InnoCare Pharma's Antibody-Conjugated NK Cell Therapy IBR854 Granted Phase II Clinical Approval in Combination with Pazopanib for Advanced Renal Cell Carcinoma

IBR854 Cell Injection is a globally innovative product developed by Imbioray that combines 5T4 antibodies with NK cells through conjugation. It is the first ACC-NK cell therapy in China for solid tumors using non-viral vectors and non-genetic modification methods. The core structure of this product involves covalently conjugating a specific antibody targeting the tumor antigen 5T4 to allogeneic NK cells via a linker. The 5T4 antigen is a highly glycosylated cell surface protein found in human placental trophoblasts and various types of human cancer cells. It shows high positive expression rates in multiple solid tumors, including renal cell carcinoma, epithelial ovarian cancer, non-small cell lung cancer, breast cancer, pancreatic cancer, cervical cancer, soft tissue sarcoma, prostate cancer, and colorectal cancer, but it is not expressed in normal tissues of healthy adults. The broad distribution of 5T4 across various malignant tumors makes it a popular target for cancer immunotherapy.

Imbioray is a clinical-stage and venture capital-backed innovative biopharmaceutical company, primarily focusing on the development of cutting-edge immuno-oncology therapies and innovative drugs for non-cancer immunotherapy, including immune-related diseases, chronic conditions, and CNS disorders. Dr. Zhenwei Miao, the founder of Imbioray, returned to China in 2016 to start the company and established the direction of developing off-the-shelf NK cell-based therapeutics. Imbioray possesses four internationally unique core technology platforms that accelerate its original innovations and has advanced expertise in large-scale, closed-system in vitro NK cell culture. Based on its proprietary antibody-conjugated NK cell platform technology, Imbioray has developed several off-the-shelf cell therapy products, such as IBR854, IBR733, and IBR822. Currently, the Phase II clinical study of IBR854 Cell Injection, the world’s first-of-its-kind treatment for advanced solid tumors, has been approved by the National Medical Products Administration.（NMPA）Imbioray's IBR733 cell injection, the world’s first treatment for acute myeloid leukemia, has completed dose-escalation trials across three dosage groups and demonstrated good safety and efficacy. It is now set to advance to Phase II clinical trials after receiving clinical implied consent. IBR822 cell injection, aimed at advanced solid tumors, is Imbioray’s third antibody-NK cell conjugate drug and entered Phase I clinical trials in September 2024. IBR900 is the fourth off-the-shelf universal NK cell product from Imbioray to receive clinical implied consent from the CDE. Its primary target population for clinical application includes B-cell lymphoma patients aged 65 or older, or those who are intolerant of or have failed current treatments. Imbioray also has multiple NK cell products at various stages of development.