BerGenBio - FDA grants fast track designation
BerGenBio (BGBIO), a pioneer in AXL biology and the development of AXL inhibitors, has two clinical-stage assets: selective tyrosine kinase inhibitor bemcentinib and functional blocking monoclonal antibody tilvestamab. FDA has granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment. BGBIO has also presented data from the ongoing BGBC003 Phase II trial (in combination with LDAC) at EHA, which supports the safety and efficacy profile seen to date in elderly relapsed AML patients. Notably durable responses were observed in the relapsed AML setting (ORR of 31%; 5/16) and median overall survival of 13.3 months (data still immature). We value BGBIO at NOK4.72bn or NOK53.8/share.BerGenBio is a clinical stage biopharmaceutical company focused on developing innovative drugs for aggressive, drug resistant cancers. Co.'s lead product, BGB324, is a selective, potent and orally available small molecule AXL inhibitor. It is in Phase II clinical development, as a single agent and in combination with marketed immuno-oncology drugs, in three cancer indications with potential: Acute myeloid leukaemia; Advanced non-small-cell lung cancer and Triple negative breast cancer. Co. is also developing a diversified pre-clinical pipeline of selective AXL inhibitors, including biologics and small molecules.
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