Symphogen has moved its anti-MET program into the clinic. The Phase I trial will ratchet up dosing of Symphogen’s mixture of two MET-targeting antibodies in patients with solid tumors, before adding an expansion cohort made up of patients with a pre-identified gene signature.
Copenhagen, Denmark-based Symphogen has tasked MD Anderson Cancer Center and South Texas Accelerated Research Therapeutics (START) with conducting the trial, which will provide an early test of the anti-MET antibody combination Sym015. The treatment is a mixture of two humanized IgG1 monoclonal antibodies, Hu9006 and Hu9338, which Symphogen expects to bind to non-overlapping epitopes in the extracellular domain of MET.
Symphogen has advanced the candidate into Phase I on the back of preclinical data suggesting it can down-modulate MET--the receptor for hepatocyte growth factor--and knowledge of an association between the pathway and poor outcomes in patients with solid tumors. These factors contributed to the two U.S. cancer centers signing up to run the first-in-human trial.
“MET is a very exciting target for several solid tumors, and may have potential across multiple other tumor types,” START President Dr. Anthony Tolcher said in a statement. “As such, Symphogen’s novel antibody mixture may provide a unique opportunity to improve the life of patients with limited therapeutic options.” START and MD Anderson have now begun enrolling patients in the clinical trial, which is expected to recruit 70 people in total.
Initially, the trial sites are looking for patients with locally advanced or metastatic solid tumors that express the KRAS wild type and have limited treatment options, either because they are refractory to the standard therapy or because no such standard exists. For the second part of the trial, Symphogen is specifically seeking patients with the genetic abnormality known as MET amplification, a trait that is a predictor of sensitivity to anti-MET compounds in preclinical models. If this carries over into the clinic, Sym015 could prove to be particularly effective in patients with the genetic abnormality.
- read the statement