Ignyta Announces Submission of IND for RXDX-101

SAN DIEGO, Feb. 27, 2014 --(BUSINESS WIRE)-- Ignyta, Inc. (OTCQB: RXDX), an oncology precision medicine biotechnology company, today announced that it has submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for RXDX-101, Ignyta's proprietary oral tyrosine kinase inhibitor targeting solid tumor indications.

Subject to the IND becoming effective, the company intends to launch a new, global Phase I/II clinical trial of RXDX-101 to be called STARTRK-1, which stands for Study Targeting ALK, ROS1 or TRKA/B/C. This trial will be a Phase I/IIa, multicenter, single-arm, open-label clinical trial of oral RXDX-101 in adult patients with metastatic cancer confirmed to be positive for relevant molecular alterations. The company anticipates that this trial will involve clinical sites in the United States, Europe, and possibly Asia.

"The submission of this IND for RXDX-101 is a significant milestone for Ignyta because it will allow us to expand our RXDX-101 clinical development program beyond the currently ongoing Phase I/II trial that was initiated by our licensor, Nerviano, at two sites in Italy," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "I would like to acknowledge the hard work of our team in accelerating the achievement of this milestone one quarter ahead of schedule, as we had previously guided to a submission of the RXDX-101 IND in the second quarter of this year and we assumed responsibility for this program from Nerviano only three months ago. It is gratifying to see the team firing on all cylinders with this program, as we are impatient to potentially make RXDX-101 available to patients as soon as possible."

About RXDX-101

As a novel, orally available, selective tyrosine kinase inhibitor of the Trk family tyrosine kinase receptors (TrkA, TrkB and TrkC), ROS1 and ALK proteins, RXDX-101 is designed as a targeted therapeutic candidate to treat patients with cancers that harbor activating alterations to TrkA, TrkB, TrkC, ROS1 or ALK. RXDX-101 has been preclinically tested in vivo in three animal species to date, the mouse, rat and dog. It 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 all three species tested. RXDX-101 is currently in a Phase I/II clinical trial at two clinical sites in Italy in patients with solid tumors who are positive for alterations in TrkA, ROS1 or ALK.

About Ignyta, Inc.

Ignyta, Inc., located in San Diego, California, is a biotechnology company developing precision medicine with integrated Rx/Dx solutions for cancer patients. The company's goal is to discover and develop revolutionary new drugs that target activated genes in cancer cells for the customized treatment of cancer patients. Ignyta's present focus is on the development of RXDX-101, its proprietary oral tyrosine kinase inhibitor that targets solid tumor indications, and advancing its novel Spark discovery programs that leverage its proprietary cancer genomic and epigenomic knowledge bases. 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 potential for the FDA to accept the company's IND filing for RXDX-101; the company successfully launching the STARTRK-1 clinical study; the progress of and data from Ignyta's clinical trials and other studies; the company's novel technologies and methods; and market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, regulatory developments in the United States and foreign countries, including any failure of Ignyta's IND for RXDX-101 to become effective; Ignyta's ability to raise the additional funding it will need to continue to pursue its business and product development plans; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; the potential for final results of the ongoing Phase 1/2 clinical trial of RXDX-101 or the STARTRX-1 clinical trial to differ from the preliminary results; Ignyta's ability to develop, complete 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 obtain and maintain intellectual property protection for its product candidates; 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 its Current Report on Form 8-K dated October 31, 2013 and amended November 14, 2013 and December 9, 2013.

Source: Ignyta, Inc.

Posted: February 2014

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