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Philochem Begins Patient Imaging in Phase I Trial of Tumor-Targeted Radioligand

NEW YORK – Philochem on Tuesday said it has imaged the first three patients at the National Cancer Institute of Milan in a Phase I trial of its radiopharmaceutical 68-Ga-OncoFAP for detection and localization of solid tumors.

Philochem, a Zurich-based subsidiary of Philogen, is conducting the trial under a March 2022 licensing agreement with Blue Earth Diagnostics, giving Blue Earth the right to develop and commercialize 68-Ga-OncoFAP worldwide.

In the trial, researchers will enroll about 20 patients with solid tumors in two cohorts to receive a single intravenous bolus of 68-Ga-OncoFAP. Cohort A will comprise three female and three male patients with a primary tumor only. Cohort B will consist of six to 14 patients with a primary tumor or advanced disease with a quantifiable number of lesions. Investigators will measure safety and determine the effective and absorbed doses of 68-Ga-OncoFAP via PET/CT imaging as primary outcome measures of the trial. Secondary outcome measures will include pharmacokinetics, biodistribution, and lesion detection rate.

OncoFAP is a non-internalizing small organic ligand of fibroblast activation protein (FAP), a tumor-associated antigen expressed in more than 90 percent of epithelial cancers. Philochem is developing OncoFAP for radiotracer and targeted drug conjugate products. 68-Ga-OncoFAP is a construct of OncoFAP and the chelating agent DOTAGA labeled with gallium-68 connected by a chemical linker. Philochem is planning a clinical trial of 177-Lu-OncoFAP as a radioligand therapy for FAP-positive tumors.