trending Market Intelligence /marketintelligence/en/news-insights/trending/bdxgubd6fzka43jcqxrh8a2 content esgSubNav
In This List

Five Prime, Roche developing tests to identify patients for drug candidates

Blog

A Pharmaceutical Company Capitalizes on M&A Activity with Brokerage Research

Blog

2021 Year in Review: Highlighting Key Investment Banking Trends

Blog

Insight Weekly: US stock performance; banks' M&A risk; COVID-19 vaccine makers' earnings

Blog

Global M&A By the Numbers: Q3 2021


Five Prime, Roche developing tests to identify patients for drug candidates

Five Prime Therapeutics Inc. entered a collaboration with Roche Holding AG to develop companion diagnostic assays to use with its targeted immuno-oncology agents for patients with advanced gastric cancer.

A companion diagnostic is an imaging tool that provides information essential to the safe and effective use of a corresponding drug.

The companies are collaborating to develop, validate and commercialize a tissue-based immunohistochemistry companion diagnostic procedure to help identify patients whose tumors overexpress fibroblast growth factor receptor 2b or FGFR2b and are eligible for treatment with bemarituzumab, an anti-FGFR2b.

Bemarituzumab is an anti-FGFR2b humanized monoclonal antibody in clinical development as a targeted immune therapy for tumors that over-express FGFR2b.

Immunohistochemistry, or IHC, is a process of detecting antigens in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues.

The companion diagnostic assay will be used in Five Prime's global registrational study of bemarituzumab in combination with a regimen known as mFOLFOX6 as front-line treatment in patients with advanced gastric or gastroesophageal junction cancer. The study is expected to start in the second half of 2018.

The mFOLFOX6 combination chemotherapy regimen includes 5-fluorouracil, leucovorin, and oxaliplatin.

Five Prime plans to use the Roche IHC assay along with a circulating tumor DNA test in its clinical trial to identify the estimated 10% of patients with gastric and gastroesophageal junction cancer who would be eligible for treatment with bemarituzumab.

The two companies will also jointly work to develop and validate a tissue-based IHC diagnostic assay for use as a laboratory developed test to help identify patients whose tumors overexpress B7-H4 to use with Five Prime's FPA150, a B7-H4 antibody.

Five Prime said it plans to use this IHC assay in the expansion portion of the ongoing phase 1 clinical trial of FPA150 to identify patients with advanced or metastatic breast, ovarian, endometrial and bladder cancers whose tumors overexpress B7-H4.