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

Basilea Pharmaceutica AG / Basilea starts clinical phase 2a expansion with BAL101553 in ovarian cancer and glioblastoma . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Basel, Switzerland, June 26, 2018 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the first patient has been dosed in the phase 2a expansion part of Basilea's ongoing phase 1/2a clinical study with its novel tumor checkpoint controller BAL101553, administered as weekly 48-hour intravenous (i.v.) infusion. The study is exploring BAL101553 in patients with recurrent glioblastoma and in patients with platinum-resistant or refractory ovarian cancer to further characterize the safety and tolerability and to obtain efficacy data in these selected cancer types.

Glioblastoma is the most common type of primary brain cancer and one of the most lethal types of cancer.¹ There is also a high medical need in ovarian cancer as recurrence after initial therapy is common and patients with platinum-resistant cancers have limited treatment options.²

Dr. Marc Engelhardt, Chief Medical Officer, said: "The start of the phase 2a expansion study marks a significant milestone towards establishing clinical proof-of-concept for our biomarker-driven development strategy with our novel tumor checkpoint controller BAL101553. There are only very limited treatment options available for patients with recurrent glioblastoma and for patients with platinum-resistant or platinum-refractory ovarian cancer. Our decision to explore the potential clinical benefit in these specific patient populations is based on the results from our phase 1 studies and our comprehensive non-clinical profiling."

The phase 2a single-agent, open label study is anticipated to include up to 40 patients with platinum-resistant or platinum-refractory ovarian cancer and recurrent glioblastoma and will be conducted in a number of hospitals in Switzerland. Additional information on this clinical study is available at www.clinicaltrials.gov (identifier: NCT02895360).

In January, Basilea reported the completion of the dose-escalation in advanced solid tumor patients in two phase 1/2a studies with once-daily oral and weekly 48-hour i.v. administration of BAL101553 as a single-agent therapy. The maximum tolerated doses for these dosing regimens in solid tumor patients have been established. Data from these studies were presented at the annual conference of the American Society of Clinical Oncology (ASCO) in June.