NEW YORK – Ann Arbor, Michigan-based Strata Oncology announced on Tuesday that it has partnered with Elevation Oncology, a New York-based precision oncology startup, to genomically profile and identify patients eligible for enrollment in a Phase II study for the investigational drug seribantumab.
Under the terms of the partnership, Strata will use its StrataNGS comprehensive genomic profiling test to help Elevation identify and enroll the patients for its Crestone clinical trial evaluating seribantumab in recurrent or metastatic solid tumors characterized by NRG1 gene fusions.
Earlier data in more than 800 patients showed that the HER3-inhibiting monoclonal antibody was safe and tolerated. The Phase II study will now assess seribantumab's ability to shrink tumors in patients with previously treated NRG1 fusion-positive sarcomas, and lung, pancreatic, gallbladder, breast, ovarian, colorectal, and neuroendocrine cancers.
Strata's next-generation sequencing test is designed to assess DNA and RNA from especially small tissue samples and identify a range of actionable genomic variants such as mutations, amplifications, and gene fusions. The test is currently being used to match patients to genomically guided therapies, both investigational and approved, within the Strata Trial, an observational registry study aiming to enroll 100,000 participants. A recent analysis of data from the ongoing trial showed that StrataNGS's small-sample profiling capabilities identified actionable biomarkers in an expanded proportion of patients, many of whom did not have large enough samples to use with leading commercially available genomic profiling tests.
"NRG1 fusions are rare oncogenic drivers … [and] we believe our nationwide network of health systems will help drive identification and enrollment of patients into this important study," Strata CEO Dan Rhodes said in a statement.