WestGene, a China-based biotech company focused on mRNA technology, has secured the US Food and Drug Administration (FDA) IND approval for its mRNA therapeutic cancer vaccine.
The FDA approval of the cancer vaccine, dubbed WGc-043, represents a significant advance in cancer treatment, supporting patients with advanced EB virus-related cancers.
It is the world`s first approval of an EB virus-related mRNA therapeutic cancer vaccine.
EB virus is highly correlated with malignancies such as NPC, NKTL gastric cancer, lung cancer, liver cancer, oesophageal cancer, breast cancer, cervical cancer, and autoimmune diseases among others.
WestGene said: “With a relentless pursuit of scientific excellence, WestGene`s latest milestone underscores its commitment to advancing the frontiers of biomedicine.
“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.”
According to the company, its WGc-043 vaccine shows promising efficacy, low toxicity, broad applicability, efficient scalability, and cost-effectiveness.
It has already completed investigator-initiated trials (IIT) in NPC and NKTL, showing superior safety and efficacy compared to other mRNA therapeutic cancer vaccines.
Upon launching, WGc-043 is anticipated to provide a new treatment option for patients with advanced EB virus-positive solid tumours and haematologic malignancies, said WestGene.
WestGene added: “With a diverse pipeline of over 20 mRNA-based therapeutic products targeting a spectrum of diseases, WestGene is poised to reshape the biopharmaceutical landscape.
“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 ionizable lipids has been granted in countries and regions such as China, the United States and Europe.”
