InnBiori Launches Phase I Clinical Trial of IBR822, the World’s First Trop-2-Targeted CAR-NK Cell Therapy for Solid Tumors

On September 13, 2024, the Phase I clinical trial launch meeting for IBR822 Cell Injection, independently developed by Imbioray (Hangzhou) Biomedical Co., Ltd. to treat solid tumors, was successfully held at the Zhejiang Cancer Hospital.

This trial is led by Professor Song Zhengbo from Zhejiang Cancer Hospital and collaboratively conducted by well-known clinical research centers in China, including Jiaxing First Hospital and Fuyang Cancer Hospital.

The launch meeting invited Professor Song Zhengbo, Director of the Phase I Clinical Trial Ward at Zhejiang Cancer Hospital, Ms. Hong Dan, Deputy Director of the GCP Center, and related department clinical research teams, the Imbioray Clinical Medicine Team, and the CRO ClinChoice Enterprise Management and Operations Team to attend. The launch meeting was chaired by Professor Song Zhengbo. The meeting introduced the implementation process and details of the Phase I clinical trial protocol for IBR822 cell injection in the treatment of solid tumors. Participants thoroughly discussed and analyzed the key points and difficulties of this trial and proposed numerous practical suggestions and measures, laying a solid foundation for the high-quality execution of the trial.

The successful launch of this kick-off meeting marks the official start of Imbioray's IBR822 Cell Injection for the treatment of solid tumors in Phase I clinical trial and the recruitment of subjects. Subsequently, Imbioray will work together with various clinical centers and experts to advance this clinical trial with high quality and efficiency, expecting fruitful clinical research results to benefit a large number of patients with advanced solid tumors.

IBR822 Cell Injection is a product developed by Imbioray using proprietary intellectual property. It is the world's first non-viral, non-gene-edited NK cell (CAR-raNK) therapy capable of specifically targeting the Trop2 antigen and possessing the ability to kill tumor cells.Its unique Trop2, a specific antibody targeting tumor antigens, is chemically covalently conjugated to NK cells through a linker, giving IBR822 extremely high safety and powerful tumor cell-killing ability.

Preclinical studies have shown 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. IBR822 Cell Injection has previously been involved in multiple investigator-initiated clinical trials (IIT), achieving excellent results in both safety and efficacy. On April 19, 2024, IBR822 Cell Injection (Acceptance No.: CXSL2400067) successfully obtained the tacit approval for clinical trials from the National Medical Products Administration (NMPA) (Notice No.: 2024LP00986).

IBR822 Cell Injection 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."

IBR822, imbioray’s CAR-NK product targeting Trop2 for the treatment of solid tumors, marks an important step forward in China's cell therapy field. This represents not only a technological innovation but also a triumph for China’s healthcare system.

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