Recently, the clinical trial application (IND) for IX001 TCR-T injection submitted by ImmuXell Biotech was accepted by the CDE. According to publicly available information from ImmuXell Biotech, this is the company’s first investigational product for which a registration clinical trial has been filed. It is a TCR-T cell therapy targeting the KRAS G12V mutation and is being developed to treat pancreatic cancer, often referred to as the "king of cancers."
Screenshot source:CDE Official Website
Public information shows that IX001 TCR-T Injection is the fastest progressing product in ImmuXell Biotech's R&D pipeline. This novel TCR-T cell therapy product had previously completed TCR screening, in vitro functional identification, in vivo efficacy testing, and Investigator-Initiated Trials (IIT) targeting advanced pancreatic ductal adenocarcinoma across multiple clinical centers. The submission of its clinical trial application in China marks a significant advancement for this innovative therapy.
ImmuXell Biotech was founded in January 2021, located in the Kangqiao Industrial Zone of Shanghai's Zhangjiang Science City. It is a clinical-stage biopharmaceutical innovation company focused on the research and development and production of breakthrough immunotherapy drugs, with its main product being novel immune cell formulations targeting solid tumors. In October 2023, ImmuXell Biotech completed an A-round financing of over 100 million yuan.Dr. Hu Hongming, the founder of the company, has深耕多年 in the field of tumor immunology and has extensive experience in basic and clinical research of tumor immunity as well as translational medicine. Several immune therapeutics he originally developed have entered the clinical trial stage. Based on this, ImmuXell Biotech has developed multiple product pipelines with independent intellectual property rights. Among them, the TCR-T cell therapy product targeting KRAS mutations has completed TCR screening, in vitro functional identification, and in vivo efficacy experiments. Investigator-initiated trials (IIT) for advanced pancreatic ductal adenocarcinoma have been carried out across multiple clinical centers, and it is currently in the preparation stage for IND submission. Additionally, other product pipelines of ImmuXell Biotech have also made breakthrough progress, including TCR-NK products that can serve as allogeneic cell therapies, and TCR fusion protein products that can be mass-produced and supplied off-the-shelf.Since its establishment, ImmuXell Biotech has achieved rapid development in platform construction, pipeline building, and product layout. The future goal is to identify shared gene mutations and tumor neoantigens, develop a series of TCR products for treating recurrent and refractory malignant tumors such as pancreatic cancer, integrate personalization with universality in cell therapy products, enhance the efficacy and accessibility of cell therapies, and benefit a broader patient population.In order to allow everyone to better learn and communicate with each other,"WeChat Official Account 'Cell Gene Therapy' Team"A WeChat group for cell therapy and gene therapy has been established. Interested friends can scan the QR code below to add the editor's WeChat and join the cell therapy and gene therapy discussion group.。
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Disclaimer: The content is sourced from ImmuXell Biotech and other official sources. The content of this article aims to share knowledge, all content is for reference only and does not constitute any advice.
