ImPact Biotech to Present Interim Phase 3 Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade UTUC at Upcoming Medical Conferences

• Preliminary results from Phase 3 ENLIGHTED study in low grade upper tract urothelial cancer (UTUC) to be presented at AUA and ASCO
• Trial design for Phase 1 study of Padeliporfin VTP in pancreatic ductal adenocarcinoma (PDAC) to be presented at ASCO

TEL AVIV, Israel, April 24, 2024 (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 three abstracts, including preliminary results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment of patients with low-grade UTUC, were accepted for presentation at upcoming medical conferences.

“We look forward to sharing preliminary data from ENLIGHTED, our ongoing Phase 3 study of Padeliporfin VTP in low grade UTUC, at AUA and ASCO. We are eager to build upon proof-of-concept data from our Phase 1 study, which showed powerful effect and a good safety profile, as we seek to demonstrate advantages over the current standard of care in this indication,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “In addition, we continue to expand applications of our platform to treat other solid tumors. In pancreatic cancer (PDAC), a hard-to-treat cancer, our goal is to convert unresected patients with locally advanced disease to resectable ones, thereby expanding the treatable population. We have opened clinical sites in a Phase 1 study in this indication that is on track to begin dosing patients in the coming weeks.”

In a podium presentation at the American Urology Association (AUA) 2024 Annual Meeting, taking place May 3 – 6, in San Antonio, Texas, the Company will present preliminary data from ongoing ENLIGHTED study. Presentation details are as follows:

Abstract Title: Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for treatment of low-grade upper tract urothelial cancer (LG UTUC): Phase 3 preliminary results
Presenter: Prof. Ronald Kaufman
Abstract Number: 24-4646
Session Title: PD20-02: Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): Phase 3 preliminary results
Session Date: May 4, 2024

Two abstracts were also selected for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 31 – June 4, in Chicago, Illinois. This includes additional data, from a data cutoff beyond the presentation at AUA, from the Phase 3 ENLIGHTED study in low grade UTUC as well as a trials-in-progress poster highlighting design of the planned Phase 1 study of Padeliporfin VTP in PDAC, which is expected to begin recruiting patients in the coming several weeks. Presentation details are as follows:

Abstract Title: ENLIGHTED phase 3 study: Efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) for treatment of low-grade upper tract urothelial cancer (LG UTUC).
Authors: Vitaly Margulis, Ronald P. Kaufman Jr., Gautier Marcq, Neal D. Shore, Marc Colombel, Edward M. Uchio, Sarah P. Psutka, Marcos Aller, Steffen Rausch, Carles Raventos, Asaf Shvero, Axelle Mroz, Natalia Kudinova, Yaniv Cohen, Inna Krasnopolskaya, Genia Alpert, Avigdor Joshua Scherz, Jonathan Coleman.
Abstract Number: TPS4204
Session Title: Genitourinary Cancer – Kidney and Bladder
Session Date/Time: June 2, 2024, 9:00am-12:00pm CDT

Abstract Title: Phase 1 study to evaluate safety and preliminary efficacy of padeliporfin vascular targeted photodynamic therapy (VTP) in patients with locally advanced (LA) unresectable pancreatic ductal adenocarcinoma (PDAC).
Authors: Nadine Abi-Jaoudeh, Jennifer Brooke Valerin, David K Imagawa, Dina Preise, Zachary Sacks, Yaniv Cohen, Julia Rothman, Keren Brook, Eyal Morag, Avigdor Joshua Scherz, Inna Krasnopolskaya, Genia Alpert, Vincent Chung, Laleh Golkar Melstrom, Jonathan Kessler.
Abstract Number: TPS4622
Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date/Time: June 1, 2024, 1:30pm-4:30pm CDT

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.

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