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
Key Highlights
- ➤FDA grants VIR-5500 Fast Track designation for late-line metastatic castration-resistant prostate cancer
- ➤VIR-5500 Phase 3 trials anticipated to begin in 2027
- ➤VIR-5500 Phase 1 evaluates six monotherapy and combination dose-expansion cohorts
- ➤Earlier Phase 1 data showed generally well-tolerated treatment and promising anti-tumor activity
- ➤Astellas and Vir Biotechnology are co-developing VIR-5500 through a global strategic collaboration
Expert Statements
Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology
“Receiving Fast Track designation reflects the potential of VIR-5500 to address an area of serious unmet need in late-line mCRPC and the strong momentum we have achieved with Astellas as we prepare to enter pivotal Phase 3 development in 2027”
Marianne De Backer, President and Chief Executive Officer of Vir Biotechnology
“We look forward to working with the FDA to rapidly advance the development of VIR-5500 for people living with mCRPC.”
Moitreyee Chatterjee-Kishore, Executive Vice President and Head of Oncology Development, Astellas
“People living with advanced prostate cancer need new treatment options that can offer meaningful and durable benefit”
Moitreyee Chatterjee-Kishore, Executive Vice President and Head of Oncology Development, Astellas
“This Fast Track designation reinforces the importance of advancing VIR-5500 with urgency, and we are committed to exploring its potential to make a meaningful difference for patients and their families.”
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, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN(®) dual-masked T-cell engager (TCE), for the treatment of late-line metastatic castration-resistant prostate cancer (mCRPC). VIR-5500 is being co-developed by Astellas Pharma Inc. and Vir Biotechnology through a global strategic collaboration.
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