Systemic Lupus Erythematosus (SLE) is a typical B-cell-related systemic autoimmune disease, predominantly affecting women of childbearing age between 16 and 40. SLE can involve multiple organs and systems, with a diverse clinical course characterized by periodic remissions and relapses, imposing a heavy burden on patients, their families, and society. Current treatments for SLE include corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs, and cytotoxic immunosuppressants. For severe SLE patients, immunosuppressants and glucocorticoids are often used concurrently. However, the efficacy of existing drugs is limited, and they are usually administered in various combinations rather than as single agents, leading to an increased risk of toxicity.

IBR900 is an allogeneic, non-genetically modified universal NK cell derived from healthy donor PBMCs with the ability to kill tumor cells. NK cells in healthy donor PBMCs can be activated through imbioray's proprietary culture process, enhancing their immune regulatory functions and their capacity to kill tumors without prior sensitization. No cytokine release syndrome (CRS), neurotoxicity (ICANS), or graft-versus-host disease (GVHD) has been observed, offering significant safety advantages. IBR900 cells can eliminate activated B cells in SLE patients through antibody-dependent cell-mediated cytotoxicity.

   About Imbioray

Imbioray is a clinical-stage and venture capital-backed innovative biopharmaceutical company primarily focused on the development of cutting-edge immuno-oncology therapies for cancer treatment, as well as novel immunotherapies for non-cancer indications such as immune-related diseases, chronic conditions, and CNS disorders. Dr. Zhenwei Miao, the founder of Imbioray, returned to China in 2016 to establish the company, setting the direction for developing off-the-shelf cell therapies based on NK cells. Imbioray has four internationally unique core technology platforms that accelerate its original innovations, along with world-leading advanced processes for large-scale, closed-system in vitro NK cell cultivation. Based on its proprietary antibody-conjugated NK cell platform technology, Imbioray has developed multiple off-the-shelf cell therapy products, including IBR854, IBR733, and IBR822. Currently, IBR854, the world's first cell injection for advanced solid tumors, is about to enter Phase II clinical trials. IBR733, the world’s first cell injection targeting acute myeloid leukemia, has progressed to the second dose cohort in Phase I clinical trials. IBR822, an antibody-NK cell conjugate for advanced solid tumors, is the third drug of its kind developed by Imbioray and initiated registration clinical trials in September this year. IBR900 is the fourth off-the-shelf NK cell product from Imbioray to receive clinical trial approval (CTA) from the CDE, targeting patients aged 65 and above with B-cell lymphoma or those who are intolerant to or have failed existing treatments. Imbioray also has several other NK cell products at various stages of development.

Imbioray is committed to becoming a pioneer and leader in the global NK cell immunotherapy field, with a core focus on patient needs and clinical value, upholding the concept of "The Light of Immunotherapy, Igniting New Hope for Life."