Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced that it has entered into a strategic collaboration with Debiopharm for the development of a companion diagnostic (CDx) test using its newly-launched Whole Transcriptome Sequencing (WTS) assay for mRNA analysis called MI Transcriptome™
| IRVING, Texas, May 30, 2019 /PRNewswire/ -- Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, today announced that it has entered into a strategic collaboration with Debiopharm for the development of a companion diagnostic (CDx) test using its newly-launched Whole Transcriptome Sequencing (WTS) assay for mRNA analysis called MI Transcriptome™. The assay, which was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in early May, reliably detects rare fibroblast growth factor receptor (FGFR1, FGFR2 and FGFR3) fusion events.
“This agreement supports our vision for optimizing the detection of rare fusion events using RNA, and building value on our multi-platform tumor profiling approach,” said W. Michael Korn, M.D., Chief Medical Officer at Caris Life Sciences. “We continue to develop novel technologies to provide the most comprehensive molecular profiling possible.” Under this agreement, MI Transcriptome™ will be used to identify eligible patients for Debiopharm’s FUZE Phase II Pivotal Trial of Debio 1347, a selective FGFR inhibitor that Debiopharm is evaluating for the treatment of patients with non-central nervous system solid tumors that have a specific FGFR gene fusion. Debio 1347 received Fast Track designation from FDA earlier this year. In addition to developing MI Transcriptome CDx, Caris will use its MI Trials service to improve the identification of patients eligible to enroll in the FUZE trial, analyzing the tens of thousands of patients profiled by Caris Life Sciences each year. The FUZE study is an open-label, blinded, multicenter, pan-cancer international Phase II Basket Trial that plans to enroll 125 patients across more than 20 countries. “This collaboration represents a key milestone in the advancement of a new tumor-agnostic approach,” explained Angela Zubel, Chief Development Officer at Debiopharm International SA. “We believe that a whole transcriptome assay is particularly relevant to detect oncogene fusions and to identify tumor expression profiles that could benefit from Debio 1347 therapy.” “When investigating novel targeted therapies in small, genetically-defined subpopulations which can be found in a broad range of cancers, it is critical that molecular screening be conducted in the broadest possible group of potential trial participants,” said Keith Flaherty, Director of Clinical Research at the Massachusetts General Hospital Cancer Center. “Kinase fusions across multiple histologies have become very important targets in precision oncology but we know that detection methods based purely on DNA can unfortunately miss some patients who might otherwise benefit from these therapies,” said David Hyman, Chief of Early Drug Development at Memorial Sloan Kettering Cancer Center. “We are excited to see the increasing adoption of RNA-based, unbiased screening technologies in the clinic.” As opposed to DNA-only based methods, MI Transcriptome™ RNA profiling has the ability to detect any fusion event independent of breakpoint locations and fusion partners. It can distinguish between different fusion or rearrangement types and has the potential to discover previously uncharacterized events, which is critical to identifying every potential patient who may benefit from targeted therapies. MI Transcriptome™ also uses the capabilities of high-throughput transcript sequencing to gain insight into the gene expression profiles of patients’ tumors and builds upon Caris’ offering of the most comprehensive tumor profiling approach, which assesses DNA, RNA and proteins for every patient. About Caris Life Sciences About Debiopharm About Debio 1347 Caris Life Sciences Company Contact & Media: Caris Life Sciences Investor Inquiries: Debiopharm Company Contact:
SOURCE Caris Life Sciences |
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