WestGene to Advance Clinical Trials Following Dual IND Approvals for World’s First EB Virus-Related mRNA Therapeutic Cancer Vaccine.
On 6 August, the Center for Drug Evaluation (CDE) of the NMPA approved the clinical trial application for WGc-043 injection, allowing the initiation of Phase I clinical trials. This dual approval further validates WestGene’s expertise in core mRNA technologies such as delivery vectors and sequence design, and accelerates the commercialisation of effective and low-toxicity anti-tumour mRNA vaccines worldwide.
EBV, classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC), infects more than 90% of the world’s population and is associated with more than ten malignancies, including nasopharyngeal carcinoma, lymphoma, gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer and cervical cancer. WGc-043 is now approved in both countries for treating EBV-positive solid tumors and hematologic malignancies. This new immunotherapy option, backed by high-quality preliminary data, is expected to demonstrate excellent safety and anti-tumor activity in upcoming clinical trials.
WGc-043 has completed investigator-initiated trials (IITs) in nasopharyngeal carcinoma and natural killer T-cell lymphoma, demonstrating superior safety and efficacy compared to existing mRNA cancer vaccines. Its launch is expected to be a major breakthrough in mRNA immunotherapy for EBV-positive tumours.
