CLDI News & Events

Calidi Biotherapeutics presented 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 being held in Los Angeles, California. RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment, 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, 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 of BiTEs in solid tumors.

Calidi Biotherapeutics will present 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 conference being held in Los Angeles, California, from February 18-21, 2026. RedTail is Calidi's systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment, 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, a known T-cell activator, in the TME. BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show efficacy in solid tumors where the TME inhibits T-cell activity. In immunocompetent models of metastatic disease, the RedTail platform has demonstrated that it can alter the TME and induce T-cell activation through its ability to convert tumors into local producers of IL-15 superagonist. Given the high capacity for genetic payloads with RedTail, it is possible to have simultaneous high levels of expression of multiple tumor-localized payloads, such as an IL-15 superagonist, along with a tumor-specific BiTE. Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The company anticipates submitting an Investigational New Drug application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.

Calidi Biotherapeutics recapped 2025 successes and provided an update on the Company's upcoming 2026 milestones. 2026 Anticipated Milestones Company intends to file an IND in Q4 2026 for its first RedTail lead candidate, CLD-401, a systemic delivered, targeted genetic medicine engineered to convert tumors into IL-15 superagonist producers. Calidi expects to present proof of concept data demonstrating the versatility of RedTail platform to deliver tumor-localized Bi-specific T cell engager alongside T-cell amplifiers. Calidi expects to present proof of concept data for use of RedTail platform into non-oncology indications.

Calidi Biotherapeutics presented new data on its first therapeutic candidate from its RedTail platform, CLD-401, at the Society of Immunotherapy for Cancer, SITC, Annual Meeting. "Our latest data demonstrate that in our syngeneic murine models, our RedTail platform is protected from immune clearance after systemic administration and can find and specifically replicate in tumor cells at metastatic sites," said Antonio Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "The data also demonstrate that the platform can effectively express genetic medicines at the tumor site in concentrations that are similar to what is achievable with localized dosing while avoiding systemic exposure."