68Ga-OncoFAP is a small molecule radiotracer with ultra high affinity for Fibroblast Activation Protein (FAP). The product is suitable for the non-invasive detection of a variety of metastatic solid tumors, as FAP is overexpressed in more than 90% of epithelial cancers (e.g., malignant breast, colorectal, ovarian, lung, skin, prostate and pancreatic cancers, as well as in some soft tissue and bone sarcomas).
68Ga-OncoFAP consists of (i) a small organic ligand targeting FAP, (ii) an innovative spacer structure and (iii) a DOTAGA chelator for the incorporation of 68Gallium.
68Ga-OncoFAP displays best-in-class performance both in vitro and in vivo with the highest reported affinity to the FAP antigen. In preclinical models of cancer, the product has shown a rapid and selective accumulation in the tumor mass with an extraordinarily low kidney uptake.
The exceptional targeting activity of 68Ga-OncoFAP has been confirmed by PET scans in more than 200 patients with a variety of solid tumors.
A Phase I clinical trial has been completed. The program is partnered with Blue Earth Diagnostics (part of the Bracco Group) who is in charge of further development and commercialization of the molecule.
ONGOING CLINICAL TRIALS
- OncoFAP-68Ga has recently entered in a first-in-man imaging study in patients with advanced solid cancers
- Additional studies with OncoFAP-68Ga (Imaging) and OncoFAP-177Lu (Therapy) are about to start
ONGOING CLINICAL TRIALS
A first-in-human imaging study with 68Ga-OncoFAP in patients with advanced solid cancers (NCT05784597) has been completed.
References
Puglioli et al. (2022) Chem, doi: 10.1016/j.chempr.2022.10.006
Galbiati et al. (2022) J Nucl Med, numed.122.264036
Backhaus et al. (2021) Eur J Nucl Med Mol Imaging, 10.21203/rs.3.rs-969176/v1
Millul et al. (2021) PNAS, 118, 16, e2101852118