FDA Grants Fast Track Designation to Padeliporfin ImPACT for Steba biotech

– Ambitious development program for multiple solid tumors with high unmet need, starting with low grade upper tract urothelial cancer (UTUC)

– Follows successful clearance of the IND application in Dec 2020 allowing initiation of pivotal Phase 3 clinical trial in patients with low grade UTUC; results to form basis of application for FDA approval

Steba biotech, pioneering developer of the IMmune Photo Activate Cancer Treatment (ImPACT), announced today that 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 swiftly 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 innovative 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.

Barak Palatchi, CEO of Steba, said: “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.”

Dr David Perry, Head of Steba R&D, 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.”

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