InnoCare Pharma's IBR854 Cell Injection Receives NMPA IND Approval as China's First Non-Genetically Modified CAR-raNK Therapy for Solid Tumors

Imbioray Bio announced on January 31,CompanyIBR854 Cell Injection Receives Implied Approval for Clinical Trials from the National Medical Products Administration (NMPA),IBR854 Injection is the first domestically developed CAR-raNK cell therapy in China that targets solid tumors using a non-gene editing approach. It is an allogeneic, off-the-shelf CAR-raNK cell product derived from peripheral blood., Indicated for the treatment of patients with unresectable locally advanced or metastatic solid tumors who are currently without or intolerant to standard treatments, is a globally pioneering FIC (First in class) product.

About IBR854 Injection

IBR854 Injection is a globally innovative 5T4 antibody and NK cell conjugate product independently developed by Imbioray. It is the first CAR-raNK cell therapy in China targeting solid tumors using a non-gene editing approach. The core structure of this product involves covalently conjugating a tumor antigen 5T4-specific antibody to allogeneic NK cells via a linker.

5T4 antigen is a highly glycosylated cell surface protein found in human placental trophoblasts and various types of human cancer cells, but it is either not expressed or expressed at very low levels in normal tissues of healthy adults. In 80% of solid tumors, including non-small cell lung cancer, epithelial ovarian cancer, breast cancer, pancreatic cancer, cervical cancer, prostate cancer, and colorectal cancer, 5T4 shows a high expression rate. Its broad 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. The data from the investigator-initiated clinical trial (IIT) conducted by Imbioray has already demonstrated excellent safety and potential efficacy against various solid tumors, including non-small cell lung cancer and ovarian cancer, showing very broad application prospects. Its clinical trial application was accepted by the National Medical Products Administration on November 9, 2022, and received tacit approval on January 31, 2023.

About Imbioray

Imbioray is dedicated to addressing the unmet clinical needs in the treatment of tumors and immune-related diseases, primarily focusing on the development of cutting-edge NK cell therapies and cell engagers globally. Imbioray possesses internationally leading tiNK and CAR-raNK cell technology platforms and has advanced processes for large-scale, closed-system in vitro cultivation of NK cells. Based on its proprietary platform technologies, Imbioray has developed several off-the-shelf cell therapy products such as IBR733 and IBR854. Investigator-initiated trials (IITs) have preliminarily demonstrated their safety and efficacy, and multiple new drugs targeting solid tumors and hematologic malignancies will gradually advance into clinical stages.

Imbioray, centered on patients and adhering to the concept of "The Light of Immunotherapy, Igniting New Hope for Life," is committed to becoming a global leader in the NK cell therapy field.

Editor: Dadasiva

Disclaimer: This article is a reprint from Yaozhi.com. The images and text are the original property of the author, and the purpose of the reprint is to convey more information. It does not represent the views of this platform. If there are any issues regarding the content, copyright, or other aspects, please leave a message on this platform, and we will address it promptly.