WestGene Biopharma is proud to announce that its innovative mRNA therapeutic cancer vaccine, WGc-043, has received dual Investigational New Drug (IND) approvals from both China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). This unprecedented achievement marks the world's first mRNA vaccine for Epstein-Barr Virus (EBV)-related cancers to be IND-approved in both the United States and China.

Revolutionary Advancement in mRNA Technology

WGc-043 represents a significant leap forward in the field of cancer immunotherapy, building on WestGene’s expertise in mRNA technologies such as delivery vectors and sequence design. With the green light from regulatory authorities, WestGene is now poised to advance clinical trials, moving toward the commercialization of an effective, low-toxicity anti-tumor mRNA vaccine.

WGc-043 stands out for its:

1. AI-Assisted Antigen Screening: Leveraging artificial intelligence, WestGene has identified the broadest and safest protein sequences for inclusion in the vaccine. A globally unique immuno-enhancer (IE) has been incorporated into the mRNA molecule to activate robust anti-tumor immunity. This design stimulates the generation of cytotoxic T-cells (CTLs), antigen-specific antibodies, and memory T-cells, offering anti-cancer effects comparable to combined CAR-T and monoclonal antibody therapies, while also preventing tumor recurrence.

2. Advanced Delivery System: The vaccine employs a newly developed lipid nanoparticle (LNP) delivery system, patented across multiple regions including China, the U.S., Europe, Canada, Australia, and South Africa. This system has demonstrated exceptional safety and delivery efficiency in clinical trials for three of WestGene's proprietary products.

Significant Market Potential and Innovative Immunotherapy for EBV-Related Cancers

Epstein-Barr Virus, a Group 1 carcinogen as classified by the International Agency for Research on Cancer (IARC), infects over 90% of the global population and is linked to more than ten types of malignancies, including nasopharyngeal carcinoma, lymphoma, gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer, and cervical cancer. WGc-043, now approved in both China and the United States, is set to target EBV-positive solid tumors and hematologic malignancies. Early clinical trials have shown promising safety and anti-tumor activity, positioning WGc-043 as a potential breakthrough in mRNA immunotherapy for EBV-positive cancers.

WGc-043 has already completed investigator-initiated trials (IITs) for nasopharyngeal carcinoma and natural killer T-cell lymphoma, where it demonstrated superior safety and efficacy compared to existing mRNA cancer vaccines. Its introduction is expected to significantly advance the landscape of EBV-related cancer treatment.

Expanding Pipeline and Strategic Commercialization

WestGene Biopharma continues to push the boundaries of scientific innovation, with a robust R&D pipeline encompassing over 20 products, including mRNA cancer vaccines, mRNA preventive vaccines for infectious diseases, and therapeutic drugs targeting conditions such as obesity and aging. In addition to WGc-043, WestGene’s novel nano-adjuvant, WGa01, received Emergency Use Authorization (EUA) in China last year, underscoring the company’s commitment to advancing domestic production capabilities.

As WestGene advances its pipeline, the company remains open to various forms of commercial collaboration, including pipeline licensing, co-development, and technology licensing. With its pioneering spirit and dedication to innovation, WestGene is poised to revolutionize the field of mRNA technology and cancer therapy.