Investment in the pipeline at Basilea has been focused on generating a meaningful oncology franchise. A key part of the strategy has been to target specific populations who are most likely to benefit, increasing the probability of approval.
First up is the FGFR inhibitor derazantinib with multiple studies ongoing in biliary (FIDES-01), bladder (FIDES-02) and gastric cancer (FIDES-03). Derazantinib may not be first in class but it has the potential to be highly differentiated from currently approved FGFRis and provide an effective treatment option in various FGFR driven cancers.
The key to achieving this level of differentiation starts with a more benign safety profile. Ultimately, it will be the ability of derazantinib to boost the important checkpoint inhibitor class which will drive commercial success. Derazantinib seeks to capitalise on its additional activity against CSF1R, which should help transform immunologically cold cancers into those more tractable to checkpoint inhibition. The dose intensification strategy employed (400mg) with derazantinib should further improve the probability of success. In the release today, Basilea has updated timelines with interim readouts from FGFR refractory patients receiving derazantinib plus atezolizumab (300mg) in urothelial cancer (FIDES-02) as well as in iCCA patients with non-fusion FGFR aberrations (FIDES-01), now expected in H1 2022.
Lisavanbulin represents an important programme targeting the mitotic spindle. Unlike older MTAs, lisavanbulin is orally available and can cross the blood-brain barrier allowing it to target the major unmet need of glioblastoma. Although still early days, such has been the scale of the benefit observed in some glioblastoma patients that we await, with considerable enthusiasm, the result of the ongoing Phase 2 trial. The data will provide evidence regarding whether a novel biomarker (EB1) can help identify patients who would benefit from lisavanbulin treatment. With enrolment progressing, interim data are expected in H1 2022.
Further commitment to establishing a significant oncology franchise has been evidenced by Basilea's intention to add a third oncology programme to the pipeline. In this regard, Basilea has submitted an IND application to the US FDA to start clinical studies with a novel drug candidate, BAL0891. Few details have been provided so far apart from the disclosure that BAL0891 is a potential first-in-class small-molecule kinase inhibitor. With a Phase 1 study in patients with advanced solid tumours planned to begin Q1 2022, we look forward to further details on BAL0891 in the not too distant future.
We have calculated a discounted cash flow fair value of CHF120 for Basilea.
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Basilea Pharmaceutica is a client of Calvine Partners and as such, this publication is not independent and should be considered a marketing communication under FCA Rules. None of the information contained in this publication should be considered as any form of advice.