[¹⁸F]Fluorthanatrace ([¹⁸F]FTT)
[¹⁸F]Fluorthanatrace ([¹⁸F]FTT) is a PET labeled PARP inhibitor analog which provides quantitative images of regional PARP expression and can be an important complement to genomic assays currently used to select patients who will benefit from PARPi. [¹⁸F]FTT can measure the presence or absence of PARP-1, and as such, can serve as a PARPi companion diagnostic to identify those most likely to respond to PARPi therapy, and importantly, those unlikely to respond. One of the major strengths of Trevarx is the network of academic collaborators located at world class cancer institutions like University of Pennsylvania, MD Anderson Cancer Center, Washington University at St. Louis, University of Washington and others. Early clinical trial data in ovarian and breast cancer research carried out at the numerous institutions support the accuracy of [¹⁸F]FTT tumor uptake as an in-vivo measure of regional PARP-1 drug binding and indicate its potential as a more effective PARPi imaging predictive biomarker than currently used HRD genomics-based assays.
[¹⁸F]FTT has a rapidly emerging body of published academic research by our academic collaborators, representing a 2-3 year lead over other competitive PET PARPi imaging agents that have only recently completed first-in-human studies. A Phase 2 multi-center trial in breast cancer under a Trevarx sponsored IND will start in Spring 2022, led by MD Anderson Cancer Center with participation by the University of Pennsylvania and Washington University at St. Louis. Trevarx is developing the validated GMP synthesis and testing for [¹⁸F]FTT that is required to support commercial production for Phase 3 multi-center trials and NDA submission and prompt clinical rollout after drug approval, enabling better guidance of PARPi treatment for cancer patients.
[¹⁸F]FTT Publications
Radiotracer Methods Quantify PARP-1 and Predict Response to PARPi Therapy in Human Tumor Cell Lines: Drs. Mehran Makvandi, Kuying Xu, Robert Mach (Cancer Research, 2016)
FTT PET Visualized PARP-1 Expression in Multiple Tumor Types: (Drs. Loren Michel, Samantha Dryoff, Delphine Chen, Radiology, 2017)
FTT Ovarian Cancer Images of PARP-1 Correlate with Tumor Biopsy Results and Can ID Differing Levels of PARPi Uptake Across Different Sites of Metastatic Cancer in Single Scan: Drs Mehran Makvandi, Austin Pantel, Lilie Lin (J. Clin.Invest., 2018)
FTT Imaging in Breast Cancer Shows PARP-1 Expression Independent of BRCA: Drs. Elizabeth McDonald, Robert Doot, David Mankoff, JAMA Oncol. 2020)
FTT Pharmacokinetics in Ovarian Cancer Patients: Drs. Anthony Young, Robert Doot and Austin Pantel (Yang, J. Nucl Med, 2021)
FTT Can Visualize And Quantify the Effects of PARPi in Humans (Early Breast Cancer Results): Drs. Elizabeth McDonald, Austin Pantel, Sean Carlin, JCI Insight 2021)