NEW YORK (GenomeWeb) – Personal Genome Diagnostics said today that it has entered a collaboration with Five Prime Therapeutics to develop a blood-based companion diagnostic assay for use with Five Prime's investigational drug candidate, bemarituzumab.
Under the agreement, PGDx is creating and validating a circulating tumor DNA test to identify the approximately 10 percent of gastric and gastroesophageal junction cancer patients whose tumors are FGFR2 gene-amplified and therefore eligible for treatment with the drug.
Five Prime will use the assay initially to select patients for the Phase 3 portion of the its registrational FIGHT trial, which is evaluating bemarituzumab in combination with chemotherapy as front-line treatment in patients with advanced gastric or gastroesophageal junction cancer with FGFR2 amplification. Phase 3 is expected to begin in the second half of 2018.
PGDx said it also intends to submit the assay for regulatory approval and commercialize it in the United States, Europe, Japan, China and other countries.
"Patients with advanced gastric and gastroesophageal junction cancer need new treatment options," Five Prime CEO Aron Knickerbocker said in a statement. "Prognosis is especially poor for patients whose tumors overexpress FGFR2b or have FGFR2 gene amplification. We believe that a targeted therapy like bemarituzumab may provide a clinical benefit in this setting and expect that PGDx's plasma-based assay will be an accessible and flexible tool to inform patient selection."
Financial terms of the agreement were not disclosed.