YingBaiRui's IBR854 Cell Injection Receives CDE IND Acceptance for Second Solid Tumor Indication – China’s First Non-Genetically Modified Universal CAR-raNK Therapy

Dec 26, 2024 16:32 CST Updated 16:32

iMBioRay

CAR-NK Cell Therapy Drug Developer

Recently, according to the announcement on the CDE official website, Imbioray (Hangzhou) Biopharmaceutical Co., Ltd. (referred to as "Imbioray") submitted"IBR854 Cell Injection" (Acceptance No.: CXSL2400891) New Drug Clinical Trial Application (IND) Has Been AcceptedThis is the IND application for IBR854 cell injection targeting the second indication, with specific details of the indication yet to be disclosed.

▲ Image Source: CDE Official Website

IBR854 cell injection, independently developed by Imbioray, is a globally innovative investigational drug that combines 5T4 antibodies with NK cells. It is China's first CAR-raNK therapy targeting solid tumors using a non-gene editing approach. The core structure of this investigational drug involves covalently conjugating a tumor antigen 5T4-specific antibody to allogeneic NK cells through a linker.

5T4 antigen is a highly glycosylated cell surface protein, present in human placental trophoblasts and various types of human cancer cells, but not expressed or very lowly expressed in normal tissues of healthy adults. It can be found in non-small cell lung cancer, epithelial ovarian cancer, breast cancer, pancreatic cancer, cervical cancer, prostate cancer, colorectal cancer, etc.80% of solid tumors have a high expression rate of 5T4.Its wide distribution across multiple cancer types makes 5T4 an ideal target for cancer immunotherapy.

IBR854 can specifically bind to tumor cells expressing the 5T4 target antigen, thereby achieving targeted recognition and killing of tumor cells. Data from investigator-initiated clinical trials (IIT) conducted by Imbioray have shown promising results.Excellent safety and potential efficacy against various solid tumors, including non-small cell lung cancer and ovarian cancer。

Notably, on January 31, 2023, Imbioray's IBR854 Cell Injection received the CDE clinical trial implied permission, intended for use inTreatment for patients with unresectable locally advanced or metastatic solid tumors who are currently without or intolerant to standard treatmentAccording to publicly available online information, the IBR854 cell injection for advanced solid tumors is about to enter Phase II clinical trials.

Based on the available information, it can be reasonably speculated that the IND application for the IBR854 cell injection is another new indication for solid tumors. Moreover, the IBR854 injection is developed based on Imbioray's proprietary antibody-conjugated NK cell platform technology. Several other cell therapy drugs under research, such as IBR733 and IBR822, are also developed based on this platform.

Currently,The World's FirstIBR733 Cell Injection for Acute Myeloid Leukemia Has Completed the Second Dose Group Phase of Phase I Clinical Trial. IBR822 Cell Injection for Advanced Solid Tumors is Imbioray's third Antibody-NK Cell Conjugate drug under research, which has been ongoing this year.Entered Phase I clinical trial in SeptemberTrial. IBR900 is the fourth product of Imbioray to receive clinical trial approval by CDE.Universal NK Cell Product, The main target population for clinical application isB-cell lymphoma patients aged 65 or above, or tumor patients who are intolerant to or have failed existing treatmentsImbioray has multiple NK cell drugs under development at various stages.

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SoundMing: The content is sourced from the company's official website and the CDE official website, this articleAim to share knowledge, all content is for reference only and does not constitute any advice.