WGc-043 / WestGene Biopharma - LARVOL DELTA

An exploratory study to assess the safety, immunogenicity, and preliminary anti-tumor activity of the EBV mRNA vaccine (WGc-043 injection) in patients with NK/T cell lymphoma (ESMO 2024) - P1 | "WGc-043 is well tolerated with a safety profile that reflects its potential for favorable patient outcomes. The observed efficacy in the NKTCL cohort suggests a promising clinical benefit. Further research is needed to confirm these findings and to explore the full potential of the vaccine in larger studies."

Clinical • Hematological Malignancies • Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Application of mRNA Immunotherapy Technology in EB Virus Related Diseases (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Xinqiao Hospital of Chongqing

New P1 trial • Gastric Cancer

A Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of the Epstein-Barr virus mRNA vaccine (WGc-043 injection) in patients with Epstein-Barr virus positive relapsed or refractory lymphomas (ChiCTR) - P1 | N=24 | Recruiting | Sponsor: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine / West China Hospital, Sichuan University; WestGene Biopharma Co., Ltd.

IO biomarker • New P1 trial • B Cell Lymphoma • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Natural Killer/T-cell Lymphoma • Oncology • PD-L1

Application of mRNA immunotherapy in EBV associated refractory malignant tumors (ChiCTR) - P=N/A | N=49 | Recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University | Not yet recruiting ➔ Recruiting | Phase classification: P1 ➔ PN/A | N=18 ➔ 49

Enrollment change • Enrollment open • Phase classification • Gastric Cancer • Natural Killer/T-cell Lymphoma • Solid Tumor

Evaluation of WGc-043 Injection in Advanced Solid Tumors: Phase I Study (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P1 trial • Oncology • Solid Tumor

Application of mRNA Immunotherapy Technology in Epstein-Barr Virus-related Refractory Malignant Tumors (clinicaltrials.gov) - P1 | N=19 | Active, not recruiting | Sponsor: West China Hospital | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2025 ➔ May 2025 | Trial primary completion date: Jan 2024 ➔ May 2025

Enrollment closed • Trial completion date • Trial primary completion date • Epstein-Barr Virus Infections • Solid Tumor

Mechanistic Study of EBV mRNA Vaccine (WGc-043) in EBV-Positive Relapsed/Refractory Lymphoma (clinicaltrials.gov) - P=N/A | N=15 | Not yet recruiting | Sponsor: Ruijin Hospital

New trial • Epstein-Barr Virus Infections • Hematological Malignancies • Lymphoma • Oncology

WestGene Biopharma Presents Groundbreaking mRNA Vaccine Data at ESMO 2024 (PRNewswire) - "WestGene Biopharma...presented the latest clinical data for its EBV-positive tumour mRNA vaccine, WGc-043, during a mini-oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024....Interim clinical data presented at ESMO 2024 highlighted the vaccine's ability to activate the patient's immune system, leading to the production of cytotoxic T cells, antigen-specific antibodies and memory T cells that target and destroy cancer cells. This novel mechanism offers a promising alternative to conventional CAR-T and monoclonal antibody therapies and also aims to prevent tumor recurrence, providing a triple benefit, particularly for patients with late-stage nasopharyngeal carcinoma and NK/T cell lymphoma."

P1 data • Nasopharyngeal Carcinoma • Non-Hodgkin’s Lymphoma

Safety, tolerability, and immunogenicity of WGc-043 in subjects with EBV-positive cancers: Results from an investigator-initiated trial. (ASCOBT 2024) - P1 | "This exploratory study underscores the safety and potential efficacy of WGc-043 as an mRNA vaccine for EBV-associated cancers, demonstrating its ability to induce specific immune responses and achieve substantial disease control in a challenging patient population, although further studies in larger clinical trials are needed. These results not only support the advancement of WGc-043 as a candidate for immunotherapy in EBV-positive cancers, but also highlight the translational potential of mRNA vaccine technology in the oncology landscape."

Clinical • IO biomarker • Epstein-Barr Virus Infections • Immunology • Infectious Disease • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • IFNG

WestGene to Advance Clinical Trials Following Dual IND Approvals for World’s First EB Virus-Related mRNA Therapeutic Cancer Vaccine (PRNewswire) - "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....Its launch is expected to be a major breakthrough in mRNA immunotherapy for EBV-positive tumours."

New P1 trial • Oncology • Solid Tumor

WestGene leads the way in mRNA innovation at the 4th mRNA Therapeutics Summit (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....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."

Clinical • Head and Neck Cancer • Hematological Malignancies • Lymphoma • Nasopharyngeal Carcinoma • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

WestGene's mRNA Therapeutic Cancer Vaccine Receives FDA Approval (PRNewswire) - "WestGene...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....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."

IND • Breast Cancer • Cervical Cancer • Esophageal Cancer • Gastric Cancer • Hematological Malignancies • Immunology • Liver Cancer • Lung Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor