On June 28, 2023, Imuno Pharm successfully developed a new generation of anti-tumor drug called IM83 Chimeric Antigen Receptor T Cell Injection (IM83 CAR-T Cell Injection, referred to as 'IM83' for short). This drug has obtained the clinical trial license from the National Medical Products Administration for the treatment of advanced liver cancer. As a strategic partner of Imuno Pharm, Daxiang Biotech provides CAR-T drug efficacy evaluation services based on tumor organoid. This allows for the quick and accurate screening of effective candidate CAR-T drugs. The relevant data from this evaluation are included in the IND application data package. As of now, IM83 has become the first cell gene therapy (CGT) drug in China to be approved by CDE using organoid chip data.
In recent years, cellular immunotherapy has gained significant attention in the field of tumor treatment. CAR-T cell drugs, in particular, have demonstrated their effectiveness in treating hematological tumors and are now showing promise in the treatment of solid tumors. However, evaluating the true efficacy of cell therapy drugs in patients during the non-clinical research stage poses challenges due to species differences and immune deficiency. Traditional animal models are unable to accurately assess the effectiveness of these drugs.
In 2021, the CDE released the 'Technical Guidelines for Non-clinical Research of Gene-Modified Cell Therapy Products'. According to these guidelines, when there is a lack of relevant animal models, cell- and tissue-based models (such as two-dimensional or three-dimensional tissue models, organoids, and microfluidics) can be used. These models provide valuable supplementary information for assessing the efficacy and safety of gene-modified cell therapy products.
Humanized and highly advanced organoids on chips models have emerged as a crucial technology platform for evaluating cell therapy drugs and conducting translational medicine research.
In September 2022, Daxiang Biotech and Imuno Pharm entered into a strategic cooperation agreement to expedite the development of novel anti-tumor drugs using organoid on chips. Both parties have agreed to collaborate closely in various areas, including the development of cell gene drugs, leveraging their respective strengths to accelerate the research and development of innovative drugs while significantly reducing the cost and time required for drug development. Apart from evaluating the effectiveness of cell drugs using the organoids on chips platform, the two parties have also conducted research on its safety and plan to collaborate further in the future for the development of new pipelines.
The collaboration between Daxiang Biotech and Imuno Pharm, utilizing the innovative organoids on chips to assess the effectiveness of IM83 and obtaining clinical approval, is a significant milestone in the strategic partnership between the two entities. Daxiang Biotech is eager to collaborate with additional pharmaceutical companies in order to advance the utilization of organoids on chips across all stages of drug development. This will enhance the success rate and expedite the overall drug development process.