[E-Daily Reporter KIM SAE-MI ] GI Innovation ( GI Innovation Inc.(358570)) announced on the 5th that it has initiated the first patient dosing in a global Phase 1b/2 clinical trial evaluating the combination of its immuno-oncology candidate “GI-102” and Johnson & Johnson’s (J&J) T-cell engager “pasritamig” in patients with metastatic castration-resistant prostate cancer (mCRPC).

GI Innovation Inc. announced on the 5th that it has initiated the first patient dosing in a global Phase 1b/2 clinical trial evaluating the combination of its immunotherapy candidate “GI-102” and Johnson & Johnson’s (J&J) T-cell engager “pasritamig” in patients with metastatic castration-resistant prostate cancer (mCRPC).

GI Innovation Inc. has been preparing for this combination clinical trial in prostate cancer patients who have failed standard treatment since signing a contract with J&J’s Janssen Research & Development in March to supply investigational drugs. Starting with the first patient dosing on the 2nd, the company plans to evaluate the safety and antitumor efficacy of the combination of the two candidate drugs.

Pasritamig is a first-in-class T-cell engager designed to simultaneously bind to CD3 on the surface of T cells and KLK2, a prostate cancer-associated antigen. Its mechanism of action involves activating T cells and directing them toward prostate cancer cells that express KLK2 to attack the cancer cells. Safety and antitumor activity have been confirmed in previous clinical trials, and a global Phase 3 clinical trial is currently underway.

GI-102 aims to enhance the antitumor effects of Pasritamig by promoting the proliferation and activation of T cells. Additional antitumor effects are also anticipated through the proliferation and activation of natural killer (NK) cells.

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in the U.S., who spearheaded the early-stage clinical trials of Pasritamig. A total of nine institutions are participating, including Columbia University, Johns Hopkins University, Thomas Jefferson University Hospital, and the University of Wisconsin–Madison in the U.S., as well as Asan Medical Center, Severance Hospital, Seoul St. Mary’s Hospital, Korea University Anam Hospital, and Ewha Womans University Mokdong Hospital in South Korea.

Professor Mark Stein stated, “Prostate cancer has historically been one of the cancer types that has benefited the least from immuno-oncology treatments,” adding, “We hope this clinical trial will serve as an important turning point in exploring new possibilities for immuno-oncology treatment of prostate cancer.”

Jang Myung-ho, CEO of GI Innovation Inc., emphasized, “This global clinical trial is a significant milestone in expanding GI-102’s combination development strategy into the field of next-generation T-cell engagers,” adding, “We will accumulate robust clinical evidence to accelerate commercialization and focus our company-wide capabilities on creating new treatment opportunities.”