ImPact Biotech Reaches 50% Enrollment in Phase 3 Trial for Padeliporfin VTP in Low-Grade Urothelial Cancer

**ImPact Biotech Announces Significant Progress in Phase 3 ENLIGHTED Study**

TEL AVIV, Israel, Sept. 27, 2024 – ImPact Biotech, a clinical-stage biotechnology company, has announced a milestone achievement in its Phase 3 ENLIGHTED (ENdoluminal LIGHT ActivatED) trial. The study, which is examining the efficacy of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for patients with low-grade Upper Tract Urothelial Carcinoma (UTUC), has now surpassed the 50% patient enrollment mark. This advancement positions the company to complete full enrollment by the first quarter of 2025.

Dr. Eyal Morag, Chief Medical Officer of ImPact Biotech, expressed optimism about the trial's progress. "Reaching over 50 percent enrollment in our Phase 3 ENLIGHTED study is an important achievement for ImPact Biotech," he said. With the current momentum in patient recruitment and positive preliminary results, the company is poised to advance the development of Padeliporfin VTP. Backed by a significant investment from the European Innovation Council (EIC), ImPact Biotech is on track to deliver a potentially best-in-class treatment for low-grade UTUC.

In June 2024, ImPact Biotech presented interim results at the American Society of Clinical Oncology, revealing that 10 out of 13 response-evaluable patients (77%) achieved complete response (CR) at the end of the Induction Treatment Phase (ITP). The company plans to release additional interim data from the ENLIGHTED study in the fourth quarter of this year.

The Phase 3 ENLIGHTED study is designed as a single-arm, non-randomized, open-label, pivotal trial, comprising two parts: the Induction Treatment Phase (ITP) and the Maintenance Treatment Phase (MTP). Padeliporfin, a photosensitizing drug, is administered intravenously, followed by VTP therapy during an outpatient endoscopy. This procedure involves applying laser fiber illumination for 10 minutes near the tumor, which activates Padeliporfin locally within the tumor microenvironment.

**About ImPact Biotech**

ImPact Biotech is a cutting-edge clinical-stage oncology company dedicated to the development and commercialization of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy. This minimally invasive drug-device combination targets unresectable solid tumors selectively. The innovative VTP platform utilizes non-thermal laser light delivered via optical fibers to activate Padeliporfin within the tumor. Currently, Padeliporfin VTP is being evaluated in a pivotal Phase 3 study for low-grade UTUC, with additional studies planned or ongoing for high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC), and non-small cell lung cancer (NSCLC).

ImPact Biotech has established significant academic and clinical partnerships, including collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center. The company operates in the European Union, Israel, and the United States.

For more information about ImPact Biotech and the ENLIGHTED clinical trial, please visit their respective websites.