ImPact Biotech Shares New Interim Phase 3 Data on Padeliporfin VTP in Low Grade UTUC at EMUC 2024

ImPact Biotech, a clinical-stage biotechnology company based in Tel Aviv, Israel, has announced promising interim results from its ongoing Phase 3 study of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for low-grade upper tract urothelial cancer (UTUC). The announcement was made at the 16th European Multidisciplinary Congress on Urological Cancers (EMUC 2024) in Lisbon, Portugal.

Dr. Gautier Marcq, Assistant Professor in the Urology Department at Centre de Universitaire Régional Hospitalier de Lille in France and an investigator in the study, highlighted the potential of Padeliporfin VTP to revolutionize treatment for UTUC patients. Dr. Marcq emphasized that current treatments often involve invasive surgeries that can lead to organ damage or removal, or other rigorous therapies that may not be as effective as surgery. The data presented suggests that Padeliporfin VTP could be an effective alternative that spares patients from these difficult choices.

The Phase 3 study, known as ENLIGHTED, is a single-arm, non-randomized, open-label trial evaluating the efficacy and safety of Padeliporfin VTP in patients with low-grade, non-invasive UTUC of the kidney or ureter. The study, which spans 29 clinical sites worldwide, aims to enroll up to 100 patients with either new or recurrent cases of the disease. The trial is divided into two phases: the Induction Treatment Phase (ITP) and the Maintenance Treatment Phase (MTP). During the ITP, patients receive one to three treatments of VTP therapy at four-week intervals until a complete response (CR) is observed. In the MTP, patients continue with standard-of-care treatment while receiving VTP therapy every three months for up to a year.

The primary goal of the study is to assess the rate of response to Padeliporfin VTP at the end of the ITP, with secondary objectives focusing on safety, tolerability, and response duration. As of April 29, 2024, 22 patients had begun treatment, with 14 completing the ITP and being evaluable for efficacy.

The interim results reveal a high efficacy rate, with 86% (12 out of 14) of the response-evaluable patients achieving a complete response at the end of the ITP. Additionally, Padeliporfin VTP was well-tolerated among patients, showing a safety profile that aligned with previous Phase 1 and preliminary Phase 3 data. Most adverse events were mild to moderate (Grade 1 or 2) and resolved within two to seven days, primarily involving pain. Only one patient experienced a Grade 3 serious adverse event related to the treatment, which resolved within two days, and there were no Grade 4 or 5 serious adverse events.

Dr. Eyal Morag, Chief Medical Officer of ImPact Biotech, expressed optimism regarding these consistent patient responses. He noted that the further expansion of the dataset reinforces the potential of Padeliporfin VTP to become a transformative treatment option for UTUC, providing efficacy comparable to current standards without the risk of organ damage. The company aims to complete enrollment by early 2025 and anticipates that subsequent data will support the registration of Padeliporfin VTP for low-grade UTUC. Furthermore, ImPact Biotech plans to explore the effectiveness of this therapy in other unresectable solid tumors, starting with an upcoming Phase 1 study in pancreatic ductal adenocarcinoma (PDAC).

ImPact continues to recruit participants for the ENLIGHTED study, having already exceeded 50% enrollment. The interim data and the overall progress of the study underscore the potential benefits and future applications of Padeliporfin VTP in oncology.