PR96833

SHANGHAI, July 4, 2022 /PRNewswire=KYODO JBN/ --

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). 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 3rd leading

cause of cancer death1. The 5-year survival rate was 15%-19% in North America.

The disease burden of liver cancer was particularly high in China. Liver cancer

was the 4th most common malignancies, the 2nd leading cause of cancer deaths,

and the 5-year survival rate was only 12.1% in China. The ratio of 1:0.9

between the incidence and mortality indicated the poor prognosis of liver

cancer, 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

patients. 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.  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

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.

SOURCE: JW Therapeutics