JW Therapeutics Announces Initiation of Clinical Study of JWATM214 in Patients with Advanced Hepatocellular Carcinoma

SHANGHAI, Feb. 28, 2023 /PRNewswire/ -- JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced the initiation of clinical study of JWATM214 in patients with advanced hepatocellular carcinoma (HCC) and the first patient infusion.

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.

References

Di-Yang Xie, Zheng-Gang Ren, Jian Zhou, Jia Fan, and Qiang Gao. 2019 Chinese clinical guidelines for the management of hepatocellular carcinoma: updates and insights. Hepatobiliary Surg Nutr. 2020 Aug; 9(4): 452–463.

Shi, D., Shi, Y., Kaseb, A.O., Qi, X., Zhang, Y., Chi, J., Lu, Q., Gao, H., Jiang, H., Wang, H., et al. (2020). Chimeric Antigen Receptor-Glypican-3 T-Cell Therapy for Advanced Hepatocellular Carcinoma: Results of Phase I Trials. Clin Cancer Res 26, 3979-3989. 10.1158/1078-0432.CCR-19-3259.

About JWATM214

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.

About JW Therapeutics

JW Therapeutics (HKEX: 2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, and is committed to becoming an innovation leader in cell immunotherapy. Founded in 2016, JW Therapeutics has built a world-class platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and worldwide, and leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit www.jwtherapeutics.com/.

Forward-Looking Statements

The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEX) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: www.jwtherapeutics.com/en/forward-looking-statements/.

SOURCE JW Therapeutics