IPSEF - Fusion Pharma wins FDA nod to start trials for solid tumor candidate

• The clinical-stage oncology company Fusion Pharmaceuticals ( NASDAQ: FUSN ) announced on Thursday that the FDA cleared its Investigational New Drug (IND) applications for [225Ac]-FPI-2059 and the corresponding imaging analogue [111In]-FPI-2058.
• FPI-2059 is a small molecule designed to deliver actinium-225 to tumor tissue expressing neurotensin receptor 1 (NTSR1), a protein that is excessively detected in multiple solid tumor types.
• Fusion ( FUSN ) intends to launch a Phase 1, non-randomized, open-label clinical trial for the candidate targeting patients with solid tumors expressing NTSR1. The trial particpants will undergo a screening process with the administration of FPI-2058, an imaging analogue of FPI-2059.
• In April 2021, Ipsen ( OTCPK:IPSEY ) ( OTCPK:IPSEF ) sold [177Lu]-IPN-1087 (IPN-1087), a lutetium-based beta-emitting radiopharmaceutical to Fusion ( FUSN ) which later converted it to alpha-emitting [225Ac]-FPI-2059.

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