WestGene’s mRNA Therapeutic Cancer Vaccine Receives FDA Approval

CHENGDU, China, May 10, 2024 /PRNewswire/ — WestGene, a biotech company dedicated to mRNA technology, announces a historic milestone with the FDA IND approval of its mRNA therapeutic cancer vaccine, WGc-043. This landmark achievement marks the world’s first approval of an EB virus-related mRNA therapeutic cancer vaccine.

Founded by renowned Dr. Yuquan Wei, Academician of the Chinese Academy of Sciences, and Dr. Xiangrong Song, WestGene has become a driving force in mRNA technology research and innovative drug development. 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 represents a significant advance in cancer treatment, offering new hope to patients with advanced EB virus-related cancers. 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. These are potential indications for WGc-043.

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

As WestGene moves forward, its strategic focus on global collaboration underscores its vision for commercial expansion and market penetration. 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.

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.

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

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