Fusion Pharmaceuticals Announces First Patient Dosed in Phase 1 Study of FPI-2059, a Targeted Alpha Therapy (TAT) for the Treatment of Solid Tumors Expressing NTSR1
Fusion Pharmaceuticals (Nasdaq: FUSN) has announced the first patient dosing in a Phase 1 study for [225Ac]-FPI-2059, a targeted alpha therapy aimed at treating solid tumors with neurotensin receptor 1 (NTSR1). The therapy targets tumors overexpressing NTSR1, seen in various cancers. The trial aims to assess the safety, tolerability, and early efficacy of FPI-2059. This marks Fusion's fourth clinical program, showcasing their potential in the radiopharmaceutical market. With promising early data from prior studies, the company is set to advance its pipeline of innovative therapies.
- First patient dosed in Phase 1 study of [225Ac]-FPI-2059, a significant milestone.
- FPI-2059 targets NTSR1, overexpressed in numerous solid tumors, offering potential for new treatments.
- Previous related compound (IPN-1087) showed promising safety and anti-tumor activity in early studies.
- No guarantees on successful advancement of FPI-2059 through clinical trials and regulatory approval.
- Possible delays in patient recruitment could impact study timelines.
- Dependence on securing actinium-225 for manufacturing poses a risk.
HAMILTON, ON and BOSTON,
"Tremendous opportunity exists in the radiopharmaceutical field to look beyond the few established targets, particularly when using a potent payload like actinium-225. The initiation of the Phase 1 study of FPI-2059 marks an important milestone in this regard, bringing us a step closer to providing a differentiated therapy for patients," said Chief Executive Officer,
Fusion acquired [177Lu]-IPN-1087 (IPN-1087), a lutetium-based beta-emitting radiopharmaceutical, from Ipsen in
The Phase 1, multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-2059 as well as preliminary anti-tumor activity in participants with neurotensin receptor 1 (NTSR1) expressing advanced metastatic solid tumors. The study will employ a 3+3 dose escalation design to identify the recommended Phase 2 dose (RP2D) of FPI-2059 administered intravenously every 56 days for up to four cycles.
Fusion plans to provide guidance on timing for pharmacokinetic, imaging and safety data following early experience with FPI-2059 patient screening and enrollment.
About FPI-2059
FPI-2059 is a small molecule radiopharmaceutical targeting neurotensin receptor 1 (NTSR1) which is overexpressed in multiple solid tumors, including pancreatic ductal adenocarcinoma, colorectal, squamous cell carcinoma head & neck, gastric, Ewings sarcoma, and neuroendocrine differentiated prostate. FPI-2059 is based upon a compound previously referred to as IPN-1087 and 3BP-227 that had previously been studied in investigator sponsored studies and a Phase 1 clinical trial as a beta-emitting radiopharmaceutical. Fusion acquired the asset in 2021 and converted it to an alpha-emitting radiopharmaceutical using actinium-225. The diagnostic analogue which uses indium-111 in place of actinium-225 is referred to as FPI-2058.
About Fusion
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Contact:
Senior Director of Investor Relations & Corporate Communications
(617) 967-0207
cray@fusionpharma.com
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