from
eight centers in Italy and five in
the U.S. Interim data analysis show that 46 patients receiving
chemoimmunotherapy have significantly extended progression free
survival (p=0.0009) and also overall survival (p=0.0025) relative
to the 49 patients receiving standard of care chemotherapy alone,
with median estimates not yet reached and estimable for either
parameter in the chemo-immunotherapy arm. Disease recurrence
or death had occurred in 65% of the standard of care group, but
only 36% of the combinatorial chemotherapy-oregovomab treated
patients, for whom a median time to recurrence was not yet
estimable.
The chemotherapy alone arm has exhibited outcomes consistent
with historical expectations. Results of the study are also
consistent in Italy and in the
U.S. A Cox regression analysis did not identify any
explanatory imbalances, although it was noted that the patients
with the more aggressive higher grade and stage IIIC and IV disease
appeared to benefit most from immunotherapy treatment, with a
hazard ratio for relapse of 0.35 for each factor and p values of
(0.0007) and (0.0016) respectively. Also of note, the adverse
event profile was similar in both treatment arms, with no evident
added toxicity associated with the addition of the indirect
immunizing antibody.
"Findings from this randomized controlled study are very
encouraging and of medical significance," commented Dr.
Madiyalakan. "The performance of the standard of care group
is consistent with expectation, but the combinatorial immunotherapy
arm has significant improvements for both relapse and survival
relative to that standard."
"The result seems likely to be the clinical translation of the
schedule-dependent interaction of carboplatin paclitaxel and
oregovomab observed in earlier preclinical and clinical
studies. The magnitude of the effect, especially without
incremental toxicity, suggests a major advance in the understanding
of these immune interactions, and points to a registration strategy
for the product in front line treatment of this disease," said Dr.
Christopher Nicodemus, Chairman of
the OncoQuest Clinical Advisory Board and Principal of AIT
Strategies, Franconia New
Hampshire. "In addition, the company is using what we
have learned in this trial to advance oregovomab in two additional
Phase 2 studies in treatment resistant recurrent disease settings
of ovarian cancer, one in combination with a checkpoint inhibitor,
Nivolumab and the other in combination with a TLR3 agonist,
Hiltonol®," added Dr. Nicodemus.
About Oregovomab
Oregovomab is OncoQuest's high
affinity monoclonal antibody (Mab B43.13) that is designed to bind
to the tumor associated antigen CA125 (also designated MUC16) and
initiate a cascade of immune responses against this
glycoprotein. CA125 is expressed in epithelial ovarian cancer
on the tumor surface but it is also shed into the
circulation. OncoQuest believes that carboplatin paclitaxel
based chemotherapy used in front line treatment in precisely
scheduled combination with oregovomab can improve outcomes relative
to chemotherapy alone and is currently exploring the role of select
immune adjuvants and checkpoint inhibition to assess oregovomab's
application in advanced disease settings. The Company plans
to initiate Phase 3 development of this product in an optimal
combination with commercial grade antibody product when the current
combinatorial Phase 2 program is completed.
About OncoQuest
OncoQuest is a subsidiary of Quest
PharmaTech Inc. (TSXV-QPT) ("Quest"), and is a privately held,
Canadian-based pharmaceutical company focused on the development
and commercialization of immunotherapies for cancer.
OncoQuest's technology platform includes a panel of tumor antigen
specific monoclonal immunoglobulins including CA125, MUC1, PSA and
Her2/neu; and the application of combinatorial immunotherapy to
enhance tumor specific immunity and clinical outcome.
OncoQuest's lead product is oregovomab for the treatment of ovarian
cancer that is currently undergoing multiple Phase 2 clinical
trials. OncoQuest's MUC1 program has already undergone a
Phase 1 clinical trial in breast cancer patients, and its
development is being led by OncoVent Co. Ltd., OncoQuest's joint
venture partner that has licensed the rights of the immunotherapy
technologies in the territory of Greater China. OncoQuest's
next-generation products are based on immunoglobulin E licensed
from UCLA, Stanford University and Advanced Immune
Therapeutics, Inc. These antigen-specific monoclonal IgE
antibodies are currently in preclinical development.
Forward Looking Statements
This press release includes forward-looking statements. In
some cases, forward-looking statements can be identified by
terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are
based upon current beliefs, expectations and assumptions and
include statements regarding OncoQuest's study results seeming
likely to be the clinical translation of the schedule-dependent
interaction of carboplatin paclitaxel and oregovomab observed in
earlier preclinical and clinical studies, the magnitude of the
effect, especially without incremental toxicity, suggesting a major
advance in the understanding of these immune interactions, and
pointing to a registration strategy for the product in front line
treatment of this disease, OncoQuest's belief that carboplatin
paclitaxel based chemotherapy used in front line treatment in
precisely scheduled combination with oregovomab can improve
outcomes relative to chemotherapy alone and OncoQuest's plans to
initiate Phase 3 development of its product in an optimal
combination with commercial grade antibody product when the current
combinatorial Phase 2 program is completed. These statements
are based on management's expectations and assumptions as of the
date of this press release and are subject to a number of risks and
uncertainties, many of which are difficult to predict that could
cause actual results to differ materially from current expectations
and assumptions from those set forth or implied by any
forward-looking statements, including the ability of
OncoQuest's product candidates to demonstrate safety and efficacy,
as well as results that are consistent with prior results, the
ability to enroll patients and complete the clinical trials on time
and achieve desired results and benefits, the company's ability to
obtain regulatory approvals for commercialization of product
candidates or to comply with ongoing regulatory requirements,
regulatory limitations relating to the company's ability to
promote or commercialize its product candidates for specific
indications, acceptance of its product candidates in the
marketplace and the successful development, marketing or sale of
products, the company's ability to maintain its license agreements,
the continued maintenance and growth of its patent estate, its
ability to establish and maintain collaborations, its ability
to obtain or maintain the capital or grants necessary to fund its
research and development activities, and its ability to retain its
key scientists or management personnel. The information in
this release is provided only as of the date of this release and
the company undertakes no obligation to update any forward-looking
statements contained in this release based on new information,
future events, or otherwise, except as required by law.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
SOURCE OncoQuest Inc.