CLD-401

June 24, 2026: Calidi Biotherapeutics, Inc. (NYSE: CLDI) presented preclinical platform data at the T-cell Engager Therapeutic Summit (San Diego) on its systemically delivered RedTail oncolytic virotherapy approach designed to remodel the tumor microenvironment (TME) and drive in situ expression of therapeutic payloads. The company highlighted RedTail viruses engineered to express both a functional tumor-targeting T-cell engager and an IL-15 superagonist (IL-15 SA) at high concentrations in the TME, aiming to enable simultaneous T-cell activation and local T-cell engager activity in solid tumors (where T-cell engagers have historically shown limited benefit).

Calidi’s lead RedTail-derived candidate, CLD-401, is engineered to express IL-15 SA in the TME and is currently in IND-enabling studies; the company expects to file an IND for CLD-401 by the end of 2026. The release states CLD-401 targets non-small cell lung cancer, head and neck cancer, and other tumor types.

The company is also developing CLD-501, a TROP2-targeting T-cell engager program intended to confine engager expression to the TME to limit off-tumor/on-target toxicity. Additional T-cell engager targets under pursuit include EGFR, EpCAM, and Nectin-4. Calidi also noted it is pursuing strategic partnerships to accelerate clinical development.