ImPact Biotech Shares Early ENLIGHTED Trial Outcomes for Padeliporfin VTP in UTUC

The ENLIGHTED clinical trial is a pivotal Phase 3 study that aims to evaluate the safety and efficacy of Padeliporfin Vascular Targeted Photodynamic (VTP) therapy for patients with low-grade upper tract urothelial cancer (UTUC). This non-invasive treatment approach is designed to target and ablate tumors within the urinary tract, offering a potential alternative to conventional surgery.

The study is being conducted at multiple centers globally, with a focus on enrolling up to 100 patients who have been diagnosed with new or recurrent low-grade UTUC. The trial is structured into two phases: an Induction Treatment Phase (ITP) and a Maintenance Treatment Phase (MTP). During the ITP, participants receive intravenous administration of the photosensitizing drug Padeliporfin, followed by VTP therapy, which utilizes a laser fiber to activate the drug locally in the tumor area. The MTP involves standard care alongside periodic VTP therapy for up to 12 months.

Preliminary results from the ENLIGHTED trial indicate that Padeliporfin VTP is well-tolerated and has demonstrated a clinical benefit in the majority of patients. Notably, 67% of the response-evaluable patients achieved a complete response (CR) at the end of the ITP. The safety profile of the treatment aligns with previous findings, with most adverse events being mild (Grade 1 or 2) and resolving quickly.

Dr. Eyal Morag, Chief Medical Officer of ImPact Biotech, the company sponsoring the ENLIGHTED study, expressed enthusiasm for the initial findings, stating that they reinforce the potential of Padeliporfin VTP as a safe and effective kidney-sparing treatment option for UTUC. The company plans to present additional interim results at the American Society for Clinical Oncology (ASCO) Annual Meeting and continues to recruit patients for the study, with the aim of completing enrollment by the end of 2024.

ImPact Biotech is also exploring the application of Padeliporfin VTP in treating other types of solid tumors, such as pancreatic ductal adenocarcinoma (PDAC), high-grade UTUC, and non-small cell lung cancer (NSCLC). The company anticipates initiating a Phase 1 study for PDAC in the near future and will share further details at ASCO.

The ENLIGHTED study represents a significant step forward in the development of minimally invasive therapies for UTUC, offering hope for patients who may not be suitable candidates for traditional surgical interventions. The ongoing evaluation of Padeliporfin VTP's safety and efficacy will be crucial in determining its place in the future treatment landscape for UTUC and other solid tumors.