Market Overview

Ignyta Reports FDA Clearance of IND for RXDX-106, a Novel Immunomodulatory Agent and TYRO3, AXL, MER (TAM) Inhibitor


Inc. (NASDAQ:RXDX), a biotechnology company focused on
precision medicine in oncology, today announced that the U.S. Food and
Drug Administration (FDA) has cleared its Investigational New Drug (IND)
application for RXDX-106, a novel oral immunomodulatory agent and TAM
inhibitor, in patients with solid tumors.

Under this IND, the company intends to initiate the TITAN (Targeted
Immunomodulatory TAM
ANtagonist) study, a first-in-human,
open label, multicenter, dose escalation study of RXDX-106 in patients
with locally advanced or metastatic solid tumors. TITAN is designed to
determine the safety, tolerability, pharmacokinetics, pharmacodynamics,
and preliminary clinical activity of RXDX-106.

"RXDX-106 represents a new class of immuno-oncologic precision medicines
that we are excited to advance to the clinic. In preclinical studies,
RXDX-106 has demonstrated the potential to elicit and potentiate an
immune response to cancer, by targeting the TAM family of receptors in
the tumor microenvironment, both as a single agent and in combination
with checkpoint inhibitors," said Jonathan Lim, M.D., chairman and CEO
of Ignyta. "This agent furthers our commitment to advancing new
medicines to help patients in their fight against cancer. We look
forward to commencing this Phase 1 study in early 2018."

About RXDX-106

RXDX-106 is a novel oral immunomodulatory agent with potent nonclinical
antitumor activity that appears to restore and enhance overall immune
function by reversing immunosuppression of innate immune cells in the
tumor microenvironment (TME) through inhibition of the receptor tyrosine
kinases (RTKs) TYRO3, AXL, and MER (collectively, TAM). In the TME, TAM
RTKs contribute to cancer cell evasion of the immune system and tumor
progression by promoting anti-inflammatory and pro-tumorigenic
activities. RXDX-106 is a potent and selective TAM inhibitor designed to
reverse TAM RTK-mediated immunosuppression and inhibit tumor growth and

About Ignyta

At Ignyta, we work tirelessly on behalf of patients with cancer to offer
potentially life-saving, precisely targeted therapeutics (Rx) guided by
diagnostic (Dx) tests. Our integrated Rx/Dx strategy allows us to enter
uncharted territory, illuminating the molecular and immunological
drivers of cancer and quickly advancing treatments to address them. This
approach embraces even those patients with rare 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.

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 RXDX-106, the preclinical data or plans
underlying RXDX-106, our ability to design and conduct development
activities for RXDX-106, the timeline associated with such development
program and the potential efficacy of RXDX-106. 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; our dependence on third party
manufacturers for supply of our product candidates and any approved
products; 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
including without limitation Ignyta's Annual Report on Form 10-K for the
year ended December 31, 2016 and subsequent Quarterly Reports on Form

View Comments and Join the Discussion!