Five Prime Therapeutics Presents Initial Safety Data from the Phase 1 Trial of FPT155 at the Society for Immunotherapy of Cancer Annual Meeting
Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, today presented initial safety data from the Phase 1 clinical trial of FPT155 in patients with advanced solid tumors in a poster presentation at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting in National Harbor, Maryland. The poster can be found on the Publications Page of the Five Prime Therapeutics website.
“FPT155 is a first-in-class CD80 fusion protein with potential dual mechanisms to activate T cells,” said Helen Collins, M.D., Executive Vice President and Chief Medical Officer of Five Prime Therapeutics. “Importantly, the initial safety results for FPT155 suggest that it may not cause the same safety issues seen with a prior molecule targeting CD28. This allows us to continue enrolling patients to study additional dose escalation cohorts and identify a dose for future studies.”
The FPT155 data presented at SITC included initial safety results from the Phase 1a dose escalation portion of the trial, which is designed to characterize the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profile of FPT155 and identify a recommended dose for the Phase 1b portion of the trial. This included data from 15 patients with solid tumors that were treated with FPT155 at doses of 0.07 mg, 0.21 mg, 0.7 mg, 2.1 mg, 7 mg, 21 mg, and 42 mg. The key highlights from the presentation include:
- FPT155 was well tolerated at all dose levels, with no dose-limiting toxicities and no grade 4 or higher adverse events.
- There is no evidence of clinical or laboratory cytokine release syndrome, an adverse event associated with a prior therapy targeting CD28.
- Dose escalation with FPT155 is ongoing with the study currently enrolling patients at the 70 mg dose level.
The Phase 1a/1b open-label, multicenter, dose escalation, dose exploration and dose expansion study will evaluate the safety and tolerability of FPT155 in patients with advanced solid tumors. The Phase 1a dose escalation portion of the trial will characterize the safety and PK/PD profile of FPT155 and will identify a recommended dose for the Phase 1b portion of the trial. The Phase 1b portion of the trial is intended to further characterize the safety, PK/PD profile, and preliminary efficacy of FPT155.