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Press Release

Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors

SAN DIEGO, April 17, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, 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 Newsroom

Calidi Biotherapeutics Announces FDA Clearance of IND Application for CLD-201 in Solid Tumors

Calidi Biotherapeutics Collaborates with SIGA Technologies to Advance Calidi’s Revolutionary RTNova Virotherapy for Lung Cancer and Metastatic Solid Tumors

Calidi Biotherapeutics Presents CLD-101 Phase 1 Trial Update and Preclinical Data Highlighting RTNova and CLD-201 at 2024 ASCO Annual Meeting

Non-Clinical Evidence Supporting the Upcoming CLD-201 Clinical Trial: Cell-Based Oncolytic Virotherapy for Multiple Solid Tumors

Phase 1 Study of Multiple Intracerebral Doses of a Neural Stem Cell-based Oncolytic Virotherapy for Treatment of Recurrent High-grade Gliomas

Transforming Tumor Immune Microenvironments with a Novel Systemic Enveloped Oncolytic Virotherapy Targeting All Tumor Sites

Calidi Biotherapeutics Announces Exercise of Warrants for $2.1 Million Gross Proceeds

Calidi Biotherapeutics Announces Presentation at 6th Annual Oncolytic Virotherapy Summit

Calidi Biotherapeutics Announces Exclusive License Agreement with City of Hope and the University of Chicago for Novel Oncolytic Virotherapy Technology

Calidi Biotherapeutics Announces Agreement with Northwestern University for Exclusive Commercial Rights to their IND for Treatment of Malignant Glioma

Calidi Biotherapeutics Announces Partnership with GenScript ProBio for Distribution of its SuperNova-1 Technology

Calidi Biotherapeutics Announces European Patent Granted by EPO: Combination Immunotherapy Approach for Treatment of Cancer

Calidi Biotherapeutics Announces FDA Approval for COVID-19 Treatment Manufactured by Partner, Personalized Stem Cells

Transforming all Tumor Sites: The Power of Systemic Enveloped Virotherapy

Phase 1 Study of Multiple Intracerebral Doses of a Neural Stem Cell-based Oncolytic Virotherapy for Treatment of Recurrent High-grade Gliomas

Non-Clinical Evidence Supporting the Upcoming CLD-201 Clinical Trial: Cell-Based Oncolytic Virotherapy for Multiple Solid Tumors

Transforming Tumor Immune Microenvironments with a Novel Systemic Enveloped Oncolytic Virotherapy Targeting All Tumor Sites

Stem Cell Platforms for Enhanced Oncolytic Virotherapy

Deciphering Anticancer Mechanisms of Oncolytic Virus-loaded Stem Cells

Scientific Advisory Board Member Interview - Santosh Kesari, M.D./Ph.D.

Scientific Advisory Board Member Interview - Bernard Fox, Ph.D.

Scientific Advisory Board Member Interview - W.K. Alfred Yung, M.D.

Scientific Advisory Board Member Interview - Ashok Srivastava, M.D./Ph.D.

Big Biz TV - Stephen Thesing

Big Biz TV - Allan Camaisa

Analyst Bullish On Calidi Biotherapeutics, Newly Listed Cancer Treatment Player

Calidi Biotherapeutics: A Promising Player in the Cancer Treatment Market

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