Five Prime Therapeutics Presents Initial Safety Data from the Phase 1 Trial of FPT155 at the Society for Immunotherapy of Cancer Annual Meeting
- Results Demonstrate FPT155 was Well Tolerated in all Patients through Seven Cohorts, Allowing for Continuation of Dose Escalation and Dose Finding -
“FPT155 is a first-in-class CD80 fusion protein with potential dual mechanisms to activate T cells,” said
The FPT155 data presented at
- 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.
FPT155 is a first-in-class CD80 fusion protein that (i) directly engages CD28 to enhance its co-stimulatory T-cell activation activity without inducing super agonism, and (ii) blocks CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T-cell activation in the tumor microenvironment. FPT155 has also demonstrated its ability to retain anti-tumor activity independent of its engagement with CTLA-4, suggesting a differentiated mechanism of action from CTLA-4-blocking antibodies. Studies in preclinical models suggest FPT155 has the potential to be a potent T-cell co-stimulator with strong monotherapy anti-tumor activity.
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