Primary hepatic cancer is a common malignant tumor of the digestive system worldwide, with high malignancy and hepatic prognosis. As the most common pathological type, HCC accounts for 85% to 90% of primary liver cancer. China has the highest incidence rate and mortality rate of primary hepatic cancer in the world, with 466,000 new cases and 422,000 deaths each year. The median progression-free survival of patients after first- and second-line current treatment is approximately 6 months, providing limited benefits for patients. Therefore, there is an urgent need to develop an effective treatment for patients with recurrent and metastatic advanced HCC.

This first-in-human study of JWATM214 aims to evaluate the safety and tolerability, determine the recommended phase 2 dose (RP2D), and evaluate the pharmacokinetic profile and preliminary efficacy of JWATM214 in adult patients with GPC-3-expressing advanced HCC.

As overexpressed in many malignant tumors including HCC, glypican-3 (GPC-3) has become a target for the diagnosis and treatment of HCC. The feasibility of T-cell immunotherapy targeting GPC-3 for the treatment of HCC patients has been preliminarily demonstrated and reported. JWATM214 is an autologous T-cell immunotherapy candidate drug targeting GPC-3, independently developed by JW Therapeutics based on the ARTEMIS^® platform of Eureka and Lyell's T cell anti-exhaustion technology. It combines the high affinity and specificity of GPC-3 monoclonal antibody, and added cJun protein regulation based on JWATM204 to delay T cell exhaustion, to achieve more durable and superior anti-tumor activity, potentially providing novel treatment for GPC-3-expressing advanced HCC patients.

JW Therapeutics reached agreements with Eureka and Lyell in 2020, and in-licensed the rights of Eureka's ARTEMIS^® technology and Lyell's T cell anti-exhaustion technology to develop, manufacture and commercialize products in China (including mainland China, Hong Kong, Macao and Taiwan) and the member countries of the Association of Southeast Asian Nations.