WestGene to Progress Clinical Trials After Dual IND Approvals for First EB Virus-Linked mRNA Cancer Vaccine

CHENGDU, China, Aug. 7, 2024 -- WestGene Biopharma has announced that its mRNA therapeutic cancer vaccine, WGc-043, has secured dual Investigational New Drug (IND) approvals from China's National Medical Products Administration (NMPA) and the US FDA. This achievement signifies a landmark in the development of mRNA vaccines specifically targeting Epstein-Barr Virus (EBV)-related cancers in both the United States and China.

Groundbreaking Milestone in Cancer Immunotherapy

On August 6th, the NMPA's Center for Drug Evaluation (CDE) approved WestGene's clinical trial application for WGc-043 injection, enabling the commencement of Phase I clinical trials. These dual approvals underscore WestGene's proficiency in core mRNA technologies, such as delivery vectors and sequence design, and expedite the global commercialization of effective, low-toxicity anti-tumor mRNA vaccines.

Revolutionary Technology

WGc-043 is part of WestGene's extensive portfolio of over 20 mRNA vaccine candidates. The innovative aspects of WGc-043 include:

1. AI-Assisted Antigen Screening: Utilizing artificial intelligence to select the safest and most comprehensive protein sequences, along with incorporating a unique immuno-enhancer (IE) into the mRNA molecule. This design triggers the patient's anti-tumor immunity, producing cytotoxic T-cells (CTLs), antigen-specific antibodies, and memory T-cells. These responses offer potent anti-cancer effects akin to combined CAR-T and monoclonal antibody therapies, and help in preventing tumor recurrence.

2. Advanced Delivery System: The newly devised LNP delivery system, patented in multiple regions including China, the US, Europe, Canada, Australia, and South Africa, has shown safety and delivery efficiency in clinical trials involving three of WestGene's proprietary products.

Significant Market Potential and Innovative Immunotherapy for EBV-Related Cancers

The Epstein-Barr Virus (EBV), classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC), affects over 90% of the global population and is linked to more than ten types of malignancies such as nasopharyngeal carcinoma, lymphoma, gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer, and cervical cancer. WGc-043 has now received approval in both China and the US for treating EBV-positive solid tumors and hematologic malignancies.

This new immunotherapy option, supported by promising initial data, is anticipated to exhibit excellent safety and anti-tumor activity in forthcoming clinical trials. WGc-043 has already completed investigator-initiated trials (IITs) in nasopharyngeal carcinoma and natural killer T-cell lymphoma, showcasing superior safety and efficacy compared to existing mRNA cancer vaccines. Its introduction is poised to be a significant advancement in mRNA immunotherapy for EBV-positive tumors.

Comprehensive Pipeline and Commercialization Progress

Building on its scientific milestones, WestGene has established five research and development platforms. The company's pipeline includes over 20 products, ranging from mRNA cancer vaccines to mRNA preventive vaccines for infectious diseases, and therapeutic drugs for conditions such as obesity and aging. Besides the IND approval for its cancer product, WestGene's innovative nano-adjuvant WGa01 received Emergency Use Authorization (EUA) in China last year, marking a pivotal step in domestic production.

As WestGene progresses, its pioneering ethos and dedication to innovation are set to transform the field of mRNA technology and cancer therapy. The company is currently open to various forms of commercial collaboration, including pipeline licensing, co-development, and technology licensing.

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