FDA Granted Orphan Drug Designation to Novel ImPACT Agent in Upper Tract Urothelial Cancer

The FDA has granted an Orphan Drug Designation to Padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for the treatment of adult patients with upper tract urothelial cancer, according to a press release from Steba Biotech.

“We are delighted to receive Orphan Drug Designation for Padeliporfin ImPACT in upper tract urothelial cancer, further validating Steba’s technology and the benefits our product could bring to people suffering from upper tract urothelial cancer. It has been less than a year since we embarked on our new strategy, refocusing Padeliporfin ImPACT on diseases for patients with limited treatment options,” said Barack Palatchi, chief executive officer, Steba Biotech, in a statement.

Following an Investigation New Drug Application, which was accepted by the FDA, a phase 3 clinical trial (ENLIGHTED; NCT04620239) has been initiated to further study the use of Padeliporfin ImPACT. Enrollment is expected to begin later this month.

ENLIGHTED is a single-arm, non-randomized, multicenter study with a target enrollment of 100 patients with low-grade upper tract urothelial cancer. The primary end point of the study is the number of patients with the absence of upper tract urothelial cancer tumors in the entire ipsilateral renal pelvis and ureter. The secondary end points of the study include the duration of response at the entire ipsilateral kidney, at the entire ipsilateral kidney, and at the treatment area of the ipsilateral kidney; overall renal function; the number of patients with kidney organ loss or preservation; and the number of patients with ureteral obstruction.

Padeliporfin ImPACT is an endoluminal light-activated treatment that involves the placement of optical light fiber with a ureteroscope and intravenous administration of Padeliporfin at 4 mg/kg over 10 minutes and the illumination of each area for 10 minutes in the study. The treatment triggers the constriction of the blood supply in the affected area upon activation and leads to targeted tumor necrosis and antitumor immunity.

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