Vir Biotechnology is making significant strides in its oncology program, focusing on developing dual-masked T-cell engagers (TCEs) for solid tumors. The company's pipeline includes VIR-5818, VIR-5500, and VIR-5525, targeting HER2, PSMA, and EGFR, respectively. These TCEs are designed to minimize off-tumor toxicity, potentially allowing for higher doses and increased efficacy in treating various cancers.
Clinical Development of VIR-5818, VIR-5500, and VIR-5525
VIR-5818, a dual-masked HER2-targeted T-cell engager, is currently in a Phase 1 basket study. This study evaluates VIR-5818 as a monotherapy and in combination with pembrolizumab across multiple tumor types, including metastatic breast cancer and metastatic colorectal cancer. Initial clinical data is anticipated in the first quarter of 2025.
VIR-5500, a dual-masked PSMA-directed T-cell engager, is undergoing a Phase 1 dose escalation study. The study aims to assess the safety profile and determine optimal dose levels for future development in metastatic castration-resistant prostate cancer. Initial clinical data is expected in the first quarter of 2025.
VIR-5525, a dual-masked EGFR-targeted T-cell engager, has received Investigational New Drug (IND) application clearance from the U.S. FDA. A Phase 1 basket study is planned to commence in the first quarter of 2025, targeting patients with solid tumor indications of high unmet need, such as metastatic head and neck squamous cell carcinoma, metastatic adenocarcinoma, squamous non-small cell lung cancer, and metastatic colorectal cancer.
Strategic Shift and Financial Update
In August 2024, Vir Biotechnology announced an exclusive worldwide license agreement with Sanofi for three clinical-stage masked T-cell engagers. This agreement includes exclusive use of the PRO-XTEN™ masking platform for oncology and infectious diseases. Key employees from Sanofi with expertise in TCEs and the PRO-XTEN™ platform have joined Vir following the agreement's closing on September 9, 2024.
Vir Biotechnology has updated its operating expense guidance for the full year 2024, projecting GAAP operating expenses between $660 million and $680 million. This includes a $103 million upfront payment to Sanofi recognized as R&D expense in the third quarter of 2024.
Marianne De Backer, M.Sc., Ph.D., MBA, Chief Executive Officer of Vir Biotechnology, stated, "This quarter was transformational for Vir. We have bolstered our clinical pipeline with three potential best-in-class dual-masked T-cell engagers in oncology, and have sharpened our focus within infectious diseases to the areas where we believe we can make the most significant impact for patients."
Vir Biotechnology's strategic focus on oncology and infectious diseases, combined with its advancements in dual-masked T-cell engager technology, positions the company to address significant unmet needs in cancer treatment.
