WGc-043

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 Continue Reading WestGene to Advance Clinical Trials Following Dual IND Approvals for World's First EB Virus-Related mRNA Therapeutic Cancer Vaccine 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. SOURCE WestGene

BOSTON, Aug. 1, 2024 /PRNewswire/ -- July 29-31 - The 4th mRNA Therapeutics Summit, one of the most important conferences in the global mRNA industry, took place in Boston, USA. Over 400 industry experts and 65 leading researchers in mRNA development gathered to discuss the latest breakthroughs and expanding applications of mRNA technology. Dr Xiangrong Song, co-founder of Chengdu-based WestGene Biopharma, was invited to attend and share insights into WestGene's pioneering work in mRNA therapeutics, with a particular focus on the world's leading EBV-related cancer mRNA therapeutic vaccine, WGc-043. Continue Reading General Manager Dr Xiangrong Song, General Manager & co-founder of Chengdu-based WestGene Biopharma Highlighting breakthroughs in mRNA therapeutics Dr. Song presented the latest research data and technological advancements of WGc-043, the first mRNA therapeutic vaccine targeting EBV-related tumors to achieve IND milestones in both China and the US. In her keynote presentation, Dr. Song detailed the development of WGc-043, highlighting its safety and efficacy in the treatment of NKT cell lymphoma (NKTCL) and nasopharyngeal carcinoma (NPC). The vaccine utilizes WestGene's breakthrough technologies in mRNA sequence design, novel delivery vectors and scalable manufacturing to ensure high standards of safety and efficacy. During the Summit, Dr Song also discussed the broader challenges and opportunities within the mRNA industry, in particular the need to improve protein expression and delivery system efficiency while reducing production costs. She emphasized the importance of balancing efficacy and safety, a principle that has guided WestGene's R&D efforts from the outset. Dr. Song also highlighted WestGene's collaborative approach, which includes pipeline licensing for access to validated candidates, co-development projects that leverage combined expertise, and technology licensing to enable partners to use WestGene's cutting-edge solutions in their own developments, thus accelerating innovation and therapeutic advancements. The Summit featured in-depth discussions on the latest clinical data, platform development, regulatory insights, and frontier applications of mRNA therapeutics to address various indications, including oncological, rare, and infectious diseases. Dr. Song concluded, "Presenting our research at such platform is very meaningful. mRNA technology offers new hope and options for the treatment of malignancies, and our studies underscore the immense potential of this therapy in terms of safety and efficacy. WestGene Biopharma remains committed to pushing the boundaries of mRNA therapeutics, leveraging its proprietary technologies and collaborative framework to bring transformative therapies to patients worldwide. SOURCE WestGene