Overview

• The Phase I study of 2141-V11 treated 12 patients with metastatic cancers via intratumoral injections across four dose levels, achieving tumor shrinkage in six participants and complete remission in two.
• No patients experienced the severe inflammatory side effects or dose-limiting toxicities seen with earlier intravenous CD40 therapies, demonstrating a favorable safety profile.
• Pathological analyses revealed formation of tertiary lymphoid structures in both injected and distant lesions, indicating local immune orchestration driving systemic antitumor effects.
• Both complete responders had high pre-treatment T-cell clonality, suggesting that baseline immune repertoire may predict which patients benefit most from 2141-V11.
• Nearly 200 patients are now enrolled in multiple Phase I/II trials at institutions including Memorial Sloan Kettering and Duke to confirm efficacy, refine dosing and validate response biomarkers.