Ignyta Announces New Data Highlighting Broad Potential of Both RXDX-106 and Entrectinib at the 2017 AACR Annual Meeting
April 04 2017 - 1:00PM
Business Wire
Ignyta, Inc. (Nasdaq: RXDX), a biotechnology
company focused on precision medicine in oncology, today announced
that preclinical data on RXDX-106 – which represents a novel class
of immunomodulatory agents that appears to restore innate immunity
in preclinical models via potent inhibition of the TYRO3, AXL and
MER (or TAM) family of receptors – will be presented at the 2017
Annual Meeting of the American Association for Cancer Research
(AACR) in Washington D.C. In addition, the company will also
showcase its first ever data in hematological malignancies for
entrectinib – an orally available, CNS-active tyrosine kinase
inhibitor targeting tumors that harbor TRK, ROS1 or ALK fusions –
in molecularly defined acute myeloid leukemia (AML). Entrectinib is
currently being studied in a registration-enabling Phase 2 clinical
trial known as STARTRK-2.
“We continue to be excited by our pipeline progress, including
the emerging preclinical profile of RXDX-106 and its potential to
restore and enhance a patient’s immune response to cancer,” said
Jonathan Lim, M.D., Chairman and CEO of Ignyta. “Our preclinical
data confirm TAM receptors as novel immuno-oncologic targets in the
fight against cancer, highlighting both the single agent activity
of RXDX-106, as well as a possible synergistic effect when combined
with other immuno-oncology treatments such as checkpoint
inhibitors. Furthermore, the preclinical data on entrectinib
activity in AML highlight the rationale for studying entrectinib in
molecularly defined hematological malignancies in a clinical
setting, in addition to the ongoing clinical studies of entrectinib
in solid tumors.”
In the RXDX-106 data to be presented, researchers studied the
activity of RXDX-106 in a commonly studied syngeneic mouse colon
carcinoma model in matched immunocompetent and immunocompromised
mice, finding that RXDX-106 had greater tumor growth inhibition in
the immunocompetent animals, which suggested that RXDX-106 effects
in this system were modulated by the immune system.
Immuno-phenotypic modulation by RXDX-106 was also observed in the
mouse model, including an increase in tumor infiltrating
lymphocytes (TILs), an increase in the ratio of M1/M2 macrophages,
and an increase in expression of CD69 and PD-1 on CD8 T Cells. In
another syngeneic mouse model, RXDX-106 inhibited tumor growth as a
single agent and demonstrated further tumor growth inhibition in
combination with anti-PD-1 or anti-CTLA-4 antibodies, which was
accompanied by increased levels of IFNɣ in the blood. In a separate
preclinical investigation of RXDX-106 targets, AXL and MER fusion
proteins were shown to independently act as oncodrivers and,
therefore, may be viable therapeutic targets for patients harboring
such molecular alterations. The preclinical data to be presented at
the AACR Annual Meeting suggest that RXDX-106 can act as both an
anti-tumor immuno-modulator and TAM oncodriver inhibitor and
support clinical development of RXDX-106 in a wide variety of
cancers (Abstract number 4698; Abstract number 4191).
Researchers will also present new preclinical data investigating
entrectinib as a potential treatment for patients with NTRK
rearranged acute myeloid leukemias. Entrectinib treatment inhibited
cell proliferation in vitro with sub-nanomolar EC50 values. In a
mouse model, entrectinib treatment at clinically relevant doses
resulted in tumor regression, which was accompanied by elimination
of residual cancer cells from the bone marrow (Abstract number
5158). Based on these data, we intend to evaluaute entrectinib
further in molecularly defined hematological malignancies.
About Ignyta, Inc.
Blazing a New Future for Patients with
Cancer™
At Ignyta, we work tirelessly on behalf of patients with cancer
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. With our
pipeline of potentially first-in-class or best-in-class precision
medicines, we are pursuing 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 about
Ignyta 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 development of
Ignyta's product candidates, references to our pipeline progress,
including the emerging preclinical profile of RXDX-106 and its
potential to restore and enhance a patient’s immune response to
cancer, the possible synergistic effect of RXDX-106 when combined
with other immuno-oncology treatments, the potential for AXL and
MER fusion proteins to be viable therapeutic targets for patients
harboring such molecular alterations and the potential advantages
and first-in-class or best-in-class nature of these drug programs.
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, 2016 and subsequent Quarterly Reports on Form
10-Q.
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version on businesswire.com: http://www.businesswire.com/news/home/20170404005494/en/
Ignyta, Inc.Jacob Chacko, M.D.CFO858-255-5959jc@ignyta.com
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