NTRC announces IND approval for the TTK/PLK dual inhibitor BAL0891 in its collaboration with Swiss pharmaceutical company Basilea

Oss, 17 December 2021 – NTRC, a Dutch precision medicine company that is 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.

‘We are excited to announce our collaboration with Basilea that started in 2018 as well as the IND approval milestone,’ said Rogier Buijsman, Managing Director of NTRC Therapeutics. ‘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.’

About BAL0891

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.

About NTRC

NTRC is a privately owned biotech company based in Oss in the Netherlands that has two subsidiary companies: NTRC Therapeutics B.V. and Oncolines B.V.

NTRC Therapeutics is a precision medicine company that is specialized in discovery and development of innovative kinase inhibitors to treat cancer patients. Using its proprietary EPriL platform NTRC Therapeutics is now developing next-generation kinase inhibitors to treat acquired drug resistance observed in cancer patients treated with first generation inhibitors. Please visit ntrctx.com

Oncolines is a precision medicine services company in oncology and cancer immunotherapy. Oncolines helps to bring improved and novel therapies to the right patient population faster by offering a set of complimentary services to enable clients to characterize their compounds, and to determine activities, selectivities and mechanism of action. Please visit oncolines.com

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 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.

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The development of medicines in Oss began one hundred years ago. It was then that the foundations were laid for what would become a flourishing pharmaceutical sector in the Netherlands, leading to groundbreaking discoveries such as insulin and the anti-conception pill.

Today, the entire chain is still represented in Oss, from early-stage research to the commercial scale production of medicines. Working in Oss, we focus on the health of people all over the world. Employees at dozens of companies large and small put their heart and soul into new medicines, products and services that will improve lives worldwide. Together, our strength lies in our combination of broad knowledge about the development of medicines and a thorough understanding of the requirements of high-quality production.

This shared past and common values stimulate strong bonds among everyone who works in pharmaceuticals in Oss. We build on qualities, expertise and networks that go back decades. And with a wide variety of pharmaceutical companies, suppliers and scientific institutions all located nearby, we offer an attractive business climate and an excellent basis for international collaboration.

We are proud to work together to create a better and healthier future for all, a collaboration that in turn fuels growing employment: today, most pharmaceutical jobs in the Netherlands are in Oss. Here we connect talent and companies and stimulate entrepreneurship, while our expert employees are our most important asset. Their drive ensures that Oss has an influence on health all over the world.

Pharma in Oss offers endless opportunities to startups and talent in a city and region that is a joy to live and work in. We are committed to collaboration and sustainable and successful entrepreneurship. Oss’s pharmaceutical companies are intrinsically competitive while also being committed to quality and safety. This, plus their focus on new health solutions and contemporary technology, makes us a leader in our pursuit of a better life for people worldwide.