Phase 1 Trial of JWATM214 Initiates in GPC-3-Expressing Hepatocellular Carcinoma

The first patient has been infused with JWATM214, commencing the phase 1 study of the agent for the treatment of patients with glypican-3 (GPC-3)-expressing advanced hepatocellular carcinoma (HCC), according to JW Therapeutics.¹

JWATM214 is an autologous T-cell immunotherapy candidate drug targeting GPC-3. The agent was created using the Artemis platform from Eureka and incorporates T-cell anti-exhausting technology.

Through combining the high affinity and specificity of GPC-3 monoclonal antibody and cJun protein regulation to delay T-cell exhaustion, the JWATM214 may achieve more durable anti-tumor activity. If successful, this can potentially provide a new and novel treatment option for patients with GPC-3-expressing advanced HCC.

In this first-in-human study of JWATM214, investigators will evaluate the safety and tolerability of the agent, determine the recommended phase 2 dose (RP2D), and evaluate its pharmacokinetic profile and preliminary efficacy in adult patients with GPC-3-expressing advanced HCC.

GPC-3 is overexpressed in many malignant tumors, including HCC, which accounts for 85%-90%of primary liver cancer. Currently, the median progression-free survival among patients after first- and second-line standard therapy is approximately 6 months, highlighting the unmet need for more effective treatment options for patients with recurrent and metastatic advanced HCC.

Previously in 2021, the company completed technical transfer of the product manufacturing and released assays for the JWATM214 program. A partnership between JW Therapeutics, Eureka, and Lyell planned to combine Lyell’s technology in T-cell anti-exhaustion functionality with JWATM204, an innovative immune T-cell therapy targeting GPC-3 developed by JW Therapeutics, to create JWATM214, this next-generation innovative autologous cell therapy for the treatment of HCC.²

Based on promising preclinical results of JWATM204 showed the clinical development potential of the agent for the treatment of HCC. Now, JWATM204 is being evaluated in a first-in-human study, also in adult patients with advanced HCC. The trial aims to evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetic profile, and explore the anti-tumor activity of JWATM204 in this patient population.

REFERENCES:

1. JW Therapeutics announces initiation of clinical study of JWATM214 in patients with advanced hepatocellular carcinoma. News release. JW Therapeutics. February 28, 2023. March 2, 2023. https://bit.ly/3IIhj46

2. JW Therapeutics announces initiation of clinical study of JWATM204 in patients with advanced hepatocellular carcinoma. News release. JW Therapeutics. July 4, 2023. Accessed March 2, 2023. https://prn.to/3J6cliU