Partnership explores innovative models for real-time identification, patient referral and enrollment of patients with solid tumors with a rare gene fusion
IRVING, Texas, Aug. 11, 2020 – Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, announced today that it has entered into a strategic partnership with Elevation Oncology to enhance patient enrollment practices for genomically-driven, tumor-agnostic clinical trials. Using Caris’ suite of market-leading molecular profiling offerings, the Caris Pharmatech Just-In-Time (JIT) clinical trial solutions, and the Caris Precision Oncology Alliance™ (POA) network, the companies will improve traditional enrollment in Elevation Oncology’s registration-directed Phase 2 CRESTONE trial through the real-time, nationwide identification of eligible patients with neuregulin-1 (NRG1) fusion-positive tumors and use of flexible enrollment models for rapid initiation of study treatment.
“We are pleased to partner with Elevation Oncology and look forward to working with them to enhance their clinical trial recruitment efforts, with the ultimate goal of reducing the disease burden on NRG1 fusion-positive patients across a range of solid tumors,” said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer. “The future of cancer treatment depends on today’s clinical trials, and we are excited to use our industry-leading suite of precision medicine technologies to address the challenges typically encountered in genomically-driven, tumor-agnostic trials.”
Under the terms of the agreement, Caris will help Elevation Oncology identify patients with advanced solid tumors that harbor the NRG1 fusions for participation in Elevation Oncology’s CRESTONE trial. Eligible patients will be confirmed for participation in Elevation Oncology’s Phase 2 CRESTONE trial of seribantumab in adult patients with recurrent, locally advanced or metastatic solid tumors that harbor the NRG1 gene fusion.
Sarah Cannon Research Institute (Sarah Cannon) has been selected as the first strategic site for CRESTONE and is currently open and enrolling patients. Eligible patients, including those within the Caris Pharmatech oncology trial network and the Caris Precision Oncology Alliance network, may potentially enroll into CRESTONE directly at their local oncology center, minimizing travel and keeping patients safe in the face of ongoing restrictions due to COVID-19, and helping to bring treatment opportunities directly to the patients that need them.
“The identification of oncogenic drivers, like an NRG1 gene fusion, through advanced molecular testing is a critical first step in a patient’s treatment journey,” said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. “Based upon the unique genomic signature of their tumor, physicians can identify the appropriate therapeutics or investigational trial for each individual patient. As an industry, we must emphasize the importance of collaborations between diagnostic providers and therapeutic developers in order to ensure that the best possible outcome for patients with rare, genomically-driven cancers can be achieved.”
For more information about seribantumab and the CRESTONE study, please visit www.NRG1fusion.com.
About Caris Life Sciences
Caris Life Sciences® is a leading innovator in molecular science focused on fulfilling the promise of precision medicine through quality and innovation. The company’s suite of market-leading molecular profiling offerings assesses DNA, RNA and proteins to reveal a molecular blueprint that helps physicians and cancer patients make more precise and personalized treatment decisions. MI Exome™ whole exome sequencing with 22,000 DNA genes, and MI Transcriptome™ whole transcriptome sequencing with 22,000 RNA genes along with cancer-related pathogens, bacteria, viruses and fungi analysis run on every patient provides the most comprehensive and clinically relevant DNA and RNA profiling available on the market.
Caris is also advancing precision medicine with Caris MAI™ (Molecular Artificial Intelligence) that combines its innovative service offerings, Caris Molecular Intelligence® with its proprietary artificial intelligence analytics engine, DEAN™, to analyze the whole exome, whole transcriptome and complete cancer proteome. This information, coupled with mature clinical outcomes on thousands of patients, provides unmatched molecular solutions for patients, physicians, payers and biopharmaceutical organizations.
Caris Pharmatech is changing the paradigm and streamlines the clinical trial process by assisting biopharma companies with accessing research-ready oncology sites for clinical trials. With over 200 research sites within the Caris Pharmatech JIT Oncology Network, biopharma companies can identify and enroll more patients, faster. Caris Pharmatech Just-In-Time Clinical Trial Solutions focus on rapid site activation and patient enrollment to streamline the drug development process. By implementing a Just-In-Time (JIT) Research System, site activation and patient enrollment is achievable within 14 days for pre-registered locations with pre-qualified patients.
Headquartered in Irving, Texas, Caris Life Sciences has offices in Phoenix, Denver, New York, and Basel, Switzerland. Caris provides services throughout the U.S., Europe, Asia and other international markets. To learn more, please visit www.CarisLifeSciences.com or follow us on Twitter (@CarisLS).
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Caris Life Sciences Partners with Elevation Oncology to Advance Enrollment in Phase 2 Trial of Patients with Solid Tumors Harboring NRG1 Gene Fusions