By Chris Wack

 

Fusion Pharmaceuticals Inc. shares were down 10% to $2.93, its 52-week low, after the company said the U.S. Food and Drug Administration cleared its investigational new drug applications for FPI-2059 and the corresponding imaging analogue FPI-2058, both cancer treatments.

The company said it plans to initiate a Phase 1 clinical trial in patients with solid tumors expressing neurotensin receptor 1, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose.

FPI-2059 is a targeted alpha therapy designed to use a small molecule to target and deliver actinium-225 to tumor sites expressing neurotensin receptor 1, a protein that is overexpressed in multiple solid tumor types, including colorectal, pancreatic, gastric, neuroendocrine differentiated prostate, head and neck squamous cell carcinoma, and Ewing sarcoma cancers, Fusion Pharma said.

Fusion acquired IPN-1087, a lutetium-based beta-emitting radiopharmaceutical, from Ipsen in April 2021, and converted the compound to the alpha-emitting FPI-2059. In clinical studies, IPN-1087 showed promising early safety data and good uptake in multiple tumor types.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

June 23, 2022 13:28 ET (17:28 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
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