Basilea Commences Phase 1/2 Study FIDES-03 with Derazantinib

Basilea Commences Phase 1/2 Study FIDES-03 with Derazantinib

by Pranali Mehta

Basilea Pharmaceutica has started the phase 1/2 study, FIDES-03, along with the FGFR inhibitor derazantinib. The research is assessing derazantinib in people suffering from advanced gastric cancer along with FGFR genetic abnormality. Derazantinib is reported to be evaluated as monotherapy coupled with extra cancer treatments; for example, Roche’s PD-L1 checkpoint inhibitor, atezolizumab.

The Chief Medical Officer of Basilea, Dr. Marc Engelhardt stated that their development strategy for derazantinib focuses on solidifying the clinical evidence on the difference against other FGFR inhibitors. Derazantinib’s exceptional kinase inhibition profile results from preclinical studies and the tolerability and safety profile detected in clinical studies, provide a robust rationale for assessing the drug in patients suffering from advanced gastric cancer with FGFR genetic abnormality, in combination therapy and monotherapy. Advanced gastric cancer is related to a very poor prognosis and is a region of unmet medical needs.

Gastric cancer is the 5th most common cancer globally and the 3rd most lethal cancer type. Average survival hardly exceeds 12 months and 5-year survival is less than 10%. Basilea estimates that per year there are around 190,000 new cases of gastric across the top 5 countries of EU, Japan, and the US. In around 10% of patients, FGFR genetic aberrations have been detected.

Derazantinib is a new orally managed small-molecule FGFR inhibitor with robust activity against FGFR1, 2, and 3. FGFR kinases are critical drivers of cell proliferation, migration, and differentiation. FGFR genetic aberrations, for instance, mutations, amplifications, or gene fusions have been recognized as potentially significant therapeutic targets for various cancers. Including breast, lung, intrahepatic cholangiocarcinoma, gastric and urothelial cancers. In these FGFR genetic abnormalities are observed in a range of 5% to 30%.

Headquartered in Basel, Switzerland, Basilea Pharmaceutica Ltd is a biopharmaceutical company focusing on creating products that address the medical challenges in the therapeutic areas of infectious diseases and oncology. The company is dedicated to determining, developing, and commercializing advanced pharmaceutical products to meet the medical requirement of patients suffering from life-threatening and serious conditions.




Pranali Mehta

A chemical engineer by qualification, Pranali Mehta dutifully walked down the slated path and worked in a chemical firm for a year. Her passion for writing however, pushed her into experimenting with the same as a career. With over three years of experience in content writ Read more...