Overview

• In the first-in-human Phase 1 trial (NCT04059588), intratumoral 2141-V11 induced tumor shrinkage in six of 12 patients, including complete remissions in melanoma and breast cancer cases.
• Patients saw regression of non-injected lesions, demonstrating that localized dosing elicited systemic antitumor immunity.
• No dose-limiting or serious systemic toxicities were reported, marking a clear safety advantage over previous intravenous CD40 agonists.
• Analysis of treated tumors revealed dense immune cell infiltration and de novo tertiary lymphoid structures correlating with clinical responses.
• Follow-on Phase 1/2 studies in bladder, prostate and glioblastoma are now enrolling nearly 200 patients to optimize dosing and validate biomarkers such as baseline T-cell clonality.