The US Food and Drug Administration (FDA) has approved an IND to conduct a clinical trial that evaluates an mRNA therapeutic cancer vaccine developed by China-based biotech WestGene.
As per the company, this decision marks the world’s first approval to study an mRNA therapeutic to treat Epstein Barr (EB)-virus-related cancers.
The IND approval was based on results from investigator-initiated trials that evaluated the vaccine in patients with nasopharyngeal carcinoma (NPC) and natural killer T cell lymphoma.
EB virus is a part of the herpesvirus family and spreads primarily through bodily fluids. The illness infects more than 90% of the global adult population but does not always lead to cancer, as detailed by Cancer Research UK. The virus has been linked with NPC, gastric cancer, lung cancer and other diseases. In a 10 May press release, WestGene highlighted liver cancer, oesophageal cancer, breast cancer and the aforementioned diseases as potential future indications for the vaccine.
The Chinese company has a pipeline that includes four infectious disease vaccines, seven anti-tumour immunotherapies, and three gene editing treatments amongst other therapies.
In 2010, the FDA approved Dendreon Pharmaceutical’s prostate cancer prophylactic Provenge (sipuleucel-T) as the first marketed therapeutic cancer vaccine. Since its approval, other therapeutic cancer vaccines have entered the US market, with eight being available in the US, according to GlobalData.
GlobalData is the parent company of Pharmaceutical Technology.
In 2021, Pfizer and BioNTech gained the first-ever FDA approval for an mRNA vaccine with Comirnaty (BNT162b2) as a preventative measure against Covid-19. Since this milestone, several preventive and therapeutic mRNA vaccines have been in development for a wide range of conditions.
Some pharmaceutical companies are using the mRNA approach to develop vaccines for other infectious diseases such as respiratory syncytial virus (RSV), Influenza A, Influenza B and cytomegalovirus while companies, including Moderna, Curevac, and Cartesian Therapeutics, are developing therapeutic mRNA vaccines for treating different cancers.
Correction: The headline and first three paragraphs of this article have been updated to reflect that the WestGene received an IND approval to study the vaccine. An earlier version incorrectly stated that the vaccine has been approved.
