ImPact Biotech’s Padeliporfin VTP Receives IND Clearance for Pancreatic Cancer Study

December 20, 2023—ImPact Biotech, which is developing a padeliporfin vascular targeted photodynamic (VTP) therapy platform to treat a range of solid tumors, announced that its investigational new drug (IND) application for padeliporfin VTP has been cleared by the FDA. The IND approval allows the company to begin a phase 1 study of padeliporfin VTP therapy in patients with unresectable pancreatic adenocarcinoma (PDAC).

According to the company, the phase 1 study is a two-part, multicenter, nonrandomized, open-label clinical trial. It is 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 of the study 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.

ImPact Biotech stated that its VTP therapy intravenously delivers an inactive drug, padeliporfin. The platform delivers nonthermal laser light via optical fibers to locally activate padeliporfin in the tumor microenvironment. 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 antitumor immunity which in-turn enhances cancer cell eradication. The therapy is intended to provide surgery-like efficacy combined with healthy-tissue or organ preservation.

Padeliporfin VTP is currently being evaluated in a pivotal phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) as well as earlier stage studies are ongoing or planned in high-grade UTUC, PDAC, and non–small cell lung cancer.

“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,” commented ImPact’s CEO Barak Palatchi in the company’s press release. “Moreover, alongside our ongoing pivotal study in UTUC 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 nonsurgical alternative with potential to improve outcomes and expand the treatable population of patients across a range of solid tumors.”