CLD-401 / Calidi Biotherap - LARVOL DELTA

CLD-401, an IL-15 superagonist gene medicine via redtail virotherapy, achieves sustained tumor eradication (AACR 2026) - "CLD-401 supported repeat dosing, achieving superior efficacy compared to single-dose regimens indicating a lack of a neutralizing response.Conclusions Systemic CLD-401 enables tumor-specific amplification and high-level IL-15 SA expression, achieving durable regression without off-target toxicity. These findings support IND-enabling studies for CLD-401 and highlight the potential of the RedTail platforms as a next-generation systemic virotherapy with targeted and efficient delivery of genetic payloads."

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • CD55 • CD8

Calidi Biotherapeutics Presents Data on its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform at the 2026 AACR-IO Conference (GlobeNewswire) - "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....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 is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform."

Preclinical • Solid Tumor

Calidi Biotherapeutics…announced 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 Immuno-Oncology (AACR-IO) conference (GlobeNewswire) - "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....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."

IND • Late-breaking abstract • Preclinical • Solid Tumor

Calidi Biotherapeutics Presents New Data on its Therapeutic Lead, CLD-401, at the 2025 SITC Annual Meeting and Holds Its First Investor Day at SITC (GlobeNewswire) - "'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'...'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'.....Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026."

IND • Preclinical • Solid Tumor

In Situ Tumor Delivery of IL-15 superagonist via RedTail Gene Therapy Achieves Durable Tumor Clearance (SITC 2025) - "CLD-401 transforms tumors into producers of an IL-15 superagonist (IL-15(N72D)-IL-15Rα), a next-generation cytokine known to activate and expand natural killer (NK) cells and CD8+ T cells—both critical for antitumor immunity and with demonstrated clinical efficacy.Methods The resistance of RT to humoral immunity was assessed using modified plaque assays...This strategy achieved complete responses in metastatic models and induced durable immunological memory. The RedTail platform offers a promising approach for localized delivery of diverse therapeutic payloads while minimizing systemic toxicity, addressing a critical challenge in the treatment of metastatic disease."

Gene therapy • Breast Cancer • Lung Cancer • Oncology • Solid Tumor • CD55 • CD8

Matica Biotechnology (Matica Bio), the U.S. subsidiary of CHA Biotech, announced on November 3 that it has signed a commercial project contract for contract development and manufacturing organization (CDMO) services with Calidi Biotherapeutics (Calidi), a U.S.-based biotechnology company. (The Asia Business Daily) - "Under this agreement, Matica Bio will support Calidi’s development of 'CLD-401' by providing analytical development (AD), process development (PD), and GMP manufacturing, as well as assisting with the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA)."

Commercial • IND • Solid Tumor

Calidi Biotherapeutics Announces New Data to be Presented on its Therapeutic Lead, CLD-401, at the 2025 SITC Annual Meeting (GlobeNewswire) - "'In our syngeneic models, CLD-401 can reach metastatic sites when administered systemically where it can destroy tumor cells through a novel mechanism that also induces an immune priming effect.'....Calidi is currently conducting IND-enabling studies for CLD-401 and anticipates submitting an Investigational New Drug (IND) application by the end of 2026."

IND • Preclinical • Solid Tumor

Calidi Biotherapeutics Reports Second Quarter 2025 Financial Results and Recent Operational Highlights (GlobeNewswire) - "Presented preclinical data at the American Society of Clinical Oncology (ASCO) on CLD-401 demonstrating biological efficacy IL-15 superagonist delivery to metastatic tumor sites and reduced immune clearance through engineered CD55 membrane expression; IND filing expected by the end of 2026....Raised $4.6 million gross proceeds through a warrant inducement offering with existing investors that further strengthens the company’s balance sheet and extends its runway."

Financing • IND • Preclinical • Solid Tumor

Systemic antitumor virotherapy: Pre-clinical evaluation of tumor targeting, efficacy, and safety of lead candidate (CLD-401). (ASCO 2025) - "We have developed a new scalable process to manufacture extracellular enveloped antitumor virotherapies and identified the first lead candidate from RTNova Platform, designated as CLD-401. This candidate, CLD-401, demonstrates promising therapeutic efficacy and safety in preclinical models. It effectively addresses the challenge of targeting and treating metastatic lung cancer by delivering Immunotherapeutics directly to disseminated tumors."

IO biomarker • Preclinical • Lung Cancer • Oncology • Solid Tumor • CD55