CLD-201 / Calidi Biotherap - LARVOL DELTA

Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors (GlobeNewswire) - "Calidi Biotherapeutics Inc...announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201. This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head & neck cancer and soft tissue sarcoma....The upcoming clinical trials will assess the safety, tolerability, and preliminary efficacy of CLD-201 in patients with these difficult-to-treat tumors, addressing significant unmet medical needs."

IND • New trial • Breast Cancer • Head and Neck Cancer • Soft Tissue Sarcoma • Solid Tumor

Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Operational Highlights (GlobeNewswire) - "Filed IND in March 2025 for CLD-201 company sponsored Phase 1 trial to treat multiple solid tumors....Upcoming Anticipated Milestones:...Q3 2025: First patient dosed in CLD-201 Phase 1 trial."

IND • New P1 trial • Solid Tumor

Calidi Biotherapeutics Announces Launch of Nova Cell Subsidiary and $3 Million Aggregate Investment from Dr. Ronald Rigor (GlobeNewswire) - "Calidi Biotherapeutics...announced a $2 million strategic investment by Dr. Ronald Rigor into its new subsidiary, Nova Cell, Inc. ('Nova Cell'), to advance Calidi’s Adult Adipose Allogeneic (AAA) stem cell innovative programs. Dr Rigor also invested an additional $1 million into Calidi to further its oncology pipeline of assets...The investment comprises of (i) a $1 million dollar subscription agreement to purchase a combination of CLDI common stock at a 10% discount to the closing price on July 22, 2024 and warrants to purchase 600,000 shares of common stock at a 20% premium to the closing price on July 22, 2024....With reasonable rights of first refusal, Dr. Rigor also receives an exclusive license to purchase and use the AAA stem cell line in the Philippines for regenerative purposes and to administer Calidi’s CLD-201 product (Super Nova platform addressing multiple solid tumors) for clinical investigations or commercial use in the Philippines."

Commercial • Licensing / partnership • Oncology • Solid Tumor

Calidi Biotherapeutics Announces Issuance of New U.S. Patent Covering Novel SuperNova Technology Platform (GlobeNewswire) - "Calidi Biotherapeutics...announced the issuance of a new patent for the company’s SuperNova technology, strengthening its intellectual property portfolio and positioning Calidi to advance its CLD-201 program into the clinic. The United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,036,278 titled, 'Smallpox Vaccine for Cancer Treatment,' directed to Calidi’s SuperNova platform composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus....The patent covers methods and compositions related to immunotherapy of cancer, specifically compositions combining a smallpox vaccine with stem cells, selected from among 19 different stem cell types and their combinations."

Patent • Solid Tumor

Non-clinical evidence supporting the upcoming CLD-201 clinical trial: Cell-based oncolytic virotherapy for multiple solid tumors. (ASCO 2024) - "Prior clinical studies have demonstrated the effectiveness of autologous stem cells loaded with Vaccinia virus CAL1 (ACAM2000) in multiple tumor types, especially when combined with checkpoint inhibitors. CLD-201 offers several important advantages over the autologous approach, including enhanced potency through significant viral amplification within the stem cells, improved manufacturing reproducibility, off-the-shelf ability to treat multiple cancer types, and significantly lower cost. Non-clinical studies revealed that both intratumoral and systemic administration were well-tolerated. A phase I non-randomized clinical trial has been designed to evaluate the safety and initial anti-tumor effects of intratumoral administration of CLD-201."

Clinical • Oncolytic virus • Breast Cancer • Melanoma • Oncology • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • CD4 • CD8

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

Calidi Biotherapeutics Announces Upcoming Presentations at the 2024 ASCO Annual Meeting (Businesswire) - "Calidi Biotherapeutics...announced the acceptance of three abstracts that will be presented in a poster session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting....The posters will include an update from a City of Hope-led Phase 1 study of Calidi's CLD-101 program, focusing on the treatment of recurrent high-grade glioma, now advancing into its fourth cohort of participants....Calidi will also present preclinical data highlighting its RTNova delivery platform...and its CLD-201 program, which is expected to dose its first patient in a Phase 1 trial in the second half of 2024 subject to Calidi’s ability to raise additional capital."

