WestGene's mRNA therapeutic cancer vaccine receives FDA approval

Published: 10-May-2024

The novel mRNA therapeutic is the first EB virus-related cancer vaccine to be approved by the FDA

WestGene, a biotech company dedicated to mRNA technology, has received FDA IND approval of its mRNA therapeutic cancer vaccine, WGc-043. This achievement marks the world's first approval of an EB virus-related mRNA therapeutic cancer vaccine.

The FDA approval of WGc-043 represents a significant advance in cancer treatment, offering new hope to patients with advanced EB virus-related cancers.


EB and its impact on cancer risk

EB virus is highly correlated with more than ten malignancies, including nasopharyngeal carcinoma (NPC), natural killer T-cell lymphoma (NKTL), gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer, cervical cancer and autoimmune diseases such as multiple sclerosis and systemic lupus erythematosus, which could be potential indications for WGc-043.

WGc-043 shows promising efficacy, low toxicity, broad applicability, efficient scalability and cost effectiveness.

It has already completed investigator-initiated trials (IIT) in NPC and NKTL, demonstrating superior safety and efficacy compared to other publicly available mRNA therapeutic cancer vaccines.

Once successfully launched, WGc-043 will provide a new treatment option for patients with advanced EB virus-positive solid tumours and hematologic malignancies.


WestGene's other initiatives 

WestGene has made significant breakthroughs in the three key technologies of mRNA drug development: mRNA sequence design, delivery vectors and manufacturing. And the patent for ionisable lipids has been granted in countries and regions such as China, the United States and Europe.

The FDA approval of WGc-043 marks a turning point in the fight against cancers and underscores WestGene's commitment to mRNA technology. As WestGene continues to push the boundaries of scientific discovery, its pioneering spirit promises to open new frontiers in cancer therapy and beyond.

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