ImPact Biotech announced it will present new data on its Padeliporfin vascular targeted photodynamic (VTP) therapy at the upcoming American Urological Association's 2025 Annual Meeting in Las Vegas, Nevada, from April 26-29, 2025.
The clinical-stage biotechnology company will showcase updated preliminary results from its ENLIGHTED Phase 3 study evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial cancer (UTUC). Additionally, the company will present long-term follow-up data from the PCM-204 Phase 2b trial of Padeliporfin VTP in men with intermediate-risk prostate cancer.
"We are excited for the opportunity to share positive updates from the ENLIGHTED trial, which we believe will continue to reinforce Padeliporfin VTP's potential to shift the treatment paradigm as a promising non-invasive option for patients with low-grade UTUC," said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech.
ENLIGHTED Phase 3 Study in Low-Grade UTUC
The poster presentation on the ENLIGHTED Phase 3 study will be delivered by Vitaly Margulis, Professor of Urologic Oncology at the University of Texas Southwestern Medical Center, on April 27, 2025. The presentation will focus on the efficacy and safety of Padeliporfin VTP for treating low-grade UTUC.
The ENLIGHTED study is a single-arm, non-randomized, open-label pivotal trial evaluating Padeliporfin VTP across more than 20 clinical sites globally. The study aims to enroll up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter.
The trial consists of two phases:
- An Induction Treatment Phase (ITP) involving one-to-three treatments with VTP therapy at four-week intervals until a complete response is achieved
- A Maintenance Treatment Phase (MTP) with standard-of-care follow-ups every three months, alongside potential single VTP treatments, for up to 12 months
The primary endpoint of the study is to assess the efficacy and response rate to Padeliporfin VTP treatment at the end of the ITP, with secondary objectives evaluating safety, tolerability, and duration of response.
Long-Term Data in Prostate Cancer
Jonathan Fainberg, Urologic Surgeon at Memorial Sloan Kettering Cancer Center, will present the 48-month follow-up results from the PCM-204 Phase 2b trial of partial-gland ablation with Padeliporfin VTP in men with intermediate-risk prostate cancer. This podium presentation is scheduled for April 27, 2025.
Dr. Morag noted, "We also look forward to presenting results from longer-term evaluation of Padeliporfin VTP in intermediate-risk prostate cancer, where our mechanism of action is already well-understood in low-risk disease."
Innovative Treatment Approach
Padeliporfin VTP represents a minimally invasive drug-device combination therapy. The treatment involves intravenous administration of Padeliporfin, a photosensitizing drug, followed by laser fiber illumination delivered via a ureteroscope for 10 minutes in close proximity to the tumor. This process leads to local activation of Padeliporfin specifically in the tumor tissue.
This targeted approach potentially offers patients a non-invasive alternative to current standard treatments, which may involve more invasive surgical procedures or less effective conservative management options.
Company Pipeline Expansion
ImPact Biotech continues to expand its evaluation of Padeliporfin VTP beyond UTUC and prostate cancer. The company is also exploring applications in other solid tumor indications, with earlier-stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC), and non-small cell lung cancer (NSCLC).
The company anticipates completing enrollment of the ENLIGHTED trial in the second half of 2025, marking a significant milestone in the development of this novel therapeutic approach.
ImPact Biotech maintains longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center, with operations spanning the EU, Israel, and the US.
