Five Prime Announces Third Quarter 2016 Results And Provides Business Update

SOUTH SAN FRANCISCO, Calif., Nov. 03, 2016 (GLOBE NEWSWIRE) -- Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, today provided a corporate update and reported financial results for the third quarter ended September 30, 2016.

"We have continued to make progress on all of our clinical and preclinical programs during the quarter," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "We achieved an important milestone by advancing into the Phase 1b portion of our clinical trial evaluating the immunotherapy combination of cabiralizumab (FPA008) with nivolumab in multiple tumor types. We believe targeting both the CSF1R and PD-1 pathways has the potential to produce a synergistic therapeutic effect. Our Phase 1 trial evaluating FPA144 in patients with gastric cancer is also progressing well. We have added cohorts to enroll gastric cancer patients with tumors at varying levels of FGFR2b expression as well as a cohort to evaluate bladder tumors that overexpress FGFR2b. Additionally, we continue to advance our pre-clinical programs and have begun IND-enabling activities for three of our immuno-oncology therapeutic candidates."

Business Highlights and Recent Developments

Clinical Pipeline:
  • Cabiralizumab (FPA008): an investigational antibody that inhibits CSF1R and has been shown to block the activation and survival of monocytes and macrophages. In the setting of advanced cancer, tumor-associated macrophages can inhibit the immune system's ability to eradicate the disease. In pigmented villonodular synovitis (PVNS), a CSF-1-driven tumor, the bulk of the tumor mass in joints is formed by the macrophages themselves. Five Prime and Bristol-Myers Squibb (BMS) have an exclusive worldwide collaboration agreement for the development and commercialization of cabiralizumab for these and potentially additional indications.
    • Initiated Phase 1b portion of cabiralizumab/OPDIVO trial.In October 2016, Five Prime initiated the Phase 1b portion of the clinical trial evaluating the immunotherapy combination of cabiralizumab with the PD-1 immune checkpoint inhibitor OPDIVO® (nivolumab) in multiple tumor types. Five Prime and BMS are evaluating the safety, tolerability and preliminary efficacy of the combination in advanced solid tumors, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer. The Phase 1a/1b trial is expected to enroll approximately 280 patients.
    • Advanced the Phase 2 trial of cabiralizumab in patients with PVNS.Five Prime continued enrollment and dosing in the Phase 2 trial of cabiralizumab in PVNS. During Phase 2, Five Prime is evaluating clinical measures, including response rate, pain and range of motion, in approximately 30 PVNS patients.
  • FPA144: an isoform-selective antibody in development as a targeted immuno-therapy for tumors that overexpress FGFR2b, a splice variant of a receptor for some members of the fibroblast growth factor (FGF) family. FPA144 has been engineered for enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) to increase direct tumor cell killing by recruiting natural killer (NK) cells. Five Prime retains global development and commercialization rights to FPA144. 
    • Opened new gastric cancer cohorts and added a bladder cancer cohort in Phase 1 monotherapy trial of FPA144. Enrollment continues in the expansion portion of the trial evaluating the safety, PK and efficacy of biweekly 15 mg/kg infusions of FPA144 in patients with gastric cancer whose tumors highly overexpress FGFR2b. During the quarter, Five Prime added cohorts to evaluate FPA144 in patients with bladder cancer whose tumors overexpress FGFR2b and in patients with gastric cancer whose tumors express moderate or low levels of FGFR2b. Five Prime reported encouraging initial single-agent efficacy and safety data at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.
    • Announced FDA Orphan Drug Designation for FPA144 in July for the treatment of gastric cancer and cancer of the gastroesophageal junction in patients whose tumors overexpress FGFR2b. 
  • FP-1039: a protein drug designed to intervene in FGF signaling. As a ligand trap, FP-1039 binds to and neutralizes FGF ligands (such as FGF2), preventing these signaling proteins from reaching FGFR1 on the surface of tumor cells.
    • Although Five Prime regained full rights to FP-1039 from GlaxoSmithKline (GSK) in September, GSK will complete the ongoing Phase 1b trial combining FP-1039 with first-line pemetrexed and cisplatin in untreated, unresectable mesothelioma. GSK concluded trial recruitment with 25 patients enrolled at the 15 mg/kg dose, and continues to dose and follow patients. Five Prime plans to make decisions on potential future development of FP-1039 in mesothelioma once objective response rate, disease control rate and progression-free survival data are sufficiently mature.

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