BerGenBio is a clinical stage biopharmaceutical company developing innovative drugs for aggressive diseases, including immune evasive, drug resistant and metastatic cancers. It focuses on AXL inhibitors bemcentinib (small molecule) and tilvestamab (mAb).
BerGenBio has presented two positive datasets for its lead asset bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) at ASH 2020. Following these data, we anticipate a registrational Phase III study of bemcentinib plus low-dose cytarabine (LDAC) in relapsed elderly AML patients to start in 2021. We still forecast the NDA submission for this indication in 2023 (FDA fast-track has been granted). Bemcentinib is an oral, first-in-class, highly selective AXL tyrosine kinase inhibitor in Phase II development for a range of cancers and could be the first selective AXL inhibitor to market. Data from the Phase II study in second-line NSCLC in combination with Keytruda are expected at WCLC (for details see our initiation report, Bemcentinib leading the AXL charge). We value BerGenBio at NOK59.1 per share.
Understanding the tumour microenvironment and why even with initial positive response to treatment, cancers often exhibit tumour proliferation, metastasis and treatment resistance is becoming an ever-more critical focus area. The role of AXL is becoming increasingly defined in tumorigenesis, propagation and treatment resistance.