SAN DIEGO, California — February 20, 2026 — Leads & Copy — Calidi Biotherapeutics, Inc. (NYSE American: CLDI) presented data at the AACR Immuno-Oncology (AACR-IO) conference in Los Angeles, California, on its novel approach to using BiTEs in solid tumors, utilizing its systemically delivered RedTail platform.
The RedTail platform is Calidi’s systemically delivered virotherapy platform that selectively targets tumors, remodels the tumor microenvironment (TME), and enables high-level expression of therapeutic genetic payloads directly within the tumor. The lead candidate derived from the RedTail platform, CLD-401, is engineered to express high levels of IL‑15 superagonist (IL-15 SA), a known T-cell activator, in the TME.
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. This allows for simultaneous alteration of the TME, T-cell activation, and introduction into the TME of a solid-tumor targeting BiTE.
While BiTEs have shown efficacy in hematological malignancies, they have not demonstrated 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.
Eric Poma, PhD, Chief Executive Officer of Calidi, stated that the RedTail platform allows for the systemic and targeted delivery of genetic payloads to distal sites of disease. He added that RedTail can induce high levels of expression of one or more genetic payloads once at the target, representing a major advance in the delivery of genetic medicines.
Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi, noted that the data highlight the ability of the RedTail platform to functionally overexpress complex biologics like BiTEs and cytokines directly within the tumor microenvironment. He added that simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to allow for T-cell engagement precisely where it is needed.
Calidi is conducting IND-enabling studies with CLD-401 and 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 and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.
Calidi Biotherapeutics (NYSE American: CLDI) is headquartered in San Diego, California. Calidi’s proprietary Redtail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. The advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver genetic medicine(s) to metastatic locations.
CLD-401, the lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need.
A link to the poster is available on the company’s website.
Source: Calidi Biotherapeutics
