IASO Bio Receives FDA Approval of IND Application for IASO-782 for Treatment of Autoimmune Disease

2023-06-17

免疫疗法孤儿药临床申请临床1期细胞疗法

The second product of IASO to receive IND approval from the FDA

SHANGHAI and NANJING, China and SAN JOSE, Calif., June 17, 2023 /PRNewswire/ -- IASO Biotechnology ("IASO Bio"), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its IASO-782 Injection for use in U.S. clinical trials for Autoimmune hematological disorders, including primary immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA).

The IND approval of IASO-782 Injection in the U. S. follows closely on the heels of IASO's in-house developed CT103A for relapsed/refractory multiple myeloma (RRMM) receiving FDA approval for clinical trials within just six months and is a significant milestone in IASO Bio's internationalization process. With a focus on expanding overseas clinical trial programs, IASO Bio will accelerate its overseas clinical trials and the development and implementation of innovative immunotherapy drugs to benefit more patients globally.

About IASO-782 Injection

IASO-782 Injection is a fully human monoclonal antibody targeting human CD19, with Fc mutations to enhance ADCC function, and keep other Fc functions untouched (ADCP, CDC, FcRn binding et al.). The B cell surface antigen CD19 is expressed through out B cell development, from pre-B cells through plasmablasts and in some plasma cells. Many autoimmune diseases, such as ITP and AIHA, are mainly mediated by auto-reactive antibodies produced by pathogenic B & plasma cells. IASO-782 can efficiently deplete CD19+ B cells, plasmablast cell, and some plasma cell in human, thus reduce or completely eliminate auto-reactive antibodies produced by these cells. IASO-782 has the potential to treat a range of autoimmune diseases associated with auto-reactive antibodies.

About Immune Thrombocytopenia (ITP)

Immune thrombocytopenia (ITP) is a rare disorder that makes blood clot poorly due to

low platelets, the cells that plug wounds, which is more prevalent in females. In the United States, the incidence and prevalence of ITP is 6.0 and 20.3 per 100,000, respectively. In China, the incidence and prevalence of ITP is 2.9 and 11.02 per 100,000, respectively. The primary type accounting for approximately 79%. ITP is estimated to affect 68,000 and 156,000 patients in China and US in 2022, respectively.

About Warm Antibody Autoimmune Hemolytic Anemia

(wAIHA)

Warm antibody type autoimmune hemolytic anemia (wAIHA) is the most prevalent form of autoimmune hemolytic anemia, accounting for 70% to 80% of all case. The incidence of wAIHA is about 0.1 to 0.5 per 100,000, with a prevalence of about 0.3 to 1 per 100,000 in Asian populations. The incidence of wAIHA is about 1.77 per 100,000, with a prevalence of about 17 per 100,000 in European populations.

About IASO Bio

IASO Bio is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and autoimmune diseases. Leveraging its proprietary fully human antibody discovery platform (IMARS), high-throughput chimeric antigen receptor T-cell (CAR-T) drug screening platform, and proprietary manufacturing processes, IASO Bio is developing a rich clinical-stage pipeline of multiple autologous and allogeneic CAR-T and biologics product candidates. This pipeline includes a diversified portfolio of over 10 novel products, including IASO's leading asset, Equecabtagene Autoleucel (CT103A), a fully human BCMA CAR-T injection. Equecabtagene Autoleucel received New Drug Application (NDA) acceptance from China's National Medical Products Administration (NMPA) and U.S. FDA IND approval for the treatment of RRMM. IASO also received Breakthrough Therapy Designation (BTD) from the NMPA in February 2021 and Orphan Drug Designation (ODD) from the FDA in February 2022. In addition to multiple myeloma, NMPA has accepted IASO's IND application for the extended indication of Neuromyelitis Optica Spectrum Disorder (NMOSD).

Additionally, the company's in-house developed fully human CD19/CD22 dual-targeted CAR-T cell therapy has received two IND clearances for treating relapsed/refractory B-cell non-Hodgkin's lymphoma (r/r B-NHL) and relapsed/refractory acute B-lymphoblastic leukemia (r/r B-ALL). It is currently in Phase I clinical trial for r/r B-NHL. It was also granted ODD for the treatment of acute lymphoblastic leukemia by the FDA in October 2021.

Leveraging its strong management team, innovative product pipeline, integrated manufactural and clinical capabilities, IASO aims to deliver transformative, curable and affordable therapies that fulfil unmet medical needs to the patients in China as well as around the world. For more information, please visit www.iasobio.com or www.linkedin.com/company/iasobiotherapeutics.

Contact: [email protected]

SOURCE IASO Bio