GI Innovation announced on 19th that it has entered into a clinical supply agreement with Johnson & Johnson to evaluate a combination therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) in a phase 1b clinical trial.
GI Innovation Announces First Clinical Supply Agreement to Explore Combination Therapy for Prostate Cancer

This trial aims to evaluate the combination of GI Innovation's immuno-oncology agent GI-102 with pasritamig (KLK2-CD3), a first-in-class bispecific T-cell engager. This trial will explore the therapeutic potential of the combination regimen in patients with mCRPC, a disease area with limited treatment options.

Under the terms of the clinical supply agreement, Johnson & Johnson will provide pasritamig to GI Innovation, who will be the sponsor of the Phase 1b clinical trial. The study will be conducted in both Korea and the United States. Dr. Mark Stein of Columbia University Irving Medical Center will serve as the global coordinating investigator. In Korea, leading tertiary hospitals including Asan Medical Center and Severance Hospital will participate in the study.

Dr. Myoung-ho Jang, CEO of GI Innovation, stated, "This agreement represents a meaningful step toward validating the potential of GI-102 in combination with next-generation modalities such as T cell engagers together with Johnson & Johnson. As combination strategies become increasingly important in the field of immuno-oncology, clinical collaborations with global partners will serve as an important opportunity to further strengthen the technological credibility of our platform".

*Referenced agreement was entered into by Janssen Research & Development, LLC.