Fusion Warms to FDA Nod

Fusion Pharmaceuticals Inc. (NASDAQ:FUSN) rose Thursday after the company announced Food and Drug Administration clearance of the IND for FPI-1966 for the treatment of head, neck and bladder cancers expressing fibroblast growth factor 3.

The Boston-based Fusion, with offices in Hamilton, Ontario, is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines.

Today, it announced that the FDA has cleared the Company's Investigational New Drug (IND) applications for FPI-1966, which is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. FPI-1966 utilizes Fusion's Fast-Clear™ linker to connect vofatamab to actinium-225.

Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966.

The first cohort will comprise four sub-groups in which various doses of non-radiolabeled vofatamab ("cold antibody") will be evaluated to assess the impact of pre-dosing on tumor uptake. As part of the screening process, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who meet predefined tumor uptake and safety criteria will go on to receive FPI-1966.

FUSN shares climbed 67 cents, or 8.2%, to $8.88