– Complete response (CR) observed in 70% (35/50) of patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase (ITP)
– Initial durability data shows all patients (100%) who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date
– Padeliporfin VTP treatment continues to be safe and well-tolerated, establishing profile consistent with prior results alongside additional follow-up in MTP
– Complete enrollment in study expected in Q1 2026, with topline data anticipated in the first half of 2026
TEL AVIV, Israel, Dec. 04, 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 updated interim results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment of patients with low-grade upper tract urothelial cancer (UTUC). These data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology (SUO 2025) on December 4, 2025, in Phoenix, Arizona.
“We are pleased to share updated data from the Phase 3 ENLIGHTED study, which further strengthen Padeliporfin VTP’s profile as a next-generation treatment option for LG UTUC with potential to improve long-term patient outcomes,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We continue to see significant efficacy, with complete responses achieved in 70% of patients, and consistent established safety with similar observations to date. Moreover, this first look at the program’s durability profile shows complete responses were sustained in patients for over twelve months following the Maintenance Treatment Phase, and we are excited to advance this minimally invasive, organ-sparing therapy further towards our goal of transforming the treatment landscape for patients with unresectable solid tumors. Padeliporfin VTP is well-positioned to address the current unmet medical need in LG UTUC as we look to complete enrollment by Q1 2026 and report topline data in the first half of 2026.”
Key results from the preliminary analysis of the Phase 3 ENLIGHTED study of Padeliporfin VTP:
As of July 28, 2025, the data cut-off for the poster presentation at SUO 2025, 68 patients had begun treatment, of which 50 had completed ITP and were evaluable for efficacy.
Clinical Profile:
- Overall response rate 88%.
- 35 of the 50 (70%) response-evaluable patients achieved a CR at the end of ITP.
- 9 of the 50 (18%) response-evaluable patients achieved a partial response (PR) at the end of ITP.
Durability Profile:
- All patients (100%) who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date with additional patients progressing in the MTP that have yet to complete the 12-month evaluation period.
Safety and Tolerability Profile:
- Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results.
- Adverse events (AEs): the majority of treatment-emergent adverse events (TEAEs) were mild or moderate, primarily related to the ureteroscopic procedure, and resolved within a few days. One Grade 3 serious adverse event related to VTP treatment was reported and resolved within two days. No TEAEs of special interest were reported and no TEAE led to discontinuation of the study treatment.
ImPact continues to recruit for the ENLIGHTED study and expects to complete enrollment in the first quarter of 2026. The company anticipates the presentation of topline ENLIGHTED data in the first half of 2026.
Poster & Session Details:
Poster Title: ENLIGHTED Phase 3 study: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC)
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern
Medical Center
Poster Number: 166
Session Title: SUO Top Abstract Tour
Session Date & Time: December 4, 2025, 4:30 PM MST
About ENLIGHTED
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 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 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 Padeliporfin 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 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.
Contacts
Global Head of Business Development
Guy Schmidt
guy.schmidt@impactbiotech.com
