On January 10, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) announced on its official website that tricision's mRNA-DC vaccine for glioblastoma multiforme—Survivin-Targeting DC Cell Injection—had received Clinical Trial Permission (CTP) (Approval No.: 2023LP00065), making it the world's first Survivin-targeting mRNA-DC therapeutic cancer vaccine approved for clinical trials.

Survivin-Targeting DC Cell Injection involves loading antigen mRNA into dendritic cells (DCs) and administering them to patients via intradermal injection and intravenous infusion—inducing antigen-specific CD4+ and CD8+ T lymphocyte responses. This provides a novel therapeutic approach for primary GBM patients to eliminate residual tumor cells post-surgery, prevent recurrence, extend survival, and achieve long-term anti-tumor effects.

This vaccine is the first mRNA-DC cancer vaccine product to receive domestic IND approval after eight years of dedicated R&D since tricision's founding in 2015. In the field of mRNA-encoded DC personalized cancer vaccines in China, tricision is both a pioneer and a frontrunner. Preclinical studies and investigator-initiated exploratory clinical trial data have demonstrated that this mRNA-DC vaccine induces anti-Survivin-specific tumor immune responses with good safety and significant efficacy, markedly extending patient overall survival.

Survivin—selectively expressed in tumor tissues but not in normal differentiated mature tissues—is considered an ideal target for cancer therapy. A Phase IIa clinical trial targeting Survivin for GBM patients, published in the Journal of Clinical Oncology (IF: 50.717) on December 15, 2022, enrolled 64 newly diagnosed GBM patients. After surgical resection and chemoradiotherapy, patients received SurVaxM peptide vaccine injections alongside adjuvant temozolomide chemotherapy. Results showed median progression-free survival (PFS) of 11.4 months and median overall survival (OS) of 25.9 months. SurVaxM stimulated Survivin-specific CD8+ T cell and antibody responses, with clear clinical benefit observed in both MGMT-methylated and unmethylated patients.

Throughout the R&D of Survivin-Targeting DC Cell Injection, tricision applied a novel TriVac technology to functionally modify tumor antigens, effectively enhancing major histocompatibility complex (MHC) class I and II antigen presentation and substantially increasing antigen-specific T cell responses. By loading antigen mRNA into patient-derived autologous DCs—the most potent antigen-presenting cells in the body and the initiators of specific immune responses—this approach achieves high efficiency in antigen uptake, processing, and presentation.

As an innovative Cell and Gene Therapy (CGT) approach, tricision combines high-safety, high-efficiency autologous DCs as mRNA delivery vehicles with proprietary TriVac antigen modification technology—forming a unique R&D strategy. Combined with personalized combination immunotherapy tailored to each patient's condition, integrating cell therapy and gene therapy modalities, this provides dual technical support—product and clinical application for effective treatment of highly malignant GBM.

A recent Phase III non-randomized controlled trial for glioma, conducted by researchers from King's College London and other institutions and published in JAMA Oncology on November 17, demonstrated that DCVax-L (dendritic cell vaccine loaded with autologous tumor lysate) significantly extended median OS in both newly diagnosed and recurrent GBM patients compared to controls—the first such significant result in 17 years for newly diagnosed GBM and 27 years for recurrent GBM.

tricision is also exploring combination approaches—including chemotherapy, antibody drugs, and immune checkpoint inhibitors—to further enhance DC vaccine-specific tumor killing. In early November 2022, a research team including tricision, Xijing Hospital, Air Force Medical University, Johns Hopkins University, and Duke University published a case report demonstrating that combining this mRNA-DC vaccine with anti-PD-1 and Poly I:C resulted in over 5 years of progression-free survival in a Grade IV GBM patient—the first global report of this triple combination immunotherapy achieving the intended goal: "maximizing the possibility of cure."

Notably, tricision's mRNA-DC cancer vaccine targets a panel of tumor-associated antigens not only applicable to glioma but also with positioning in melanoma, head and neck cancer, cervical cancer, lung cancer, gastric cancer, liver cancer, esophageal cancer, colorectal cancer, breast cancer, and more. As more clinical trials advance and data emerge, mRNA-DC cancer vaccines will undoubtedly become a powerful tool in cancer treatment, offering patients safer, more effective, and feasible therapeutic options.

As one of the earliest biopharmaceutical enterprises in China to engage in cellular immunotherapy and mRNA nucleic acid drug technological innovation, tricision upholds the mission of "transforming cancer into a chronic, manageable disease." With its "One Body" (nucleic acid technology) and "Two Wings" (LNP delivery and DC delivery) technology platforms, the Company supports R&D of multiple products across therapeutic cancer vaccine and prophylactic infectious disease vaccine pipelines, striving to promote innovative R&D, manufacturing translation, and clinical application of mRNA and other nucleic acid drugs for the prevention and treatment of malignant tumors, infectious diseases, autoimmune disorders, and genetic diseases.