OncoQuest to Present Oregovomab Phase II Interim Clinical Results for Front Line Treatment of Ovarian Cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting
Geschrieben am 24-05-2017 |
Edmonton, Alberta (ots/PRNewswire) -
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.
"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 chemoimmunotherapy 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.
Contact:
Dr. Madi R. Madiyalakan
Chief Executive Officer, OncoQuest Inc.
Tel: (780)-448-1400 Ext. 204
Email: madi@oncoquestinc.com
Internet: http://www.oncoquestinc.com
Investor Relations:
Amato and Partners LLC
E-mail: admin@amatoandpartners.com
ots Originaltext: OncoQuest Inc.
Im Internet recherchierbar: http://www.presseportal.de
Original-Content von: OncoQuest Inc., übermittelt durch news aktuell
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