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Roche, Five Prime Therapeutics to Develop CDx Assays for Immuno-Oncology Drug Trials

NEW YORK (GenomeWeb) – Clinical-stage biotech Five Prime Therapeutics said today that it is collaborating with Roche to develop immunohistochemistry companion diagnostic assays for use with Five Prime’s investigational drug candidates, bemarituzumab, an anti-FGFR2b antibody, and FPA150, a B7-H4 antibody.

Financial terms of the agreement were not disclosed.

The firms are collaborating to develop, validate, and commercialize a tissue-based IHC CDx assay to help identify patients whose tumors overexpress the FGFR2b protein and are eligible for treatment with bemarituzumab.

Five Prime said that it will use the CDx assay in a global registrational study, called the FIGHT trail, expected to start in the second half of this year. The study will analyze bemarituzumab in combination with 5-fluorouracil, leucovorin, and oxaliplatin, a regimen used as a front-line treatment in patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress the FGFR2b protein or have FGFR2 gene amplification. Five Prime said it also plans to use the Roche IHC assay along with a circulating tumor DNA test to identify the estimated 10 percent of patients with gastric and gastroesophageal junction cancer eligible for treatment with bemarituzumab.

The firms will also collaborate to develop and validate a tissue-based IHC assay for use as a laboratory developed test to help identify patients whose tumors overexpress the B7-H4 protein. Five Prime said that it plans to use the IHC assay in the expansion portion of an ongoing Phase I clinical trial of FPA150. The trial aims to identify patients with advanced or metastatic breast, ovarian, endometrial, and bladder cancers whose tumors overexpress B7-H4.

In April, Personal Genome Diagnostics said it had entered a collaboration with Five Prime to develop a blood-based companion diagnostic assay for use with bemarituzumab.