On March 28, 2018 Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, reported that it initiated patient dosing in its Phase 1 clinical trial of FPA150, a first-in-class immuno-oncology antibody that targets B7-H4 (Press release, Five Prime Therapeutics, MAR 28, 2018, View Source [SID1234525038]).
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"We’re excited to advance into the clinic our targeted, first-in-class B7-H4 antibody, FPA150, which offers a differentiated approach to existing immunotherapies," said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. "We’re studying FPA150 in patients whose tumors overexpress B7-H4 and in which there is high unmet need for immuno-oncology treatments, such as in breast, ovarian and endometrial cancer. We’re hopeful that a targeted therapy such as FPA150 may provide clinical benefit."
Five Prime designed the Phase 1 trial of monotherapy FPA150 with a 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 bladder cancers. 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.
About FPA150
FPA150 is a novel, fully human, afucosylated monoclonal antibody targeting B7-H4. B7-H4 expression is observed in multiple solid tumors, including breast, bladder and gynecologic cancers, and has been documented to correlate with poor prognosis. FPA150 is designed with a dual mechanism of action: blocking the T cell checkpoint activity of B7-H4 as well as delivering potent ADCC against tumor cells expressing B7-H4.