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Game-changing uPAR-targeting dye for guiding surgical treatment of cancer

Periodic Reporting for period 1 - INSTAGLOW (Game-changing uPAR-targeting dye for guiding surgical treatment of cancer)

Reporting period: 2020-07-01 to 2021-06-30

Surgery is a cornerstone in treatment of cancer. Approximately 80% of patients with cancer will receive surgical treatment once during their disease. In almost half of the patients cancer is recurring after the surgery due to incomplete tumour removal. The recurring of cancer leads to patient suffering and causes a huge financial burden on the healthcare system, and it can even cause death of the patient. There is a major unmet need to delineate cancer accurately, sparing healthy tissue, identifying local metastases, and aiding surgeons to precisely remove the entire tumour. FluoGuide will deliver FG001, a breakthrough, real-time, surgical visualisation solution that lights up cancer and improve surgical precision during surgery. FG001 is the first actively targeting fluorescent tumour marker in development that targets uPAR, a receptor extensively expressed in a wide range (>50%) of solid tumours such as brain (high grade glioma including glioblastoma (GBM)), lung, breast, colorectal and head and neck cancers. FluoGuide’s proprietary FG001 will revolutionise cancer surgery to improve the surgical outcome of >3 million cancer patients undergoing surgery every year.

To realise this huge potential, FluoGuide is working on accelerating the development of FG001. Our initial focus is on high grade glioma including GBM. This disease has poor survival rates, only half of the patients surviving 14 months on average. Moreover, surgical precision is extremely important as removing too much brain tissue can severely disable the patient. FG001 can thus enormously improve surgery of GBM patients. The funding from EIC accelerator pilot will accelerate and substantiate FG001’s clinical phase IIb/III study for GBM, and catapult FluoGuide to become a leader in cancer surgery guidance. We will generate revenues by 1) direct sales, paid for via reimbursement by insurance companies and governments, and 2) through partners, by a combination of revenue generated by selling finished products to partners for distribution to their customers and revenue generated by royalty paid by partners for having rights to our patent portfolio.
Results obtained during the project:
• Clinical trial with FG001 in high grade glioma (incl. GBM): FG001 has been well tolerated and light up cancer in patients with high grade glioma . The pathology examination remains and will determinate that the tissue lighting up is actual cancer and the tissue that does not light up is normal tissue.

• Manufacturing of FG001: The process has been developed for late stage clinical development and being prepared for commercial stage needed before phase III studies can be initiated.

• Quality Assurance: The quality system in FluoGuide has been established. This is important for many reasons including to support documentation for approval of FG001.

• Relevance of FG001 in other cancer indications: The support for FG001 being effective in additional and more prevalent cancer types is strengthened. One patient has been included in the ongoing study ‘suspected to have GBM’, however, it turned out that this patient had a non-brain derived cancers. It is common that some patients ‘suspected to have GBM’ have another type of cancers, e.g. a metastasis from a lung cancer. In the case of INSTAGLOW, this result strengthen the potential for FG001 in additional cancer indications

• Market research of FG001 in high grade glioma: The first study has been conducted and the results are feed back into the development. In short, the need for more precise surgery of brain cancer is unmet.

• Photothermal therapy (‘PTT’) property of FG001: The fluorophore in FG001 exhibits photothermal therapy potential, whereby excitation of light causes the product to heat up and destroy nearby cells to which it is bound, but does not harm surrounding cells. FG001 binds specifically to uPAR (urokinase plasminogen activator receptor) which is a cancer specific receptor. FG001’s photothermal therapy property can therefore potentially be used for highly targeted destruction of cancer cells, while sparing the surrounding healthy cells. This unique property of FG001 is combined with its core objective to vastly improve the outcome of brain cancer surgery.
The expected result of INSTAGLOW is to develop a product that saves lives of patients with glioblastoma and saves treatment costs for hospitals and society – FG001.

Unique Selling Points of FG001:
• Unique target: FG001 is the first fluorescent agent in development that targets uPAR, a receptor that is present extensively in most patients with solid tumour indications. uPAR is especially expressed at the invasive front of the tumour, making uPAR an ideal target for fluorescence-guided surgery.
• Safe: FG001 is made of a targeting molecule linked to a NIR fluorophore, which is well tolerated by humans, and provides an optical imaging ligand with high receptor affinity in vivo.
• Compatible with current workflows: In line with current practice, surgeons will administer FG001 intravenously prior to surgery and can visualise all solid tumours for up to 24 hours after injection.
• Equipment independent: Surgeons are not restricted on choice of equipment as almost all equipment is compatible with fluorescent light specification of FG001.

So far, the INSTAGLOW project strongly supported this Unique Selling Points, as planned. The final proof will be reached by the end of the project. In addition, during the first year of INSTAGLOW, additional milestones have been achieved, such as:
• Photothermal therapy (‘PTT’) property of FG001 has been proven in vivo studies (not funded by INSTAGLOW).
• Strong support for the effect of FG001 to guide surgical removal of other cancer types than high grade glioma.
• Hypothesis for design of phase III being validated during the remaining period of INSTAGLOW.
FG001: Simple procedure, profound impact
The concept of FG001 has already been proven in preclinical models