[Edaily Reporter YU JIN-HEE ] #Cellbion Co., Ltd, a company developing new radiopharmaceuticals, announced on the 22nd that it has signed an agreement with the Korea Drug Development Fund (KDDF, Director Park Young-min) regarding a Phase 1 clinical trial for a combination therapy targeting patients with metastatic castration-resistant prostate cancer (mCRPC).

This agreement is being carried out as part of the National New Drug Development Project’s “New Drug Clinical Development Support Program.” The official project title is “Phase 1 Clinical Trial of the Combination Therapy of 177Lu-DGUL and Pembrolizumab in Patients with Castration-Resistant Prostate Cancer.”

Through this project, Cellbion Co., Ltd plans to evaluate the safety and preliminary efficacy of a combination therapy using its prostate cancer-targeted radiopharmaceutical candidate, “Lutetium Pocubotide” (active ingredient: 177Lu-DGUL), and the immunotherapy “Pembrolizumab” (brand name Keytruda).

This clinical trial will enroll patients with metastatic castration-resistant prostate cancer whose disease has progressed despite treatment with an androgen receptor pathway inhibitor (ARPI). The trial will compare a group receiving lutetium pocubotide monotherapy with a group receiving combination therapy with pembrolizumab to gather efficacy and safety data.

Industry observers view this combination trial as an opportunity to validate the potential for radioligand therapies to induce immunogenicity in cancer tissues and improve the tumor microenvironment, thereby maximizing the therapeutic efficacy of immune checkpoint inhibitors. Through this trial, Cellbion Co., Ltd aims to secure key data necessary for advancing to subsequent clinical trials and to strengthen the foundation for future clinical development and technology commercialization.

Kim Kwon, CEO of Cellbion Co., Ltd, stated, “Through this agreement with the National New Drug Development Project, we are now able to fully advance the development of combination therapy for lutetium-pocubotide, our core pipeline.” He added, “Since metastatic castration-resistant prostate cancer remains an area with significant unmet medical needs, we will do our utmost to successfully conduct this clinical trial and provide patients with a new treatment option.”

Meanwhile, the National New Drug Development Project is a cross-ministerial national R&D initiative launched to strengthen the global competitiveness of Korea’s pharmaceutical and biotech industries. Since 2021, the project has been supporting all stages of the new drug development lifecycle for a period of 10 years, with the goals of strengthening the domestic new drug R&D ecosystem, facilitating global commercialization, and generating public-interest outcomes in the healthcare sector.