Ignyta Announces Approval of an Investigational Device Exemption (IDE) for the Companion Diagnostic Assay to the STARTRK-2 Tr...
August 31 2016 - 7:00AM
Business Wire
Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on
precision medicine in oncology, today announced that the U.S. Food
and Drug Administration (FDA) has approved an investigational
device exemption (IDE) for its RNA-based companion diagnostic,
next-generation sequencing (NGS) assay (Trailblaze Pharos™). The
Trailblaze Pharos assay is intended for use in identifying
patients, including those who are treatment-naïve, who have solid
tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to
fusion proteins, to determine eligibility for enrollment into the
global STARTRK-2 trial, a Phase 2 study of entrectinib, a novel,
orally available, CNS-penetrant tyrosine kinase inhibitor targeting
tumors that harbor NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1, or
ALK gene fusions.
“We are pleased to have been granted this IDE approval for our
investigational companion diagnostic assay, as it allows us to
screen potential patients for STARTRK-2 who might not otherwise
have access to tumor profiling for these fusions and therefore may
never have been identified,” said Jonathan Lim, M.D., Chairman and
CEO of Ignyta. “We look forward to continuing to work with the FDA
on developing and providing a robust assay to help physicians
identify cancer patients who may be eligible for our clinical
studies.”
An IDE allows an investigational device, in this case the
Trailblaze Pharos assay, to be used in a clinical study in order to
collect safety and effectiveness data required to support a
Premarket Approval (PMA) application submission to FDA. An IDE
application is approved only after direct review by the FDA on many
aspects of the device validation and how clinical testing will be
performed.
About Trailblaze Pharos
The Trailblaze Pharos™ assay for NTRK1/2/3, ROS1, and ALK gene
rearrangements is a next-generation sequencing (NGS) based assay
for the qualitative detection of fusions in the NTRK1/2/3, ROS1, or
ALK genes in the RNA from formalin-fixed paraffin-embedded (FFPE)
human solid tumor tissue. The assay is intended to be used as an
aid in selecting patients, including those who are treatment-naïve,
with solid tumors that harbor a gene rearrangement in NTRK1/2/3,
ROS1, or ALK, for whom enrollment in the STARTRK-2 study may be
appropriate. A laboratory developed test (LDT) version of the
Trailblaze Pharos assay was previously used to identify
non-treatment-naïve patients with NTRK1/2/3, ROS1, or ALK gene
rearrangements who might be eligible for the STARTRK-2 study.
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.
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 unique 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.
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 Trailblaze Pharos
assay 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/20160831005375/en/
Ignyta, Inc.Jacob Chacko, M.D.CFO858-255-5959jc@ignyta.com
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