-- Complete response (CR) observed in 86% (12/14) of evaluable patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase --
-- Padeliporfin VTP treatment continues to be safe and efficacious, establishing profile consistent with prior results alongside additional follow-up in Maintenance Treatment Phase --
TEL AVIV, Israel, Nov. 07, 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 updated interim results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial cancer (UTUC), at the 16th European Multidisciplinary Congress on Urological Cancers (EMUC 2024) taking place in Lisbon, Portugal.
“The overall profile and robustness of response to Padeliporfin VTP underscores its potential to reshape the therapeutic landscape in patients with UTUC,” said Gautier Marcq, M.D., Assistant Professor Urology Department, Centre de Universitaire Régional Hospitalier de Lille, Lille, France and an investigator in the ENLIGHTED study. “Current standards of care in this indication often require an invasive surgical intervention, resulting in many cases in organ injury or loss, or a burdensome therapeutic regimen that fails to match surgery in efficacy. These results highlight Padeliporfin VTP as a compelling alternative, which may not require patients to compromise between sparing their organs and treating their cancer. I am encouraged by these data and look forward to additional analyses towards improved treatment and better outcomes for patients with UTUC.”
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 29 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 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. 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 treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.
As of April 29, 2024, the data cut-off for this presentation, 22 patients had begun treatment, of
which 14 had completed ITP and were evaluable for efficacy.
Key updated preliminary results from the Phase 3 ENLIGHTED study of Padeliporfin VTP:
Clinical Profile:
- Twelve of the 14 (86%) response-evaluable patients achieved a CR at the end of ITP.
Safety and Tolerability Profile:
- Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results.
- Adverse events (AEs) observed were primarily Grade 1 or 2, most of which were pain related, and all resolved within two to seven days. Only one patient experienced a Grade 3 serious adverse event that was related to the VTP therapy, which resolved within two days.
- There were no Grade 4 or 5 serious adverse events observed.
“We are highly encouraged to see consistent patient responses to Padeliporfin VTP treatment as we progress the ENLIGHTED Phase 3 study,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “This expansion of our dataset presented in June further establishes the potential for Padeliporfin VTP to transform the treatment landscape for UTUC, by providing efficacy in line with standard of care without incurring risk of organ injury or loss. With trial enrollment on track to conclude by early 2025, we look forward to providing subsequent data updates that we expect to provide basis for registration of Padeliporfin VTP in low grade UTUC. In parallel, we will look to replicate this effect in other unresectable solid tumors, beginning with our planned Phase 1 study in PDAC.”
ImPact continues to recruit for the ENLIGHTED study. As previously announced in September, the Company has exceeded 50% enrollment in the study and expects to complete enrollment by early 2025.
The poster will be viewable during the EMUC24 Networking and Abstract Discussion Session on Saturday, November 9, 2024, 17:30 GMT.
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
