IASO Bio Announces NMPA IND Approval for IASO-782, a Fully Human Anti-CD19 Monoclonal Antibody, for Autoimmune Blood Disorders

Nanjing, Shanghai, and San Jose, USAJune 25, 2023PR Newswire -- IASO Bio, a clinical-stage biopharmaceutical company dedicated to the development of innovative cell therapies, announced thatFully Human Antibody Developed In-HouseCD19 Monoclonal Antibody IASO-782 Injection New Drug Clinical Trial Application (IND) Receives Implicit Approval from the National Medical Products Administration (NMPA) (Acceptance No.:CXSL2300272), Indications: Autoimmune Hematologic Disorders - Immune Thrombocytopenia (ITP) and Warm Antibody Autoimmune Hemolytic Anemia (wAIHA), just one week after the product's IND was approved by the FDA in the United States.

The field of autoimmune diseases is the second largest drug market, only after the oncology field. Building on its foundation of developing drugs for hematological tumors, IASO Bio has been deeply committed to the field of autoimmune diseases. IASO Bio is one of the first companies in the world to initiate research on CAR-T therapy in the field of autoimmune diseases (hereinafter referred to as "autoimmune diseases"). The company's first CAR-T product for treating autoimmune diseases—Neuromyelitis Optica Spectrum Disorder (NMOSD) positive for AQP4-IgG (Idecabtagene Vicleucel Injection, R&D code CT103A)—received IND approval from the NMPA in August 2022, marking the expansion of the company’s CAR-T therapy from malignant tumors into the autoimmune field. The recent approval of the IND application in China for another product, IASO-782 Injection, an antibody therapy, has expedited the exploration of innovative therapies in the autoimmune disease space, offering patients more treatment options.

In addition, in October 2022, IASO Bio granted Cabaletta the globally exclusive rights to develop, manufacture, and commercialize modified T-cell products using a clinically validated fully human CD19 sequence for autoimmune diseases. Through this collaboration, IASO Bio is eligible to receive up to $162 million in upfront payments, potential development and commercialization milestone payments, and sales royalties for up to two products. Meanwhile, IASO Bio holds the priority to develop and commercialize products utilizing the licensed sequence in Greater China. Currently, Cabaletta’s autoimmune CAR-T product CABA-201, which uses the licensed sequence, has received FDA approval for IND applications for two indications: active lupus nephritis (LN) or active systemic lupus erythematosus (SLE) without kidney involvement, and idiopathic inflammatory myopathy (IIM). A Phase 1/2 clinical trial is planned to be initiated.

About IASO-782 Injection

IASO-782 Injection is a fully human anti-CD19 monoclonal antibody that enhances the ADCC effect through Fc modification. It eliminates CD19+ B cells and plasma cells via Antibody-dependent cell-mediated cytotoxicity (ADCC) and Antibody-dependent cellular phagocytosis (ADCP), thereby reducing the production of autoantibodies to treat antibody- or B-cell-mediated autoimmune diseases. Meanwhile, as a fully human antibody, IASO-782 has potentially low immunogenicity and is less likely to induce anti-drug antibodies after repeated dosing, offering potential advantages for treating autoimmune diseases that require long-term repeated administration.

Immune Thrombocytopenia (ITP)

Immune Thrombocytopenia (ITP) is an autoimmune disease, mainly characterized by the body's immune system attacking its own platelets, leading to a reduced number of platelets and thereby causing poor blood clotting. Immune thrombocytopenia is a condition that predominantly affects women. The annual incidence rate of immune thrombocytopenia in China is approximately 2.9 per 100,000, with primary cases accounting for about 79%, and the prevalence rate is approximately 11.02 per 100,000. In the United States, the annual incidence rate of immune thrombocytopenia is about 6.0 per 100,000, with a prevalence rate of about 20.3 per 100,000. It is estimated that the number of patients with immune thrombocytopenia in China and the U.S. in 2022 were 156,000 and 68,000, respectively.

Warm Antibody Autoimmune Hemolytic Anemia (wAIHA)

Warm antibody type autoimmune hemolytic anemia (wAIHA) is the most common type of autoimmune hemolytic anemia, with approximately 70% to 80% of adult patients with autoimmune hemolytic anemia being of the warm antibody type. Studies in Asian populations show that the annual incidence of autoimmune hemolytic anemia is about 0.1~0.5 per 100,000, and the prevalence rate is about 0.3~1 per 100,000. In European populations, the annual incidence of autoimmune hemolytic anemia is about 1.77 per 100,000, and the prevalence rate is about 17 per 100,000.

About IASO Bio

IASO Bio is a clinical-stage biopharmaceutical company dedicated to the development of innovative cell-based drugs. With a focus on hematological tumor cell therapies and antibody drugs as its innovative foundation, the company is expanding into solid tumors and autoimmune diseases. It possesses comprehensive capabilities across the entire process from early discovery, clinical development, regulatory submission, to commercial-scale production. The company has independently developed five major technology platforms, including a fully human antibody development platform, an immune cell drug development platform, an end-to-end manufacturing and testing technology platform, a pharmacology and efficacy platform, and a clinical development platform.

The company currently has more than 10 varieties under research at different stages of development. Among them, the fastest progressing product, Ixaloten Cel Injection (fully human BCMA chimeric antigen receptor autologous T-cell injection), has had its New Drug Application (NDA) officially accepted by the National Medical Products Administration (NMPA) and has been approved for registration clinical trials by the U.S. FDA for the treatment of relapsed/refractory multiple myeloma. This product has been included in the NMPA's "Breakthrough Therapy Designation" category and has successively received the FDA’s "Orphan Drug Designation (ODD)," Regenerative Medicine Advanced Therapy (RMAT) designation, and Fast Track (FT) status. In addition to multiple myeloma, the Investigational New Drug (IND) application for the expanded indication of Ixaloten Cel Injection—AQP4-IgG-positive Neuromyelitis Optica Spectrum Disorder (NMOSD)—has been approved by the NMPA. The company's independently developed innovative candidate product CT120 (fully human CD19/CD22 dual-target CAR-T cell injection) has entered the clinical research stage for indications including CD19/CD22-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL) and relapsed/refractory acute B lymphoblastic leukemia (B-ALL). Its acute B lymphoblastic leukemia (B-ALL) indication has been granted "Orphan Drug Designation (ODD)" by the FDA. The IND for the fully human anti-CD19 monoclonal antibody product IASO-782 Injection has completed FDA review and has been approved to conduct clinical trials in the United States for autoimmune hematological diseases—Immune Thrombocytopenia (ITP) and Warm Antibody Autoimmune Hemolytic Anemia (wAIHA).

The company has successively reached BD licensing or R&D cooperation with overseas cell therapy companies Sana Therapeutics, Cabaletta Bio, and Umoja Biopharma based on IASO Bio's clinically validated fully human CAR structure or sequence, actively exploring the development of next-generation cell therapy products. With its strong management team, innovative product pipeline, in-house GMP manufacturing, and robust clinical development capabilities, IASO Bio aims to provide transformative and curative innovative therapies to meet unmet medical needs of patients in China and around the world.