globenewswire news

• Completion of light dose-escalation Part A of Phase 1 study identifies regimen for further evaluation in Part B, supporting advancement of Padeliporfin VTP for treatment of locally advanced pancreatic cancer
• 75% (9/12) of treated patients have undergone surgical resection or scheduled for surgery, highlighting encouraging preliminary clinical outcomes in patients initially considered unresectable
• Over 55% of resected patients achieved pathology-confirmed R0 resections, demonstrating negative surgical margins following treatment
• Padeliporfin VTP showed a favorable safety profile across three escalating light-dose cohorts, with no major safety concerns reported to date

TEL AVIV, Israel, Oct. 23, 2026 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company developing Padeliporfin vascular targeted photodynamic (VTP) therapy for the treatment of solid tumors, today 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).

Part A of the Phase 1 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 characterized by substantial unmet medical need and limited treatment options.

Of the 12 patients treated at varying light doses, seven have subsequently 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 tumor 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 tumors," said Barak Palatchi, Chief Executive Officer of ImPact Biotech. "For patients whose tumors 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 favorable safety profile, these results strengthen the rationale to rapidly advance our pancreatic cancer program 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 Phase 1 study suggest that Padeliporfin VTP has potential to 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 Dr. Eyal Morag, Chief Medical Officer of ImPact Biotech. "Moreover, 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 favorable 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 these encouraging 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.

About the Phase 1 PDAC Clinical Trial

The ongoing Phase 1 trial is a multicenter, nonrandomized, open-label study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Padeliporfin VTP in patients with Stage III, locally advanced, unresectable pancreatic ductal adenocarcinoma.

The study consists of two parts: a light dose-escalation part designed to evaluate three light-dose levels and identify a recommended light dose, followed by an expansion cohort part B with the selected light dose from part A, intended to further assess safety and preliminary clinical activity.

An important exploratory efficacy measure is the proportion of patients who become eligible for surgical resection following Padeliporfin VTP treatment.

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 Phase 1 study in pancreatic ductal adenocarcinoma (PDAC). For more on ImPact Biotech Ltd., visit: www.impactbiotech.com.

Contacts

Global Head of Business Development
Guy Schmidt
guy.schmidt@impactbiotech.com