{"id":84362,"date":"2026-09-09T13:13:00","date_gmt":"2026-09-09T13:13:00","guid":{"rendered":"https:\/\/english.saigonbiz.com\/vn\/?p=84362"},"modified":"2026-09-10T00:09:47","modified_gmt":"2026-09-10T00:09:47","slug":"impact-biotech-announces-completion-of-treatment-in-phase-3-enlighted-trial-of-padeliporfin-vtp-in-lg-utuc-and-positive-regulatory-updates","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/impact-biotech-announces-completion-of-treatment-in-phase-3-enlighted-trial-of-padeliporfin-vtp-in-lg-utuc-and-positive-regulatory-updates\/","title":{"rendered":"ImPact Biotech Announces Completion of Treatment in Phase 3 ENLIGHTED Trial of Padeliporfin VTP in LG-UTUC and Positive Regulatory Updates"},"content":{"rendered":"<p align=\"center\"><em>\u2013\u00a0<\/em><em>Successful <\/em><em>t<\/em><em>reatment of <\/em><em>91<\/em><em> patients <\/em><em>with <\/em><em>consistent <\/em><em>safety and efficacy results <\/em><em>observed to date<\/em><em>; <\/em><em>interim<\/em> <em>data to be presented at ESMO Congress<\/em><em> in October 2026<\/em> <em>\u2013<\/em><\/p>\n<p align=\"center\"><em>\u2013<\/em><em> W<\/em><em>ritten feedback <\/em><em>from FDA <\/em><em>following pre-NDA meeting acknowledg<\/em><em>e<\/em><em> the <\/em><em>potential clinical meaningfulness of Padeliporfin VTP in LG-UTUC<\/em><em> and support path to <\/em><em>NDA submission in 2027<\/em> <em>\u2013<\/em><\/p>\n<p align=\"center\"><em>\u2013<\/em> <em>Expanded <\/em><em>a<\/em><em>ccess <\/em><em>p<\/em><em>rogram (EAP) <\/em><em>d<\/em><em>iscussions with the FDA <\/em><em>a<\/em><em>re<\/em><em> currently<\/em> <em>u<\/em><em>nderway<\/em><em> to expand patient reach<\/em> <em>and support real-world<\/em><em> clinical <\/em><em>use<\/em> <em>\u2013<\/em><\/p>\n<p align=\"justify\">TEL AVIV, Israel, Sept.  09, 2026  (GLOBE NEWSWIRE) &#8212; ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin 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 Padeliporfin 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&#8217;s planned reporting of topline data and anticipated NDA submission in 2027.<\/p>\n<p align=\"justify\">\u201cThe 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,\u201d said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. \u201cPreliminary clinical data to date show encouraging complete response rates, durability of response, and a consistent safety profile, further supporting Padeliporfin VTP\u2019s potential to provide a minimally invasive, organ-sparing treatment option in LG-UTUC. This, alongside the existing dataset for Padeliporfin across solid tumor indications, gives us confidence in its potential to shift the treatment paradigm for these difficult-to-treat diseases and improve patient outcomes.\u201d<\/p>\n<p align=\"justify\">Following ImPact\u2019s positive pre-NDA meeting in April 2026, \u201cthe FDA acknowledged the clinical considerations around the potential clinical meaningfulness of Padeliporfin-VTP as a treatment option for low-grade UTUC including the potential clinical value of durable CR in the treated area.\u201d The agency has confirmed the registrational pathway and streamlined package requirements allowing ImPact to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporfin VTP in advanced localized prostate cancer for submission in LG-UTUC in 2027.<\/p>\n<p align=\"justify\">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 Padeliporfin VTP to qualifying patients prior to potential regulatory approval.