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On January 25, 2024, the clinical trial application for imbioray's IBR822 Cell Injection was accepted by the National Medical Products Administration (Acceptance No.: CXSL2400067). IBR822 Injection is a Class I biological product independently developed by imbioray. It is an allogeneic, off-the-shelf cell product derived from peripheral blood, indicated for advanced solid tumors.
About IBR822 Cell Injection
IBR822 Cell Injection is an antibody-NK cell conjugate drug. A full-length monoclonal antibody targeting the human Trop2 antigen is chemically conjugated, via a linker, to NK cells derived from the peripheral blood of allogeneic healthy donors expanded in vitro. This results in a non-viral vector, non-genetically modified antibody-NK conjugate drug (Trop2 CAR-raNK) that specifically targets the Trop2 antigen and possesses the ability to kill tumor cells.This product has the following characteristics:1) Ordinary NK cells non-specifically recognize target cells, while this product has stronger targeting ability. It can specifically target tumor cells with the Trop2 antigen through the anti-Trop2 monoclonal antibody and exert cytotoxic effects on tumor cells via five major mechanisms of NK cells: "direct lysis of target cells," "cytokine secretion," "induction of apoptosis," "ADCC," and "immune checkpoint pathways."2) IBR822 exhibits excellent specificity in target recognition and binding capacity, maximizing the killing effect on target cells in clinical applications while minimizing off-target toxicity.3) This product is non-gene-modified NK cells specifically targeting tumor antigens, which can avoid integration caused by viral/non-viral vectors.Insertion MutationCarcinogenic risk, superior safety.Trop2, or human trophoblast cell surface glycoprotein antigen 2, is a type I cell surface glycoprotein that is highly expressed in human cancers. It is often overexpressed in many types of cancer and plays a crucial role in tumor cell proliferation, metastasis, apoptosis, and invasion, impacting the treatment and survival of cancer patients. In advanced solid tumors, targetingTROP2TargetThe drug under development has enormous therapeutic potential. Currently, many pharmaceutical companies in and outside of China have entered the Trop2 field, primarily focusing on Trop2-ADC products. The research covers a broad range of solid tumors, including indications such as non-small cell lung cancer, breast cancer, gastric/gastroesophageal junction cancer, urothelial carcinoma, and more. Trodelvy (Sacituzumab Govitecan) is the first approved Trop2-ADC drug. However, the safety issues of Trop2-ADC drugs cannot be ignored, such as neutropenia and diarrhea, which have been given a black box warning by the FDA. IBR822 NK Cell Injection offers hope forTriple-Negative Breast CancerPatients with solid tumors such as colorectal cancer and esophageal cancer bring new hope.Imbioray is a clinical-stage and venture capital-backed biopharmaceutical company primarily focused on the global cutting-edge development of immuno-oncology therapies, as well as innovative drugs for immune-related diseases, chronic conditions, and CNS disorders. Dr. Miao Zhenwei, the founder of Imbioray, returned to China in 2016 to establish the company, setting the direction for the development of off-the-shelf NK cell-based therapeutics. Imbioray has four internationally unique core technology platforms that accelerate its original innovations, along with world-leading advanced processes for large-scale in vitro closed-system cultivation of NK cells. Based on its proprietary antibody-conjugated NK cell platform technology, Imbioray has developed several off-the-shelf cell therapy products, including IBR854, IBR733, and IBR822. Currently, IBR854, the world’s first cell injection for advanced solid tumors, is in Phase I clinical trials. IBR733, the world's first cell injection targeting acute myeloid leukemia, has received IND approval from the CDE and is about to enter the registration clinical stage. IBR822, Imbioray's third antibody-NK cell conjugate drug, recently completed its IND filing and has been accepted by the CDE.
