ImPact Biotech has announced the successful completion of treatment in part A of its phase 1 clinical trial in patients with Stage III, locally advanced, unresectable pancreatic ductal adenocarcinoma (PDAC).
The trial evaluated escalating light doses to identify the optimal regimen to advance for further evaluation in part B. Amid dose escalation, encouraging preliminary clinical observations suggest that Padeliporfin VTP may have the potential to expand surgical treatment opportunities for previously unresectable patients with locally advanced pancreatic cancer, a disease characterised by substantial unmet medical need and limited treatment options.
Of the 12 patients treated at varying light doses, seven have since undergone successful pancreatic surgical resection, with two additional patients scheduled for surgery. Among the seven completed resections, four achieved pathology-confirmed R0, indicating no microscopic tumour at the surgical margins.
“These early clinical observations represent an exciting step forward for ImPact Biotech and reinforce our belief in the potential of Padeliporfin VTP to address some of the most challenging solid tumours,” said Barak Palatchi, chief executive officer of ImPact Biotech.
“For patients whose tumours are considered unresectable, treatment options are particularly limited, and it is therefore highly encouraging to see seven patients proceed to surgery following treatment in this early-stage study. Together with Padeliporfin’s favourable safety profile, these results strengthen the rationale to rapidly advance our pancreatic cancer programme and explore the broader potential of our technology.”
Surgical resection remains a central component of potentially curative treatment for pancreatic cancer. However, since patients diagnosed with locally advanced unresectable disease are not eligible for surgery due to the extent of vascular involvement, enabling surgical intervention in this group of patients remains an important therapeutic objective and an area of significant clinical interest.
The preliminary findings from ImPact Biotech’s study suggest Padeliporfin VTP can increase surgical eligibility in this challenging patient population and support continued evaluation of the therapy.
“Completion of part A of this study represents an important milestone in the clinical advancement of Padeliporfin VTP for treatment of pancreatic cancer,” said Eyal Morag, chief medical officer of ImPact Biotech.
“Seeing patients who entered the study with locally advanced unresectable disease proceed to surgical resection, several with pathology-confirmed R0 resections, is an encouraging early signal to observe amid dose escalation. Together with the favourable safety profile observed to date, we are confident in advancing to the next clinical phase and hope to demonstrate that VTP can change the treatment paradigm for this group of patients.”
Building on the preliminary clinical findings, ImPact Biotech plans to meet with regulatory authorities to explore the most efficient clinical and regulatory development pathway for Padeliporfin VTP in pancreatic cancer.