The new platform clinical trial will evaluate FDA-approved therapies in novel biomarker profiles learned from real-world data

Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, today announced the Strata Precision Indications for Approved Therapies, or “Strata PATH,” trial. Strata PATH is a multi-drug, multi-arm, biomarker-driven clinical trial designed to evaluate the efficacy of FDA-approved targeted- and immunotherapies in new Strata-defined biomarker indications. Pfizer Inc. (NYSE: PFE) will provide marketed, targeted drugs for four study arms at no cost to participants. Additional pharmaceutical companies are expected to participate after the study launch.

The trial will use Strata-defined biomarker profiles from comprehensive DNA and RNA profiling to match patients to one of several different investigational treatment arms. Strata Oncology is leveraging its clinical-molecular database, which includes genomic and transcriptomic data with paired treatment outcomes, to define novel, pan-tumor biomarker hypotheses for existing FDA-approved therapies. Strata PATH will enroll patients with advanced solid tumors who have exhausted standard lines of therapy, are positive for specific biomarker profiles assessed by the StrataNGS test and have not previously been treated with the identified class of therapy.

“The Strata PATH study is another example of our commitment to deliver the best possible treatment for each patient with cancer,” said Dan Rhodes, PhD, co-founder and chief executive officer, Strata Oncology. “We are using the latest clinical-molecular insights to devise better biomarker-guided treatment hypotheses, and then partner with biopharma to test those hypotheses in patients. Pfizer is on the forefront of precision medicine, and we are pleased to work with them to translate these insights into prospective studies that may accelerate the availability of treatments for patients with cancer.”

“We are excited to be a part of Strata Oncology’s innovative trial to identify and test novel biomarker-guided treatment hypotheses,” said Chris Boshoff, MD, PhD, Chief Development Officer, Pfizer Oncology. “Using Strata’s data-driven approach, the PATH study will provide an opportunity to explore whether it’s possible for patients to benefit from precision therapies that are approved in other selected cancer types.”

About StrataNGS

StrataNGS is a comprehensive genomic profiling (CGP) test that features the lowest tumor tissue requirements in the industry (>2mm² surface area). The 429-gene assay is performed on co-isolated RNA and DNA. Single-/multi-nucleotide variants (SNVs), short insertions and deletions (indels), copy number alterations (CNAs; amplifications and deep deletions), microsatellite instability (MSI) status, gene fusions, and tumor mutation burden (TMB) are assessed simultaneously.