New P1 trial • P1 data • Preclinical • Glioma

Calidi Biotherapeutics Presents New Data on the Mechanisms of Action for Virotherapy-Loaded Stem Cells Used in the Company’s Novel Immunotherapies at the AACR Annual Meeting 2024 (Businesswire) - "Calidi previously announced that its partner, City of Hope, dosed the first patient in a Phase 1 clinical trial evaluating CLD-101 in recurrent high-grade glioma patients. The company expects to report a clinical update in the second quarter of 2024....The company expects to start clinical trials with CLD-201 by the end of 2024, subject to the company’s continued ability to raise the capital necessary to fund its clinical development programs."

New trial • P1 data • Trial status • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Calidi Biotherapeutics Presents New Data on the Mechanisms of Action for Virotherapy-Loaded Stem Cells Used in the Company’s Novel Immunotherapies at the AACR Annual Meeting 2024 (Businesswire) - "In the studies presented at AACR, scientists at Calidi Biotherapeutics and City of Hope researched the stem cells secretome transcriptomic of CLD-101 and CLD-201. The transcriptomic analysis showed that immunomodulatory cytokines, and chemokines, are induced following oncolytic virus infection demonstrating a potential immunotherapeutic role of the cells, in addition to the delivery and protection of the oncolytic viruses. Together these findings suggest that the enhanced antitumor actions of Calidi’s therapies are partially due to the alterations in the stem cells’ secretome, reinforcing the potential of the company’s novel approach to treat solid tumors."

Preclinical • Oncology • Solid Tumor

Deciphering anticancer mechanisms of oncolytic virus-loaded stem cells (AACR 2024) - "Our findings suggest that the enhanced therapeutic efficacy of stem cells loaded with OV is, at least partially because of qualitative and quantitative alterations in stem cells' secretome (including immunostimulatory cytokines and chemokines), These findings advance our knowledge of the molecular mechanisms underlying the immunostimulatory role of OV-loaded stem cells and specifically help to understand the mechanism of action of the promising clinical immunotherapies CLD-101 and CLD-201."

IO biomarker • Oncolytic virus • Oncology

Calidi Biotherapeutics to Highlight Novel Systemic Enveloped Oncolytic Virotherapy Platform Designed to Target All Tumor Sites at Upcoming Conference (Businesswire) - "Stephen Thesing, Chief Business Officer of Calidi, will be presenting at the Biocom Global Life Science Partnering & Investor Conference on February 28, 2024 at 3:00 p.m. PT, to discuss the Company’s newly announced systemic enveloped oncolytic virotherapy program targeting all tumor types, including advanced metastatic disease, and provide an update on the clinical development progress of Calidi’s CLD-101 (NeuroNova) and CLD-201 (SuperNova) programs....Preclinical models have demonstrated ImmunoNova's efficacy in transforming tumor immune microenvironments and eradicating distant and diverse tumors. In addition, the program exhibits synergistic potential with other immunotherapies, including cell therapies, enhancing its ability to attack and eliminate disseminated solid tumors."

Preclinical • Oncology • Solid Tumor

Calidi Biotherapeutics Announces Presentation of Clinical Study for NeuroNova with Recurrent High Grade Glioma at the 8th Oncolytic Virotherapy Summit (Businesswire) - "Calidi Biotherapeutics, Inc...announced three presentations on Calidi’s NeuroNova (NNV) and SuperNova (SNV) allogeneic stem cell-based virotherapy platforms at the upcoming 8th Oncolytic Virotherapy Summit to be held December 12-14, 2023 in Boston, Mass....The company plans to file its IND application for the clinical development of CLD-201 to enable the initiation of a Phase 1 clinical trial for SNV1 during the second half of 2024."

