GI Innovation begins prostate cancer trial with J&J drug

South Korean biotech firm GI Innovation has administered the first dose in a global clinical trial combining its experimental immunotherapy GI-102 with Johnson & Johnson's prostate cancer drug candidate pasritamig, marking a new step in its efforts to develop treatments for advanced cancer.

The company said Thursday that the first patient was dosed Monday in the Phase 1b/2 JET trial, which is evaluating the combination in patients with metastatic castration-resistant prostate cancer, an advanced form of the disease that continues to progress despite testosterone-suppressing treatment.

The trial follows a clinical drug supply agreement signed in March with Janssen Research & Development, a Johnson & Johnson subsidiary, which is providing pasritamig for the study.

GI-102 is designed to boost the body's immune response against tumors by stimulating cancer-fighting T cells and natural killer cells. It combines CD80, a protein involved in immune regulation, with a modified form of interleukin-2, a molecule that helps activate immune cells.

Pasritamig, meanwhile, is a T-cell engager designed to direct immune cells toward prostate cancer cells. It targets CD3, a protein involved in T-cell activation, and KLK2, a protein predominantly expressed in prostate tissue.

Researchers will assess whether combining the two experimental therapies can safely enhance antitumor activity. Pasritamig is also being evaluated separately in global Phase 3 trials.

Mark N. Stein of Columbia University's Herbert Irving Comprehensive Cancer Center leads the JET trial. It involves nine medical institutions across the United States and South Korea, including Johns Hopkins University School of Medicine, Asan Medical Center and Severance Hospital.

"Prostate cancer has historically been one of the tumor types that has benefited least from immunotherapy," Stein said.

GI Innovation CEO Jang Myoung Ho said the study expands the company's GI-102 development program into combination therapies involving next-generation T-cell engagers.