Basilea expands ongoing Phase I/IIa clinical trial of BAL101553 to include glioblastoma patients


Swiss biopharmaceutical company Basilea has expanded its ongoing Phase I/IIa clinical trial of BAL101553 to include adult patients with recurrent or progressive glioblastoma.

BAL101553, the pro-drug form of BAL27862, is a small molecule oncology drug candidate being developed as a potential therapy for diverse cancers.

The active moiety of BAL27862 fuses with the colchicine site of tubulin with distinct effects on microtubule organisation, triggering the formation of the 'spindle assembly checkpoint', resulting in tumour cell death.

The ongoing Phase I/IIa study has included patients with advanced or recurrent solid tumours who have failed standard therapy or for whom no effective standard therapy was available.

The Phase I dose escalation part of the study is being conducted to determine the maximum tolerated dose (MTD) of daily oral dosing.

"We are excited to explore BAL101553 in a separate glioblastoma study arm to our ongoing phase I/IIa clinical study."

The subsequent phase IIa extension of the study will evaluate the safety, tolerability and determine the pharmacokinetic profile of oral BAL101553 at the MTD, and to assess its anti-tumour activity.

The biomarkers will be evaluated in both the phase I and phase IIa parts of the study to determine their efficacy in identifying patients who are suitable to treatment, including biomarkers with potential relevance to glioblastoma.

Basilea chief medical officer professor Achim Kaufhold said: "We are excited to explore BAL101553 in a separate glioblastoma study arm to our ongoing phase I/IIa clinical study.

“Glioblastoma is a cancer indication associated with high medical need. There are limited treatment options for glioblastoma patients due in part to the challenge of getting medication into the brain through the blood brain barrier.

“BAL101553 has been shown to enter the brain and has demonstrated anticancer activity with oral dosing in various preclinical models of glioblastoma, including models refractory to or with reduced sensitivity to standard therapies.”