NODE101(223Ra) – alfa‑emitterende legemiddel for primære og sekundære svulster

Offentlig prosjektsammendrag

Node Pharma is developing NODE101, a theranostic solution composed for a Ra‑223 alpha‑emitting nanomedicine and Ga-68 PET tracer for treatment of liver tumors. Current standards (Y‑90 TARE) face Lung Shunt Fraction‑related exclusions (~10–18%) and dose cuts, and weak therapy–imaging concordance. NODE101 will be administrated transarterialley starting with a pre-treatment of NODE101(68Ga) to map distribution during segmental infusion, then the NODE101(223Ra) payload to treat the identical territory. Alpha particles have high LET and short path length, causing DNA breaks in tumour while sparing liver parenchyma. Preclinical PK/biodistribution indicates hepatic confinement with minimal pulmonary deposition, supporting eligibility and safety. A first‑in‑human study in Oslo will test safety, dosimetry, PK/PD and early activity to define RP2D and seek orphan designation. Parallel rodent xenografts will broaden indications.