On August 29, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the first patient has been dosed in the Phase 1/2 study evaluating [225Ac]-FPI-1966 (FPI-1966) in patients with advanced solid tumors expressing fibroblast growth factor receptor three (FGFR3) (Press release, Fusion Pharmaceuticals, AUG 29, 2022, View Source [SID1234618738]). FPI-1966 utilizes Fusion’s Fast-Clear linker to connect vofatamab, a human monoclonal antibody that targets FGFR3, with actinium-225.
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"Dosing of the first patient in this Phase 1/2 study of FPI-1966 demonstrates our continued ability to bring innovative targeted alpha therapies (TATs) into the clinic," said Chief Executive Officer John Valliant, Ph.D. "This study will evaluate FPI-1966 in patients with solid tumors expressing FGFR3, a validated cancer target found in multiple tumor types with substantial unmet need, notably bladder, ovarian and head and neck cancers. FPI-1966, and the growing number of TATs in our pipeline, are designed as next generation antibody drug conjugates (ADCs) in that they leverage the potency of actinium-225 and alpha particle radiation in place of chemical toxins to selectively eradicate cancer cells. Given the prevalence of the FGFR3 target, and the use of a precision medicine approach that employs an imaging analogue to enable patient selection, we believe FPI-1966 has the potential to become an important new treatment paradigm for cancer patients."
The Phase 1/2 multi-center, open-label clinical trial is designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics of FPI-1966 in patients with FGFR3-expressing advanced, inoperable, metastatic, and/or recurrent solid tumors. The study employs a 3 + 3 dose escalation design to evaluate multiple ascending doses of FPI-1966. The first cohort will comprise 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 and pharmacokinetics. As part of the trial, patients will be administered an imaging analogue of FPI-1966, FPI-1967, and only those who upon imaging meet predefined tumor uptake will go on to receive FPI-1966. The Phase 2 portion of the study will consist of two tumor-specific cohorts and one basket cohort.
Fusion plans to provide guidance on timing for preliminary pharmacokinetic, imaging and safety data following initial experience with patient screening via imaging with FPI-1967, in order to more accurately predict the cadence of patient enrollment.
For additional detail about the study, please visit View Source;draw=2&rank=1.
About FPI-1966
FPI-1966 is a targeted alpha therapy designed to target and deliver an alpha emitting medical isotope, actinium-225, to cancer cells expressing FGFR3; a receptor that is overexpressed on several tumor types, including bladder, ovarian and head and neck cancers. FPI-1966 utilizes Fusion’s Fast-Clear linker to connect vofatamab, a human monoclonal antibody that targets FGFR3, with actinium-225. Vofatamab was previously evaluated as a therapeutic agent in a Phase 1b/2 trial and was reportedly well-tolerated.