ImPact Biotech Shares More Interim Data from ENLIGHTED Study on Padeliporfin VTP in Low-Grade Upper Tract Urothelial Cancer

ImPact Biotech, a clinical-stage biotechnology company developing Padeliporfin vascular targeted photodynamic (VTP) therapy, has unveiled new efficacy and safety data from its ongoing Phase 3 ENLIGHTED trial. This pivotal study is evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial cancer (UTUC), a condition that is challenging to treat effectively without damaging surrounding organs. The interim results were showcased at the 2024 Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

The ENLIGHTED study is a single-arm, non-randomized, open-label trial conducted at 29 global clinical sites. It aims to enroll up to 100 patients with new or recurrent low-grade, non-invasive UTUC affecting the kidney or ureter. The study is structured into two phases: an Induction Treatment Phase (ITP) and a Maintenance Treatment Phase (MTP). Padeliporfin, a photosensitizing drug, is administered intravenously, followed by a vascular photodynamic therapy (VTP) session, which involves outpatient endoscopy and laser fiber illumination for 10 minutes to activate the drug locally at the tumor site.

The ITP involves one to three VTP treatments at four-week intervals until a complete response (CR) is achieved. If a CR is observed, patients proceed to the MTP, which includes standard-of-care treatments alongside VTP therapy every three months for up to a year. The main goal of the study is to determine the response rate by the end of the ITP, while secondary goals focus on safety, tolerability, and response duration.

As of the data cut-off on January 21, 2024, 17 patients had started treatment, and 13 of them had completed the ITP and were assessable for efficacy. Notably, 10 of these 13 patients (77%) achieved a CR, showing promising results for the effectiveness of Padeliporfin VTP.

In terms of safety, Padeliporfin VTP was well-tolerated, with adverse events (AEs) mostly being mild to moderate (Grade 1 or 2), primarily gastrointestinal-related. Only 9% of patients experienced Grade 3 events, which were resolved within two to seven days. No severe Grade 4 or 5 AEs were observed, consistent with previous data from Phase 1 and initial Phase 3 results.

Vitaly Margulis, M.D., a Professor of Urology at UT Southwestern Medical Center, highlighted the significance of these findings, noting the difficulty in treating UTUC without causing organ damage. He emphasized that Padeliporfin VTP could present a viable alternative to current treatments, potentially transforming the therapeutic landscape for UTUC patients by sparing the kidney or ureter while delivering profound efficacy.

Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech, expressed optimism about the continuous progress of the ENLIGHTED study. He underscored the potential of Padeliporfin VTP to offer clinical benefits comparable to surgical interventions but without the high risk of organ injury or loss. The company is eager to further evaluate the treatment's distinct advantages and to explore its applicability in other unresectable solid tumors.

ImPact Biotech is actively recruiting participants for the ENLIGHTED study and aims to complete enrollment by the end of 2024. An additional interim analysis is anticipated in the second half of 2024. The company also plans to assess Padeliporfin VTP in other solid tumors, including pancreatic ductal adenocarcinoma (PDAC), high-grade UTUC, and non-small cell lung cancer (NSCLC). At ASCO, ImPact presented a poster outlining the design of its Phase 1 study in PDAC, marking the initiation of patient dosing in the upcoming weeks. This study aims to evaluate the safety, tolerability, and preliminary efficacy of Padeliporfin VTP in locally advanced, unresectable PDAC.

ImPact Biotech remains committed to developing and commercializing innovative oncology treatments. Its VTP platform, which selectively ablates tumors using non-thermal laser light, continues to show promise across various cancer types.