Norroy Completes Phase I/II Clinical Trial of 68Ga-NYM005, a Novel CAIX-Targeted PET Imaging Agent

Norroy Bioscience recently announced the completion of patient enrollment and dosing for its independently developed PET imaging agent, 68Ga-NYM005 (NY104), in a Phase I/II clinical trial. Targeting carbonic anhydrase IX (CAIX), 68Ga-NYM005 is designed for PET/CT imaging to detect primary or metastatic lesions of clear cell renal cell carcinoma (ccRCC). This marks the company’s second radiopharmaceutical to advance into late-stage clinical development.

ccRCC is the most common histological subtype of renal cancer, accounting for approximately 80–85% of all kidney cancers. About 30% of patients present with distant metastases at initial diagnosis, and the five-year survival rate for metastatic renal cell carcinoma remains under 5%. The open-label study aims to evaluate the pharmacokinetics, biodistribution, radiation dosimetry, and safety profile of 68Ga-NYM005 (NY104) in both healthy volunteers and patients with metastatic ccRCC.

Compared with investigational antibody-based imaging agents, 68Ga-NYM005 offers faster imaging capabilities due to its small-molecule design. Recent data published in EJNMMI highlights the agent’s strong diagnostic performance in metastatic ccRCC patients[1], suggesting 68Ga-NYM005 could become a new, non-invasive and convenient diagnostic tool for kidney cancer management.

To date, over 100 subjects have participated in exploratory clinical studies of 68Ga-NYM005, laying a solid foundation for future Phase III trials. A therapeutic counterpart targeting the same CAIX pathway is currently undergoing preclinical and early clinical evaluation, and Norroy is actively advancing a next-generation pipeline of CAIX-targeted agents.

Moving forward, Norroy remains committed to accelerating the development of innovative radiopharmaceuticals, particularly in the areas of urologic and gastrointestinal oncology, to deliver precision diagnostics and treatments that benefit patients worldwide.