SAN FRANCISCO – Vir Biotechnology, Inc. (NASDAQ:VIR) announced Monday that it has dosed the first patient in an expansion cohort of its Phase 1 trial evaluating VIR-5500, a prostate-specific membrane antigen-targeted T-cell engager for metastatic prostate cancer.
The Phase 1 trial is assessing the safety, pharmacokinetics and preliminary efficacy of VIR-5500 in metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer, according to a press release statement. The trial includes three expansion cohorts evaluating VIR-5500 as monotherapy in late-line mCRPC and in combination with an androgen receptor pathway inhibitor in early-line mCRPC and mHSPC.Investors have responded positively to the company’s clinical progress, with shares delivering a 72% return over the past year and trading at $9.50 with a market capitalization of $1.52 billion. Analysts maintain a bullish outlook with price targets ranging from $17 to $30, suggesting significant upside potential.
The monotherapy expansion cohort in late-line mCRPC is the first to begin enrollment. The selected dose regimen is Q3W 800/2000/3500 µg/kg step-up dosing. This cohort will measure safety and efficacy, including Prostate-Specific Antigen response rate and Objective Response Rate in patients with mCRPC who are refractory following treatment with multiple prior lines of therapy.
The expansion follows dose-escalation data presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in February 2026, which showed VIR-5500 has a favorable safety profile and anti-tumor activity in mCRPC.
Dose-escalation of VIR-5500 in combination with enzalutamide continues in early-line mCRPC patients. The company anticipates dosing first patients in the combination dose-expansion cohorts in both early-line mCRPC and mHSPC over the coming months, followed by Phase 3 trials in 2027.While the clinical pipeline shows promise, InvestingPro data reveals the company is burning through cash with negative earnings of $3.16 per share over the last twelve months. The platform offers 10 additional ProTips for VIR, plus comprehensive Pro Research Reports covering this and 1,400+ US equities with actionable intelligence for informed investment decisions.
VIR-5500 is described as a dual-masked T-cell engager designed to remain inactive until reaching the tumor microenvironment, where tumor-specific proteases activate it. The company states it is the only dual-masked PSMA-targeting TCE in clinical evaluation.
In other recent news, Vir Biotechnology has successfully completed a public offering of its common stock, raising approximately $172.5 million in gross proceeds. This offering included the sale of 20,294,117 shares at a price of $8.50 per share. The company initially offered 17,647,059 shares and granted underwriters a 30-day option to purchase an additional 2,647,058 shares, which they exercised in full. In related developments, H.C. Wainwright has raised its price target for Vir Biotechnology to $20 from $15, maintaining a Buy rating. This adjustment is linked to Vir’s strategic collaboration with Astellas Pharma to develop VIR-5500, a treatment for metastatic prostate cancer. Similarly, Leerink Partners increased its price target for the company to $20 from $16, following updates on the partnership with Astellas and the recent capital raise. These moves reflect growing analyst confidence in Vir Biotechnology’s strategic initiatives and partnerships.
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