Clinical-stage biopharmaceutical company Vir Biotechnology Inc (Nasdaq:VIR) announced on Thursday that the US Food and Drug Administration (FDA) has granted Fast Track designation to VIR-5500, a PSMA-targeted PRO-XTEN dual-masked T-cell engager, for late-line metastatic castration-resistant prostate cancer.
VIR-5500 is being co-developed by Vir Biotechnology and Astellas Pharma (TYO:4503) under a global strategic collaboration.
The therapy is being evaluated in a Phase 1 study across six dose-expansion cohorts, including monotherapy and combination regimens targeting different stages and treatment settings of prostate cancer.
Earlier Phase 1 data showed that VIR-5500 was generally well tolerated and demonstrated promising anti-tumour activity in patients with metastatic castration-resistant prostate cancer.
Fast Track designation is intended to facilitate and expedite development and review of treatments for serious conditions with unmet medical needs.
Phase 3 trials for VIR-5500 are anticipated to begin in 2027.
Akeso reports first patient dosed in Phase III study of cadonilimab in colon cancer
Natera secures FDA Breakthrough Device designation for multi-cancer early detection assay
FDA approves Genentech's Tecentriq combination therapy for stage III colon cancer
Alpheus Medical starts new clinical trial of PoMA therapy in butterfly glioblastoma
Sophos IRB and ALCMI partner to support lung cancer research
Northwest Biotherapeutics and NHSBT collaborate to support production of DCVax-L
argenx reports positive Phase 2 results for FB102 in coeliac disease
Vir Biotechnology's VIR-5500 receives FDA Fast Track designation for prostate cancer
FDA accepts Bayer's application for KERENDIA in chronic kidney disease without diabetes
Roche Diagnostics supplies molecular testing instruments to support Ebola response in the DRC
Voyager signs cancer research mission management contract
Mozart Therapeutics presents MTX-101 clinical and preclinical data at EASD Annual Meeting