ImPact Biotech Announces New Data Presentations at AUA 2025 Highlighting Safety and Efficacy of Padeliporfin VTP

- Company to present updated preliminary results from ENLIGHTED Phase 3 Study in LG UTUC -

- Additional podium presentation to provide updates from long-term evaluation of Padeliporfin VTP in intermediate-risk prostate cancer -

/EIN News/ -- TEL AVIV, Israel, April 11, 2025 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin vascular targeted photodynamic (VTP) therapy to treat a range of solid tumors, today announced that the company will present updated preliminary results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial cancer (UTUC), as well as long-term follow up from the PCM-204 Phase 2b trial evaluating Padeliporfin VTP in men with intermediate risk of prostate cancer, at the American Urological Association’s 2025 Annual Meeting taking place April 26-29, 2025 in Las Vegas, Nevada.

“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. “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. ImPact continues to progress evaluation of Padeliporfin VTP in LG UTUC and other solid tumor indications, and we anticipate completing enrollment of the ENLIGHTED trial in 2^nd half of 2025.”

Podium and Poster Session Details:

Poster Title: 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

Presenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: IP-12-14
Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma
Session Date & Time: April 27, 2025, 1:00 PM

Podium Session Title: 48-Month Follow up of Results of the PCM-204 Phase 2b Trial of Partial-Gland Ablation for Men with Intermediate-Risk Prostate Cancer with Padeliporfin (WST11 or Tookad) Vascular-Targeted Photodynamic Therapy
Presenter: Jonathan Fainberg, Urologic Surgeon, Memorial Sloan Kettering Cancer Center
Podium Session Number: PD19-06
Session Date and Time: April 27, 2025, 4:10 PM

About ENLIGHTED
The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. Across over 20 clinical sites globally, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed via a ureteroscope, applying laser fiber illumination for 10 minutes in the close vicinity of the tumor, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care 3 month follow ups, alongside potential single VTP treatment, for up to 12 months. The study’s primary objective is to assess the efficacy and response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response. 

About ImPact Biotech

ImPact Biotech is an advanced clinical-stage oncology company focused on the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy, a minimally invasive drug-device combination for selective ablation of unresectable solid tumors. The novel VTP platform delivers non-thermal laser light via optical fibers to locally activate Padeliporfin in the tumor microenvironment. Padeliporfin VTP is currently being evaluated in a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: www.impactbiotech.com and the ENLIGHTED clinical trial website (for the US): https://www.enlighted-study.com.

Contacts

Global Head of Business Development
Guy Schmidt
guy.schmidt@impactbiotech.com

Precision AQ
Josh Rappaport
josh.rappaport@precisionaq.com