Primo Biotech announced today a significant advancement in the development of PB-012, its proprietary radiotracer focusing on angiogenesis. The company has successfully completed the First Patient In (FPI) for the Phase I clinical trial at a medical center in Kaohsiung. This clinical trial aims to evaluate the diagnostic efficacy and safety of PB-012 in patients with colorectal cancer liver metastases (CRCLM), establishing a critical foundation for subsequent therapeutic clinical trials.
Advancing the “Theranostics” Frontier
Dr. Ya-Ting Huang, R&D Director of Primo Biotech, stated that this clinical trial utilizes the cutting-edge “Theranostics” (a portmanteau of therapeutics and diagnostics) concept. PB-012 is a diagnostic radiopharmaceutical designed to target the FOLH1 molecule. The primary objective is to systematically assess the safety and diagnostic performance of PB-012 in patients with colorectal cancer liver metastases.
“The key to radiotheranostics lies in using pilot diagnostic imaging to confirm target expression, thereby screening patient groups with high therapeutic potential,” Dr. Huang explained. “This is followed by the administration of therapeutic radiopharmaceuticals for highly specific tumor destruction.” This strategy maximizes therapeutic benefits while minimizing unnecessary radiation exposure and potential toxicity, aligning perfectly with the current global trends in precision medicine and personalized oncology.
According to the 2022 Cancer Registry Report, colorectal cancer remains the second most prevalent cancer in Taiwan. Chien-Chang Lu, M.D., a surgeon in the Department of Colorectal Surgery at Dali Renai Chang Gung Memorial Hospital, noted that approximately 30% of colorectal cancer patients develop liver metastases during their illness. For resectable liver metastases, combining surgical resection with ablation therapy can significantly prolong survival and improve long-term cure rates, highlighting the vital importance of early diagnosis.
Primo Biotech is simultaneously conducting non-clinical radiobiology research and integrating translational data regarding diagnostic imaging and treatment response. These efforts further support the scientific rationale and safety assessment of radioligand therapy for clinical applications.
With the successful enrollment of the first patient, Primo Biotech will accelerate the clinical development of PB-012. This innovative technology, which merges nuclear medicine with precision targeting, is poised to provide patients with more accurate image-guided treatment strategies, eliminate diagnostic blind spots, and secure timely intervention and the optimal window for cancer treatment.
