CHENGDU,
China, Aug. 7, 2024 /PRNewswire/ -- WestGene
Biopharma is proud to announce that its mRNA therapeutic cancer
vaccine, WGc-043, has received dual IND approvals from China's National Medical Products
Administration (NMPA) and the US FDA. This unprecedented
achievement marks the world's first IND-approved mRNA vaccine for
EBV-related cancers in both the United
States and China.
Groundbreaking milestone in cancer immunotherapy
On 6 August, the Center for Drug Evaluation (CDE) of the NMPA
approved the clinical trial application for WGc-043 injection,
allowing the initiation of Phase I clinical trials. This dual
approval further validates WestGene's expertise in core mRNA
technologies such as delivery vectors and sequence design, and
accelerates the commercialisation of effective and low-toxicity
anti-tumour mRNA vaccines worldwide.
Revolutionary technology
WGc-043 is part of WestGene's portfolio of more than 20 mRNA
vaccine candidates. The innovative aspects of WGc-043 include
1. AI-assisted antigen screening: The use of AI to select the
broadest and safest protein sequences with the introduction of a
globally unique immuno-enhancer (IE) into the mRNA molecule. This
design activates the patient's anti-tumour immunity, generating
cytotoxic T-cells (CTLs), antigen-specific antibodies and memory
T-cells, providing highly effective anti-cancer effects comparable
to combined CAR-T and monoclonal antibody therapies, and preventing
tumour recurrence.
2. Advanced delivery system: The newly developed LNP
delivery system, patented in China, the US, Europe, Canada, Australia and South
Africa, has demonstrated safety and delivery efficiency in
clinical trials of three of WestGene's proprietary products.
Significant market potential and Innovative immunotherapy for
EBV-related cancers
The EBV, classified as a Group 1 carcinogen by the International
Agency for Research on Cancer (IARC), infects more than 90% of the
world's population and is associated with more than ten
malignancies, including nasopharyngeal carcinoma, lymphoma, gastric
cancer, lung cancer, liver cancer, esophageal cancer, breast cancer
and cervical cancer. WGc-043 is now approved in both countries for
treating EBV-positive solid tumors and hematologic malignancies.
This new immunotherapy option, backed by high-quality preliminary
data, is expected to demonstrate excellent safety and anti-tumor
activity in upcoming clinical trials.
WGc-043 has completed investigator-initiated trials (IITs) in
nasopharyngeal carcinoma and natural killer T-cell lymphoma,
demonstrating superior safety and efficacy compared to existing
mRNA cancer vaccines. Its launch is expected to be a major
breakthrough in mRNA immunotherapy for EBV-positive tumours.
Comprehensive pipeline and commercialisation progress
Building on its scientific achievements, WestGene has
established five R&D platforms. WestGene's pipeline includes
more than 20 products, including mRNA cancer vaccines, mRNA
preventive vaccines for infectious diseases, and therapeutic drugs
for conditions such as obesity and ageing. In addition to the IND
approval for its cancer product, WestGene's novel nano-adjuvant
WGa01 received EUA in China last
year, marking a significant milestone in domestic production.
As WestGene moves forward, its pioneering spirit and commitment
to innovation promise to revolutionise the field of mRNA technology
and cancer therapy. WestGene is currently open to various forms of
commercial collaboration, including but not limited to pipeline
licensing, co-development and technology licensing.
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SOURCE WestGene