After U.S. markets closed for trading yesterday afternoon, clinical-stage biotechnology company Five Prime Therapeutics Inc. (FPRX:NASDAQ), which is focused on the development of immune modulators and treatment for solid tumor cancers, announced "positive topline results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial."
The firm advised that the Phase 2 FIGHT trial was designed and structured to "compare mFOLFOX6 chemotherapy in combination with bemarituzumab (bema, FPA144), a first-in-class targeted therapy, in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive (non HER2+) front-line advanced gastric or gastroesophageal junction (GEJ) cancer."
Five Prime Therapeutics' EVP and Chief Medical Officer Helen Collins, M.D., commented, "These results bring us one step closer to the first potential targeted therapy for advanced gastric cancer in over a decade...Benefit was observed in patients whose tumors overexpressed FGFR2b, even without evidence of amplification, and that may broaden the therapeutic potential of bemarituzumab in more cancer types. We are excited about the results of the FIGHT trial and the opportunity to advance the development of bemarituzumab, the first and only investigational treatment targeting FGFR2b+."
The company reported that all three of the pre-specified efficacy endpoints in the Global Phase 2 FIGHT trial of bemarituzumab were achieved and the data recorded met statistical significance. These primary endpoints were identified as median progression-free survival (PFS), Median overall survival (OS) and Overall response rate (ORR). The firm advised that all efficacy endpoints favored bemarituzumab despite the fact that there was a higher frequency of discontinuation of bemarituzumab in the study versus placebo. The firm noted that the trial enrolled a total of 155 patients in 15 countries across Asia, the EU and the U.S.
Five Prime stated that "overall, the Phase 2 FIGHT trial results validate the importance of the novel target, FGFR2b, which is overexpressed in approximately 30 percent of HER2- gastric cancers worldwide."
Zev A. Wainberg, M.D., associate professor of medicine at UCLA, co-director of the Gastrointestinal Oncology Program and director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center, remarked, "We have known for some time that FGFR is a viable target in gastric cancer and many other malignancies...This is the first data to signal that a targeted therapy directed to FGFR2b may reduce the risk of disease progression and improve overall survival in gastric cancer. This study result showing bemarituzumab's potential benefit is an important and exciting development."
The company explained that "bemarituzumab (anti-FGFR2b, FPA144) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pathways and that blocking FGFR2b activation is thought to slow cancer progression." The firm stated that it is developing bemarituzumab for use as a targeted therapy for tumors that overexpress FGFR2b in treatment of gastric and GEJ cancer.
Five Prime noted that it collaborated with Zai Lab Ltd. (ZLAB:NASDAQ) on the Phase 2 FIGHT trial and has granted an exclusive license to that firm to develop and commercialize bemarituzumab in greater China.
The company explained that gastric (stomach) cancer and GEJ cancer account for the third highest cause of cancer deaths globally. The firm indicated than more than 1 million new cases are diagnosed annually, and in areas where routine screening is not readily available as many as 90% of these cases are not found until the disease has reached an advanced, inoperable level.
Five Prime Therapeutics is headquartered in South San Francisco, Calif., and stated that "it is focused on researching and developing immuno-oncology and targeted cancer therapies paired with companion diagnostics to identify patients who are most likely to benefit from treatment with its product candidates."
Five Prime Therapeutics started off the day with a market cap of around $203.1 million with approximately 38.04 million shares outstanding and a short interest of about 3.0%. FPRX shares opened more than 300% higher today at $22.51 (+$17.17, +321.54%) over yesterday's $5.34 closing price and reached a new 52-week high price this morning of $24.00. The stock has traded today between $16.63 and $24.00 per share and is currently trading at $18.60 (+$13.26, +248.31%).[NLINSERT]
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