Clinical Trials

tricision’s proprietary Survivin-targeting dendritic cell (DC) injection has achieved a key milestone, as the CDE has listed the product’s clinical trial information (Registration No. CTR20261465), paving the way for the initiation of its Phase II trial.

                                                                       CDE Clearance for Phase II Trial

Phase II Clinical Trial Introduction (Polished Official Version)

A Phase II Clinical Trial: First in China, Benchmarking Against International Standards

The Phase II trial focuses on newly diagnosed glioblastoma (GBM, WHO Grade IV) and will evaluate the vaccine’s efficacy and safety. It marks the first advancement of a Survivin-targeting immunotherapeutic vaccine into Phase II clinical development in China.

Survivin is widely recognized as a core tumor antigen closely linked to tumor proliferation, recurrence, and drug resistance. Globally, only SurVaxM — a peptide vaccine developed by MimiVax, Inc. (USA) that targets the same antigen — has advanced to Phase IIb. Leveraging its proprietary mRNA-DC technology platform, tricision's vaccine underscores China’s growing capabilities in cellular immunotherapy R&D.

This milestone delivers a potentially accessible, safe, and effective treatment option for GBM, a disease with limited therapeutic alternatives under current standard-of-care regimens. As the clinical program progresses and its scope of application expands, the candidate is well-positioned to reshape the global GBM treatment landscape and provide patients with new prospects for long-term survival and durable disease control.

Promising Clinical Data: Dual Breakthroughs in Long-Term Survival and Safety

Published clinical data demonstrate encouraging clinical outcomes:

·   Median Progression-Free Survival (PFS) of over 26 months, with the longest observed Overall Survival (OS) exceeding 101 months

·   Adverse events (AEs) were limited to mild fever, with no dose-limiting toxicity (DLT) or serious adverse events (SAEs) observed across studies

·   Key study findings have been published in authoritative international journals, including Cancer Immunology, Immunotherapy and Biomedicine & Pharmacotherapy.