CHENGDU, China, Aug. 8, 2024. WestGene Biopharma is proud to announce that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals from China’s National Medical Products Administration (NMPA) and the US FDA. This unprecedented achievement marks the world’s first IND-approved mRNA vaccine for EBV-related cancers in both the United States and China.
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.
Revolutionary technology
WGc-043 is part of WestGene’s portfolio of more than 20 mRNA vaccine candidates. The innovative aspects of WGc-043 include
1. AI-assisted antigen screening: The use of AI to select the broadest and safest protein sequences with the introduction of a globally unique immuno-enhancer (IE) into the mRNA molecule. This design activates the patient’s anti-tumour immunity, generating cytotoxic T-cells (CTLs), antigen-specific antibodies and memory T-cells, providing highly effective anti-cancer effects comparable to combined CAR-T and monoclonal antibody therapies, and preventing tumour recurrence.
2. Advanced delivery system: The newly developed LNP delivery system, patented in China, the US, Europe, Canada, Australia and South Africa, has demonstrated safety and delivery efficiency in clinical trials of three of WestGene’s proprietary products.
Significant market potential and Innovative immunotherapy for EBV-related cancers
The 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.
Comprehensive pipeline and commercialisation progress
Building on its scientific achievements, WestGene has established five R&D platforms. WestGene’s pipeline includes more than 20 products, including mRNA cancer vaccines, mRNA preventive vaccines for infectious diseases, and therapeutic drugs for conditions such as obesity and ageing. In addition to the IND approval for its cancer product, WestGene’s novel nano-adjuvant WGa01 received EUA in China last year, marking a significant milestone in domestic production.
Posted: August 2024
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