News Releases

Year

ImPact Biotech Presents Preliminary Phase 3 Results from ENLIGHTED Study of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer

Encouraging response rate shown; CR in 67% (6/9) of patients who completed the Induction Treatment Phase Padeliporfin VTP generally well-tolerated, consistent with prior results and reinforcing differentiated organ-sparing profile Preliminary data presented in a podium session at AUA; additional interim results to be presented at ASCO TEL AVIV, Israel, May 06, 2024 (GLOBE NEWSWIRE) — … Continued
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ImPact Biotech to Present Interim Phase 3 Data from ENLIGHTED Study of Padeliporn VTP in Low Grade UTUC at Upcoming Medical Conferences

Preliminary results from Phase 3 ENLIGHTED study in low grade upper tract urothelial cancer (UTUC) to be presented at AUA and ASCO Trial design for Phase 1 study of Padeliporfin VTP in pancreatic ductal adenocarcinoma (PDAC) to be presented at ASCO TEL AVIV, Israel, April 24, 2024 (GLOBE NEWSWIRE) — ImPact Biotech, a clinical-stage biotechnology … Continued
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ImPact Biotech Announces Appointment of Eyal Morag, M.D. as Chief Medical Officer

TEL AVIV, Israel, Dec. 18, 2023 (GLOBE NEWSWIRE) — ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy to treat a range of solid tumors, today announced the appointment of Eyal Morag, M.D., as Chief Medical Officer (CMO). Dr. Morag brings extensive experience as a practicing clinical radiologist, specializing in … Continued
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ImPact Biotech Receives FDA Clearance of IND Application for Padeliporfin VTP in Pancreatic Cancer

Phase 1 clinical trial expected to initiate in 1H 2024 IND clearance in third indication reflects broad platform potential for Padeliporfin VTP across a range of solid tumors   TEL AVIV, Israel, Dec. 20, 2023 (GLOBE NEWSWIRE) — ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic (VTP) therapy to treat … Continued
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ImPact Biotech Announces Research Collaboration to progress a treatment to arrest Pathologic Myopia using its Padeliporfin minimally invasive platform

ImPact Biotech to collaborate with Maastricht University researchers to progress a treatment to arrest the progressive condition Pathologic Myopia, a leading cause of irreversible sight impairment and blindness among adults   TEL AVIV, August 13, 2023 — ImPact Biotech, a leader in photodynamic therapy, recently announced an agreement with Maastricht University to collaborate in research focused … Continued
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ImPact Biotech receives FDA Clearance for Padeliporfin VTP Phase 1 Clinical Program in Peripheral Lung Cancer

Padeliporfin VTP Phase 1 trial in Peripheral Non-Small Cell Lung Cancer to start by end Q4 2023   TEL AVIV, August 1, 2023 — ImPact Biotech, the IMmune Photo Activated Cancer Treatment (IMPACT) specialist announces the U.S. Food and Drug Administration cleared ImPact’s clinical investigation plan of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for the treatment of patients with Peripheral Lung Cancer. … Continued
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ImPact Biotech receives FDA Orphan Drug Designation for Padeliporfin VTP in Pancreatic Cancer

Designation confers advantages including marketing exclusivity and tax credits  Padeliporfin VTP Phase 1 trial in Pancreatic cancer to start by end Q4 2023   TEL AVIV, July 3, 2023 — ImPact Biotech, the IMmune Photo Activated Cancer Treatment (IMPACT) specialist announces the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to Padeliporfin Vascular Targeted Photodynamic therapy (VTP) for the treatment of patients with … Continued
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Steba Biotech Treats First Patient in Pivotal ENLIGHTED Study of Padeliporfin ImPACT in Low Grade Upper Tract Urothelial Cancer

Pivotal Phase 3 trial recruiting 100 patients, and examining complete response of tumors as the primary endpoint. Consists of induction and maintenance phases, with follow up 12 months post treatment The activation of ENLIGHTED marks a significant milestone for Steba’s ambitious development program LUXEMBOURG, April 20, 2021 (GLOBE NEWSWIRE) —  Steba Biotech, the pioneering Immune Photo Activate Cancer Treatment (ImPACT) specialist, … Continued
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Steba Biotech receives FDA Orphan Drug Designation for Padeliporfin ImPACT in Upper Tract Urothelial Cancer

Designation confers advantages including marketing exclusivity and tax credits  Padeliporfin ImPACT pivotal Phase 3 trial in UTUC to start end Q1 2021 LUXEMBOURG, March 08, 2021 (GLOBE NEWSWIRE) — Steba Biotech, the IMmune Photo Activate Cancer Treatment (IMPACT) specialist today announces the U.S. Food and Drug Administration granted Orphan Drug Designation (ODD) to Padeliporfin ImPACT for the treatment of adult patients with Upper Tract Urothelial … Continued
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FDA Grants Fast Track Designation to Padeliporfin ImPACT in LG-UTUC

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   Luxembourg … Continued
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