Girentuximab nears the finish line, maybe

After nearly 30 years' kicking around at various companies the anti-CAIX antibody girentuximab might, perhaps, be approaching the finish line. Its current owner, Telix, has just moved to start the pivotal Luteon study of a lutetium-177 radiolabelled version of girentuximab coded TLX250. Curiously, this seeks to enrol just 40 relapsed/recurrent kidney cancer patients, and is uncontrolled, according to a new listing on the clinicaltrials.gov registry. Telix earlier said this design had been submitted to ethics committees in Australia, where Luteon is to take place, so presumably it's now received the go-ahead. Telix's ownership of girentuximab dates back to 2017, when it licensed the MAb from the German company Wilex (now Heidelberg Pharma), whose own phase 3 Ariser study, testing the naked girentuximab antibody, had failed five years previously. Wilex had briefly sublicensed US girentuximab rights to Prometheus, and its own efforts with the MAb date back at least to 2004, when it started its first human trial. Girentuximab was actually originated by the Ludwig Institute for Cancer Research, which first tested the molecule clinically back in 1998. That study concerned an iodine-131 labelled version, so Telix's efforts represent something of a return to girentuximab's roots as a radiotherapeutic.