NTRC announces IND approval for the TTK/PLK dual inhibitor BAL0891 in its collaboration with Swiss pharmaceutical company Basilea
Oss – Venture Challenge alumnus NTRC, specialized in discovery and development of innovative kinase inhibitors to treat cancer patients, today announces that the U.S. Food and Drug Administration (FDA) has approved an 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. BAL0891 has been developed by NTRC and has been licensed to Basilea Pharmaceutica International Ltd. (“Basilea”), a commercial-stage biopharmaceutical company headquartered in Switzerland. Under this collaboration, NTRC remains eligible to receive development, regulatory and commercial milestone payments up to CHF 170 million and royalties. Basilea is planning to initiate a phase I clinical study in the first quarter of 2022.
Rogier Buijsman, Managing Director of NTRC Therapeutics:
'We are excited to announce our collaboration with Basilea that started in 2018 as well as the IND approval milestone. BAL0891 will be the first compound to enter the clinic that was designed and developed by the dedicated team of scientists at NTRC. Our strong capabilities in the discovery of innovative kinase inhibitors together with the highly skilled R&D team of Basilea has resulted in this next step of bringing BAL0891 to patients.’
Basilea’s CSO Laurenz Kellenberger stated this morning in a press release: ‘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 in a unique way. 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.’
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 rapid disruption of the SAC driving the 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.