Basilea Pharmaceutica Ltd a commercial-stage biopharmaceutical company committed to meeting the needs of patients with cancer and infectious diseases, announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), to start clinical studies with the company’s novel drug candidate BAL0891 in cancer therapy. BAL0891 is a potential first-in-class small-molecule kinase inhibitor. If the IND is granted, Basilea plans to initiate a phase 1 study in patients with advanced solid tumors in the first quarter of 2022.
Dr. Laurenz Kellenberger, Chief Scientific Officer said: “We are very pleased with the progress made in the project. Submitting this IND is an important regulatory milestone for Basilea as we are moving closer to adding BAL0891 as the third oncology drug candidate to our clinical pipeline.”
The two oncology drug candidates already in clinical development are derazantinib, an inhibitor of the fibroblast growth factor receptor (FGFR) family of kinases, which is currently in clinical studies for the treatment of bile duct (iCCA), urothelial and gastric cancers (the FIDES studies), and lisavanbulin, a tumor checkpoint controller, currently in clinical studies with patients with glioblastoma, the most aggressive primary brain cancer.
Dr. Marc Engelhardt, Chief Medical Officer, said: “We are expecting to complete enrolment of the number of patients required to support interim analyses in three oncology studies around year-end. This is the phase 2 study with lisavanbulin in glioblastoma patients whose tumors tested positive on the potentially response-predictive biomarker EB1. For derazantinib, this is the cohort of patients with urothelial cancer refractory to prior FGFR inhibitors in the FIDES-02 study and the cohort of patients with intrahepatic cholangiocarcinoma, or iCCA, with non-fusion FGFR2 genetic aberrations in the FIDES-01 study. With enrolment progressing, we now have more visibility on the timelines and expect that interim data read-outs will become available over the course of the first half of 2022.“
