SHANGHAI, China, Aug. 07, 2020 (GLOBE NEWSWIRE) — Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, today announced that the first patient has been dosed in a Phase 1b/2 study evaluating FGF401 in combination with PD-1 inhibitor, pembrolizumab, in patients with advanced solid tumors, such as hepatocellular carcinoma (HCC).
This multi-center, open-label dose escalation trial is designed to determine the appropriate dose of FGF401 in combination with PD-1 inhibitor, pembrolizumab, in Phase 1b, and Phase 2 will assess the anti-tumor effects in patients with advanced stage solid tumors in mainland China. The entire trial will enroll up to 70 patients. FGF401 is an ATP-competitive, reversible-covalent inhibitor of fibroblast growth factor receptor 4, or FGFR4, for which Everest Medicines obtained global development and commercial rights from Novartis AG, or Novartis.
“Growing evidence demonstrates that the activation of the FGF19-FGFR4 pathway is associated with the formation of solid tumors. FGF401’s FGFR4 inhibition mechanism of action and safety profile, as demonstrated in past trials, suggest that FGF401 has the potential to provide a novel treatment option to patients with advanced tumors, such as HCC which represents 90% of all liver cancers and is highly prevalent in China,” said Yang Shi, MD, Chief Medical Officer for Oncology and Immunology at Everest Medicines. “Dosing the first patient in this trial is an important first step as we work to bring this pioneering therapy to patients in Greater China and the rest of the world to address a high unmet medical need.”
FGF401 is an ATP-competitive, reversible-covalent inhibitor of FGFR4 for which Everest Medicines obtained exclusive global development and commercial rights from Novartis. FGF401 binds in a reversible-covalent manner to the FGFR4 kinase domain and inhibits the activity of FGFR4, which leads to an inhibition of tumor cell proliferation. Everest is developing FGF401 as a potential new treatment for HCC and other solid tumors associated with activation of the FGF19-FGFR4 pathway. FGF401 has undergone a phase 1/2 study in cancer patients that determined the appropriate dose for single agent and demonstrated single agent responses and safety profile in HCC patients.
About Everest Medicines
Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eight potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company’s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com.
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