EORTC and Ignyta Expand Collaborative Agreement for Precision Medicine

Montag, 19.09.2016 13:00



SAN DIEGO --(BUSINESS WIRE)--

Ignyta, Inc. (Nasdaq: RXDX),a biotechnology company focused on precision medicine in oncology, today announced that EORTC, the European Organisation for Research and Treatment of Cancer, is expanding its collaborative agreement with Ignyta. Under this collaboration, Ignyta will serve as a diagnostic laboratory performing fusion testing for EORTC’s SPECTA (Screening Patients for Efficient Clinical Trial Access) initiative.

Part of the testing will include identifying patients who harbor a gene fusion for the NTRK, ROS1 or ALK genes for potential inclusion of these patients in Ignyta’s global STARTRK-2 Phase 2 clinical study of entrectinib. The genetic data obtained from this screening will also be available for potential future academic research as part of EORTC’s SPECTA initiative.

“EORTC’s SPECTA network includes a broad pool of clinical trial sites, tissue samples and patient data, which is helping us identify patients with a variety of tumor histologies across Europe who could potentially be enrolled in our STARTRK-2 clinical trial, and may benefit from entrectinib, our CNS-penetrant, targeted Trk, ROS1 and ALK inhibitor,” said Zachary Hornby, COO at Ignyta. “We are happy to work with EORTC to demonstrate the value of biomarker-driven clinical trials to bring forward innovative, targeted cancer medicines.”

EORTC’s SPECTA program is a pan-European biobank and molecular profiling platform for patients in colorectal, brain, lung, melanoma and rare cancers, which aims to optimize drug access, help advance the development of targeted treatments and accelerate new healthcare delivery. Built as a collaborative network, SPECTA provides access to large sets of patient-level clinical and biological data for international, multidisciplinary clinical research.

“Identification of specific genetic mutations provides opportunities for improving treatment efficacy in cancer patients,” said Vassilis Golfinopoulos, Medical Director at EORTC. “This is at the heart of our SPECTA program, which helps oncologists find trials that are adapted to their patients’ needs. The collaboration with Ignyta is allowing more patients to be screened, and providing more data to advance the development of precision medicine in cancer.”

The Ignyta STARTRK-2 Phase 2 study is evaluating the effectiveness of entrectinib, a selective tyrosine kinase inhibitor targeting tumors that harbor NTRK, ROS1 or ALK gene fusions. The STARTRK-2 trial is actively enrolling and working with leading cancer centers worldwide, including nine countries throughout Europe.

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 4,600 collaborators from all disciplines involved in cancer treatment and research in more than 640 hospitals in over 37 countries. A unique pan-European clinical research infrastructure, EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices through translational and clinical research.

www.eortc.org

About Ignyta, Inc.

At Ignyta, we work tirelessly on behalf of cancer patients 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. We are blazing a new future for cancer patients with our pipeline of first-in-class and best-in-class precision medicines – with 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.

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 primary and metastatic CNS disease. 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.

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 EORTC’s SPECTA initiative 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 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, 2015, and subsequent Quarterly Reports on Form 10-Q.

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