VIR-5500 is an investigational PSMA-targeted PRO-XTEN dual-masked CD3 T-cell engager in Phase 1 development for metastatic prostate cancer. Ongoing cohorts evaluate monotherapy in late-line mCRPC and combination with androgen receptor pathway inhibitors in earlier-line metastatic settings, with potential pivotal Phase 3 trials planned for 2027. It is not approved for marketing.
Vir Biotechnology has dosed the first patient in a Phase I VIR-5500 expansion cohort for metastatic prostate cancer. The trial is evaluating VIR-5500 as monotherapy and in combination settings across mCRPC and mHSPC.
An experimental immunotherapy drug shows tumor shrinkage in prostate cancer patients, while Eli Lilly's selpercatinib reduces recurrence risk in early-stage lung cancer. A separate study reveals persistent racial disparities in curative treatment for lung cancer patients.
A T-cell engager drug called VIR-5500 demonstrated tumor shrinkage or growth halt in 45% of evaluable patients with advanced prostate cancer in a phase 1 trial, with 88% experiencing only mild side-effects.
Vir Biotechnology reported Q4 EPS of ($0.31), beating estimates by $0.23, with revenue of $64.07 million. The company announced a global strategic collaboration with Astellas for VIR-5500 and reported $781.6 million in cash and investments.
Vir Biotechnology announced a global strategic collaboration with Astellas for VIR-5500, a PSMA-targeted dual-masked T-cell engager for prostate cancer, and reported $781.6 million in cash and investments as of December 31, 2025.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05997615 |
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer |
RECRUITING | PHASE1 |
