FDA Grants Fast Track Designation to Padeliporfin ImPACT

Steba biotech announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for padeliporfin ImPACT for the treatment of adult patients with low-grade and unifocal high-grade Upper Tract Urothelial Cancer (UTUC). This follows clearance of the Investigational New Drug (IND) application granted in December 2020 allowing initiation of the pivotal Phase 3 clinical trial of padeliporfin ImPACT in patients with low-grade UTUC, expected to begin enrollment in Q1 2021.

Steba biotech is focusing on the development of padeliporfin ImPACT as an oncology platform with the potential to offer surgery-like efficacy, combined with organ preservation in UTUC and other solid tumors where the needs of the high-risk surgical patient are not being met – either because surgery is not the preferred clinical option (e.g. to delay the loss of a kidney) or the risk of surgery is too high.

"Momentum is building towards unlocking the significant potential of padeliporfin ImPACT in a range of solid tumors – first with the IND green light and now Fast Track designation. In the last nine 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," Barak Palatchi, CEO of Steba, said.

"There is currently a high unmet medical need in UTUC, given the clinical aim to preserve the patient's kidney, rendering surgery as a last resort. Good initial efficacy data from the Phase 1 clinical trial in patients with UTUC, coupled with strong safety and efficacy data previously obtained in prostate cancer make us confident that padeliporfin ImPACT has the potential to be a well-tolerated, safe and efficacious treatment in UTUC and other cancer indications,” Dr. David Perry, Head of Steba R&D, said.

Padeliporfin ImPACT (Immune Photo Activated Cancer Therapy) offers surgery-like efficacy combined with organ preservation. ImPACT is Steba's oncology platform comprising the intravenous delivery of an inactive drug, padeliporfin. Upon activation, the drug rapidly triggers the constriction of the blood supply in the illuminated area only, resulting in targeted tumor necrosis that activates anti-tumor immunity which enhances cancer cell eradication.

Upper tract urothelial carcinoma (UTUC) is a type of cancer that grows either from the urothelium, a thin, continuous, protective layer of cells which line the ureter from kidney to bladder or the kidney lining itself. UTUC obstructs the flow of urine from the kidney causing severe flank pain and blood to appear in urine, which may not be visible with the naked eye and delays diagnosis. It currently accounts for 5-10 percent of urinary tract cancers, but prognosis, already worse than bladder cancer, has been worsening over time, increasing the strain on healthcare services.

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs, with the intention of getting important new drugs to patients earlier. Specifically, Fast Track designation facilitates meetings with the FDA to discuss aspects of development to support licensure and provides the opportunity to submit sections of a NDA on a rolling basis as data become available. Additionally, another potential benefit of Fast Track designation is priority review, which reduces the standard 10 months NDA review to six months.