JNM: Norroy Announces First-in-Human Clinical Results of Second-Generation Small-Molecule Radiopharmaceutical for Kidney Cancer

In December 2024, the latest research findings on Norroy’s second-generation small-molecule carbonic anhydrase IX (CAIX)-targeted PET tracer, [68Ga]-NYM046, were published in The Journal of Nuclear Medicine (JNM), a top-tier journal in nuclear medicine. This study preliminarily validated the diagnostic potential of [68Ga]-NYM046 in kidney cancer through tumor models and patient applications. Following the groundbreaking success of NYM005, the world’s first small-molecule radiopharmaceutical for kidney cancer, this achievement marks another major breakthrough for Norroy, ushering in a new era of precision diagnosis and treatment for kidney cancer.

Clear cell renal cell carcinoma (ccRCC) is the most common type of kidney cancer, where early diagnosis and accurate staging are crucial for personalized therapy. The research team evaluated 12 ccRCC patients, assessing 9 primary tumors, 96 metastatic lymph nodes, and 147 distant metastases (each patient underwent both [68Ga]-NYM046 and [18F]-FDG PET/CT scans). A head-to-head comparison of the two tracers revealed:

[68Ga]-NYM046 PET/CT detected significantly more lesions than [18F]-FDG, including primary tumors (9 vs. 1), involved lymph nodes (95 vs. 92), and distant metastases (137 vs. 127).

Higher tumor uptake: Primary tumors showed significantly higher SUVmax with [68Ga]-NYM046 (mean 13.5 vs. 2.4; z = -2.668, P = 0.008).

Strong correlation with CAIX expression: Immunohistochemistry confirmed a positive correlation (R² = 0.8274) between CAIX expression in primary tumors and [68Ga]-NYM046 uptake.

These results suggest that [68Ga]-NYM046 could become a more precise imaging tool for ccRCC, offering a practical strategy for diagnosis and treatment monitoring while overcoming the limitations of [18F]-FDG in kidney cancer detection. This innovation fills a global gap in small-molecule radiopharmaceuticals for ccRCC diagnosis.

Norroy has consistently published cutting-edge research in top-tier nuclear medicine journals, with two kidney cancer-related papers released in less than a month. To date, the company has four publications in JNM and EJNMMI on this topic. The upcoming Phase II clinical results for its first-generation kidney cancer tracer and the latest data on third- and fourth-generation molecules will further demonstrate Norroy’s speed of innovation and R&D capabilities.

Leveraging its proprietary technology platforms, Norroy continues to advance its theranostic radiopharmaceutical pipeline, driving early diagnosis and precision therapy for cancer patients worldwide and bringing new hope to global healthcare.

About The Journal of Nuclear Medicine

The Journal of Nuclear Medicine (JNM) is a leading academic journal in nuclear medicine, published by the Society of Nuclear Medicine and Molecular Imaging (SNMMI). Since its inception in 1960, JNM has been a premier platform for groundbreaking research in nuclear medicine, molecular imaging, radiopharmaceuticals, and related diagnostic and therapeutic technologies.

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Key Features:

✔ Higher detection sensitivity than [18F]-FDG

✔ Strong CAIX-targeting specificity

✔ Potential for theranostic applications (diagnosis + therapy)

✔ Norroy’s rapid pipeline advancement – from discovery to clinical validation

This milestone reinforces Norroy’s leadership in next-generation radiopharmaceuticals and commitment to transforming cancer care.