FDA Grants Fast Track Status to Padeliporfin ImPACT for Upper-Tract Urothelial Cancer

The FDA has granted a fast track designation to padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for use in the treatment of patients with low-grade and unifocal upper-tract urothelial cancer (UTUC), according to an announcement from Steba Biotech.¹

The decision follows the December 2020 clearance of an investigational new drug (IND) application for the treatment, with permitted the launch of a phase 3 trial examining padeliporfin ImPACT in patients with low-grade UTUC. Enrollment for the trial is anticipated to begin in Q1 2021.

“Momentum is building toward unlocking the significant potential for padeliporfin ImPACT in a range of solid tumors – first with the IND green light and now fast track designation,” Barak Palatchi, CEO of Staba Biotech, stated in a press release. “In the last 9 months, under the new leadership team, we have transformed the organization with a bold strategy and focused execution. Achieving these important regulatory milestones in quick succession is a powerful acknowledgement of the technology and will accelerate the pace by which we can make padeliporfin ImPACT available for people living with cancer.”

A minimally invasive, targeted treatment option, ImPACT was approved for use in Europe, Israel, and Mexico in the treatment of patients with early-stage prostate cancer. The treatment approach is also under evaluation in patients with other localized tumors, such as urothelial cancer, esophageal cancer, lung cancer, and pancreatic cancer.

Specifically, ImPACT is a drug/device combination that comprises a photosensitive drug with activation via a nonthermal light delivery system, according to Steba Biotech.² The drug component is given intravenously; light fibers deliver low-energy, nonthermal laser light to activate the agent locally. Once activated, the drug quickly starts to constrict the blood supply to the illuminated area only; this leads to targeted tumor necrosis anticancer immunity activation, which further augments the eradication of tumor cells.

“This therapeutic approach enables targeted ablation of solid tumors locally and minimizes the risk of side effects by preserving the surrounding healthy tissues and organs,” according to the biotechnology company. “It thereby enables treatment of sometimes inoperable tumors and optimizes quality of life of patients.”

Steba Biotech partnered up with Weizmann Institute and Memorial Sloan Kettering Cancer to further explore this therapeutic approach in several indications to see where the technology can be successfully applied.

References

1. FDA grants fast track designation to padeliporfin ImPACT for Steba biotech. News release. Steba Biotech. January 17, 2021. Accessed January 18, 2021. http://prn.to/3bMVWzL.
2. A novel treatment path. Steba Biotech. Accessed January 18, 2021. http://bit.ly/38VrvWb.