IND • New P1 trial • Oncology • Solid Tumor

Calidi Biotherapeutics Announces Issuance of New U.S. Patent Covering Novel SuperNova Technology Platform and Updates Anticipated Clinical Milestones (Businesswire) - "Calidi Biotherapeutics, Inc...announced the issuance of a new patent for the company’s SuperNova technology, strengthening its intellectual property portfolio and positioning Calidi to advance its CLD-201 program into the clinic....The United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,655,455 titled, 'Enhanced systems for cell-mediated oncolytic viral therapy,' directed to Calidi’s SuperNova platform composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus....Anticipated Clinical Milestones: 1H 2024: First patient dosed in CLD-101 (NeuroNova) Phase 1b/2 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients; 2H 2024: First patient dosed in CLD-201 (SuperNova) Phase 1 trial."

New P1 trial • Patent • Trial status • Brain Cancer • CNS Tumor • Glioma • Oncology • Solid Tumor

Calidi Biotherapeutics Reports Third Quarter 2023 Operating and Financial Results (Businesswire) - "Calidi Biotherapeutics, Inc...reports its financial results for the third quarter 2023 and reviews recent business highlights...The poster also detailed the clinical readiness of the product and plans to launch a Phase 1 study in 2024...Upcoming Anticipated Milestones: 4Q 2023: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients....1H 2024: First patient dosed in CLD-201 Phase 1 trial."

New P1 trial • Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Calidi Biotherapeutics (NYSEAM: CLDI) Presents Data on CLD-201 Demonstrating Inhibition of Tumor Growth and Induction of Robust Anti-Tumor Immunity at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC 2023) (Businesswire) - "Calidi Biotherapeutics, Inc...announced the presentation of new preclinical data from the company’s CLD-201 (SuperNova) allogeneic stem cell-based platform and announces readiness for clinical trial launch in 2024 at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting....Additionally, the poster presents the readiness of the product and plans to launch clinical trial in 2024....Multiple allogeneic adipose tissue-derived mesenchymal stem cell banks were generated, and one was selected for GMP manufacturing and loaded with the oncolytic vaccinia virus CAL1, creating CLD-201. CLD-201 demonstrated greater resistance to inactivation by the humoral immune system compared to the unprotected CAL1 virus. CLD-201 significantly inhibited the growth of the tumors even at the very low dose of 1.5x103 cells containing 1.6x104 viral plaque forming units (PFU)."

New trial • Preclinical • Oncology • Solid Tumor

A novel stem cell-based platform for delivery and potentiation of oncolytic virotherapies (SITC 2023) - "A phase I non-randomized clinical trial has been designed to evaluate the safety and initial anti-tumor effects of CLD-201, both as a monotherapy and in combination with checkpoint inhibitors. Additionally, multiple immune biomarkers will be assessed to measure the biological activity of CLD-201."

IO biomarker • Oncolytic virus • Oncology

Calidi Biotherapeutics Debuts as a Publicly Traded Company Focused on Arming the Immune System to Fight Cancer with a New Generation of Targeted Immunotherapies (Businesswire) - "Calidi Biotherapeutics, Inc...announced the completion of its business combination with First Light Acquisition Group (FLAG), a special purpose acquisition company....The Company believes that the proceeds available to the Company from the transactions will be sufficient to fund its operations into 2025....In June 2023, the first brain tumor patient was treated at City of Hope in a multicenter, Phase 1 clinical trial evaluating CLD-101 for the treatment of HGG....Interim clinical results are expected in the first half of 2024....Calidi has conducted the pre-IND meeting with the FDA and expects cGMP final drug product manufacturing to be completed in the first quarter of 2024. In the second half of 2024, Calidi anticipates initiating a Phase 1/2 study evaluating CLD-201 in patients with advanced metastatic solid tumors, including triple-negative breast cancer, unresectable melanoma, and squamous cell head and neck carcinoma."

