Glioblastoma is the most common type of primary brain cancer and one of the most lethal types of cancer.2 In the open-label study, patients will receive once daily oral lisavanbulin. To identify patients with EB1-positive glioblastoma, a tissue screening program has been implemented using a CE-marked immunohistochemistry clinical trial assay developed for the lisavanbulin program.
Dr.
EB1 was selected by Basilea as a potential response-predictive biomarker for lisavanbulin based on preclinical studies in glioblastoma models and initial clinical signals from earlier clinical studies. One glioblastoma patient in the phase 1 portion of the current study, whose tumor tissue was strongly positive for EB1, was reported as an exceptional long-lasting responder.3 This patient continues on treatment for more than two years now and shows a more than 80% area reduction of the brain tumor.
About lisavanbulin (BAL101553)
Basilea's oncology drug candidate lisavanbulin (BAL101553, the prodrug of BAL27862)4 is being developed as a potential therapy for diverse cancers.1, 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 Lisavanbulin efficiently distributes to the brain, with anticancer activity in glioblastoma models.10, 11, 12 In preclinical studies, end-binding protein 1 (EB1) was identified as a potential response-predictive biomarker in glioblastoma models.12 The active moiety BAL27862 binds to the colchicine site of tubulin, with distinct effects on microtubule organization,13 resulting in the activation of the "spindle assembly checkpoint" which promotes tumor cell death.14
About Basilea
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References
- ClinicalTrials.gov identifier: NCT02490800
- B. M. Alexander, T. F. Cloughesy. Adult Glioblastoma.
Journal of Clinical Oncology 2017 (35), 2402-2409 J. S. Lopez , R. Kristeleit, R. Rulach et al. Phase 1/2a study of once daily oral BAL101553, a novel tumor checkpoint controller (TCC), in adult patients with progressive or recurrent glioblastoma (GBM) or high-grade glioma.Journal of Clinical Oncology 2019, 37, 15 supplement, 2025J. Pohlmann , F. Bachmann, A. Schmitt-Hoffmann et al. BAL101553: An optimized prodrug of the microtubule destabilizer BAL27862 with superior antitumor activity.American Association for Cancer Research (AACR) annual meeting 2011, abstract 1347;Cancer Research 2011, 71 (8 supplement)- ClinicalTrials.gov identifier: NCT03250299
- ClinicalTrials.gov identifier: NCT02895360
- A. Sharmq, A. Broggini-Tenzer, V. Vuong et al. The novel microtubule targeting agent BAL101553 in combination with radiotherapy in treatment-refractory tumor models. Radiotherapy Oncology 2017 (124), 433-438
- G. E. Duran, H. Lane, F. Bachmann et al. In vitro activity of the novel tubulin active agent BAL27862 in MDR1(+) and MDR1(-) human breast and ovarian cancer variants selected for resistance to taxanes.
American Association for Cancer Research (AACR) annual meeting 2010, abstract 4412;Cancer Research 2010, 70 (8 supplement) F. Bachmann , K. Burger, G. E. Duran et al. BAL101553 (prodrug of BAL27862): A unique microtubule destabilizer active against drug refractory breast cancers alone and in combination with trastuzumab.American Association for Cancer Research (AACR) annual meeting 2014, abstract 831;Cancer Research 2014, 74 (19 supplement)A. Schmitt-Hoffmann , D. Klauer, K. Gebhardt et al. BAL27862: a unique microtubule-targeted agent with a potential for the treatment of human brain tumors. AACR-NCI-EORTC conference 2009, abstract C233; Molecular Cancer Therapeutics 2009, 8 (12 supplement)- A. C. Mladek, J. L. Pokorny, H. Lane et al. The novel tubulin-binding 'tumor checkpoint controller' BAL101553 has anti-cancer activity alone and in combination treatments across a panel of GBM patient-derived xenografts.
American Association for Cancer Research (AACR) annual meeting 2016, abstract 4781;Cancer Research 2016, 76 (14 supplement) - R. Bergès, A. Tchoghandjian, S. Honoré et al. The novel tubulin-binding checkpoint activator BAL101553 inhibits EB1-dependent migration and invasion and promotes differentiation of glioblastoma stem-like cells. Molecular Cancer Therapeutics 2016 (15), 2740-2749
- A. E. Prota, F. Danel, F. Bachmann et al. The novel microtubule-destabilizing drug BAL27862 binds to the colchicine site of tubulin with distinct effects on microtubule organization.
Journal of Molecular Biology 2014 (426), 1848-1860 F. Bachmann , K. Burger, H. Lane. BAL101553 (prodrug of BAL27862): the spindle assembly checkpoint is required for anticancer activity.American Association for Cancer Research (AACR) annual meeting 2015, abstract 3789;Cancer Research 2015, 75 (15 supplement)
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- Press release (PDF)
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