YingBaiRui's Off-the-Shelf Trop2-Targeted CAR-raNK Therapy IBR822 Receives IND Approval for Advanced Solid Tumors
iMBioRay
CAR-NK Cell Therapy Drug Developer
April 22, 2024
eMedClub News
2024Year4Month19Day, with internationally originalCAR-raNKImbioray (Hangzhou) Biopharmaceutical Co., Ltd., a cell technology platform, independently developed the second drug targeting solid tumors.IBR822Cell Injection" (Application No.:CXSL2400067), successfully obtained the approval from the National Medical Products Administration (NMPA) has received clinical trial implied permission (Notice No.:2024LP00986）。
▲ Image Source:CDE Official Website
IBR822 Cell Injection is developed by Imbioray using its proprietary intellectual property.The world's first non-viral, non-genetically modified drug that specifically targets the TROP2 antigen and has cytotoxic effectsNK Cells with Tumor Cell Killing Ability (CAR-raNK) Product。Its innovative specific antibody TROP2, which targets tumor antigens, is chemically conjugated to NK cells via a linker, giving IBR822 extremely high safety and potent tumor cell-killing ability.
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According to the 2022 National Cancer Report recently released by the National Cancer Center, in 2022, there were 4.8247 million new cancer cases and 2.5742 million deaths in China. For patients with advanced malignant solid tumors, most are no longer suitable for surgery, radiotherapy, or concurrent chemoradiotherapy, and have failed systemic standard treatment. Although immunotherapy based on immune checkpoint inhibitors has shown significant efficacy in some patients with advanced solid tumors, a considerable number of patients in clinical practice do not respond to immune checkpoint inhibitors or fail to produce long-term responses. Therefore, it is necessary to explore more new treatment options for advanced solid tumors.
TROP2 is a transmembrane glycoprotein associated with the proliferation, migration, and invasion of tumor cells. It is highly expressed in various malignant tumors and serves as a factor influencing poor prognosis. The expression rate of TROP2 in breast cancer can reach 78%, while in triple-negative breast cancer (TNBC), it is as high as 95%. Regarding prostate cancer, studies have shown that basal cells expressing TROP2 in immunodeficient mice can undergo malignant transformation. Other related studies indicate that TROP2 can enhance the activity of prostate cancer cells. Trodelvy (sacituzumab govitecan) is the first approved Trop2-ADC drug to be marketed. However, the safety issues of Trop2-ADC drugs cannot be ignored, such as neutropenia and diarrhea, which have been flagged with a black box warning by the FDA.
Preclinical studies show that IBR822 cell injection has significant killing effects on non-small cell lung cancer, gastrointestinal tumors, breast cancer, prostate cancer, ovarian cancer, and cervical cancer cell lines.In animal experiments, IBR822 cell injection showed significant tumor-inhibiting effects and good tolerability in mouse models of breast cancer, prostate cancer, and others. IBR822 cell injection has previously been involved in multiple investigator-initiated clinical trials (IIT), achieving excellent results in both safety and efficacy.
IBR822 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 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 demonstrates excellent specific target recognition and binding ability, maximizing the killing effect on target cells in clinical applications while reducing off-target toxicity. 3) This product consists of non-genetically modified NK cells that specifically target tumor antigens, avoiding the risk of insertional mutagenesis caused by viral or non-viral vector integration, thus offering superior safety. The IBR822 NK Cell Injection holds new hope for patients with solid tumors such as triple-negative breast cancer, colorectal cancer, and esophageal cancer.
About Imbioray
Imbioray is a clinical-stage and venture capital-backed innovative biopharmaceutical company primarily focused on the development of novel immunotherapies for cutting-edge global oncology treatments, as well as immune-related diseases, chronic conditions, and CNS disorders. Dr. Zhenwei Miao, 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 the company’s innovation from the ground up, 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 multiple off-the-shelf cell therapy products, including IBR854, IBR733, and IBR822. Currently, IBR854, the world's first cell injection for advanced solid tumors, and IBR733, the world's first cell injection targeting acute myeloid leukemia, have both entered Phase I clinical trials. IBR822 is Imbioray’s third antibody-NK cell conjugate drug, which has recently received IND approval with tacit permission from the CDE. Imbioray also has several 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 focus on patient needs at its core and clinical value as its guide. It upholds the philosophy of "The Light of Immunotherapy, Igniting New Hope for Life."
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