EORTC and Ignyta Expand Collaborative Agreement for Precision Medicine
September 19 2016 - 7:00AM
Business Wire
Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on
precision medicine in oncology, today announced that EORTC, the
European Organisation for Research and Treatment of Cancer, is
expanding its collaborative agreement with Ignyta. Under this
collaboration, Ignyta will serve as a diagnostic laboratory
performing fusion testing for EORTC’s SPECTA (Screening Patients
for Efficient Clinical Trial Access) initiative.
Part of the testing will include identifying patients who harbor
a gene fusion for the NTRK, ROS1 or ALK genes for potential
inclusion of these patients in Ignyta’s global STARTRK-2 Phase 2
clinical study of entrectinib. The genetic data obtained from this
screening will also be available for potential future academic
research as part of EORTC’s SPECTA initiative.
“EORTC’s SPECTA network includes a broad pool of clinical trial
sites, tissue samples and patient data, which is helping us
identify patients with a variety of tumor histologies across Europe
who could potentially be enrolled in our STARTRK-2 clinical trial,
and may benefit from entrectinib, our CNS-penetrant, targeted Trk,
ROS1 and ALK inhibitor,” said Zachary Hornby, COO at Ignyta. “We
are happy to work with EORTC to demonstrate the value of
biomarker-driven clinical trials to bring forward innovative,
targeted cancer medicines.”
EORTC’s SPECTA program is a pan-European biobank and molecular
profiling platform for patients in colorectal, brain, lung,
melanoma and rare cancers, which aims to optimize drug access, help
advance the development of targeted treatments and accelerate new
healthcare delivery. Built as a collaborative network, SPECTA
provides access to large sets of patient-level clinical and
biological data for international, multidisciplinary clinical
research.
“Identification of specific genetic mutations provides
opportunities for improving treatment efficacy in cancer patients,”
said Vassilis Golfinopoulos, Medical Director at EORTC. “This is at
the heart of our SPECTA program, which helps oncologists find
trials that are adapted to their patients’ needs. The collaboration
with Ignyta is allowing more patients to be screened, and providing
more data to advance the development of precision medicine in
cancer.”
The Ignyta STARTRK-2 Phase 2 study is evaluating the
effectiveness of entrectinib, a selective tyrosine kinase inhibitor
targeting tumors that harbor NTRK, ROS1 or ALK gene fusions. The
STARTRK-2 trial is actively enrolling and working with leading
cancer centers worldwide, including nine countries throughout
Europe.
About EORTC
The European Organisation for the Research and Treatment of
Cancer (EORTC) brings together European cancer clinical research
experts from all disciplines for trans-national collaboration. Both
multinational and multidisciplinary, the EORTC Network comprises
more than 4,600 collaborators from all disciplines involved in
cancer treatment and research in more than 640 hospitals in over 37
countries. A unique pan-European clinical research infrastructure,
EORTC offers an integrated approach to drug development, drug
evaluation programs and medical practices through translational and
clinical research.
www.eortc.org
About Ignyta, Inc.
At Ignyta, we work tirelessly on behalf of cancer patients to
offer potentially life-saving, precisely targeted therapeutics (Rx)
guided by companion diagnostic (Dx) tests. Our integrated Rx/Dx
strategy allows us to enter uncharted territory, illuminating the
molecular drivers of cancer and quickly advancing treatments to
address them. This approach embraces even those patients with the
rarest cancers, who have the highest unmet need and who may
otherwise not have access to effective treatment options. We are
blazing a new future for cancer patients with our pipeline of
first-in-class and best-in-class precision medicines – with the
ultimate goal of not just shrinking tumors, but eradicating cancer
relapse and recurrence in precisely defined patient populations.
For more information, please visit: www.ignyta.com.
About Entrectinib
Entrectinib is a novel, orally available, selective tyrosine
kinase inhibitor targeting tumors that harbor activating
alterations to NTRK1/2/3 (encoding TrkA/ TrkB/TrkC), ROS1 or ALK.
Entrectinib is the most potent Trk inhibitor in the clinic, without
undesirable off-target activity, and the only Trk inhibitor with
clinically demonstrated activity against primary and metastatic CNS
disease. This product candidate is in a Phase 2 clinical trial
called STARTRK-2, which is the second of the “Studies of Tumor
Alterations Responsive to Targeting Receptor Kinases.” The trial is
a global, multicenter, open label, potentially
registration-enabling Phase 2 clinical trial of entrectinib that
utilizes a basket design with screening of patient tumor samples
for the relevant targets. Such a basket design takes full advantage
of entrectinib’s demonstrated preliminary clinical activity across
a range of different tumor types and molecular targets.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Statements in
this press release that are not purely historical are
forward-looking statements. Such forward-looking statements
include, among other things, references to the EORTC’s SPECTA
initiative resulting in enrollment of patients in Ignyta clinical
trials and Ignyta’s ability to successfully conduct clinical trials
for its product candidates. Actual results could differ from those
projected in any forward-looking statements due to numerous
factors. Such factors include, among others, the inherent
uncertainties associated with developing new products or
technologies and operating as a development stage company; Ignyta’s
ability to develop, initiate or complete preclinical studies and
clinical trials for, obtain approvals for and commercialize any of
its product candidates; changes in Ignyta’s plans to develop and
commercialize its product candidates; the potential for final
results of the ongoing clinical trials of entrectinib or other
product candidates, or any future clinical trials of entrectinib or
other product candidates, to differ from preliminary or expected
results; Ignyta’s ability to raise any additional funding it will
need to continue to pursue its business and product development
plans; regulatory developments in the United States and foreign
countries; Ignyta’s ability to obtain and maintain intellectual
property protection for its product candidates; the risk that
orphan drug exclusivity may not effectively protect a product from
competition and that such exclusivity may not be maintained; the
potential for the company to fail to maintain the CAP accreditation
and CLIA certification of its diagnostic laboratory; the loss of
key scientific or management personnel; competition in the industry
in which Ignyta operates; and market conditions. These
forward-looking statements are made as of the date of this press
release, and Ignyta assumes no obligation to update the
forward-looking statements, or to update the reasons why actual
results could differ from those projected in the forward-looking
statements. Investors should consult all of the information set
forth herein and should also refer to the risk factor disclosure
set forth in the reports and other documents the company files with
the SEC available at www.sec.gov, including without limitation
Ignyta’s Annual Report on Form 10-K for the year ended December 31,
2015, and subsequent Quarterly Reports on Form 10-Q.
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version on businesswire.com: http://www.businesswire.com/news/home/20160919005153/en/
Ignyta, Inc.Jacob Chacko, M.D.CFO858-255-5959jc@ignyta.com
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