Strata Oncology Partners with Elevation Oncology to Accelerate Enrollment of CRESTONE Study for Patients with Rare NRG1 Gene Fusions
ANN ARBOR, Mich., July 21, 2020 /PRNewswire/ -- Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, today announced it has signed an agreement with newly launched Elevation Oncology to accelerate patient identification and enrollment for Elevation Oncology's Phase 2 CRESTONE study evaluating the use of seribantumab in patients with recurrent, locally advanced or metastatic solid tumors of any origin that have a neuregulin-1 (NRG1) gene fusion.
Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (ERBB3 or HER3). The CRESTONE study builds on prior clinical experience from over 800 patients demonstrating consistent safety and tolerability. NRG1 gene fusions are oncogenic drivers that can be found in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, and neuroendocrine cancers, and sarcomas.
"Advancements in the molecular testing of tumors have created an opportunity to improve how we characterize genomic alterations and identify the appropriate therapeutics for individual patients," said Shawn Leland, PharmD, RPh, Founder and Chief Business Officer of Elevation Oncology. "Collaboration between diagnostic providers and therapeutic developers is crucial to achieve the best outcomes for patients with rare, genomically-driven cancers like NRG1 gene fusions."
Under the terms of the agreement, Strata Oncology will identify patients with advanced solid tumors that harbor the NRG1 gene fusion and meet other eligibility criteria, for consideration of enrollment into Elevation Oncology's CRESTONE study.
"This partnership exemplifies Strata Oncology's commitment to building a future where every patient with cancer receives their best possible treatment," said Dan Rhodes, Ph.D., CEO of Strata Oncology. "NRG1 fusions are rare oncogenic drivers present across several tumor types, like lung and pancreatic, and patients with these cancers are often treated in community oncology centers making efficient use of limited tissue samples critical. Through system-wide delivery of StrataNGS(TM), our tumor molecular profiling test optimized for small tissue samples, we believe our nationwide network of health systems will help drive identification and enrollment of patients into this important study."
A recent study presented at the 2020 Annual Meeting of the American Society of Clinical Oncology (ASCO) showed an expanded proportion of patients with actionable biomarkers due to the performance of StrataNGS on small tissue samples. The results from an analysis of data collected in the Strata Trial demonstrated that less than half of >20,000 formalin-fixed paraffin-embedded (FFPE) tumor tissue samples met tumor surface area requirements for leading commercial hybrid-capture-based comprehensive genomic profiling (CGP) tests. StrataNGS, a PCR-CGP test, successfully reported results in 96% of all samples received.
For more information about the CRESTONE study, please visit www.NRG1fusion.com
About StrataNGS
StrataNGS is a comprehensive genomic profiling test that assesses DNA and RNA in solid tumors. The assay requires industry-low tumor tissue sample input (>0.5mm(2 )surface area). StrataNGS is performed on co-isolated RNA and DNA and detects all classes of genomic alterations, including SNVs, small insertions and deletions, gene fusions, exon skipping mutations and copy number changes. Results include microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions.
About Strata Oncology
Strata Oncology, Inc. is a precision oncology company dedicated to transforming cancer care by building a platform to systematize precision oncology across a network of health systems and biopharma companies. Strata Oncology empowers health systems to deliver a comprehensive, system-wide precision oncology program that integrates tumor molecular profiling and a portfolio of biomarker-guided with routine care, so that all patients with advanced cancer have the opportunity to benefit. This large network of trial-ready health systems provides a mechanism to rapidly and predictably enroll precision therapy trials. For more information visit www.strataoncology.com.
Strata Inquiries:
Renee Volpini
(917) 923-8117
Renee.volpini@icrinc.com
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SOURCE Strata Oncology, Inc.
