- Successful treatment of 91 patients with consistent safety and efcacy results observed to date; interim data to be presented at ESMO Congress in October 2026
- Written feedback from FDA following pre-NDA meeting acknowledge the potential clinical meaningfulness of Padeliporn VTP in LG-UTUC and support path to NDA submission in 2027
- Expanded access program (EAP) discussions with the FDA are currently underway to expand patient reach and support real-world clinical use
TEL AVIV, Israel, Sept. 09, 2026 (GLOBE NEWSWIRE) — ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporn Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, today announced the completion of treatment for all required patients enrolled in its Phase 3 ENLIGHTED trial evaluating Padeliporn VTP in patients with low-grade upper tract urothelial carcinoma (LG-UTUC). Completion of treatment, along with a positive pre-NDA meeting held with the U.S. Food and Drug Administration (FDA) in April 2026, supports the Company’s planned reporting of topline data and anticipated NDA submission in 2027.
“The completion of treatment for all required patients in the Phase 3 ENLIGHTED trial represents a major milestone towards our goal of delivering a next-generation treatment option for patients with low-grade UTUC,” said Eyal Morag, M.D., Chief Medical Ofcer of ImPact Biotech. “Preliminary clinical data to date show encouraging complete response rates, durability of response, and a consistent safety prole, further supporting Padeliporn VTP’s potential to provide a minimally invasive, organ-sparing treatment option in LG-UTUC. This, alongside the existing dataset for Padeliporn across solid tumor indications, gives us condence in its potential to shift the treatment paradigm for these difcult-to-treat diseases and improve patient outcomes.”
Following ImPact’s positive pre-NDA meeting in April 2026, “the FDA acknowledged the clinical considerations around the potential clinical meaningfulness of Padeliporn-VTP as a treatment option for low-grade UTUC including the potential clinical value of durable CR in the treated area.” The agency has conrmed the registrational pathway and streamlined package requirements allowing ImPact to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporn VTP in advanced localized prostate cancer for submission in LG-UTUC in 2027.
Additionally, the Company has engaged in discussions with the FDA regarding a potential expanded access program (EAP) for eligible patients with LG-UTUC in the US. The program would enable access to Padeliporn VTP to qualifying patients prior to potential regulatory approval.
“With treatment now complete in the Phase 3 ENLIGHTED trial and following positive recent interactions with the FDA, our focus remains on bringing Padeliporn VTP to patients as efciently as possible,” said Barak Palatchi, Chief Executive Ofcer of ImPact Biotech. “The FDA’s feedback further supports our condence in the program and its path toward regulatory submission. Recognizing the signicant unmet need among LG-UTUC patients, the potential for an expanded access program for Padeliporn VTP underscores our commitment to expanding patient access and supporting treating physicians. We look forward to reporting topline results and advancing towards regulatory submission in 2027, while evaluating strategic commercialization opportunities to maximize patient reach.”
ImPact plans to present interim data from the Phase 3 ENLIGHTED trial in LG-UTUC at the ESMO Congress taking place from October 23-27, 2026 in Madrid.
ePoster Title: Non-Thermal, Drug-Activated Padeliporn Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC): ENLIGHTED Phase 3 Trial
Presenter: Asaf Shvero, M.D., Department of Urology, Sheba Medical Center
Poster Number: 4860eTiP
Category: Urothelial Cancer
About ENLIGHTED
The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporn VTP for the treatment of low-grade UTUC. Across 29 clinical sites globally, ImPact enrolled 91 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 a Maintenance Treatment Phase (MTP) – across which Padeliporn, a photosensitizing drug, is administered intravenously and VTP therapy was performed, via an ureteroscopy which applied a laser ber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporn in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) was achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporn VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.
About ImPact Biotech
ImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporn Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of solid tumors. The novel VTP platform delivers non-thermal laser light via optical bers to locally activate Padeliporn in the tumor microenvironment. Padeliporn VTP is currently being evaluated in a Phase 1 light dose escalation study in unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) and a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC 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.
Contacts
Global Head of Business Development
Guy Schmidt
guy.schmidt@impactbiotech.com