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Strata Oncology, Pfizer Partner to Explore New Biomarker Indications for FDA-Approved Drugs

NEW YORK – Strata Oncology on Tuesday said it will conduct a study to evaluate new biomarker-defined indications for targeted therapies and immunotherapies already approved by the US Food and Drug Administration.

So far, Pfizer has partnered with Strata to provide drugs to advanced solid tumor patients in four arms of the platform trial, dubbed Strata Precision Indications for Approved Therapies, or Strata PATH. The Ann Arbor, Michigan-based molecular profiling firm expects other pharmaceutical companies will join after the study is launched. The company doesn't have an official launch date but expects to begin the trial soon.

In order to join the study, patients must have exhausted standard lines of therapy and have biomarker profiles that match to specific treatment arms when assessed by the 429-gene StrataNGS test. Patients cannot have previously received a drug in the same class as the treatment they match to.

Platform trials are increasingly being used to discover novel, biomarker-defined indications of approved cancer therapies. The American Society of Clinical Oncology's TAPUR trial is one such effort and has reported out several positive arms. The WIN Consortium used genetic sequencing and transcriptomics to match patients to treatment arms in the WINTHER trial.

Strata is drawing on information in its clinical-molecular database to identify the new biomarker-informed, pan-tumor drug indications it is exploring in its platform trial. The database includes cancer patients' genomic and transcriptomic profiles, as well as their treatment outcomes.

Pfizer is the first pharma partner to contribute drugs for this study, but Strata has not disclosed which drugs will be evaluated in the trial, nor the biomarker-defined indications of interest. "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," Chris Boshoff, chief development office for Pfizer Oncology, said in a statement.

This year, Strata also began a study of its investigational liquid biopsy test for disease monitoring and assessing treatment response.