ImPact Biotech Shares Initial Phase 3 ENLIGHTED Study Results of Padeliporfin VTP in Low-Grade Upper Tract Urothelial Cancer

ImPact Biotech, a clinical-stage biotechnology company dedicated to developing Padeliporfin vascular targeted photodynamic (VTP) therapy for the treatment of solid tumors, announced promising preliminary results from its pivotal Phase 3 clinical trial, ENLIGHTED. This trial focuses on evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial cancer (UTUC). The latest findings were shared by Professor Ronald P. Kaufman Jr., M.D., during the American Urology Association (AUA) 2024 Annual Meeting in San Antonio, Texas.

UTUC presents significant treatment challenges due to the difficulty in surgical resection and the demanding nature of existing therapies. Dr. Kaufman, a Professor of Urology at Albany Medical College, expressed optimism regarding the preliminary data, highlighting Padeliporfin VTP as a promising kidney-sparing treatment alternative. This therapy offers selective tumor ablation through a minimally invasive procedure that has shown encouraging response rates in early tests.

The ENLIGHTED study is a single-arm, non-randomized, open-label, pivotal trial designed to assess the efficacy of Padeliporfin VTP in treating low-grade UTUC. The trial is being conducted across 29 global sites with a target enrollment of up to 100 patients who have new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study is divided into two phases: the Induction Treatment Phase (ITP) and the Maintenance Treatment Phase (MTP). During these phases, Padeliporfin, a photosensitizing drug, is administered intravenously, followed by a laser fiber illumination procedure that activates the drug locally within the tumor.

The ITP involves one to three courses of VTP therapy at four-week intervals, aiming for a complete response (CR). Following ITP, the MTP includes standard-of-care treatment along with VTP therapy every three months for up to a year. The primary goal of the study is to determine the response rate at the end of ITP, with secondary objectives focusing on safety, tolerability, and duration of response.

As of the latest data cut-off on October 31, 2023, 12 patients had initiated treatment, with nine having completed the ITP. Preliminary results are encouraging, with six out of nine response-evaluable patients (67%) achieving a CR by the end of the ITP. Padeliporfin VTP was generally well-tolerated, consistent with previous Phase 1 study data. Most adverse events were mild to moderate (Grade 1 or 2), and although three patients experienced Grade 3 events, these were resolved within two days. No severe adverse events (Grades 4 or 5) were reported.

Dr. Eyal Morag, Chief Medical Officer of ImPact Biotech, expressed enthusiasm about these initial Phase 3 results, which reinforce earlier proof-of-concept data. He emphasized the potential of Padeliporfin VTP as a safe and effective kidney-sparing treatment option for UTUC. ImPact Biotech plans to share more data at the upcoming American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

In addition to continuing patient recruitment for the ENLIGHTED study, ImPact Biotech aims to expand the application of Padeliporfin VTP to other solid tumors, including pancreatic ductal adenocarcinoma (PDAC), high-grade UTUC, and non-small cell lung cancer (NSCLC). The company anticipates launching a Phase 1 study for PDAC soon, with study design details to be presented at ASCO.

ImPact Biotech's innovative approach leverages its longstanding collaborations with prestigious institutions such as the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center. The company's operations span the EU, Israel, and the US, as it continues to advance the development and commercialization of Padeliporfin VTP therapy for various solid tumors.