On February 12, 2026 Calidi Biotherapeutics, Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported that it 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 (Free AACR Whitepaper) Immuno-Oncology (AACR-IO) conference being held in Los Angeles, California, from February 18-21, 2026.
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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, 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.
"RedTail is a major leap forward in the delivery of genetic medicine via an engineered virus," said Eric Poma, PhD, Chief Executive Officer of Calidi. "It is able to avoid immune clearance allowing for systemic delivery but can only replicate and express payload in tumor cells."
"Our work with RedTail continues to highlight the flexibility of the platform to deliver complex biologics directly within the tumor microenvironment" said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. "We believe simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to enable for T-cell engagement precisely where it is needed."
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
(IND) 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.
(Press release, Calidi Biotherapeutics, FEB 12, 2026, View Source [SID1234662648])