Ignyta and EORTC Announce Entrectinib Selected as First Investigational Cancer Agent to be Included in EORTC SPECTA Precision Medicine Clinical Trial Program

Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, and the European Organisation for Research and Treatment of Cancer (EORTC) today announced that they will collaborate via EORTC’s Screening Patients for Efficient Clinical Trial Access (SPECTA) biomarker screening initiative to identify patients who harbor a gene rearrangement to NTRK1, NTRK3, ROS1 or ALK and therefore may be eligible for Ignyta’s global STARTRK-2 Phase 2 clinical study. This study is evaluating entrectinib, Ignyta’s novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to these genes. Under the collaboration between SPECTA and Ignyta, eligible patients testing positive for a gene rearrangement to NTRK1, NTRK3, ROS1 or ALK are to be exclusively recommended for enrollment in the STARTRK-2 clinical trial.

SPECTA is a pan-European clinical trial site and cancer patient molecular screening network established by EORTC in collaboration with more than 30 leading cancer treatment centers in 11 European countries to provide efficient access for patients to molecularly driven clinical trials. Tissue samples from cancer patients being treated at SPECTA institutions throughout Europe are sent to the SPECTA program central laboratory at 14M Genomics, a spin-out of the Wellcome Trust Sanger Institute, for molecular genetic analysis. The collaboration will focus initially on SPECTA’s currently active programs to screen patients with colorectal cancer (SPECTAcolor) and lung cancer (SPECTAlung) and will expand to include additional tumor types in the future as additional SPECTA cohorts become activated. The collaboration will extend throughout the accrual phase of the STARTRK-2 study.

"Since we first initiated dialog with the leadership of the EORTC SPECTA initiative a year-and-a-half ago, we have shared their vision to conduct efficient biomarker-driven clinical trials of innovative new cancer medicines,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "We are honored to be selected by EORTC as the first biopharmaceutical partner for the SPECTA initiative and see this collaboration as an opportunity to help cancer patients throughout Europe by matching patients with certain biomarker signatures to a targeted treatment option.”

Denis Lacombe, M.D., EORTC Headquarters Director, added, "SPECTA is a unique model of partnership as it connects all stakeholders involved in drug development, enhancing joint expertise to benefit patients. We look forward to working with Ignyta to leverage the SPECTA infrastructure to study entrectinib in patients with potentially relevant molecular alterations.”

About Entrectinib

Entrectinib is a novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/ TrkB/TrkC), ROS1 or ALK. Entrectinib is the most potent Trk inhibitor in the clinic, without undesirable off-target activity, and the only Trk inhibitor with clinically demonstrated activity against CNS metastases. This product candidate is in a Phase 2 clinical trial called STARTRK-2, which is the second of the "Studies of Tumor Alterations Responsive to Targeting Receptor Kinases.” The trial is a global, multicenter, open label, potentially registration-enabling Phase 2 clinical trial of entrectinib that utilizes a basket design with screening of patient tumor samples for the relevant targets. Such a basket design takes full advantage of entrectinib’s demonstrated preliminary clinical activity across a range of different tumor types and molecular targets.

About Ignyta, Inc.

At Ignyta, we fight cancer – a formidable opponent that manifests as thousands of different molecularly defined diseases and takes away millions of lives globally, every year. In this fight, our Big Hairy Audacious Goal (BHAG) is not just to shrink tumors but to eradicate residual disease – the source of cancer relapse and recurrence – in precisely defined patient populations by 2030. We will work tirelessly to achieve this BHAG by pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. Our Rx efforts are focused on discovering, in-licensing or acquiring, then developing and commercializing, molecularly targeted therapies; cancer stem cell/dormant tumor cell targeted therapies; novel chemotherapies/cell cycle inhibitors; and cancer immunotherapies – four therapeutic cornerstones that, sequentially or in combination, are foundational for eradicating residual disease. Our Dx efforts aim to pair these product candidates with biomarker-based companion diagnostics that are designed to precisely identify, at the molecular level, the patients who are most likely to benefit from the monotherapies and polytherapies we develop. We believe that only through this integrated Rx/Dx approach can we succeed in this fight. For more information, please visit: www.ignyta.com.

About EORTC

The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 2,500 collaborators from all disciplines involved in cancer treatment and research in more than 300 hospitals in over 30 countries. Through translational and clinical research, the EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices. EORTC Headquarters, a unique pan European clinical research infrastructure, is based in Brussels, Belgium, from where its various activities are coordinated and run.
www.eortc.org

About 14M Genomics

14M Genomics aims to become a European leader in the provision of clinical genomics services and clinical decision support tools, which will inform the diagnosis, prognosis and treatment of cancer. The company employs state-of-the-art sequencing and analytical tools, coupled with an in-depth understanding of cancer biology, to reveal associations between tumour genomics and the clinical path of the individual patient. 14MG aims to work together with the oncology community, academic institutions and pharmaceutical partners to improve the lives of cancer patients.
www.14mg.co.uk

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 SPECTA programs resulting in enrollment of patients in Ignyta clinical trials and Ignyta’s ability to successfully conduct clinical trials for its product candidates. 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 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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