GI Innovation has begun dosing patients in a global clinical trial evaluating a combination of its immuno-oncology candidate GI-102 and pasritamig, a next-generation T-cell engager, in patients with metastatic castration-resistant prostate cancer.

The company said on the 5th that the first patient was dosed on the 2nd in the global Phase 1b/2 JET trial.

The trial will evaluate the combination's potential and antitumor activity in patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed despite standard treatments. Nine major medical centers in the United States and South Korea are participating.

In March, GI Innovation signed a clinical trial drug supply agreement with Janssen Research & Development, a subsidiary of Johnson & Johnson. Under the agreement, the company has secured pasritamig, which Johnson & Johnson is developing, for use in combination with its own candidate GI-102.

Pasritamig is a bispecific T-cell engager designed to bind simultaneously to CD3 on the surface of T cells and KLK2, an antigen associated with prostate cancer. It works by bringing immune T cells into close proximity to cancer cells so they can attack them.

GI-102 is intended to promote T-cell proliferation and activation, potentially enhancing pasritamig's antitumor effects. The company also expects the candidate to stimulate natural killer (NK) cell activity, potentially providing additional immuno-oncology benefits.

The trial is being led by Mark Stein, a professor at the Herbert Irving Comprehensive Cancer Center at Columbia University Irving Medical Center. Stein previously led the first-in-human Phase 1 clinical trial of pasritamig.

In the United States, participating institutions include Columbia University, Johns Hopkins University School of Medicine, Thomas Jefferson University Hospital and the University of Wisconsin-Madison.

In South Korea, five institutions are conducting the trial: Asan Medical Center, Severance Hospital, Seoul St. Mary's Hospital, Korea University Anam Hospital and Ewha Womans University Mokdong Hospital.

In April this year, GI Innovation received approval from South Korea's Ministry of Food and Drug Safety for a Phase 2 trial in metastatic melanoma directly comparing GI-102 combined with the immunotherapy Keytruda against Keytruda alone. The U.S. Food and Drug Administration had previously cleared the related clinical trial application.

GI-102 received Fast Track designation from the FDA in September last year. In February this year, the company also secured approval in Australia for a clinical trial evaluating GI-102 as a monotherapy and in combination with Keytruda or Enhertu.

The prostate cancer trial is planned to enroll up to 107 patients and run for approximately three years. The initial phase will assess the combination's safety and determine an appropriate dose, followed by an expansion phase to evaluate antitumor activity.

"Prostate cancer has historically been one of the cancer types that has benefited least from immunotherapy," Stein said. "We hope this combination will mark an important turning point in exploring new possibilities for immuno-oncology treatment of prostate cancer."

"This global trial is an important milestone in expanding GI-102's combination development strategy into the next-generation T-cell engager field," said Chang Myung-ho, CEO of GI Innovation. "We will focus our efforts on building robust clinical evidence, accelerating commercialization and providing new treatment opportunities to more patients."

GI Innovation has begun dosing patients in a global clinical trial evaluating a combinatio …

GI Innovation Begins First Patient Dosing in Combination Trial for Prostate Cancer Immunotherapy