Pharma Focus Asia

ImPact Biotech Secures FDA Approval for IND Application of Padeliporfin VTP in Pancreatic Cancer

Thursday, December 21, 2023

ImPact Biotech, a clinical-stage biotechnology company, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, allowing the initiation of a Phase 1 study for Padeliporfin Vascular Targeted Photodynamic (VTP) therapy in patients with unresectable pancreatic adenocarcinoma (PDAC).

Barak Palatchi, the CEO of ImPact Biotech, expressed excitement about exploring the potential of Padeliporfin VTP in addressing the significant unmet needs in locally advanced pancreatic cancer. The company plans to commence the study in the first half of the coming year. Palatchi also highlighted the broader implications of this IND clearance, underscoring the conviction in their platform as a non-surgical alternative with the potential to enhance outcomes for patients with various solid tumors.

The Phase 1 study is a two-part, multi-center, non-randomized, open-label clinical trial. It aims to assess 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 utilize a 3+3 dose-escalation design to evaluate the safety and tolerability of Padeliporfin VTP at ascending doses administered endovascularly via optical fiber, in combination with intravenous administration of Padeliporfin at a fixed dose. Part B will enroll an expansion cohort, dosing at the maximum tolerated dose identified in Part A, with the primary objective of evaluating preliminary efficacy.

Padeliporfin VTP therapy, described as a minimally invasive oncology platform for solid tumor treatment, combines surgery-like efficacy with the preservation of healthy tissue or organs. The therapy involves intravenous delivery of an inactive drug, Padeliporfin. Upon light activation, the drug induces rapid constriction of the blood supply in the illuminated area only, leading to targeted tumor necrosis. This process activates anti-tumor immunity, ultimately enhancing the eradication of cancer cells.



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