ImPact Biotech Announces Late-Breaking Podium Presentation at ASCO 2025 Highlighting ENLIGHTED Study Interim Analysis

Yahoo

22-05-2025

-- Company to present interim update from ENLIGHTED Phase 3 Study in LG UTUC following assessment of 50% of targeted total evaluable patient enrollment --
TEL AVIV, Israel, May 22, 2025 (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 that the company will present an interim analysis with updated data from the ongoing Phase 3 ENLIGHTED study evaluating Padeliporfin VTP in patients low-grade upper tract urothelial cancer (UTUC) in a late-breaking podium session at the American Society of Clinical Oncology Annual Meeting taking place May 30 – June 3, 2025 in Chicago, Illinois.
'Evaluation of Padeliporfin VTP in the ENLIGHTED study continues to steadily progress as we work to complete enrollment in the second half of 2025 and push towards potentially registrational topline results later this year,' said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. 'We believe this interim analysis, capturing 50% of the targeted enrollment of evaluable patients, will continue to support the robust value proposition for Padeliporfin VTP in UTUC as a best-in-class, paradigm shifting treatment option for patients currently underserved by the standard of care. We look forward to sharing these results and future updates as the data matures.'
Podium Presentation Details:
Poster Title: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the treatment of low-grade upper tract urothelial cancer (LG UTUC): ENLIGHTED phase 3 studyPresenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical CenterPoster Number: LBA4513Session Title: Bladder Cancer: Upper Tract Transitional Cell CarcinomaSession Date & Time: May 31, 2025, 1:15 PM CT
About ENLIGHTEDThe Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care follow-up visits every three months with optional VTP therapy administered on each visit for up to 12 months. The study's primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.
About ImPact BiotechImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin vascular targeted photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of unresectable solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: www.impactbiotech.com and the ENLIGHTED clinical trial website (for the US): https://www.enlighted-study.com.
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