ImPact Biotech Announces 50% Enrollment in Phase 3 ENLIGHTED Clinical Trial of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer

Phase 3 ENLIGHTED study enrollment completion expected by first quarter of 2025

TEL AVIV, Israel, Sept. 27, 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 that the Phase 3 ENLIGHTED (ENdoluminal LIGHT ActivatED) trial evaluating Padeliporfin VTP in patients with low-grade UTUC has achieved 50% patient enrollment threshold.

“We are pleased to have enrolled over 50 percent of the patients in our Phase 3 ENLIGHTED study marking an important milestone for ImPact Biotech,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “With this recent progress and continued momentum in patient recruitment, we anticipate reaching complete enrollment by the first quarter of 2025. Based on the positive preliminary results and encouraging advances in the study, as well as a substantial investment commitment from the European Innovation Council (EIC), we are well-positioned to forge ahead with the development of Padeliporfin VTP as a potential best-in-class and differentiated novel treatment in low-grade UTUC.”

ImPact Biotech shared interim results at the American Society of Clinical Oncology 2024 in June in which 10 of the 13 (77%) response-evaluable patients achieved a CR at the end of ITP. The company is expected to share additional interim data from the ongoing ENLIGHTED study in the fourth quarter of this year.

The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial consisting 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 an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, leading to local activation of Padeliporfin in the tumor.

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