Five Prime Therapeutics (FPRX) Commences Cabiralizumab Combo Phase 1b in CSF1R

October 4, 2016 9:02 AM EDT

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Five Prime Therapeutics, Inc. (Nasdaq: FPRX) announced that it has initiated the Phase 1b portion of the clinical trial evaluating the immunotherapy combination of cabiralizumab (FPA008), Five Prime's investigational monoclonal antibody that inhibits colony stimulating factor-1 receptor (CSF1R), with OPDIVO® (nivolumab), Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor, in multiple tumor types.

"We are very pleased to progress to the Phase 1b portion of this trial evaluating cabiralizumab in combination with nivolumab as a treatment for patients with multiple types of tumors, many of whom currently have no effective treatment options," said Robert Sikorski, M.D., Ph.D., Chief Medical Officer, at Five Prime. “Our goal is to develop new therapeutics that unleash the immune system’s natural anti-cancer activity. Based on the science, we believe that targeting both the CSF1R and PD-1 pathways has the potential to produce a synergistic treatment effect.”

Five Prime initiated the Phase 1a/1b trial, which is expected to enroll approximately 280 patients, in September 2015. During Phase 1a, Five Prime evaluated the safety, pharmacokinetics and biomarkers of escalating doses of cabiralizumab as a monotherapy, as well as in combination with the approved 3 mg/kg dose of nivolumab.

Five Prime will continue to run the Phase 1b portion of the trial and will evaluate the safety, tolerability and preliminary efficacy of the selected dose of cabiralizumab in combination with nivolumab for the treatment of advanced solid tumors, including but not limited to non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer.

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