NEW YORK – Ashion Analytics, a clinical laboratory of the Translational Genomics Research Institute (TGen), said on Thursday that it has partnered with New York-based drug development firm Elevation Oncology to identify patients with NRG1 fusion-positive tumors who may be eligible to enroll in Elevation's Phase II CRESTONE clinical trial.
Within the CRESTONE trial, Elevation is studying the activity of seribantumab, an anti-HER3 monoclonal antibody designed to block the tumor-proliferating NRG1 signal. Phoenix-based Ashion will use its proprietary GEM ExTra test, which detects tumor-specific mutations in both DNA and RNA, to assess patients for NRG1 fusions, estimated to show up in roughly 0.2 percent of solid tumors.
"Elevation Oncology is committed to expanding the benefit of precision medicine to all patients with cancer by developing therapies that make results from tests like GEM ExTra clinically actionable, no matter how rare the finding," Shawn Leland, Elevation's founder and chief business officer, said in a statement.
Within the partnership, Ashion will use the GEM ExTra test to conduct exome and trancriptome analyses and compare results between patients' tumor and normal tissues.
Elevation plans to enroll roughly 75 patients in a tumor-agnostic manner and will follow them to gauge their response to seribantumab. Within the trial, patients may be molecularly tested for NRG1 fusions using various assays performed at a CLIA-certified lab, including PCR tests, RNA or DNA sequencing tests, and fluorescence in situ hybridization. Elevation has announced similar partnerships with Caris Life Sciences and Strata Oncology, which are also testing patients for NRG1 fusions in the context of the CRESTONE trial.