Announcement • Apr 22
Calidi Biotherapeutics Presents New Data on Cld-401 At the Aacr Annual Meeting Calidi Biotherapeutics, Inc. presented new data at the American Association of Cancer Research annual meeting in San Diego, California. The Company showcased new data on CLD-401, a systemically delivered oncolytic virus that is designed to express high levels of IL-15 superagonist only in the tumor microenvironment, currently in IND-enabling studies. CLD-401 is the lead candidate from the Company’s RedTail platform, a 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 is engineered to express high levels of IL-15 superagonist in the tumor microenvironment. Data at AACR detailed the profound immune changes in the tumor microenvironment induced by CLD-401 including the recruitment and activation of NK, NK-T, and gamma delta T-cells that lead to a robust therapeutic response in the immunocompetent animal models. The Company expects to file an IND for CLD-401 by the end of 2026. In addition to IL-15 superagonist delivery with CLD-401, the RedTail platform has also been shown to enable in situ expression of tumor-targeted T cell engagers, as demonstrated in a separate AACR presentation focused on the CLD-501 program. The data presented at AACR characterize the changes in the tumor microenvironment induced by IL-15 superagonist expression. The ability of CLD-401 to induce high levels of IL-15 superagonist expression in the tumor microenvironment while maintaining low circulating levels may dramatically expand the therapeutic window of IL-15-mediated treatment. The Company continues to expand the functionality of the RedTail platform, with data presented at AACR across multiple programs including CLD-401 and CLD-501, and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform. 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. Calidi continues to advance its pipeline utilizing the RedTail platform including its novel approach to incorporate in situ T-cell engagers in solid tumors. Announcement • Apr 21
Calidi Biotherapeutics, Inc., Annual General Meeting, Jun 12, 2026 Calidi Biotherapeutics, Inc., Annual General Meeting, Jun 12, 2026. Announcement • Apr 01
Calidi Biotherapeutics to Presents New Data on Differentiated Approach to in Situ T-Cell Engagers Including New Candidate Targeting Trop-2 Calidi Biotherapeutics, Inc. to presented new data at the American Association of Cancer Research annual meeting in San Diego, California from April 17-22, 2026. The Company demonstrated new data on its approach of simultaneously activating T-cells while inducing the expression of T-cell engagers specifically in situ in the tumor microenvironment. 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 at the tumor site while limiting peripheral exposure. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL-15 SA, a known T and NK-cell activator, in the tumor microenvironment. The Company expects to file an IND for CLD-401 by the end of 2026. Data presented at the AACR meeting showcased RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. T-cell engagers have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the tumor microenvironment inhibits immune cell infiltration and T-cell activity. By remodeling the tumor microenvironment and driving T-cell activation in concert with expression of a T-cell engager, RedTail may overcome these historical limitations. The Company is developing a lead candidate targeting TROP2, a cell-surface glycoprotein. TROP2 expression in normal tissue and the high potential for off-tumor /on-target toxicity has made it a difficult target for T-cell engagers. The RedTail approach confines expression of the T-cell engager to the tumor microenvironment, limiting the possibility of off-tumor interactions. The Company is pursuing additional T-cell engager targets like EGFR, EpCAM, and Nectin-4. 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.