ImPact Biotech Presents Interim Analysis from Phase 3 ENLIGHTED Study of Padeliporfin VTP in LG UTUC at ASCO 2025

– Complete response (CR) observed in 73% (27/37) of evaluable patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase (ITP) –

– Padeliporfin VTP treatment continues to be safe and well-tolerated, establishing profile consistent with prior results alongside additional follow-up in Maintenance Treatment Phase (MTP) –

– Interim analysis follows evaluation of 50% of target enrollment in study; completion of enrollment anticipated in 2H25 with topline data by year end –

– Selected for late-breaking podium presentation today at 1:15 PM CT –

TEL AVIV, Israel, May 31, 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 in patients with low-grade upper tract urothelial cancer (UTUC). These data will be presented in a late-breaking podium session at the at the American Society of Clinical Oncology Annual Meeting taking place May 30 – June 3, 2025, in Chicago, Illinois.

“We are pleased to share this interim analysis, now capturing 50% of target enrollment in ENLIGHTED, which continues to reinforce Padeliporfin VTP’s best-in-class potential in low-grade UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We believe the emerging profile – a non-invasive treatment option delivering robust and sustained surgery-like efficacy, but without the associated risk of organ injury or loss – presents clear advantages over the standard of care. We are urgently progressing development to bring underserved UTUC patients this paradigm-shifting treatment and look forward to announcing potentially registrational topline data, including a view into durability, in UTUC within the year.”

Key results from the interim analysis of the Phase 3 ENLIGHTED study of Padeliporfin VTP: 

As of November 5, 2024, the data cut-off for the poster presentation at ASCO, 43 patients had begun treatment, of which 37 had completed ITP and were evaluable for efficacy. 

Clinical Profile: 

• 27 of the 37 (73%) response-evaluable patients achieved a CR at the end of ITP.
• 5 of the 37 (13.5%) response-evaluable patients achieved a partial response (PR) at the end of ITP.

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 and were primarily URS related, resolving within a few days. The most common Grade 3 serious adverse events related to VTP treatment were hematuria, dysuria and flank pain, which resolved within a few 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 second half of 2025. The company anticipates the presentation of topline ENLIGHTED data in 2025.

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 study
Presenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: LBA4513
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma
Session Date & Time: May 31, 2025, 1:15 PM CT

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 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 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

Precision AQ
John Norton
john.norton@precisionaq.com

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