ImPact Biotech Receives FDA Clearance of IND Application for Padeliporfin VTP in Pancreatic Cancer
20 Dec 2023
Phase 3INDPhase 1
Phase 1 clinical trial expected to initiate in 1H 2024 –
IND clearance in third indication reflects broad platform potential for Padeliporfin VTP across a range of solid tumors –
TEL AVIV, Israel, Dec. 20, 2023 (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 Company’s Investigational New Drug (IND) application for Padeliporfin VTP has been cleared by the U.S. Food and Drug Administration (FDA) to begin a Phase 1 study in patients with unresectable pancreatic adenocarcinoma (PDAC).
“We are excited to explore the potential of Padeliporfin VTP in addressing the tremendous unmet need in locally advanced pancreatic cancer and look forward to initiating this study in the first half of next year,” said Barak Palatchi, CEO of ImPact Biotech. “Moreover, alongside our ongoing pivotal study in upper tract urothelial cancer and plans to evaluate Padeliporfin VTP in non-small cell lung cancer, clearance of this IND reflects broadly held conviction in our platform as a non-surgical alternative with potential to improve outcomes and expand the treatable population of patients across a range of solid tumors.”
The Phase 1 study is a two-part, multi-center, non-randomized, open-label clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of Padeliporfin VTP therapy in patients with Stage 3, locally advanced and unresectable PDAC. Part A will deploy a 3+3 dose-escalation design assessing the safety and tolerability of Padeliporfin VTP at ascending doses of VTP administered endovascularly via optical fiber in combination with Padeliporfin administered intravenously at a fixed dose. Part B will enroll an expansion cohort, to dose at the maximum tolerated dose and/or recommended dose for expansion identified in Part A, with the primary objective to evaluate preliminary efficacy.
About Padeliporfin VTP
Padeliporfin VTP (Vascular Targeted Photodynamic) therapy is a minimally invasive oncology platform for the treatment of solid tumors. It offers surgery-like efficacy combined with healthy-tissue or organ preservation. VTP comprises the intravenous delivery of an inactive drug, Padeliporfin. Upon light activation, the drug rapidly triggers the constriction of the blood supply in the illuminated area only, resulting in targeted tumor necrosis that activates anti-tumor immunity which in-turn enhances cancer cell eradication.
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 CenterCancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit:
Contacts
Global Head of Business Development
Guy Schmidt
guy.schmidt@impactbiotech.com
Stern Investor Relations, Inc.
Josh Rappaport
Josh.rappaport@sternir.com
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