Calidi Reveals CLD-401 Tumor-Targeted IL-15 Superagonist Data, Plans IND by Year-End
Calidi presented data on CLD-401 at AACR showing tumor-restricted IL-15 superagonist expression drove NK, NK-T and γδ T-cell activation and antitumor responses in immunocompetent models. The company plans to file an IND for CLD-401 by year-end 2026 and is advancing its RedTail platform with CLD-501 T-cell engager studies.
1. AACR Presentation Highlights CLD-401 Data
Calidi showcased preclinical findings at the AACR meeting demonstrating that CLD-401, a systemically delivered oncolytic virus from its RedTail platform, achieves high IL-15 superagonist expression exclusively in the tumor microenvironment. Data revealed recruitment and activation of NK, NK-T and γδ T-cells, resulting in significant antitumor activity in immunocompetent animal models.
2. IND Filing and Clinical Plans
The company confirmed plans to submit an IND for CLD-401 by the end of 2026, aiming to initiate first-in-human trials shortly thereafter. This milestone marks a key step toward assessing safety and efficacy in patients with non-small cell lung, head and neck, and other solid tumors.
3. RedTail Platform Expansion
Beyond CLD-401, Calidi highlighted a second program, CLD-501, which uses the same RedTail delivery system to express tumor-targeted T-cell engagers in situ. The company is pursuing strategic partnerships to accelerate development and broaden its genetic medicine pipeline across multiple solid tumor indications.