Basilea reports preclinical data on anti-cancer activity of novel oncology drug candidate BAL0891 at ESMO TAT congress

Press Release

Basel, Switzerland, March 08, 2022

Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with infectious diseases and cancer, reported today that preclinical data on the single agent anti-cancer activity of the drug candidate BAL0891 have been presented at the Targeted Anticancer Therapies congress 2022 of the European Society of Medical Oncology (ESMO TAT 2022), which is taking place online March 7-8, 2022. BAL0891 is a potential first-in-class mitotic checkpoint inhibitor (MCI) that drives aberrant tumor cell division, leading to tumor cell death.

BAL0891 is a novel dual inhibitor of threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1).¹ TTK and PLK1 collaborate in activating the mitotic spindle assembly checkpoint (SAC), a mechanism regulating correct chromosome alignment and segregation during cell division. The preclinical data presented at ESMO TAT 2022 have been generated in collaboration with the Dutch precision medicine company, NTRC, from which Basilea in-licensed the drug candidate. The results confirm the mode of action by demonstrating that BAL0891 causes rapid disruption of the SAC, driving tumor cells through mitosis before the chromosomes are properly aligned, leading to premature cell division and tumor cell death. Confirmation of the unique dual activity of BAL0891 supports the differentiation over TTK- and PLK1-specific inhibitors. Moreover, potent activity on the SAC translates into strong anti-cancer activity in a broad panel of cancer cell lines, as well as tumor shrinkage and confirmed complete regressions in a preclinical in-vivo model of breast cancer.

Dr. Laurenz Kellenberger, Chief Scientific Officer of Basilea, said: “We are very pleased with the strong single agent anti-cancer activity observed in preclinical models. Following the approval of our IND application by the U.S. Food and Drug Administration in December 2021, we are continuing the preparations to enable the start of a phase 1 study with BAL0891 by mid-year.”

More preclinical data, including in-vivo data on the anti-cancer activity of BAL0891 in additional models of human cancers are planned to be presented at upcoming scientific conferences.

For further information please visit https://www.esmo.org/meetings/esmo-tat-2022.

About Basilea

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 needs of patients with bacterial and fungal infections and cancer. 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 several preclinical assets in both anti-infectives and cancer in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer

This communication expressly or implicitly contains 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. BAL0891 and its use is investigational and has not been approved by a regulatory authority for any use. Efficacy and safety have not been established. The information presented should not be construed as a recommendation for use. The relevance of findings in nonclinical/preclinical studies to humans is currently being evaluated.

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This press release can be downloaded from www.basilea.com.

References

1. BAL0891 was in-licensed from Dutch precision medicine company NTRC B.V. in 2018

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