FluoGuide Announces Positive Topline Results from Phase IIa Trial of FG001 in Lung Cancer

FluoGuide, a Danish biotech company that pioneers precision cancer surgery, is pleased to announce positive topline results from a phase IIa trial of its lead product FG001 in lung cancer. FG001 was shown to illuminate the majority of the patients’ lung tumors and was well tolerated in all patients. These results support further clinical development in this indication.

FG001 is a fluorophore targeting uPAR, which is a cancer-specific target expressed extensively in most solid types of cancers. The fluorophore has the same spectral specifications as indocyanine green, which is already approved, and this means FG001 can be used on current imaging equipment without adaptation. It is injected into a patient’s vein prior to surgery and lights up the cancer during surgery, helping to guide the surgeon in removing all cancer while sparing healthy tissue.

A total of 15 patients with non-small cell lung cancer (NSCLC), undergoing lung surgery (lobectomy), completed the trial, with a gender distribution of 9 females and 6 males a weight range of 50-92 kg and age range of 50-83 years. The primary objective was to evaluate FG001 for the detection of NSCLC.

“We are excited that FG001 has been shown to light up tumors in lung cancer and that we have data showing its efficacy in three cancer indications, underscoring the broad applicability of our lead product. These results are encouraging for the continuation of clinical development in lung cancer and we are looking forward to further data from our FG001 trials in head-and-neck and aggressive brain cancer in the near future. We will prepare next steps for development of FG001, considering data from all these studies and potential partner interest, over the coming months. We look forward to bringing our promising product towards market, with the aim of improving surgery outcomes for cancer patients,” says Morten Albrechtsen, CEO of FluoGuide.

“It is great to see that FG001 lighted up tumors, which is encouraging for its further development into a clinically useful tool to improve surgery and outcome for the lung cancer patients,” says René Horsleben Petersen, Professor and Chief Thoracic Surgeon at Rigshospitalet and Principal Investigator of the lung cancer study. ”I am pleased to see that the Ministry of Health has approved a pilot project in lung cancer screening in Denmark. The earlier the lung cancer is diagnosed, the better is the prognosis for patients. Early identification of lung cancer promotes precision surgery as an important factor in lung cancer treatment,”

FluoGuide expects enrollment of the last patient in its phase IIb trial of FG001 in aggressive brain cancer (high grade glioma) during the summer of 2023 and the topline result approximately 2 months after that. Interim results from the phase IIa trial of FG001 in head & neck cancer are expected in H1 2023.