Vir Biotechnology, Inc. ((VIR)) announced an update on their ongoing clinical study.
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Study Overview: Vir Biotechnology, Inc. is conducting a Phase 1 clinical study titled A Phase 1, Multicenter, Open-Label, First-in-Human Study of the Safety and Pharmacokinetics of VIR-5818 Alone and in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers. The study aims to assess the safety, pharmacokinetics, and preliminary activity of VIR-5818, both alone and combined with pembrolizumab, in treating HER2+ tumors. This research is significant as it explores new treatment avenues for challenging cancer types.
Intervention/Treatment: The study tests VIR-5818, an intravenous drug, alone and in combination with pembrolizumab, another intravenous medication. VIR-5818 is being evaluated for its potential to treat HER2-expressing cancers effectively.
Study Design: This interventional study is non-randomized and follows a sequential intervention model. It is open-label, meaning no masking is involved, and its primary purpose is treatment. The study is divided into four parts, focusing on dose escalation and expansion.
Study Timeline: The study began on April 26, 2022, with an estimated completion timeline of 52 months. The most recent update was submitted on September 19, 2025, indicating ongoing recruitment and study progress.
Market Implications: This study update could positively influence Vir Biotechnology’s stock performance by showcasing its commitment to innovative cancer treatments. The collaboration with Merck Sharp & Dohme LLC strengthens its position in the competitive oncology market, potentially boosting investor confidence.
The study is currently ongoing, with further details available on the ClinicalTrials portal.