At the start of 2024, the world's first Survivin-targeting Messenger RNA-Dendritic Cell (mRNA-DC) tumor vaccine for the treatment of Glioblastoma Multiforme (GBM), developed by Beijing tricision Biotech Co., Ltd. (tricision), completed its preparatory phase with a dendritic cell (DC) apheresis training session at the Neurosurgery Department of Beijing Tiantan Hospital, Capital Medical University. This milestone marks the transition of the clinical trial into its substantive execution phase.

GBM is the most common primary malignant tumor of the central nervous system, with an exceptionally high malignancy that has earned it the grim label of "the new king of cancers." According to the National Health Commission's 2022 guidelines, the annual incidence of glioma in China is 5–8 per 100,000 people, with a 5-year mortality rate that ranks among the highest of all systemic tumors, and high rates of recurrence within the first year post-surgery. Despite advances in treatment, progress in GBM therapy has been limited, and patient survival remains poor, with a median Overall Survival (OS) of only 13.5 months—making it one of the most challenging conditions in neurosurgery.

The drug, approved by the Center for Drug Evaluation (CDE) for the indication of "postoperative treatment of primary GBM," is a first-in-class therapeutic approach. It is China's first cancer vaccine to use DCs as a delivery vehicle for Tumor-Associated Antigens (TAAs), delivering genetic information (mRNA) encoding TAAs into the patient's body to stimulate a specific immune response that effectively eliminates tumor cells.

DC Cells: The Command Center of the Immune System

Dendritic Cells (DCs) are the most potent antigen-presenting cells in the human body. They are the initiators of specific immune responses and the only professional antigen-presenting cells capable of activating naïve T cells, placing them at the center of the immune response cascade. The training session was designed to ensure standardization and precision in DC cell blood sample collection and separation for the clinical project, thereby improving the accuracy and reliability of the trial, enhancing overall study efficiency and quality, and ensuring patient safety—all in preparation for the successful enrollment and apheresis of the first patient.

Early Clinical Exploration: A Foundation of Promise

tricision pioneered the clinical application of mRNA and DC technology for GBM treatment in China as early as 2016. Exploratory clinical studies conducted at Guangdong Sanjiu Brain Hospital and Xijing Hospital of Air Force Medical University have shown that the product can significantly extend patient OS, with one patient reported to have achieved an OS exceeding 60 months (5 years)—a remarkable and encouraging outcome.

As China's first mRNA-DC tumor vaccine to receive registered clinical trial approval, the product has now passed the ethics review at Beijing Tiantan Hospital and, with strong support from the Neurosurgery Department, has fully initiated its Phase I Clinical Trial (CT).