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

Disclaimer: Due to limited expertise, errors are inevitable, and some information may not be the most up-to-date. Comments pointing out any issues are welcome. This article is only an introduction to medical and health-related drugs, not a recommendation of treatment options (if involved); it does not constitute any investment advice.

On September 13, 2024, the Phase I clinical trial initiation meeting for IBR822 Cell Injection, independently developed by Imbioray (Hangzhou) Biopharmaceutical 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, in collaboration with renowned clinical research centers in China such as Jiaxing First Hospital and Fuyang Cancer Hospital.

The kick-off 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 the clinical research teams from relevant departments, the Imbioray Clinical Medicine Team, and the CRO ClinChoice Enterprise Management and Operations Team to attend. The 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. The participants thoroughly discussed and analyzed the key points and difficulties of this trial and proposed many 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.

About Zhejiang Cancer Hospital

The Zhejiang Cancer Hospital, established in 1963, is one of the earliest four cancer hospitals founded after the establishment of the People's Republic of China. In the first national public hospital performance assessment released in 2020, it ranked 3rd among cancer specialty hospitals in China. In December 2018, the hospital formally established a Phase I Clinical Trial Ward, which began operating as an independent ward in July 2020. This ward mainly focuses on Phase I clinical trials of anti-cancer drugs and is the only professional Phase I clinical trial ward for oncology in Zhejiang Province. It is also one of the earliest such facilities established in China and one of the most important Phase I clinical research centers in the country.

About IBR822 Cell Injection

IBR822 Cell InjectionIt is the world's first product developed by Imbioray using its proprietary intellectual property.Non-viral Non-genetic ModificationThe EnergySpecifically Targeting Trop2Antigen and capable of killing tumor cellsNK Cells (CAR-raNK)Product. Its unique specific antibody Trop2, which targets tumor antigens, is linked to NK cells through a linker.Chemical Covalent Conjugation, making IBR822 have extremely highSafetyAnd powerfulTumor Cell Killing Ability。

Preclinical studies show, IBR822 Cell Injection forNon-small cell lung cancer, gastrointestinal tumors, breast cancer, prostate cancer, ovarian cancer, cervical cancerAll tumor cell lines haveSignificant Killing Effect. IBR822 cell injection has previously been involved in several investigator-initiated studiesClinical Trial (IIT), and achieved excellent resultsSafetyEffectiveness andThe result. April 19, 2024,IBR822 Cell Injection(Application No.: CXSL2400067),Successfully Obtained Clinical Trial Implied Permission from the National Medical Products Administration (NMPA)(Notification 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 utilize NK cells."Directly lyse target cells", "Secrete cytokines", "Induce apoptosis", "ADCC", "Immune checkpoint pathway"The five major mechanisms of action exert cytotoxic effects on tumor cells.

IBR822 Targeting Trop2 for the Treatment of Solid Tumors CAR-NK Product, marking an important step for China in the field of cell therapy. This is not only a technological innovation but also a victory for China's healthcare system.

Source: imbioray