FG001

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 disappear from the systemic circulation.

FG001 is subject to clinical trial activity, showing promising properties as a solution to increase precision in curative surgery (see pipeline chart).
FG001 is made of two components, the uPAR binding molecule, which targets cancerous cells, and a fluorophore that lights up those cells.

Initial preclinical test results

FG001 has previously been tested in several preclinical studies. The latest preclinical study was conducted by a human surgeon using human equipment on human cancer transplanted into mice. The study was designed similar to the later clinical study, 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.

Clinical stage development

FG001 is currently being tested in various phase IIa and phase IIb trials.

Glioblastoma

The first indication for FG001 is glioblastoma (glioblastoma is a high-grade glioma). Almost all patients with glioblastoma have cancer expressing uPAR. A total of 60,000 patients get 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 containing vital structures often near the cancer. Local reoccurrence of glioblastoma is common and happens in almost 100% of all patients.

Images from the application of FG001 during brain surgery, where the surgeon visually needs to determine if all cancer cells have been successfully removed:

Images from: Skjøth-Rasmussen, J. et al. (2021). A new uPAR-targeting fluorescent probe for optical guided intracranial surgery in resection of a meningioma—a case report. Acta Neurochirurgica. https://doi.org/10.1007/s00701-021-05051-3

Lung cancer

The second indication for FG001 is lung cancer. FluoGuide has selected the lung indication mainly due to a high unmet need and evidence of a high concentration of uPAR expression in the lungs. Furthermore, surgeons are familiar with using endoscopes during surgery. Globally, 2.2 million individuals are diagnosed with lung cancers annually, and 1.8 million patients die every year with lung cancer. It is the second most commonly diagnosed type of cancer and the leading cause of cancer death in 2020. For patients diagnosed with localized or loco-regional cancer, which means the cancer has not spread outside of the lung, surgery is an essential treatment for the intended complete removal of the cancer. Therefore, identifying cancer early on will increase the number of patients relevant for surgery, and the demand for a product that can guide the surgeon is likely to follow.

Head and neck cancer

The third indication for FG001 is head and neck cancer. FluoGuide has selected head and neck cancer due to a high unmet need, and evidence of uPAR being overexpressed in these cancers. Head and neck cancer includes cancers in the lining of the lips, tung, mouth, or upper throat. Head and neck cancers is often occurring in close anatomical proximity to small vital structures such as blood vessels supplying the brain and many important nerves. Further, cosmetic considerations are important for most locations of head and neck cancers. Surgical precision is therefore essential for surgical removal of head and neck cancers. Most head and neck cancers arise from squamous cells and are called squamous cell carcinomas. Worldwide, head and neck cancer accounts for approximately 900,000 cases and over 400,000 deaths annually. In USA and EU head and neck cancer accounts for approximately 66,000 cases annually and 15,000 deaths, and 250,000 cases and 63,500 deaths, respectively.

Market potential

uPAR is extensively expressed in most solid cancers, three of the four most prevalent cancers, that is lung, breast, and colorectal cancer.

Number of new cases per year

FG001 has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 954904.