FDA Clears IND of Padeliporfin VTP in Unresectable PDAC

• The FDA has cleared an investigational new drug (IND) application for padeliporfin vascular targeted photodynamic (VTP), paving the way for a phase 1 clinical trial.

• Padeliporfin VTP is a minimally invasive oncology platform with surgery-like efficacy and preservation of healthy tissue or organs.

• This trial will focus on evaluating the agent in patients with unresectable pancreatic ductal adenocarcinoma (PDAC), addressing an unmet need in locally advanced pancreatic cancer.

An IND application for padeliporfin VTP was cleared by the FDA, and a phase 1 trial will be initiated to evaluate the agent in patients with unresectable PDAC.¹

“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, chief executive officer of ImPact Biotech, in a press release. “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.”

Pancreatic cancer anatomy concept , malignant tumor of pancreas: © Лилия Захарчук - stock.adobe.com

The padeliporfin VTP therapy is a minimally invasive oncology platform which uses surgery-like efficacy and healthy-tissue or organ preservation. Developed to treat patients with solid tumors, the VTP uses the intravenous delivery of padeliporfin, which is an inactive drug.

Padeliporfin VTP rapidly triggers the constriction of the blood supply in exclusively the illuminated area once light is activated. This leads to targeted tumor necrosis which then initiates antitumor immunity that then enhances cancer cell eradication.

Previously, in July 2023, the FDA granted an orphan drug designation (ODD) to the padeliporfin VTP for patients with unresectable PDAC.² The therapy has also been granted a fast track designation in this indication, and has received an ODD for the treatment of adult patients with low-grade upper tract urothelial carcinoma (UTUC).

Upon the clearance of the IND for the padeliporfin VTP therapy, a 2-part, multicenter, non-randomized, open-label, phase 1 study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the therapy. Patients with stage III, locally advanced, and unresectable PDAC will be enrolled.¹

In part A of the study, a 3+3 dose-escalation design will be utilized to assess the safety and tolerability of padeliporfin VTP at ascending doses. VTP will be given to patients endovascularly via optical fiber in combination with padeliporfin, which will be given intravenously at a fixed dose.

An expansion cohort will then be enrolled in part B. Patients in this part will be given the maximum tolerated dose and/or recommended dose for expansion identified in part A. Investigators will assess the primary end point of preliminary efficacy.

In addition to this phase 1 study, padeliporfin VTP is being evaluated in a pivotal phase 3 study for the treatment of patients with low-grade UTUC, as well as in earlier stage studies in high-grade UTUC, PDAC, and non–small cell lung cancer.

REFERENCES

1. ImPact Biotech receives FDA clearance of IND application for padeliporfin VTP in pancreatic cancer. News release. ImPact Biotech. December 20, 2023. Accessed December 20, 2023. http://tinyurl.com/bdej5fry

2. ImPact Biotech receives FDA orphan drug designation for padeliporfin VTP in pancreatic cancer. News release. ImPact Biotech. July 5, 2023. Accessed December 20, 2023. http://tinyurl.com/mry8j8rs