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99mTc-NM-01 is a radiopharmaceutical imaging agent composed of the single-domain antibody fragment NM-01 labeled with technetium-99m (99mTc). It is designed for non-invasive molecular imaging of programmed death-ligand 1 (PD-L1) expression in tumors using single-photon emission computed tomography (SPECT/CT). NM-01 binds specifically and with high affinity to human PD-L1 on the cell surface without interfering with anti-PD-L1 antibodies such as atezolizumab. The agent enables visualization and quantification of PD-L1 expression across primary and metastatic tumor sites, providing a companion diagnostic tool for patient selection and monitoring during PD-1/PD-L1 checkpoint inhibitor therapy. Preclinical studies demonstrated favorable pharmacokinetics, rapid blood clearance, renal elimination, high tumor uptake in PD-L1-positive models, and no significant toxicity at tested doses. Clinical studies have shown that [99mTc]NM-01 SPECT/CT correlates well with immunohistochemistry-based assessment of PD-L1 expression in non-small cell lung cancer (NSCLC), revealing intertumoral heterogeneity often missed by biopsy[1][3][4][7].
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