Basilea Pharmaceutica Ltd a commercial-stage biopharmaceutical company committed to meeting the needs of patients with cancer and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for the novel kinase inhibitor BAL0891, a potential first-in-class mitotic checkpoint inhibitor (MCI) that drives aberrant tumor cell division leading to tumor cell death.
Dr. Laurenz Kellenberger, Chief Scientific Officer of Basilea, said: “We are excited about the FDA approval of the IND for BAL0891, allowing us to proceed with the phase 1 clinical study, which we are planning to initiate in the first quarter of 2022. The drug candidate offers the potential for a targeted development strategy in multiple cancers. BAL0891 is differentiated through its unique kinase inhibition profile targeting both threonine tyrosine kinase and polo-like kinase 1. This may be the key factor driving its potent single agent activity seen in preclinical studies. We are looking forward to adding this potential first-in-class mitotic checkpoint inhibitor to our clinical oncology pipeline.”
The IND approval triggers a milestone payment of CHF 1.85 million to the Dutch precision medicine company, NTRC, from which Basilea in-licensed BAL0891 in 2018. Under the terms of the agreement, NTRC remains eligible to receive development, regulatory and commercial milestone payments and royalties on global sales.
BAL0891 is a first-in-class mitotic checkpoint inhibitor that pushes cells through mitosis without adequate time for correct chromosome segregation. This results in aberrant tumor cell division leading to tumor cell death. The compound is a unique dual inhibitor of threonine tyrosine kinase (TTK) and polo-like kinase 1 (PLK1). Both kinases collaborate in activating the mitotic spindle assembly checkpoint (SAC), a cell division mechanism regulating correct chromosome alignment and segregation. The dual action of BAL0891 leads to a rapid disruption of the SAC driving cells through mitosis before the chromosomes are properly aligned leading to premature cell division and tumor cell death. BAL0891 has shown anti-proliferative activity across diverse tumor cell lines in vitro and single agent efficacy in in-vivo models of solid human cancers. BAL0891 was in-licensed from NTRC in 2018.
