"World's First" IND Approval for Epstein-Barr mRNA Cancer Vaccine
The FDA has granted investigational new drug (IND) approval to an mRNA vaccine for Epstein-Barr virus (EBV)-related cancers.
The jab, called WGc-043, is developed by Chinese Biotech WestGene Biopharma who have been developing mRNA-based therapeutics for over a decade. They have called this the "world's first" approval of its kind.
The IND approval means that WestGene can begin in-human clinical trials of their vaccine for patients with EBV-related cancers.
EBV has been highly linked to over ten forms of cancer including gastric, liver, oesophageal, breast and cervical cancer, among others. This wide range of malignant implications means an expanded variety of target indications for the vaccine.
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According to Cancer Research UK, EBV is present in about 95% of adults and generally asymptomatic in most. However, the virus is responsible for around 200,000 cases of cancer per year. Incidents of nasopharyngeal carcinoma (NPC) are particularly common in China and Southeast Asia because of the virus.
Investigator-initiated trials (IITs) have already shown that WGc-043 has promising safety and efficacy for patients with NPC and natural killer T-cell lymphoma (NKTL).
Back in January 2024, Dr. Xiangrong Song, a Co-founder at WestGene, had previously presented data from this IIT trial at the 3rd mRNA-Based Therapeutics Summit. The company said that WGc-043 "has overcome significant hurdles such as tumor vaccine efficacy and immunogenicity. Its rapid production and cost-effectiveness, coupled with its high efficacy and low toxicity, significantly improve patient accessibility, and provide a more viable treatment option for a broader patient base."
WestGene continue to use their platform to develop their portfolio of over 20 patented mRNA therapies for a variety of indications. They were founded by Dr. Xiangrong Song and Dr. Yuquan Wei, both Professors and Doctoral Supervisors at Sichuan University, holders of multiple national and provincial positions, and serving on the Editorial boards of medical journals. The company is supported by the National Key Laboratory of Biotherapy at Sichuan University.Related Resources
