- GI-102 combined with pasritamig, a first-in-class KLK2xCD3 T cell engager to explore a novel immunotherapy approach

- Nine leading clinical institutions across the U.S. and Korea participate, highlighting global clinical development capabilities

Mark N. Stein, MD, Columbia University Irving Medical Center(Photo courtesy of GI Innovation)

GI Innovation Inc. announced today that the first patient has been dosed in a global clinical trial evaluating its next-generation immuno-oncology candidate, GI-102, in combination with pasritamig, a first-in-class KLK2xCD3 T cell engager, in patients with metastatic castration-resistant prostate cancer (mCRPC). Pasritamig is being provided for the trial under the previously announced clinical trial supply agreement with Janssen Research & Development, LLC, a Johnson & Johnson company.

Following the clinical trial supply agreement signed with Johnson & Johnson in March, GI Innovation has been preparing for a global Phase 1b/2 clinical trial in patients with metastatic castration-resistant prostate cancer (mCRPC) who have failed standard-of-care treatments. With the first patient now dosed, the company has officially initiated clinical evaluation of the potential synergistic effects of GI-102 in combination with a next-generation oncology modality.

Pasritamig is a novel T-cell engager designed to bind both CD3 on T-cells and KLK2—a prostate-specific antigen with minimal expression outside of the prostate. Pasritamig activates T-cells by binding to CD3 and directing them to KLK2-expressing prostate cells, engaging the body’s immune system to specifically target these cancerous cells. Previous clinical studies have demonstrated a favorable safety profile and encouraging antitumor activity, and the drug is currently being evaluated in global Phase 3 clinical trials.

GI-102 is aimed at enhancing the antitumor activity of pasritamig by expanding and activating T cells responsible for attacking cancer cells. In addition, GI-102 promotes the proliferation and activation of natural killer (NK) cells, potentially providing an additional mechanism of antitumor immune activity.

The global trial is coordinated by Dr. Mark N. Stein of the Herbert Irving Comprehensive Cancer Center (HICCC) at Columbia University Irving Medical Center, who participated in the first-in-human Phase 1 trial of pasritamig, and is being conducted at nine leading clinical institutions across the United States and Korea. Participating U.S. institutions include Columbia University Irving Medical Center, Johns Hopkins University School of Medicine, Thomas Jefferson University Hospital, and the University of Wisconsin–Madison. In Korea, participating institutions include Asan Medical Center, Severance Hospital of Yonsei University, Seoul St. Mary's Hospital, Korea University Anam Hospital, and Ewha Womans University Mokdong Hospital.  

Dr. Mark Stein, who is leading the clinical trial, commented, “Prostate cancer has historically been one of the tumor types that has benefited least from immunotherapy. The combination of pasritamig and GI-102 represents a novel therapeutic strategy aiming a  transforming the treatment landscape for prostate cancer, where conventional immunotherapies have shown limited efficacy.”. He added, “We hope this trial will mark an important turning point in exploring new possibilities for immunotherapy in prostate cancer.”

Myoung Ho Jang, CEO of GI Innovation, stated, “The toxicity associated with conventional IL-2 therapies has posed significant challenges to their combination with T-cell engagers. However, the safety profiles of GI-102 and pasritamig are being explored to develop a novel combination strategy.” He added, “This global trial represents an important milestone in expanding GI-102's combination development strategy into next-generation T-cell engager therapies.”