IASO Bio's CD20-Targeted In Vivo CAR-T Therapy IASO208 Receives FDA IND Clearance

— IASO208 is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance

— Supported by early clinical data from an investigator-initiated trial in China, IASO208 is expected to advance directly into a Phase 1b clinical study in the United States for relapsed/refractory B-cell non-Hodgkin lymphoma

SHANGHAI, NANJING, China and PLEASANTON, Calif., Sept. 16, 2026 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a commercial-stage biopharmaceutical company focused on the discovery, development, manufacturing, and commercialization of novel cell therapies and biologics for hematologic malignancies and autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for IASO208, the Company's proprietary CD20-targeted in vivo CAR-T therapy developed using its InTelliCAR™ platform.

IASO208 is the first China-originated lentiviral vector-based in vivo CAR-T therapy to receive FDA IND clearance. Supported by early clinical data from an investigator-initiated trial (IIT) in China and informed by interactions with the FDA, IASO208 is expected to advance directly into a Phase Ib clinical study in the United States for the treatment of adult patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

IASO208 is currently being evaluated in an investigator-initiated, single-arm, open-label, dose-exploration study in China to assess its safety, tolerability, and preliminary efficacy in patients with relapsed/refractory B-cell malignancies. The treatment does not require leukapheresis or lymphodepleting chemotherapy and is administered as a single intravenous infusion. To date, 11 patients have been dosed, with early data demonstrating favorable tolerability and encouraging anti-tumor activity, providing a strong foundation for larger and more systematic clinical studies. IASO Bio will continue to advance the clinical development of IASO208 to further evaluate its safety and efficacy. Ms. Jinhua Zhang, Founder, Chairwoman, and CEO of IASO Bio, said: "The FDA's clearance of the IND application for IASO208 represents an important milestone for InTelliCAR™, IASO Bio's proprietary in vivo CAR-T platform, and marks the entry of China-originated cell therapy technologies into the global race in the in vivo CAR-T field. Leveraging the proprietary InTelliCAR™ platform, IASO Bio has established a pipeline of multiple in vivo CAR-T product candidates spanning hematologic malignancies, autoimmune diseases, and solid tumors, with several of these products already in the IND-enabling stage. The FDA's clearance of IASO208 based on early IIT data from China reflects the regulator's recognition of the high quality of China's IIT clinical data, and lays a solid foundation for the international development of the platform's pipeline. Going forward, we will continue to advance the clinical development of the InTelliCAR™ platform pipeline to accelerate global patient access to China-originated cell therapies."

About IASO208

IASO208 is a replication-incompetent, self-inactivating, third-generation lentiviral vector-based therapeutic. It is pseudotyped with an engineered COCV-G viral envelope and carries a second-generation humanized anti-CD20 chimeric antigen receptor (CAR) transgene. Through selective binding to and transduction of T cells in vivo, IASO208 enables the generation of anti-CD20 CAR-T cells directly within the patient's body.

About Non-Hodgkin Lymphoma (NHL)

Non-Hodgkin lymphoma (NHL) is a group of malignant tumors originating in the lymphatic system. According to GLOBOCAN estimates, approximately 563,000 new cases of NHL were diagnosed globally in 2024, with approximately 1.721 million people living with NHL within five years of diagnosis. In the United States, approximately 74,000 new cases of NHL were estimated in 2024, with approximately 256,000 people living with NHL within five years of diagnosis.1 B-cell non-Hodgkin lymphoma (B-NHL) accounts for approximately 85% of all NHL cases, making it the largest disease category within NHL.2

1. GLOBOCAN 2024.

2. Types of B-cell Lymphoma. American Cancer Society. Last accessed September 7, 2026.

About IASO Bio

Founded in 2017, IASO Bio is one of the first few commercial-stage biopharmaceutical companies in China's Advanced Therapy Medicinal Product (ATMP) field to bring breakthrough innovations to the global market. We focus on cell therapies and biologics targeting hematologic malignancies and autoimmune diseases, with a full-process platform covering drug discovery, development, manufacturing, and commercialization.

The Company has established a robust and highly synergistic R&D pipeline comprising 10 marketed and investigational products, including its core product, Equecabtagene Autoleucel Injection. This CAR-T cell therapy has been approved for marketing in China for the treatment of relapsed/refractory multiple myeloma (r/r MM) in patients who have progressed after at least three prior lines of therapy. The Company is also developing this product for earlier lines of r/r MM treatment, as well as for autoimmune diseases including myasthenia gravis (MG), multiple sclerosis (MS), and systemic lupus erythematosus (SLE)/lupus nephritis (LN). In addition, the Company has 9 other investigational products, including 3 autologous CAR-T cell therapies, 5 in vivo CAR-T cell therapies, and 1 antibody drug candidate.

IASO Bio has also established strategic collaborations with leading global biotechnology and pharmaceutical companies such as Innovent Biologics, Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma, as well as top academic institutions and hospitals, continuously strengthening its product development capabilities.

With an experienced management team in the ATMP field, exceptional execution capabilities, a highly synergistic innovative R&D pipeline, and advanced manufacturing and CMC capabilities, IASO Bio remains dedicated to bringing transformative cell therapies to more patients worldwide.

SOURCE IASO Bio