JW Therapeutics Announces Initiation of Clinical Study of JWATM204 in Patients with Advanced Hepatocellular Carcinoma

SHANGHAI, July 4, 2022 /PRNewswire/ -- JW Therapeutics (HKEX: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced the initiation of phase I clinical study of JWATM204 in patients with advanced hepatocellular carcinoma (HCC).

Primary liver cancer (PLC), also known as liver carcinoma, is one of the common gastrointestinal malignancies worldwide. Approximately 85%-90% of liver cancers were hepatocellular carcinoma (HCC)¹. GLOBOCAN survey in 2020 found that 906 thousands of new cases were diagnosed and 830 thousand deaths world-wide each year, which took the sixth position out of malignancies and the 3^rd leading cause of cancer death². The 5-year survival rate was 15%-19% in North America³. The disease burden of liver cancer was particularly high in China. Liver cancer was the 4^th most common malignancies, the 2^nd leading cause of cancer deaths, and the 5-year survival rate was only 12.1% in China³. The ratio of 1:0.9 between the incidence and mortality indicated the poor prognosis of liver cancer³, which seriously threatened the lives and health of the Chinese population^,[1]^,[2]^,. In recent years, immunotherapies represented by immune checkpoint inhibitors have achieved Overall Response Rates (ORRs) of 17%-20% and 15%-20% for the first- and second- line therapies respectively in HCC patients¹. Nevertheless, there are still challenges including post-treatment disease progression and alternative regimens in response to relapse.

This first-in-human study of JWATM204 aims to evaluate the safety, tolerability, dose limited toxicity and pharmacokinetic profile of JWATM204 in adult subjects with advanced HCC, and also to explore the anti-tumor activity of JWATM204 in the target population. The promising preclinical results showed continued clinical development potential of JWATM204 for the treatment of HCC.

JWATM204, with high affinity and specificity of GPC-3 monoclonal antibody and developed at the ARTEMIS^® T-cell platform, is an innovative immune T-cell therapy targeting glypican-3 (GPC-3). JW Therapeutics in-licensed the rights from Eureka to develop, manufacture and commercialize JWATM204 in China (including mainland China, Hong Kong, Macao and Taiwan) and the member countries of the Association of Southeast Asian Nations in 2020, and has completed technical transfer and renovation of facilities and equipment at Shanghai Waigaoqiao manufacturing site.

James Li, Co-founder, Chairman and CEO of JW Therapeutics, said, "Solid tumors are a critical part of JW Therapeutics' product pipeline strategy. Leveraging our platform for technology and product development, we are now developing breakthrough cell immunotherapy products to address the solid tumor with high incidence in China, and advancing the pipeline products to clinical studies."

References

1.  肝细胞癌免疫治疗中国专家共识，2021年，中华医学杂志2021 年12月28日第101 卷第48期
2.  Hyuna Sung, Jacques Ferlay, Rebecca L. Siegel, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. ACS journals. 2021, 71(3):209-249
3.  CSCO原发性肝癌诊疗指南，2020年, 中国临床肿瘤学会指南工作委员会，人民卫生出版社

About JWATM204

JWATM204, with the high affinity and specificity of GPC-3 monoclonal antibody developed at the ARTEMIS^® T-cell platform, is an innovative immune T-cell therapy targeting GPC-3. GPC-3, a member of the glypican-related integral membrane proteoglycan family, is overexpressed in multiple malignancies including HCC, but not or lowly expressed in normal organs, including normal liver organs or cirrhosis liver. GPC-3 is expressed in 72% of HHC patients¹. GPC-3 holds its oncogenic effect through Wnt pathway². GPC-3 has become a popular target for HCC due to its high sensitivity and specificity. The ARTEMIS^® T cell platform, with intracellular regulatory mechanism similar to TCR-T cell therapy and precision of CAR-T therapy, is expected to significantly reduce or even eliminate cytokine release syndrome (CRS) associated with T cell over activation and other life-threatening cytokine-related toxicities. With the assistance of co-stimulatory molecules on the surface of T cells, sufficient T cell activation signals can be generated, which can promote T cell activation and strengthen the antitumor activity.

References:

1.  Capurro M, Wanless IR, Sherman M, et al. Glypican-3: a novel serum and histochemical marker for hepatocellular carcinoma. Gastroenterology. 2003; 125:89–97.
2.  Kolluri A and Ho M. The Role of Glypican-3 in Regulating Wnt, YAP, and Hedgehog in Liver Cancer. Front. Oncol. 2019, 9:708.

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 both hematologic malignancies and solid tumors. 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/.

[1] ALLEMANI C, WEIR HK, CARREIRA H, et al. Global surveillance of cancer survival 1995-2009: analysis of individual data for 25, 676, 887 patients from 279 population-based registries in 67countries (CONCORD-2) . Lancet, 2015, 385: 977-1010.
[2] TORRE LA, BRAY F, SIEGEL RL, et al. Global cancer statistics, 2012. CA Cancer J Clin, 2015, 65: 87-108.