SAN DIEGO--(BUSINESS WIRE)--Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, today announced that it has received Expedited Access Pathway (EAP) designation from the United States Food and Drug Administration (FDA) and also “European Conformity” (CE) marking for its Trailblaze Pharos companion diagnostic test service. The EAP designation enables Ignyta and FDA to have more interactive discussions of the premarket approval application (PMA) for Trailblaze Pharos, which is the proposed companion diagnostic for entrectinib, the company’s investigational, orally available, CNS-penetrant tyrosine kinase inhibitor targeting tumors that harbor NTRK1/2/3, ROS1, or ALK gene fusions.
The CE marking signifies that Trailblaze Pharos conforms to the European Union (EU) Product Directives, and allows Trailblaze Pharos to be marketed throughout the European Economic Area. The Trailblaze Pharos assay is intended for use in identifying patients who have solid tumors with NTRK1/2/3, ROS1, or ALK gene rearrangements leading to fusion proteins, and is offered globally as a no-cost test to determine eligibility for enrollment into the STARTRK-2 trial, a global phase 2 clinical basket study of entrectinib.
“We are pleased to obtain both the EAP designation from the FDA and also CE marking for Ignyta’s Trailblaze Pharos assay,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “These important milestones exemplify our strong global commitment to help identify patients with actionable TRK, ROS1 and ALK fusions and to provide them a treatment option through the STARTRK-2 clinical trial of entrectinib. They also demonstrate our commitment to an integrated Rx and Dx approach, working with regulatory agencies to develop robust diagnostic assays and new therapeutic options.”
The FDA EAP program is intended for medical devices that demonstrate the potential to address unmet medical needs for life threatening diseases or conditions, which is analogous to some features of the FDA’s expedited programs for drug reviews.
To achieve CE marking for the Trailblaze Pharos diagnostic assay, Ignyta’s test service demonstrated compliance with specific requirements and conforms to the current EU directive on in vitro diagnostic devices.
About Trailblaze Pharos
The Trailblaze Pharos assay for NTRK1/2/3, ROS1, and ALK gene rearrangements is a next generation sequencing (NGS) based assay for the qualitative detection of fusions in the NTRK1/2/3, ROS1, or ALK genes in the RNA from formalin-fixed paraffin-embedded (FFPE) human solid tumor tissue. The assay is intended to be used as an aid in selecting patients, including those who are treatment-naïve, with solid tumors that harbor a gene rearrangement in NTRK1/2/3, ROS1, or ALK, for whom enrollment in the STARTRK-2 study may be appropriate.
Entrectinib is a novel, orally available, CNS-penetrant 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.
About Ignyta, Inc.
Blazing a New Future for Patients with Cancer™
At Ignyta, we work tirelessly on behalf of patients with cancer 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. With our pipeline of potentially first-in-class and 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.
For more information, please visit: www.ignyta.com.
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 Trailblaze Pharos assay 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.