FluoGuide’s leading product – FG001 – is injected into the patient’s vein prior to surgery. It contains a fluorophore that binds to cancer cells expressing uPAR. The uPAR binding is mediated by a targeting molecule. FluoGuide’s targeting molecules bind rapidly to cancer cells but quickly disappear from the systemic circulation. Thus, the surgeon can see the uPAR expressing cancer already 30 minutes after injection. FG001 therefore fits very well into the clinical workflow.
FG001 has previously been tested in several preclinical studies. The latest study was conducted by a human surgeon, human equipment and human cancer transplanted into mice. The study was designed similar to the clinical Phase IIb/III study needed to obtain marketing authorization and it demonstrated FG001 to perform as intended. The present equipment in the surgical operating room around the world is compatible and prepared to utilize FG001.
The first indication for FG001 is glioblastoma but FG001 has potential in several indications. Almost all patients with glioblastoma have a cancer expressing uPAR. A total of 60,000 patients gets high grade glioma and more than 30.000 patients are diagnosed with glioblastoma annually in the EU and US. Approximately 8-12 % of the patients are children. The prognosis for individuals with glioblastoma is very poor. Approximately 50 % of the patients die within 14 months and only 5 % are alive after five years from diagnosis. Precise removal of glioblastoma tumors is very difficult due the brain contains vital structures often near the cancer. Local reoccurrence of glioblastoma is common and happens in almost 100% of all patients. Since uPAR is also extensively expressed in other solid cancers, the Company has the ambition to expand its business to other solid tumors. The second priority indication will be lung or breast cancer, but in the future also in head and neck cancer, colorectal cancer and pancreatic cancer. The ultimate prioritization between the different indications will be guided by clinical data when those are available during the development.
Links to published literature
Juhl, K., Christensen, A., Persson, M., Ploug, M., & Kjaer, A. (2016). Peptide-Based Optical uPAR Imaging for Surgery: In Vivo Testing of ICG-Glu-Glu- AE105. PLoS ONE, 11(2), 1–15. (Link to PubMed)
Christensen, A., Juhl, K., Persson, M., Charabi, B. W., Mortensen, J., Kiss, K., … Kjaer, A. (2017). uPAR-targeted optical near-infrared (NIR) fluorescence imaging and PET for image-guided surgery in head and neck cancer: proof-of-concept in orthotopic xenograft model. Oncotarget, 8(9), 15407–15419. (Link to PubMed)
Juhl, K., Christensen, A., Rubek, N., Schmidt, K. K., Buchwald, C. Von, & Kjaer, A. (2019). Improved surgical resection of metastatic pancreatic cancer using uPAR targeted in vivo fluorescent guidance : comparison with traditional white light surgery. Oncotarget, 10(59), 6308–6316. (Link to PubMed)
FG001 has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 954904.