Vir Biotechnology Announces PSMA-targeted PRO-XTEN® Dual-masked T-cell Engager VIR-5500 Received FDA Fast Track Designation for the Treatment of Prostate Cancer

Vir Biotechnology said the U.S. Food and Drug Administration granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager, for treating late-line metastatic castration-resistant prostate cancer (mCRPC). The company, co-developing the therapy with Astellas Pharma under a global strategic collaboration, expects to enter pivotal Phase 3 development in 2027. Fast Track is intended to expedite development and review for serious conditions with unmet needs. VIR-5500 is being evaluated in a Phase 1 study with six dose-expansion cohorts, including monotherapy groups for taxane-naïve and radioligand-therapy-naïve mCRPC, and combination regimens with enzalutamide, docetaxel, or darolutamide. Earlier Phase 1 results reported generally good tolerability and promising anti-tumor activity.