FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy for tumors that over-express FGFR2b, as determined by a proprietary immunohistochemistry (IHC) diagnostic assay. FGFR2 gene amplification (as identified by FISH) is found in a number of tumors, including in approximately 5% of gastric cancer patients, and is associated with poor prognosis.
FPA144 is designed to block tumor growth through two distinct mechanisms:
- First, it binds specifically to FGFR2b and prevents the binding of certain fibroblast growth factors that promote tumor growth.
- Second, it has been engineered to drive immune-based killing of tumor cells by antibody-dependent cell-mediated cytotoxicity (ADCC) through the recruitment of natural killer (NK) cells.
Preclinical studies have shown that FPA144 is highly effective in blocking the growth of gastric cancers that produce abnormally high levels of FGFR2b.
In June 2016, we announced that updated data from the ongoing Phase 1 trial of FPA144 was featured in an oral presentation during the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting.
We initiated a Phase 1 clinical trial for FPA144 at the end of 2014. The Phase 1 trial initially enrolled unselected patients with solid tumors and is now enrolling selected gastric cancer patients with FGFR2 gene-amplified or FGFR2b protein overexpressing tumors. In addition, we 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.We plan to use companion diagnostic tests to identify these patients in our clinical trials at all stages.
In July 2016, the U.S. Food and Drug Administration (FDA) granted FPA144 Orphan Drug Designation for the treatment of gastric cancer, including cancer of the gastroesophageal junction. FPA144 is an anti-FGF receptor 2b (FGFR2b) humanized monoclonal antibody in clinical development as a targeted immune therapy for tumors that over-express FGFR2b.
Globally, gastric cancer is the sixth most common malignancy with the third highest mortality. The prevalence of gastric cancer worldwide is approximately 1.5 million patients, of which an estimated 5%, or approximately 80,000 patients, have FGFR2 gene-amplified tumors that overexpress FGFR2b. There are an estimated 76,000 gastric cancer patients in the United States, but the prevalence of gastric cancer is much higher in Asia and other regions of the world.