WestGene to Proceed to Clinical Trials After Obtaining Two IND Approvals for World's First EB Virus-Related mRNA Cancer Therapeutic Vaccine
Overview
WestGene Biopharma is proud to announce that its mRNA therapeutic cancer vaccine, WGc-043, has received two IND approvals, one from the National Medical Products Administration (NMPA) of China and one from the U.S. FDA. This unprecedented achievement marks the world's first mRNA vaccine to receive IND approval for EB virus-related cancers in both the U.S. and China. On August 6, the NMPA Center for Drug Evaluation (CDE) approved the clinical trial application for injectable WGc-043, 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 commercialization of effective, low-toxicity mRNA anti-tumor vaccines worldwide.
About WGc-043
WGc-043 is part of WestGene’s portfolio of over 20 mRNA vaccine candidates. The innovative aspects of WGc-043 include:
1. AI-assisted Antigen Screening:
Using AI to select the broadest and safest protein sequences by introducing a unique immunostimulant into the mRNA molecule.This design activates the patient's antitumor immunity, generating cytotoxic T cells, antigen-specific antibodies, and memory T cells, achieving highly effective anticancer effects comparable to CAR-T and monoclonal antibody combination therapies and preventing tumor recurrence.
2. An Advanced Delivery System:
The novel LNP delivery system, patented in China, the United States, Europe, Canada, Australia and South Africa, has demonstrated its safety and efficacy in clinical trials involving three WestGene proprietary products.
Significant market potential and innovative immunotherapy for EB virus-related cancers
About EBV
- 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 the treatment of EBV-positive solid tumors and hematologic malignancies.
- This novel immunotherapy option, supported 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 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 advancement in mRNA immunotherapy for EBV-positive tumors.
A Complete Pipeline and Progress in Commercialization
- Building on its scientific breakthroughs, WestGene has established five R&D platforms.
- WestGene’s pipeline includes more than 20 products, including mRNA cancer vaccines, preventive mRNA vaccines for infectious diseases, and therapeutic drugs for conditions such as obesity and aging.
- In addition to the IND approval for its cancer product, WestGene’s novel nano-sized adjuvant WGa01 received emergency use authorization in China last year, marking a milestone in domestic production.
WestGene in Future
- As WestGene moves forward, its pioneering spirit and commitment to innovation promise to revolutionize the field of mRNA technology and cancer therapy.
- WestGene is currently open to various forms of commercial collaboration, including but not limited to in-licensing, co-development and technology licensing.
