SAR446368

SAR446368 is a dual-masked bispecific T-cell engager targeting both the Epidermal Growth Factor Receptor (EGFR) and CD3 on T cells. It is designed to selectively activate within the tumor microenvironment, leveraging high local protease activity to unmask the therapeutic in tumors and thereby increase the therapeutic index while reducing systemic toxicity. The drug is under development for the treatment of solid tumors—including EGFR-expressing cancers such as colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, and metastatic castration-resistant prostate cancer. It was originally developed by Amunix and is now being co-developed by Vir Biotechnology following a licensing agreement with Sanofi. As of July 2025, SAR446368 has completed IND clearance and is anticipated to begin Phase 1 clinical trials for solid tumors and specific cancer subtypes[1][3][5][7].

Other names

SAR446368SAR-446368SAR 446368AMX-525AMX525AMX 525VIR-5525VIR5525VIR 5525