FDA Approves IND for mRNA Vaccine for Epstein-Barr Virus-Related Cancer

Editor's note: An earlier version of this story incorrectly stated that the FDA had approved WGc-043. The FDA has approved the Investigational New Drug (IND) application for the vaccine.

The FDA has approved the IND for WGc-043, the first and only Epstein-Barr virus-related mRNA cancer vaccine.¹

This approval “represents a significant advance in cancer treatment, offering new hope to patients with advanced [Epstein-Barr virus-related cancers,” noted a company press release.¹ Epstein-Barr virus, a type of herpes virus that causes infectious mononucleosis, increases an individual’s risk of developing several types of cancers, including nasopharyngeal cancer, natural killer T-cell lymphoma, esophageal cancer, breast cancer, cervical cancer, and stomach cancer. It is also associated with autoimmune conditions such as multiple sclerosis and systemic lupus erythematosus.²

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The vaccine has demonstrated positive efficacy, low toxicity, and broad applicability; it has also been shown to be cost effective. Investigator-initiated trials of the WGc-043 vaccine in nasopharyngeal cancer and natural killer T-cell lymphoma showed “superior safety and efficacy compared to other publicly available mRNA therapeutic cancer vaccines.”¹

Epstein-Barr infection is lifelong, although symptoms typically abate after the first few weeks. The virus infects B lymphocites and stays present in these cells. Approximately 90% of people in the US are infected with Epstein-Barr virus by age 35.^1,3

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Currently, there are no treatments or preventive vaccines for Epstien-Barr virus. However, Moderna is currently investigating mRNA-1189, an mRNA vaccine for Epistein-Barr virus.³ The phase 1 Eclipse clinical trial (NCT05164049) is specifically evaluating the safety and immune response of this vaccine. Participants include healthy volunteers aged 12 to 30 years who will receive 3 injections of either mRNA-1189 or placebo. The trial is anticipated to continue through June 2025.

READ MORE: Immunization Resource Center

References

1. WestGene’s mRNA therapeutic cancer vaccine receives FDA approval. News release. WestGene. May 10, 2024. Accessed May 10, 2024. https://www.prnewswire.com/news-releases/westgenes-mrna-therapeutic-cancer-vaccine-receives-fda-approval-302142067.html

2. Serani S. FDA approves Epstein-Barr mRNA cancer vaccine WGc-043. Targeted Oncology. May 10, 2024. Accessed May 10, 2024. https://www.targetedonc.com/view/fda-approves-epstein-barr-mrna-cancer-vaccine-wgc-043

3. A clinical trial of an Epstein-Barr virus (EBV) vaccine in young adults. Moderna. Accessed May 10, 2024. https://trials.modernatx.com/study/?id=mRNA-1189-P101