information: Submission of a clinical trial application
Announcement: submission of a clinical trial application
Company: Five Prime Therapeutics (USA - CA)
- monoclonal antibody/immune checkpoint inhibitor. FPA150 is a novel, high affinity, afucosylated monoclonal antibody discovered by Five Prime with its protein therapeutics platform.
- FPA150 is designed with a dual mechanism of action: blocking a T cell checkpoint pathway and delivering enhanced antibody-dependent cell-mediated cytotoxicity against tumor cells expressing B7-H4. B7-H4 expression is seen in tumor types such as breast, ovarian and endometrial cancer, and has been correlated with poor prognosis in some studies.
Disease: solid tumors including advanced or metastatic breast, ovarian, endometrial and urothelial carcinomas
area: Cancer - Oncology
- • On January 3, 2018, Five Prime Therapeutics announced the December 2017 submission of an Investigational New Drug (IND) application for FPA150, a first-in-class immuno-oncology antibody that targets B7-H4. Five Prime discovered FPA150 using the company's protein therapeutics platform and anticipates initiating a Phase 1 trial of FPA150 during the first half of 2018.
- Five Prime designed the planned Phase 1 trial with a standard 3+3 dose escalation phase in patients with solid tumors, followed by dose expansion in pre-specified cohorts in tumor types based on B7-H4 expression levels. The initial targeted tumors are advanced or metastatic breast, ovarian, endometrial and urothelial carcinomas. Phase 1a dose escalation endpoints include identification of a maximum tolerated dose (MTD), safety, and pharmacokinetics (PK) of FPA150. Phase 1b dose expansion endpoints include objective response rate, as well as safety and PK.