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Advancing CAIX-targeted diagnostics and therapeutics
Surgery remains the primary treatment for early-stage renal cancer; however, a significant proportion of patients are already diagnosed with metastatic renal cell carcinoma (RCC) at presentation, and many experience recurrence or metastasis shortly after surgery. Once metastasis occurs, the prognosis worsens considerably, with substantially reduced survival times. At this stage, combined surgical and systemic therapies are typically required.
Current clinical practice faces two major challenges: first, conventional imaging techniques such as CT and MRI have limited diagnostic accuracy for clear cell renal cell carcinoma (ccRCC), falling short of the precision needed for early detection; second, although existing targeted therapies can delay disease progression, their overall efficacy is limited and resistance often develops.
Carbonic anhydrase IX (CAIX) exhibits highly specific expression in ccRCC patients, providing a precise molecular foundation for targeted theranostic approaches. The development of CAIX-targeted radionuclide drug conjugates (RDCs) holds promise to overcome existing diagnostic and therapeutic limitations, offering patients more effective and precise treatment options and addressing critical unmet clinical needs.
Our Kidney Cancer Portfolio
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Theranostic radiopharmaceutical
- 68Ga-NYM005 (NY104) is a first-in-class small-molecule radiopharmaceutical independently developed by Norroy Bioscience. It selectively targets carbonic anhydrase IX (CAIX) with high affinity. The drug has completed Phase I/II clinical trials, and a multicenter Phase III trial is expected to begin in the second half of 2025. Currently, there are no approved products of the same class worldwide.
- Recent clinical results indicate that 68Ga-NYM005 (NY104) PET/CT is a highly promising diagnostic tool, demonstrating superior diagnostic performance compared to ¹⁸F-FDG in patients with metastatic clear cell renal cell carcinoma (ccRCC), and significantly influencing clinical decision-making.
- Looking ahead, the research team will further explore the diagnostic value of 68Ga-NYM005 (NY104) PET in patients with suspected ccRCC and assess its imaging performance in individuals with primary renal tumors.
- In parallel, Norroy Bioscience is developing a next-generation series of CAIX-targeted theranostic radiopharmaceuticals with enhanced affinity. Among them, the therapeutic candidate has shown preliminary efficacy in early-stage translational studies.
See Clinical Trials