After spending over 10 years arguing that AXL kinase was an important oncology target, and that in bemcentinib it had designed a molecule that was truly selective for it, BergenBio has thrown in the towel. Wednesday's closing of bemcentinib's key remaining study, BGBC016, and move to explore "strategic alternatives", prompted a 75% share price crash on the Oslo stock exchange. BGBC016, an uncontrolled phase 1/2 trial, was testing bemcentinib plus Keytruda and chemo in first-line NSCLC patients with a STK11 mutation, and its termination effectively marks bemcentinib's discontinuation. BergenBio said the decision was taken after the trial's phase 2 portion found no responses among 10 evaluable subjects; the phase 1 stage had enrolled patients irrespective of STK11 mutation status, and after the sole complete responder was found to be positive for STK11 a decision was taken to limit phase 2 to STK11m patients. The setback follows disappointments with bemcentinib in glioblastoma, pancreatic and breast cancers, and a 2022 decision to focus on NSCLC. It's notable that perseverance with bemcentinib was driven by prior BergenBio management, while Olav Hellebø, the person who just called time on the project, only became chief executive last November. What now for AXL inhibition?ProjectCompanyModalityStatusMecbotamab vedotinBioAtlaADCPh2 NSCLC trial ends in 2025SLC-391Signalchem LifesciencesSmall-molecule inhibitorPh1/2 Keytruda combo in NSCLC ends in 2026FC084CSAFindCure BiosciencesSmall-molecule inhibitorPh1/2 Tevimbra comboAB801Arcus BiosciencesSmall-molecule inhibitorPh1 (Arc-27) in solid tumours; NSCLC expansion cohorts starting in H2 2025NTQ2494Chia Tai TianqingSmall-molecule inhibitorPh1 ends in 2026AX-0085Axceso BiopharmaSmall-molecule inhibitorPreclinicalBemcentinibBerGenBioSmall-molecule inhibitorDiscontinued after failing ph1/2 1L STK11m NSCLC trial, and several othersEnapotamab vedotinGenmabADCDiscontinued in ph1/2DubermatinibSumitomo PharmaSmall-molecule inhibitorDiscontinued in ph1/2AB-329/ DS-1205cNuvation (ex AnHeart/Daiichi Sankyo)Small-molecule inhibitorDiscontinued after failing ph1 in NSCLCMipasetamab uzoptirineADC TherapeuticsADCDiscontinued in ph1TilvestamabBerGenBioMAbDiscontinued in ph1CDX-0168Celldex TherapeuticsMAbDiscontinued in preclinicalSym028ServierMAbDiscontinued in preclinicalSource: OncologyPipeline.
After spending over 10 years arguing that AXL kinase was an important oncology target, and that in bemcentinib it had designed a molecule that was truly selective for it, BergenBio has thrown in the towel. Wednesday's closing of bemcentinib's key remaining study, BGBC016, and move to explore "strategic alternatives", prompted a 75% share price crash on the Oslo stock exchange. BGBC016, an uncontrolled phase 1/2 trial, was testing bemcentinib plus Keytruda and chemo in first-line NSCLC patients with a STK11 mutation, and its termination effectively marks bemcentinib's discontinuation. BergenBio said the decision was taken after the trial's phase 2 portion found no responses among 10 evaluable subjects; the phase 1 stage had enrolled patients irrespective of STK11 mutation status, and after the sole complete responder was found to be positive for STK11 a decision was taken to limit phase 2 to STK11m patients. The setback follows disappointments with bemcentinib in glioblastoma, pancreatic and breast cancers, and a 2022 decision to focus on NSCLC. It's notable that perseverance with bemcentinib was driven by prior BergenBio management, while Olav Hellebø, the person who just called time on the project, only became chief executive last November.
What now for AXL inhibition?
