AMX-525
- Generic Name
- AMX-525
Vir Biotechnology's Stock Surges on Promising T-Cell Engager Data in Solid Tumors and Prostate Cancer
• Vir Biotechnology's stock price soared by over 74% following the release of encouraging Phase 1 clinical data for its dual-masked T-cell engagers (TCEs).
• VIR-5818, targeting HER2-expressing solid tumors, demonstrated dose-dependent tumor shrinkage, even in patients with HER2-positive colorectal cancer with limited treatment options.
• VIR-5500, targeting PSMA in metastatic castration-resistant prostate cancer (mCRPC), showed early anti-tumor activity, with 100% of participants exhibiting PSA responses after a single dose.
• Both VIR-5818 and VIR-5500 were well-tolerated in preliminary safety data, with minimal side effects, suggesting a wide therapeutic window.
Vir Biotechnology's Dual-Masked T-Cell Engagers Show Promise in Early Cancer Trials
• Vir Biotechnology's VIR-5818 demonstrated tumor shrinkage in 50% of HER2-expressing cancer patients at doses ≥400 µg/kg.
• VIR-5500 showed PSA reductions in 100% of mCRPC patients at initial doses ≥120 µg/kg, with a 58% confirmed PSA50 response.
• Both VIR-5818 and VIR-5500 exhibited promising safety profiles with minimal cytokine release syndrome and manageable adverse events.
• The PRO-XTEN™ masking technology may enable tumor-specific activation and a wider therapeutic index for T-cell engagers.
Vir Biotechnology Advances Oncology Pipeline with Dual-Masked T-Cell Engagers
• Vir Biotechnology is advancing its oncology pipeline with three dual-masked T-cell engagers (TCEs) targeting HER2, PSMA, and EGFR.
• Clinical data for VIR-5818 (HER2-targeted) and VIR-5500 (PSMA-targeted) are expected in Q1 2025, with Phase 1 studies ongoing.
• VIR-5525 (EGFR-targeted) is set to begin a Phase 1 basket study in Q1 2025 across multiple solid tumor indications.
• Vir's strategic shift includes focusing on infectious diseases and oncology, supported by a licensing agreement with Sanofi.
Vir Biotechnology Bolsters Pipeline with Sanofi Deal and Reports Q3 2024 Results
• Vir Biotechnology reported a net loss of $213.7 million in Q3 2024, alongside total revenues of $2.4 million and cash reserves of $1.19 billion.
• The company closed an exclusive licensing agreement with Sanofi for three clinical-stage dual-masked T-cell engagers, expanding its oncology pipeline.
• Promising Phase 2 SOLSTICE data in chronic hepatitis delta was presented, with Fast Track Designation granted by the FDA for tobevibart and elebsiran combination.
• A strategic restructuring was implemented, reducing the workforce by 25%, as Vir focuses on high-value therapeutic areas and discontinues COVID-19 and influenza programs.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2025. All Rights Reserved by MedPath