NEW YORK – Eureka Therapeutics on Tuesday said that the first GPC3-positive advanced hepatocellular cancer patient received its experimental T-cell therapy ECT204 in a Phase I/II study.
The trial is enrolling patients at City of Hope in Duarte, California. Eureka and City of Hope will enroll 12 patients with GPC3-positive advanced hepatocellular carcinoma who have failed or not tolerated at least two prior systemic agents.
In order to participate in the study, patients must have immunohistochemistry testing to establish they have GPC3-expressing tumors. GPC3, or glypican 3, is found in about 70 percent of liver cancer cells, the company said, and is expressed in other solid tumors including ovarian and lung cancer.
The trial, dubbed ARYA-3 will assess safety and tolerability and determine a recommended dose for ECT204. Researchers will also evaluate the treatment's efficacy by radiographic scans and determine the maximum concentration of ECT204 T cells in patients' blood after infusion as secondary endpoints.
Eureka develops ECT204 using its ARTEMIS (Antibody Redirected T Cells with Endogenous Modular Immune Signaling) platform. The company is collecting patients' T cells in the study, engineering them using ARTEMIS to express certain cell receptors targeting GPC3, and reinfusing them back into the patients so these engineered T cells can bind to and kill GPC3-positive cancer cells.
"First patient dosing of ECT204 is a significant step forward in our commitment to expand the use of T-cell therapy into solid tumors," Eureka CEO Cheng Liu said in a statement, adding that "ARTEMIS T cells have demonstrated superior tumor infiltration and excellent safety profile in preclinical studies."
Eureka, based in Emeryville, California, is developing other T-cell therapies to treat other solid tumors, including mesothelioma, and lung, breast, and ovarian cancer. The company's lead candidate, ET140203, is undergoing two studies in adult and pediatric AFP-positive, HLA-A2-positive liver cancer. The firm is also developing treatments for blood cancers, including multiple myeloma and B-cell leukemia and lymphoma.