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Vir Biotechnology Reports Positive Early Results from Dual-Masked T-Cell Engagers Trials

Vir Biotechnology has announced encouraging preliminary safety and efficacy data from ongoing Phase 1 trials of its dual-masked T-cell engagers, VIR-5818 for HER2-expressing solid tumors and VIR-5500 for metastatic castration-resistant prostate cancer. The trials show potential in broadening the therapeutic index of TCEs with reduced toxicity, offering hope for patients with limited treatment options.

SAN FRANCISCO – Vir Biotechnology, Inc. (Nasdaq: VIR) has shared initial Phase 1 data from its dual-masked T-cell engagers (TCEs) trials, highlighting promising safety and efficacy outcomes. The trials involve VIR-5818, aimed at HER2-expressing solid tumors, and VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC).
  • VIR-5818: This candidate is under evaluation for its safety and pharmacokinetics, both alone and in combination with pembrolizumab, across various HER2-expressing cancers, including breast and colorectal cancer. The study has enrolled 79 participants, many of whom have undergone multiple prior treatments. Early results indicate dose-dependent tumor shrinkage in participants with HER2-positive tumor types, including those who have exhausted standard care options.
  • VIR-5500: Focused on mCRPC, this trial is exploring the potential of dual-masked TCEs to selectively activate in the tumor microenvironment, thereby reducing damage to healthy cells and minimizing toxicity.
The data underscore the potential of Vir Biotechnology's PRO-XTEN™ masking technology to enhance the therapeutic index of TCEs by enabling selective activation in tumors. This approach could address significant unmet needs in cancer care by overcoming the toxicity limitations associated with traditional T-cell engagers.
Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer of Vir Biotechnology, expressed optimism about the findings, stating, "We are encouraged that our candidates may enable effective treatment options for people living with a range of solid tumors."
The ongoing trials continue to explore dose escalation, with the maximum tolerated dose (MTD) not yet reached. These early results provide a foundation for further research into the efficacy and safety of dual-masked TCEs in treating various cancers, offering hope for patients with limited treatment options.
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[1]
Vir Biotechnology Announces Encouraging Safety and ...
moneycontroller.co.uk · Aug 1, 2025

Vir Biotechnology presents Phase 1 data on VIR-5818 and VIR-5500, showing promising safety and efficacy in treating HER2...

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