CLD-400 / Calidi Biotherap - LARVOL DELTA

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

Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Operational Highlights (GlobeNewswire) - "Upcoming Anticipated Milestones: (i) Q2 2025: Payload and lead candidate information revealed on CLD-400 systemic platform; (ii) Q2 2025: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients."

Pipeline update • Trial status • Glioma

Calidi Biotherapeutics Announces Presentation of New Data of Systemic Virotherapy RTNova Platform at the AACR Annual Meeting in April 2025 (GlobeNewswire) - "The data presented will focus on the development of Calidi's proprietary RTNova systemic platform, showcasing its potential to overcome current barriers in metastatic cancer treatment by enabling targeted systemic delivery to multiple tumor sites without rapid elimination by the body’s immune system....In addition to the AACR presentation, Calidi plans to submit an abstract to unveil further key data at the ASCO Annual Meeting in June 2025, highlighting its progress toward selecting a lead clinical candidate for RTNova."

Preclinical • Oncology

Calidi Biotherapeutics Presents Data Supporting RTNova Systemic Technology to Target Metastatic Lung Cancer (GlobeNewswire) - "Calidi Biotherapeutics Inc...presented data at the International Oncolytic Virotherapy Conference (IOVC) and the Society for Immunotherapy of Cancer (SITC) Annual Meeting to support the targeted capabilities of its proprietary RTNova systemic enveloped virotherapy technology. This data supports the potential use of RTNova to target every metastatic site in multiple oncology indications including metastatic lung cancer...'New data presented at IOVC and SITC demonstrated the robust therapeutic potential of our RTNova technology in an advanced lung metastasis model,'...'These findings represent a significant advancement in developing systemic antitumor virotherapy for advanced disease stages, which remains a leading cause of death in cancer patients. Additionally, the data reveals that once the virus reaches the tumors or metastases, it successfully kills and transforms tumor microenvironments and can additionally induce expression of engineered payloads in the tumor cells.'"

Clinical data • Lung Cancer • Oncology • Solid Tumor

Targeting all tumor sites: the power of systemic enveloped virotherapy (SITC 2024) - "To overcome this challenge, we established the RT-Nova program, which focuses on developing a cellular-based technology to protect oncolytic virotherapy...Conclusions The development of this innovative systemic antitumor enveloped virotherapeutic, along with advancements in its manufacturing methods, unlocks new possibilities in cancer therapy. It directly tackles the challenges posed by untargetable and untreatable metastatic diseases, offering a transformative solution with wide-ranging implications for the field."

Lung Cancer • Melanoma • Oncology • Solid Tumor

Calidi Biotherapeutics to Present Data Supporting RTNova at Upcoming Scientific Conferences (GlobeNewswire) - "Calidi Biotherapeutics Inc...will present data supporting RTNova (CLD-400), the company’s systemic antitumor virotherapy platform, at the International Oncolytic Virotherapy Conference (IOVC) in Rotterdam, Netherlands, October 27-30, 2024, and at Immuno US 2024 in San Diego, October 28-30, 2024. In addition, a poster will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Houston, November 6-10, 2024...RTNova is a systemic treatment designed for reduced elimination by the humoral immune system. It targets multiple tumor sites, killing tumor cells while altering the tumor immune microenvironment."

Clinical data • Oncology • Solid Tumor

Calidi Biotherapeutics Collaborates with SIGA Technologies to Advance Calidi’s Revolutionary RTNova Virotherapy for Lung Cancer and Metastatic Solid Tumors (Businesswire) - "Calidi Biotherapeutics, Inc...announced that it entered into a collaboration agreement with SIGA Technologies (Nasdaq: SIGA) in the first quarter of 2024, to support the development of Calidi’s systemic and targeted RTNova (CLD-400) virotherapy platform, which has the potential to provide a universal treatment for all tumor types. Calidi will initially focus on developing the RTNova platform for lung cancer and metastatic (or advanced stage) solid tumors which account for the majority of cancer deaths. The long-term collaboration between Calidi and SIGA aims to harness the capabilities of SIGA’s TPOXX, an antiviral agent effective against vaccinia virus. The initial focus for the collaboration will be on testing the capacity of TPOXX to become a safety switch to manage RTNova’s spread in vivo."

Licensing / partnership • Lung Cancer • Oncology • Solid Tumor

Calidi Biotherapeutics Presents CLD-101 Phase 1 Trial Update and Preclinical Data Highlighting RTNova and CLD-201 at 2024 ASCO Annual Meeting (Businesswire) - "Calidi’s RTNova (CLD-400) systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain...In preclinical murine models, envRT-01 targeted multiple tumor types and led to tumor growth inhibition with a single systemic injection of 4.5e6 PFU env-RT-01. envRT-01 induced changes in tumor immune microenvironment, targeted lung cancer and metastatic sites, and induced dramatic changes in lung metastasis tumor microenvironments; Non-clinical evidence supporting the upcoming SuperNova (CLD-201) clinical trial: Cell-based oncolytic virotherapy for multiple solid tumors...No toxicity findings were associated with CLD-201 in the disease-free model, and additionally, virus detection in the lungs was cleared within two weeks following the last CLD-201 treatment. CLD-201 induced potent cytolysis across multiple cancer types in in-vitro models."

Preclinical • Oncology • Solid Tumor