Vir Biotechnology Announces First Patient Dosed in Phase 1 Clinical Trial of EGFR-Targeting PRO-XTEN™ Dual-Masked T-Cell Engager VIR-5525 for the Treatment of Solid Tumors

• Phase 1 clinical trial designed to assess the safety, pharmacokinetics and preliminary efficacy of VIR-5525 alone or in combination with pembrolizumab in a variety of EGFR-expressing solid tumors such as NSCLC, CRC, HNSCC and cSCC
• VIR-5525, the Company’s third dual-masked T-cell engager leveraging the PRO-XTEN™ technology, is designed to expand the therapeutic index by selectively activating in the tumor microenvironment
• Dose escalation continues for Phase 1 studies of PRO-XTEN™ dual-masked TCEs VIR-5818 (HER2) and VIR-5500 (PSMA), with compelling early clinical response signals and promising safety profiles

Excerpt from the Press Release:

SAN FRANCISCO–(BUSINESS WIRE)–Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the first patient has been dosed in the Company’s Phase 1 clinical trial evaluating VIR-5525, an investigational dual-masked T-cell engager (TCE) targeting EGFR (epidermal growth factor receptor). VIR-5525 will be evaluated for the treatment of a variety of EGFR-expressing solid tumors in areas of high unmet need such as non-small cell lung cancer (NSCLC), colorectal cancer (CRC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (cSCC).

The Phase 1 clinical trial (NCT06960395) is a first-in-human open-label, non-randomized study designed to assess the safety, pharmacokinetics, and preliminary anti-tumor activity of VIR-5525 as a monotherapy and in combination with pembrolizumab. VIR-5525 is Vir Biotechnology’s third dual-masked TCE in clinical trials. It incorporates the Company’s clinically validated in-licensed PRO-XTEN™ masking technology, which is designed to enable the selective activation of the TCEs in the tumor microenvironment, mitigating damage to healthy cells and reducing toxicity.

EGFR is a clinically validated target known to play a key role in cancer.¹ Although EGFR-targeting therapies are available, they often face limitations due to the development of resistance mechanisms² and high toxicities associated with treatment.

Click the button below to read the entire Press Release:

Continue Reading The Press Release