Sym004 is a mAb mixture targeting the EGFR under development for the treatment of metastatic colorectal cancer (mCRC) and for recurrent glioblastoma (GBM).
Sym004 is a synergistic antibody mixture containing two recombinant mAbs, futuximab and modotuximab, which bind to different, non-overlapping epitopes of EGFR. We believe that Sym004 induces a unique mechanism of action that is dependent on the presence of both antibodies. Sym004 induces rapid internalization and degradation of the EGFR that leads to down-modulation of EGFR and subsequent inhibition of cancer cell growth.
Sym004 in metastatic colorectal cancer
Symphogen completed in December 2016 a large, randomized, sponsored–blinded Phase 2b trial with two different doses of Sym004 and a control arm (investigator's choice of best supportive care including chemotherapy), with 50% improvement in overall survival (OS) as primary endpoint.
Post-hoc analysis of data for population subgroups has revealed compelling and clinically relevant outcomes for a well-defined subgroup of the treated population. We are currently investigating the trial results, and we are initiating dialogue with relevant regulatory agencies to establish the development path for Sym004 as mCRC therapy for patients who have previously responded to EGFR therapy.
In addition, a Phase 2 trial of Sym004 in patients with recurrent GBM is currently on-going.