Basilea starts clinical phase 2a expansion with BAL101553 in ovarian cancer and glioblastoma - Seite 2

Two additional studies with BAL101553 are ongoing: dose-escalation in a separate recurrent glioblastoma arm of the phase 1/2a once-daily oral single-agent study and a phase 1 study in newly diagnosed glioblastoma patients evaluating once-daily oral BAL101553 in combination with standard radiotherapy, which is conducted in collaboration with the Adult Brain Tumor Consortium (ABTC) in the U.S.

About BAL101553

Basilea's oncology drug candidate BAL101553 (the prodrug of BAL27862)³ is being developed as a potential therapy for diverse cancers. The drug candidate is currently in phase 1/2a clinical evaluation. One study has two separate arms and evaluates once-daily oral BAL101553 in advanced solid tumors (dose-escalation completed) and recurrent glioblastoma (ongoing). A second study (phase 2a expansion) is evaluating BAL101553 as a weekly 48-hour i.v. infusion in recurrent glioblastoma and in platinum-resistant or refractory ovarian cancer. An additional phase 1 study is evaluating oral BAL101553 in combination with standard radiotherapy in patients with newly-diagnosed glioblastoma which have a reduced sensitivity to standard chemotherapy. In preclinical studies, the drug candidate demonstrated in vitro and in vivo activity against diverse treatment-resistant cancer models, including tumors refractory to conventional approved therapeutics and radiotherapy.^4, 5, 6 BAL101553 efficiently distributes to the brain, with anticancer activity in glioblastoma models.^7, 8, 9 The active moiety BAL27862 binds the colchicine site of tubulin with distinct effects on microtubule organization,¹⁰ resulting in the activation of the "spindle assembly checkpoint" which promotes tumor cell death.¹¹

About Basilea

Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company developing products that address the medical challenge of increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. With two commercialized drugs, the company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com.