JW Therapeutics, an independent and innovative biotechnology company specializing in the development, manufacture and commercialization of cellular immunotherapy, announced the start of a phase I clinical trial of JWATM204 in patients with hepatocellular carcinoma (HCC) at an advanced stage.
Primary liver cancer, also known as liver carcinoma, is one of the most common gastrointestinal diseases worldwide. Approximately 85–90% of liver cancers are hepatocellular carcinomas (HCC). According to the results of the GLOBOCAN study conducted in 2020, 906,000 new cases of this disease and 830,000 deaths are diagnosed annually in the world, which brings it to the sixth line among malignant neoplasms in terms of prevalence and the 3rd in terms of mortality. Five-year survival rate in North America was 15-19%. A particularly high incidence of liver cancer has been recorded in China. Liver cancer ranked as the 4th most common malignant neoplasm in China and the 2nd leading cancer death, with a five-year survival rate of only 12.1%. The morbidity-to-mortality ratio of 1:0.9 indicates a poor prognosis for the development of liver cancer, which posed a serious threat to the life and health of the Chinese population , In recent years, immunotherapy represented by immune checkpoint inhibitors has achieved an overall response rate (ORR) of 17–20% and 15–20% for first and second line therapy, respectively, in patients with HCC 1. However, unresolved issues remain, including disease progression after treatment and alternative treatment regimens due to relapse.
This first human trial of JWATM204 aims to evaluate the safety, tolerability, dose-limiting toxicity, and pharmacokinetic profile of JWATM204 in adult patients with advanced CHC, and to investigate the antitumor activity of JWATM204 in a targeted patient population. Promising preclinical results have demonstrated the potential for clinical trials of JWATM204 for the treatment of HCC.
Based on the ARTEMIS ® T-cell platform, JWATM204 is an innovative immune T-cell therapy targeting glypican-3 (GPC-3) with high affinity and specificity for the monoclonal antibody GPC-3. JW Therapeutics obtained from Eureka the rights to develop, manufacture and commercialize JWATM204 in China and member countries of the Association of Southeast Asian Nations, and also carried out a technical transfer and modernization of facilities and equipment at the production facility in Waigaoqiao.
“Solid tumors are a critical element of JW Therapeutics’ product development strategy. Using our technology and product development platform, we are currently developing groundbreaking cellular immunotherapy products for the treatment of high-morbidity solid tumors in China, and are also entering clinical trials.”
James Li, JW Therapeutics Co-Founder, Chairman and CEO