Almac Group Announces CE Mark of Diagnostic Assay to Support Turning Point Therapeutics’ Pivotal TRIDENT-1 Clinical Trial
June 5, 2019
Achievement marks further progress towards development of therapy and assay to assist treatment of patients with unmet medical needs
Craigavon, N.I., 05 June 2019 – Almac Diagnostic Services, a global stratified medicine company and member of the Almac Group, today announced the successful CE marking of the diagnostic assay that will be used to determine molecular eligibility for enrollmenT into the pivotal Phase 2 portion of Turning Point Therapeutics’ TRIDENT-1 clinical trial.
The next-generation sequencing (NGS) assay is intended for use in identifying patients with ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors.
Commenting on the CE mark, Stewart McWilliams, Global VP of Quality & Regulatory Affairs at Almac Diagnostic Services said: “CE marking of the assay allows it to be utilized for screening trial subjects for enrollmenT. In addition, it provides quality assurance of the assay’s analytical performance and demonstrates that the product meets the essential requirements of the European In Vitro Diagnostic Directive 98/79/EC for its intended use.”
This important milestone follows swiftly on from the recent announcement by Turning Point Therapeutics and Almac Diagnostic Services of the US Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) approval of the assay. The CE marking of the assay evidences the further utility of the test to support the European portion of the global TRIDENT-1 clinical study.
Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI), developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.
Turning Point Therapeutics’ TRIDENT-1 Phase 2 open-label, multi-cohort study is planned for initiation in the second half of 2019.
“Each milestone in our development of repotrectinib brings us one step closer to the ultimate goal of reaching global patients with new therapeutic options for their cancer,” said Athena Countouriotis, M.D., President and Chief Executive Officer of Turning Point Therapeutics. “We are pleased to gain the CE Mark for the companion diagnostic assay as we continue our planning to initiate the global Phase 2 portion of Trident-1.”
About Almac Diagnostic Services
Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests.
We partner with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. We also facilitate biomarker clinical trial management and clinical test delivery from our CLIA-accredited labs.
The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials.
For more information visit: www.almacgroup.com/diagnostics.
About Almac Group
A unique culture delivering exceptional solutions
The Almac Group is an established contract development and manufacturing organization providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Our innovative services range from R&D, biomarker discovery development and commercialization, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organization that has grown organically over the past five decades now employing over 5600 highly skilled personnel across 18 facilities including Europe, the US and Asia.
We have a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.
About Turning Point Therapeutics Inc.
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead program, repotrectinib, is a next-generation kinase inhibitor targeting genetic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients, and is planned to enter a registrational Phase 2 study in the second half of 2019. Turning Point’s kinase inhibitors are designed to bind to their targets with greater precision and affinity than existing therapies, with a novel, compact structure that has demonstrated an ability to potentially overcome treatment resistance common with other kinase inhibitors. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.
For more information, visit www.tptherapeutics.com.