Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, recently announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) applications for [²²⁵Ac]-FPI-1966 (FPI-1966) and imaging agent [¹¹¹In]-FPI-1967 (FPI-1967). FPI-1966 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.

 The Chief Executive Officer John Valliant, Ph.D said that "FGFR3 is an established and validated cancer target which is found in multiple tumor types with substantial unmet need, notably head and neck, and bladder cancers. We have an opportunity to selectively deliver alpha particles to these tumors and use precision radiation therapy as a new treatment paradigm. While the currently approved pan-FGFR inhibitor for bladder cancer requires the presence of a specific mutation, our approach requires only the over-expression of FGFR3. If successful, this could provide an opportunity to treat a larger population of patients.”

Fusion plans to initiate a Phase 1, a non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3, which is intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose.

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Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-1966, an Investigational Radiopharmaceutical for the Treatment of Head and Neck and Bladder Cancers Expressing FGFR3-CISION

Source: CISION