WestGene Biopharma has secured dual investigational new drug (IND) approvals in the US and China for its mRNA therapeutic cancer vaccine, WGc-043, to treat Epstein-Barr virus (EBV)-related cancers, paving the way for advancing clinical trials.
The therapy obtained IND approval from the National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) in China and the US Food and Drug Administration (FDA) for treating EBV-positive solid tumours and haematological malignancies.
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A Group 1 carcinogen as classified by the International Agency for Research on Cancer (IARC), EBV is linked to more than ten malignancies.
The CDE approved the clinical trial application for the WGc-043 injection, enabling the commencement of Phase I clinical trials.
WGc-043 is part of WestGene’s extensive portfolio, which includes more than 20 mRNA vaccine candidates.
The WGc-043 vaccine leverages AI for antigen screening, selecting the broadest and safest protein sequences. It also introduces a globally unique immuno-enhancer (IE) into the mRNA molecule.
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By GlobalDataThis approach activates the patient’s anti-tumour immunity and generates antigen-specific antibodies, cytotoxic T-cells (CTLs) and memory T-cells.
Furthermore, the vaccine utilises an advanced lipid nanoparticle (LNP) delivery system, which has already demonstrated safety and delivery efficiency in studies of three WestGene products.
The LNP system has been patented in multiple regions, including China, Europe, the US, Canada, Australia, and South Africa.
WGc-043 has already undergone investigator-initiated trials (IITs) for nasopharyngeal carcinoma and natural killer T-cell lymphoma, where it demonstrated efficacy and safety against existing mRNA cancer vaccines.
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