Steba Biotech announced today that it received FDA orphan drug designation (ODD) for its Padeliporfin ImPACT for treating UTUC.
Padeliporfin ImPACT (immune photo-activated cancer therapy) is designed to offer surgery-like efficacy combined with organ preservation through the intravenous delivery of an inactive drug, according to a news release.
Once activated, the drug rapidly triggers the constriction of the blood supply in the illuminated area only to produce targeted tumor necrosis, activating anti-tumor immunity to enhance cancer cell eradication.
The ODD granted by the FDA is for the treatment of adult patients with upper tract urothelial cancer (UTUC), as the drug already has the green light on an investigational new drug (IND) application to allow the initiation of a pivotal Phase 3 trial, which is expected to start enrollment this month.
“We are delighted to receive orphan drug designation for Padeliporfin ImPACT in UTUC, further validating Steba’s technology and the benefits our product could bring to people suffering from UTUC,” Steba Biotech CEO Barak Palatchi said in the release. “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. In UTUC, the current standard of care is nephrectomy; our hope is that Padeliporfin ImPACT offers these patients an effective treatment option that preserves their kidney.
“UTUC is the first indication of our ambitious 3-year plan. We are looking forward to exploring the possibility of offering Padeliporfin ImPACT to more patients coping with life-threatening cancers.”