FDA event • Licensing / partnership • New P1/2 trial • P1 data • Brain Cancer • Breast Cancer • CNS Tumor • Glioma • Head and Neck Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Calidi Biotherapeutics Announces Commitment of $25 Million in Series B Funding to Advance Stem Cell-Based Platforms for the Delivery and Potentiation of Oncolytic Viruses to Treat Cancer (Businesswire) - "Calidi Biotherapeutics...today announced the commitment of $25 million in Series B funding led by Jackson Investment Group ('JIG'), who has funded an initial investment of $5 million....The financing will enable Calidi to continue the advancement of its pipeline including CLD-101, CLD-201, and CLD-202, which utilize a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications."

Financing • Oncology

Calidi Biotherapeutics Receives Funding from the California Institute for Regenerative Medicine (CIRM) to Advance SuperNova-1 and NeuroNova-2 Development Programs (Businesswire) - "Calidi Biotherapeutics, Inc...announced that the California Institute for Regenerative Medicine (CIRM) has awarded the company a $3.1 million grant to support continued development of the company’s Supernova-1 (SNV1) pre-clinical program through Investigational New Drug (IND) application. In addition, CIRM has awarded City of Hope a $12 million grant to fund a Phase 1 physician-sponsored clinical trial evaluating Calidi’s licensed oncolytic virotherapy NeuroNova platform in patients with recurrent high-grade glioma, a form of advanced brain cancer."

Financing • Brain Cancer • Breast Cancer • CNS Tumor • Glioma • Head and Neck Cancer • Melanoma • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

CIRM grant supports progression of Calidi's Supernova-1 toward clinic (Bioworld) - "The California Institute for Regenerative Medicine (CIRM) has awarded Calidi Biotherapeutics Inc. a US$3.1 million grant to support continued development of the company's Supernova-1 (SNV-1) preclinical program through IND application. The grant was awarded to Calidi to support IND-enabling studies, finalize manufacturing and the completion of Calidi's IND application for the SNV-1 program."

Financing • Oncology

Calidi Biotherapeutics Presents Promising Pre-Clinical Data from SuperNova-1 (SNV1), a Novel Oncolytic-Cell Based Platform, at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022) (Businesswire) - "Calidi Biotherapeutics, Inc....announced the presentation of new pre-clinical data from the company’s SuperNova-1 (SNV1) platform at the upcoming Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, taking place in Boston, Massachusetts and virtually, November 8-12, 2022...The SNV1 stem cell-based platform protects and potentiates oncolytic vaccinia virus by circumventing humoral innate and adaptive immune barriers, resulting in enhanced anticancer effects in tumor-bearing mouse models."

Preclinical • Breast Cancer • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer

SuperNova1 (SNV1), a novel oncolytic-cell based platform for cancer therapy (SITC 2022) - "Conclusions The SNV1 stem cell-based platform protects and potentiates oncolytic vaccinia virus by circumventing humoral innate and adaptive immune barriers, resulting in enhanced anti-cancer effects in tumor-bearing mouse models. SNV1 provided instantly active viral particles for immediate infection in the injected tumors which help transforming tumor environment from “cold” to “hot” locally and systemically."

Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Melanoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD4 • CD8

Calidi Biotherapeutics to Present Pre-Clinical SuperNova1 (SNV1) Data at the 2022 SITC Annual Meeting (Businesswire) - "Calidi Biotherapeutics...announced a poster presentation highlighting pre-clinical data from the company’s SuperNova1 (SNV1) program at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting, taking place in Boston, Massachusetts and virtually, November 8-12, 2022."

Preclinical • Oncology

[VIRTUAL] Enhancement of the therapeutic effects of oncolytic vaccinia virus by using autologous and allogeneic cell-based delivery platforms. (ASCO 2020) - "We also developed an allogeneic cell-based platform (SuperNova1c - SNV1c) aiming to protect and potentiate OVV’s antitumor effects in large patient populations... This study establishes the timeline of treatment-related immunological changes and identifies potential immunological correlates associated with the OVV persistence in vivo. We also demonstrate the ability of our cell-based platforms to protect and potentiate OVV by circumventing innate and adaptive immune barriers, resulting in enhanced oncolytic virotherapy. Research Funding: Calidi Biotherapeutics"

Oncolytic Virus • Immune Modulation • Inflammation • Oncology • CD8