FDA Approves IND of Epstein-Barr mRNA Cancer Vaccine WGc-043
If approved, this would mark the first Epstein-Barr virus-related mRNA therapeutic cancer vaccine.
DNA helix enlarged model in bright colors and spots: © Radomir Jovanovic - stock.adobe.com
- The FDA has approved the investigational new drug application of WGc-043, an Epstein-Barr virus-related mRNA cancer vaccine.
- Epstein-Barr virus is correlated with several malignancies, making this approval significant for these disease states.
- WGc-043 has demonstrated promising efficacy and tolerability compared with other mRNA cancer vaccines.
The IND of WGc-043 is now approved by the FDA, and a clinical trial of the agent can now begin.1
The Epstein-Barr virus is highly correlated with malignancies including nasopharyngeal carcinoma (NPC), natural killer T-cell lymphoma (NKTL), gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer, and cervical cancer. Epstein-Barr is also associated with autoimmune conditions including multiple sclerosis and systemic lupus erythematosus.
Trials in NKTL and NPC have already been completed, and WGc-043 showed superiority to other mRNA cancer vaccines. Additionally, in these investigator-initiated trials, WGc-043 has demonstrated promising efficacy, manageable toxicity, broad applicability, scalability, and cost efficacy.
WestGene has 7 products in its antitumor immunotherapy pipeline.2 This vaccine and another targeted at hepatic carcinoma are in phase 1. Gastric cancer, ovarian cancer, breast cancer, and 2 pancreatic cancer vaccines are in early discovery.
REFERENCES:
1. WestGene’s mRNA therapeutic cancer vaccine receives FDA approval. News release. WestGene. May 10, 2024. Accessed May 10, 2024. https://tinyurl.com/2acwcea3 https://tinyurl.com/32xvxa36
2. Product pipeline. WestGene. Accessed May 10, 2024. https://westgenepharma.com/#/ProductLine
FDA Grants RMAT Designation to TSC-100 and TSC-101 for Hematologic Malignancies
June 1st 2024The FDA granted a regenerative medicine advanced therapy designation to TSC-100 and TSC-101 for hematologic malignancies based on encouraging ALLOHA trial data, offering expedited development and review.
Read More
