PALM BEACH GARDENS, Fla.--(BUSINESS WIRE)--Xcovery, a developer of targeted therapeutics for cancer, today announced its participation in the National Cancer Institute (NCI) and Children’s Oncology Group (COG) Pediatric MATCH clinical trial. NCI-COG Pediatric Molecular Analysis for Therapy Choice (MATCH) is a precision medicine cancer treatment clinical trial that will enroll children and adolescents with advanced cancers that have progressed on standard therapies. NCI is part of the National Institutes of Health.
“Decades of research on the biology of cancer have revealed insights into the mechanisms that drive the disease, and that even with different cancers, they may share the same genomic alterations,” said Lieming Ding, M.D., Chairman of Xcovery. “Our lead product, ensartinib, is a small molecule that inhibits anaplastic lymphoma kinase (ALK) and ROS1. We’re excited to work with NCI and COG to provide ensartinib to the Pediatric MATCH study as a novel option to children with tumors harboring ALK or ROS1 genomic alternations, regardless of the tumor type.”
The NCI-COG Pediatric MATCH trial provides an opportunity to test targeted therapies in children and adolescents with advanced cancers who have few or no other treatment options. The study will attempt to demonstrate that matching certain drugs in children and adolescents whose tumors have specific gene abnormalities will effectively treat their cancer, regardless of its type. DNA and RNA sequencing will be used to identify children whose tumors have a genetic abnormality for which an investigational targeted therapy exists. Pediatric MATCH is the first nationwide study of this type in the U.S., including over 200 COG member institutions and several pharmaceutical companies.
“This trial would not have been possible without the enthusiastic support of the partnering pharmaceutical companies, as evidenced by their willingness to provide targeted agents for this trial,” said NCI study co-chair Nita Seibel, M.D., of NCI’s Division of Cancer Treatment and Diagnosis. “Some of the agents included have not previously been tested in children, so this trial will provide broader access to targeted agents for children and adolescents.”
About NCI-COG Pediatric MATCH Study
The NCI-COG Pediatric MATCH is a precision medicine cancer treatment clinical trial that will enroll children and adolescents (ages 1 to 21 years) with cancer and will match targeted agents with specific molecular changes identified using genomic sequencing technologies in refractory/recurrent pediatric patients. NCI-COG Pediatric MATCH will employ an analytically validated next-generation sequencing targeted assay of more than 4,000 different mutations across more than 140 genes. This assay will be coupled to a computer algorithm that uses pre-existing definitions and prioritization of target-agent pairs to assign patients by actionable mutation results to a targeted treatment. All sequencing will be performed in a CLIA-certified Laboratory. The NCI-COG Pediatric MATCH study will consist of a master protocol and individual agent-specific modules (Study Arms) for each treatment agent/regimen. NCI will provide substantial funding and will be the IND sponsor for this collaborative study, and COG will be the group leading the Pediatric MATCH protocol, including the Study Arms. The clinical trial will be open to all US COG member sites.
Ensartinib (X-396) is a potent anaplastic lymphoma kinase (ALK) inhibitor currently in a global Phase 3 trial in ALK positive non-small cell lung cancer (NSCLC) patients. Besides ALK, ensartinib also potently inhibits TRKA fusions, TRKC, ROS1, EphA2, and c-MET.
Xcovery is a biopharmaceutical company working to improve the lives of patients with cancer by discovering medicines to fight advanced tumors. Xcovery is developing a pipeline of oncology therapies to target a wide range of advanced tumors. For more information, visit www.xcovery.com.
This press release contains forward‐looking statements that are based on company management’s current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is being currently projected.