Molecular Imaging

Our patented product, [¹⁸F]Fluorthanatrace  ([¹⁸F]FTT), is an accurate and safe in-vivo PET biomarker for PARPi.   PARPi have been targeted to patients with BRCA-related gene mutations, but not all BRCA-related tumors respond to PARPi. Importantly, tumors without BRCA-related mutations may respond to PARPi and current treatment excludes those patients. Genomic assays of homologous repair deficiency (HRD) have shown limited predictive efficacy outside of ovarian cancer.

A [¹⁸F]FTT) PET/CT scan is safe, quick and non-toxic and allows for non-invasive visualization and quantification of PARP-1 expression in patients via an injection of PET tracer and scan in a PET/CT machine.  Unlike tissue biopsies which require surgery, [¹⁸F]FTT  PET/CT scans can provide immediate location of PARP-1 expressing tumors as well as the existence of PARP-1 tumor metastases. The [¹⁸F]FTT) PET/CT scan looks at entirety of tumor which may be heterogeneous (assay sampling may miss key areas of tumors).  Finally, PET/CT scans are easily repeatable during stages of treatment: diagnosis, dosing, and response because they are non-invasive.

Drug binding to PARP-1 present in tumor cells is a necessary factor for effective PARPi therapy. [¹⁸F]FTT provides quantitative images of regional PARP expression and measures the presence or absence of PARP-1, serving as a PARPi companion diagnostic to identify those most likely to respond to PARPi, and importantly, those unlikely to respond. Rapidly emerging research indicates [¹⁸F]FTT’s potential as a PARPi predictive biomarker. Trevarx is applying for a company sponsored Investigational New Drug (IND) application with the FDA for [¹⁸F]FTT in fall 2021 to support Spring 2022 Phase 2 multi-center breast cancer trials led by MD Anderson Cancer Center with participation by the University of Pennsylvania and Washington University at St. Louis. Trevarx plays a key role in this effort by ensuring uniform radiopharmaceutical production across sites and providing regulatory sponsorship and monitoring with the goal of a commercial supply of [¹⁸F]FTT for clinical use.