Advancing HetSiFA® radiotheranostics
Fuzionaire Theranostics’ pipeline combines scalable PET imaging with radioligand therapy.
We develop fluorine-18 PET radiopharmaceuticals and complementary radioligand therapies. Our HetSiFA® platform enables diagnostic and therapeutic agents to be designed from chemically matched molecular scaffolds. Our pipeline includes fluorine-18 and gallium-68 PET imaging agents, lutetium-177 radioligand therapies, and lead-212 targeted alpha-therapy programs, with radionuclide selection guided by target biology, molecular pharmacology, biodistribution, and intended clinical use.
FTX-426 lead program (target GRPR)
FTX-426 is a GRPR-targeted HetSiFA®-DOTA radiopharmaceutical being developed for PET imaging and radioligand therapy of GRPR-expressing solid tumors, including prostate and breast cancer.
First-in-patient PET imaging has been performed with 18F-FTX-426 and its 68Ga-labeled analog, and radioligand therapy with 177Lu-FTX-426, with additional patient testing ongoing. A clinical trial of 18F-FTX-426 is planned to further evaluate its use as a broadly applicable GRPR PET imaging agent for disease detection, staging, and selection of patients for GRPR-targeted radioligand therapy.
GRPR alpha-theranostic program (target GRPR)
The company is developing a next-generation GRPR-targeted program pairing fluorine-18 PET with lead-212 targeted alpha therapy. The program is evaluating HetSiFA®-containing molecular designs and lead-chelation strategies to identify chemically matched imaging and therapeutic candidates with favorable target affinity, biodistribution, and therapeutic index.
The program builds on clinical and preclinical experience with the FTX-426 scaffold and is designed to leverage chemically matched fluorine-18 PET and lead-212 therapeutic compounds for patient selection, quantitative biodistribution assessment, and the development of individualized treatment-planning and dosimetry approaches.
SSTR2 radiotheranostic program (target SSTR2)
The company is applying its HetSiFA® platform to develop SSTR2-targeted radiotheranostics for neuroendocrine and other SSTR2-expressing tumors. The discovery program is evaluating fluorine-18 PET radioligands together with lead-212 and lutetium-177 therapeutic counterparts, with candidate selection guided by receptor pharmacology, biodistribution, and intended clinical use.
Both agonist and antagonist targeting strategies are being explored to identify molecular architectures best suited to diagnostic imaging and radioligand therapy.