ImPact Biotech Shares Updated Phase 3 ENLIGHTED Study Data on Padeliporfin VTP in Low-Grade UTUC at SUO 2024

TEL AVIV, Israel, Dec. 04, 2024 – ImPact Biotech, a clinical-stage biotech company dedicated to developing Padeliporfin vascular targeted photodynamic (VTP) therapy for various solid tumors, has shared updated interim findings from its ongoing Phase 3 ENLIGHTED study. This research investigates the efficacy and safety of Padeliporfin VTP in patients with low-grade upper tract urothelial cancer (UTUC). These latest results will be showcased at the 25th Annual Meeting of the Society of Urologic Oncology (SUO 2024) in Dallas, Texas, from December 4 to 6, 2024.

Eyal Morag, M.D., the Chief Medical Officer of ImPact Biotech, expressed optimism regarding the maturing data from the ENLIGHTED trial, which reveals promising and sustained efficacy signals from Padeliporfin VTP treatment. Dr. Morag highlighted the potential of Padeliporfin VTP to revolutionize the treatment landscape for low-grade UTUC by providing efficacy comparable to the standard of care, yet without the risks of organ injury or loss. The company anticipates sharing more data from the ENLIGHTED trial and advancing Padeliporfin VTP for other unresectable solid tumors in 2025.

As of July 22, 2024, which marked the data cut-off for the poster presentation at SUO, 32 patients had commenced treatment in the ENLIGHTED study. Out of these, 20 patients completed the Induction Treatment Phase (ITP) and were assessable for efficacy. The analysis indicated that 85% (17 out of 20) of these patients achieved a complete response (CR) at the conclusion of the ITP.

Concerning safety and tolerability, Padeliporfin VTP treatment was well-received, maintaining a safety profile consistent with data from the earlier Phase 1 study and preliminary Phase 3 results. The adverse events (AEs) observed were mainly Grade 1 or 2, with most being pain-related and resolving within two to seven days. Only one patient experienced a Grade 3 serious adverse event related to the VTP therapy, which also resolved within two days. No Grade 4 or 5 serious adverse events were reported.

ImPact Biotech continues to recruit participants for the ENLIGHTED study, having already surpassed 50% enrollment as of September. The company expects to complete the enrollment phase by early 2025.

Vitaly Margulis, M.D., Chair in Urology at UT Southwestern Medical Center, will present the poster titled "Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): ENLIGHTED Phase 3 study" during the SUO24 Networking and Abstract Discussion Session on December 6, 2024, at 1:45 PM CST.

The Phase 3 ENLIGHTED study is a significant single-arm, non-randomized, open-label trial designed to evaluate Padeliporfin VTP for treating low-grade UTUC. Conducted across 29 clinical sites worldwide, the study aims to enroll up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study comprises two parts: the Induction Treatment Phase (ITP) and the Maintenance Treatment Phase (MTP). Padeliporfin, a photosensitizing drug, is administered intravenously, and VTP therapy is performed using an outpatient endoscopy that applies a laser fiber illumination for 10 minutes near the tumor, resulting in local activation of Padeliporfin in the tumor. The ITP includes one to three VTP treatments at four-week intervals or until a CR is reached. The MTP involves standard-of-care treatment alongside VTP therapy every three months for up to 12 months. The primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives focusing on safety, tolerability, and response duration.

ImPact Biotech is an advanced clinical-stage oncology company committed to developing and commercializing Padeliporfin VTP therapy, which is a minimally invasive drug-device combination for the selective ablation of unresectable solid tumors. The innovative VTP platform uses non-thermal laser light delivered via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Currently, Padeliporfin VTP is being evaluated in a pivotal Phase 3 study for low-grade UTUC, with additional studies planned or ongoing for high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC), and non-small cell lung cancer (NSCLC). The company collaborates with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operates in the EU, Israel, and the US.