Calidi Biotherapeutics Presents RedTail BiTE Data at AACR-IO Conference
Calidi Biotherapeutics presented preclinical data on its RedTail virotherapy platform at the 2026 AACR Immuno-Oncology conference, demonstrating tumor-localized BiTE expression and IL-15 superagonist delivery. The company plans to submit an IND application for CLD-401 by end of 2026.
Calidi Biotherapeutics, Inc. (NYSE American: CLDI) presented preclinical data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR Immuno-Oncology (AACR-IO) conference held in Los Angeles, California from February 18-21, 2026. The data show RedTail can express a tumor-localized BiTE and high levels of IL-15 superagonist within the tumor microenvironment, potentially enabling T-cell activation in solid tumors.
RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 superagonist (IL-15 SA), a known T-cell activator, in the TME.
In data presented at the meeting, Calidi demonstrated RedTail viruses that could express both a functional BiTE, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous alteration of the TME and T-cell activation and introduction into the TME of a solid-tumor targeting BiTE. BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits T-cell activity. By remodeling the TME and driving T-cell activation while expressing a tumor-localized BiTE, RedTail may overcome the historical limitations.
CLD-401 targets non-small cell lung cancer, head and neck cancer, and other tumors with high unmet needs. The company is currently performing IND-enabling studies for CLD-401 and plans to submit an Investigational New Drug (IND) application by the end of 2026 while seeking partnerships to further its clinical development efforts.
Following the presentation, CLDI shares gained 6.60%, trading at $0.78. This price movement added approximately $325K to the company's valuation.