<\/p>\n<p align=\"justify\">\u201cWith treatment now complete in the Phase 3 ENLIGHTED trial and following positive recent interactions with the FDA, our focus remains on bringing Padeliporfin VTP to patients as efficiently as possible,\u201d said Barak Palatchi, Chief Executive Officer of ImPact Biotech. \u201cThe FDA\u2019s feedback further supports our confidence in the program and its path toward regulatory submission. Recognizing the significant unmet need among LG-UTUC patients, the potential for an expanded access program for Padeliporfin 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.\u201d<\/p>\n<p align=\"justify\">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.<\/p>\n<p align=\"justify\"><strong>ePoster<\/strong><strong> Title:<\/strong> Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC): ENLIGHTED Phase 3 Trial<br \/><strong>Presenter:<\/strong> Asaf Shvero, M.D., Department of Urology, Sheba Medical Center<br \/><strong>Poster<\/strong><strong> Number:<\/strong> 4860eTiP<br \/><strong>Category<\/strong><strong>:<\/strong> Urothelial Cancer<\/p>\n<p align=\"justify\"><strong>About ENLIGHTED<\/strong><\/p>\n<p align=\"justify\">The 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 enrolled 91 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts \u2013 an Induction Treatment Phase (ITP) and a Maintenance Treatment Phase (MTP) \u2013 across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy was performed, via an ureteroscopy which applied 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) was achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study\u2019s 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.<\/p>\n<p align=\"justify\"><strong>About <\/strong><strong>ImPact<\/strong><strong> Biotech<\/strong><br \/>ImPact 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 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 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: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=g2dR8lCP5_dbk6rZEjdJCXOI56VRAbKyZYC-KZh9xplMhgCkpvNPCPs6Wz1sq78Q5BQBOFED1bm0GzKFrMNTLvq3_X-gBFogrD4N5FA4eqM=\" rel=\"nofollow\" target=\"_blank\" title=\"\"><u>www.impactbiotech.com<\/u><\/a> and the ENLIGHTED clinical trial website (for the US): <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=zhCCKd2BPBfFTifuRyV4xP0FEoCk4ftO_QkOp4rSWxu86k83OL_9-aRtFejz1RS0wI7NcPMlKiIagowpEqWhcxKBNq1ClernwICpskWBHjbtcI0LhZCMzzRtVpe9eowc\" rel=\"nofollow\" target=\"_blank\" title=\"\"><u>https:\/\/www.enlighted-study.com<\/u><\/a>.<\/p>\n<p align=\"justify\"><strong>Contacts<\/strong><\/p>\n<p align=\"justify\"><strong>Global Head of Business Development<\/strong><br \/>Guy Schmidt<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=Ul8jGf4QoymTtosuZsYsdPpPkS0DRzOGzmJpc_MD1VMh53daeKPj7bjW_dfuHzY8IAvep0_fYaAhiz8BYDJy1nPZIWN39FWDsz0GyP-KCyxlDAmYKn9ypIsM1-9HLPOO\" rel=\"nofollow\" target=\"_blank\" title=\"\"><u>guy.schmidt@impactbiotech.com<\/u><\/a><\/p>\n<p><img alt=\"\" src='https:\/\/ml-eu.globenewswire.com\/media\/NTE2YWIzOWMtNjIyMS00OGMyLWJkNDItYzNmOWUzNzg1ZTFlLTEyNzI2MjctMjAyNi0wOS0wOS1lbg==\/tiny\/ImPact-Biotech.png' referrerpolicy='no-referrer-when-downgrade' \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u2013\u00a0Successful treatment of 91 patients with consistent safety and efficacy results observed to date; interim data to be presented at ESMO Congress in October 2026 \u2013 \u2013 Written feedback from FDA following pre-NDA meeting acknowledge the potential clinical meaningfulness of Padeliporfin VTP in LG-UTUC and support path to NDA submission in 2027 \u2013 \u2013 Expanded [&#8230;]\n","protected":false},"author":1,"featured_media":85254,"comment_status":"open","ping_status":"closed","sticky":false,"template":"Default","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-84362","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-globe-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - 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