Basilea announces U.S. FDA Orphan Drug Designation granted to lisavanbulin for the treatment of malignant glioma
Basel, Switzerland, July 29, 2021
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Basilea’s tumor checkpoint controller, lisavanbulin, for the treatment of malignant glioma (brain cancer). This includes glioblastoma, the most common type of primary brain cancer and one of the most lethal types of cancer.1 Orphan Drug Designation qualifies the sponsor of the drug for various incentives, including longer regulatory market exclusivity.
Dr. Marc Engelhardt, Chief Medical Officer, commented: “The Orphan Drug Designation of lisavanbulin by the U.S. FDA is an important milestone for the development of lisavanbulin. Glioblastoma is associated with a poor prognosis and there are only very limited therapeutic options available. Lisavanbulin, as a targeted treatment, could be a useful new approach to expand the treatment options for patients with this devastating disease.”
Basilea is currently conducting a phase 1/2 study in patients with recurrent glioblastoma, using end-binding protein 1 (EB1) for patient selection.2 In the previously reported phase 1 part of the study, long-lasting clinical benefit was observed in two patients with recurrent glioblastoma whose tumor tissues showed EB1-positive staining.3 Interim results from the phase 2 part of the study are expected in the second half of 2021.
About lisavanbulin (BAL101553)
Basilea's oncology drug candidate lisavanbulin (BAL101553, the prodrug of BAL27862)4 is currently being developed as a potential therapy for glioblastoma.2, 5, 6 In preclinical studies, lisavanbulin demonstrated in-vitro and in-vivo activity against diverse treatment-resistant cancer models, including tumors refractory to conventional approved therapeutics and radiotherapy.7, 8, 9
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the medical needs of patients with cancer and infectious diseases. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of severe bacterial infections. We are conducting clinical studies with two targeted drug candidates for the treatment of a range of cancers and have a number of preclinical assets in both cancer and infectious diseases in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.
This communication expressly or implicitlycontains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd. and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
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