Ignyta, Inc. (Nasdaq: RXDX), a precision oncology
biotechnology company, today announced that the World Health
Organization (WHO) has approved the international nonproprietary name
(INN) “entrectinib” for the company’s lead product candidate, RXDX-101.
INNs facilitate the identification of active pharmaceutical ingredients,
and each INN is a globally recognized unique name.
About Entrectinib (formerly RXDX-101)
As a novel, orally available, selective tyrosine kinase inhibitor of the
Trk family of tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and
ALK proteins, entrectinib is designed as a targeted therapeutic
candidate to treat patients with cancers that harbor activating
alterations to TrkA, TrkB, TrkC, ROS1 or ALK. Entrectinib has
demonstrated in vivo antitumor activity against various TrkA,
ROS1 or ALK-driven mouse xenograft models of different human cancers,
and has demonstrated oral bioavailability and been observed to
efficiently cross the blood brain barrier in three animal species.
Entrectinib is currently in two Phase I/II clinical trials, the
STARTRK-1 trial and the ALKA-372-001 trial. The company presented
interim results from the ALKA-372-001 study in September 2014 at the
ESMO annual meeting. The interim findings at such date showed:
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No dose-limiting toxicities were observed, and only one Grade 3 or
higher possibly drug-related adverse event was observed (Grade 3
fatigue, which subsided with dose reduction);
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Eight patients remained on active treatment across the three dosing
schedules, with four patients having received 9 to 21 cycles of
treatment;
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Entrectinib demonstrated a complete response in a patient with
ROS1-positive non-small cell lung cancer (NSCLC);
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Entrectinib demonstrated five partial responses, in patients with
three different cancer histologies (colorectal cancer, NSCLC and
neuroblastoma) and in patients with each of TrkA, ROS1 and ALK
alterations; and
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Entrectinib demonstrated prolonged stable disease in two patients: one
with ALK-positive NSCLC and one with ROS1-positive pancreatic cancer.
About Ignyta, Inc.
Ignyta, Inc., located in San Diego, California, is a precision oncology
biotechnology company pursuing an integrated therapeutic (Rx) and
companion diagnostic (Dx) strategy for treating cancer patients. The
company’s goal with this Rx/Dx approach is to discover, develop and
commercialize new drugs that target activated cancer genes and pathways
for the customized treatment of cancer. It aims to achieve this goal by
pairing each of its product candidates with biomarker-based companion
diagnostics that are designed to identify, at the molecular level, the
patients who are most likely to benefit from the precisely targeted
drugs the company develops. 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 clinical development program for entrectinib. Actual results could
differ from those projected in any forward-looking statements due to
numerous factors. Such factors include, among others, the potential for
final results of the ongoing Phase I/II clinical trials of entrectinib,
or any future clinical trials, to differ from preliminary results; the
inherent uncertainties associated with developing new products or
technologies and operating as a development stage company; regulatory
developments in the United States and foreign countries; Ignyta’s
ability to develop, 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; Ignyta’s ability to raise any additional funding it
will need to continue to pursue its business and product development
plans; Ignyta’s ability to obtain and maintain intellectual property
protection for its product candidates, including reliance on Nerviano
for the prosecution and maintenance of certain key intellectual property
for all of Ignyta’s in-licensed product candidates; the potential for
the company to fail to maintain the CLIA certification of its diagnostic
laboratory or to fail to achieve full CLIA registration of such
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, 2013 and subsequent Quarterly Reports on Form
10-Q.
Copyright Business Wire 2014