Ignyta Announces Multiple Presentations At The 2015 AACR Annual Meeting

SAN DIEGO--(BUSINESS WIRE)--Ignyta, Inc. (Nasdaq:RXDX), a precision oncology biotechnology company, today announced three poster presentations at the 106th Annual Meeting of the American Association for Cancer Research (AACR), being held April 18-22, 2015 in Philadelphia, Pennsylvania.

Each of the presentations highlights developments relating to entrectinib (formerly known as RXDX-101), Ignyta’s proprietary oral pan-Trk, ROS1 and ALK tyrosine kinase inhibitor targeting solid tumor indications. The first of the poster presentations describes the similarities and differences between Trk rearrangements and overexpression as potential oncogenic drivers and provides support for further exploration of entrectinib in cancers with Trk overexpression. The second presentation highlights a newly-developed biomarker assay to enable rapid screening of patient tumor samples to assess expression of TrkA, TrkB, TrkC and ROS1. The third poster presents data generated in collaboration with The Children’s Hospital of Philadelphia and the University of Pennsylvania School of Medicine, showing that entrectinib treatment resulted in significant tumor growth inhibition in a neuroblastoma xenograft model, both alone and in combination with conventional chemotherapy, providing support for the potential clinical evaluation of entrectinib in neuroblastoma patients.

Details of the presentations are as follows:

About Entrectinib

Entrectinib is a potent, 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 NTRK1 (encoding TrkA), NTRK2 (encoding TrkB), NTRK3 (encoding TrkC), ROS1 (encoding ROS1) or ALK (encoding ALK). Entrectinib has demonstrated in vivo antitumor activity against various TrkA, ROS1 and ALK-driven mouse xenograft models of different human cancers.

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:

• 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);
• Eight patients remained on active treatment across the three dosing schedules, with four patients having received 9 to 21 cycles of treatment;
• Entrectinib demonstrated a complete response in a patient with ROS1-positive non-small cell lung cancer (NSCLC);
• 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
• Entrectinib demonstrated prolonged stable disease in two patients: one with ALK-positive NSCLC and one with ROS1-positive pancreatic cancer.

The FDA has granted orphan drug designation for entrectinib for the treatment of neuroblastoma and for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive non-small cell lung cancer and colorectal cancer. The FDA has also granted rare pediatric disease designation for entrectinib for the treatment of neuroblastoma.

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.

Ignyta 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 progress of and data from Ignyta’s studies of entrectinib; the company’s presentation of results and discussion of entrectinib at the 2015 AACR Annual Meeting; the potential for entrectinib as a therapy for neuroblastoma or in Trk overexpression settings; and the company’s novel technologies and methods. 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; 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; the potential for final results of the ongoing Phase I/II clinical trials of entrectinib, 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; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates; the potential for the company to fail to maintain the CLIA registration of its diagnostic laboratory or to fail to achieve full CLIA accreditation 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, 2014 and subsequent Quarterly Reports on Form 10-Q.

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