Efficacy and candidate biomarker evaluation for the anti-mesothelin antibody drug conjugate (ADC) BAY 94-9343, mesothelin-ADC in mesothelin-positive preclinical xenograft models
BAY 94-9343 is a novel antibody drug conjugate consisting of a fully human monoclonal antibody directed against mesothelin conjugated with the maytansinoid derivative DM4 by a linker containing a disulfide bridge (SPDB) and currently in Phase I clinical testing. Mesothelin is expressed in a range of tumor types, such as mesothelioma, ovarian cancer, pancreatic cancer and lung cancer.
In summary, these results demonstrate that targeted delivery of DM4 resulted in higher efficacy of BAY 94-9343 in tumor models with high mesothelin expression. Responsive xenograft models were representative of clinical samples with respect to mesothelin expression scored by IHC. Quantification of mesothelin by IHC is a candidate stratification biomarker for the antibody drug conjugate BAY 94-9343 currently in Phase I testing.
more model data, nice but are we ever going to get some new HUMAN clinical trial data from an IMGN drug other than T-DM1? 22+ years in business and the only success is due to Roche's aggressive development of T-DM1. If IMGN were in charge of T-DM1 development... How long has 901 been "in development"? Too long, it should have been kissed, or killed by now, but we will finally know something in about another 6 months. My theory/speculation is that IMGN is slow playing 901 until the other drugs mature because it's not highly efficacious, but that's total speculation on my part. IMGN needs to partner their drugs with an experienced, aggressive and capable development partner like Roche. I am not even sure they are capable of successfully designing and completing a phase II trial within a reasonable time frame. Under current management IMGN is not reaching anywhere near their potential and not earning a return for the shareholders. Something needs to change ASAP!