Vir Biotechnology has dosed the first subject in the non-randomised Phase I trial to assess VIR-5525, the investigational dual-masked T-cell engager (TCE) that targets epidermal growth factor receptor (EGFR).
This trial marks a step in developing treatments for various solid tumours expressing EGFR with high unmet medical needs, including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), cutaneous squamous cell carcinoma (cSCC) and colorectal cancer (CRC).
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It is designed as the first-in-human open-label trial and will explore VIR-5525’s pharmacokinetics, preliminary anti-tumour activity, and safety as a single agent and in conjunction with pembrolizumab.
VIR-5525 utilises the PRO-XTEN masking technology, which aims to selectively activate TCEs within the tumour microenvironment, potentially decreasing toxicity to healthy cells.
Vir Biotechnology CEO Marianne De Backer said: “We are excited to bring our third PRO-XTEN dual-masked T-cell engager VIR-5525 to the clinic as we further our mission of transforming the lives of people living with hard-to-treat solid tumours.
“This achievement is a testament to Vir Biotechnology’s commitment to advancing innovative therapies that address substantial unmet needs in oncology.”
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By GlobalDataThe latest announcement has triggered a $75m milestone payment by Vir as part of its exclusive global licence agreement signed with Sanofi last year for the PRO-XTEN platform and clinical-stage TCEs.
Since the closing of the transaction, this expected milestone payment has been held as restricted cash and was not counted in the company’s $1.02bn in cash, cash equivalents, and investments as of 31 March 2025.
This payment is set to be identified as a research and development expense in the third quarter of this year.
The company is also progressing with dose escalation for its other dual-masked TCEs, VIR-5818 and VIR-5500, targeting HER2-expressing solid tumours and PSMA in metastatic castration-resistant prostate cancer, respectively.
In March 2025, Vir Biotechnology enrolled the first subject in the Phase III ECLIPSE registrational programme of tobevibart and elebsiran in those with chronic hepatitis delta (CHD).
