Drug intelligence / Profile preview

NM-02

Development stage
Phase 1
Lead developer
Radiopharm Theranostics, Ltd
Modality
Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Nanobodies (VHH) → Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

NM-02 is a single-domain antibody (nanobody) targeting the extracellular domains I and II of the HER2 (receptor tyrosine-protein kinase erbB-2) protein. It has been developed as a radiolabeled agent for both imaging and therapy: as 99mTc-NM-02 for SPECT/CT imaging to noninvasively visualize HER2 expression, and as 188Re-NM-02 for radionuclide therapy, emitting ionizing radiation to deliver cytotoxic effects to HER2-positive tumors. The antibody blocks HER2-related signaling pathways and is studied primarily in HER2-positive breast cancer and gastric cancer. The original developer is NanoMab Technology, with active involvement from University Hospital Aachen and Radipharm Theranostics. As of 2025, its primary clinical focus has been early-phase trials in HER2-positive cancers for both diagnostic and therapeutic applications[1][2][3][4][5][6][8][9].

Other names
Rhenium 188 NM 02Rhenium188 NM 02Rhenium-188 NM 02Technetium-99m NM-02Technetium99m NM-02Technetium 99m NM-02anti-HER2-sdAbanti-HER-2-sdAbanti-HER 2-sdAb
02

Targets

ERBB2 (Erb-b2 receptor tyrosine kinase 2)

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