ImPact Biotech Phase 1 data show seven PDAC patients reach surgery
ImPact Biotech has reported early clinical data from Part A of its Phase 1 study of Padeliporfin vascular targeted photodynamic (VTP) therapy in locally advanced, unresectable pancreatic ductal adenocarcinoma (PDAC), with seven of twelve treated patients subsequently undergoing surgical resection. Two further patients are scheduled for surgery, bringing the proportion who have reached or are approaching the operating table to 75% of the treated cohort.
The Tel Aviv-based company said four of the seven completed resections achieved pathology-confirmed R0 status, meaning no microscopic tumour was detected at the surgical margins, an important surrogate for curative intent in a disease where surgery is otherwise unavailable to this patient group. The company described the safety profile across three escalating light-dose cohorts as favourable, with no major safety concerns reported.
What Padeliporfin VTP does
Padeliporfin VTP is a drug-device combination that delivers non-thermal laser light via optical fibres to activate the photosensitising agent padeliporfin within the tumour microenvironment, inducing localised vascular disruption. The approach is minimally invasive and does not rely on the thermal ablation mechanisms used in some other local tumour destruction techniques. Part A of the trial was designed as a light dose-escalation exercise to identify the optimal regimen; the company will now take that dose forward into an expansion cohort in Part B.
Chief medical officer Eyal Morag said the observation of R0 resections in patients who entered the study as unresectable was "an encouraging early signal to observe amid dose escalation," and that the company was "confident in advancing to the next clinical phase." Chief executive Barak Palatchi said the results "strengthen the rationale to rapidly advance our pancreatic cancer program."
ImPact said it plans to meet with regulatory authorities to determine the most efficient clinical and regulatory development pathway before progressing further.
Market context and competitive landscape
Locally advanced, unresectable PDAC carries a poor prognosis, with standard-of-care chemotherapy regimens such as FOLFIRINOX and gemcitabine-nab-paclitaxel offering modest survival benefit in this population. Surgical resection remains the only potentially curative option, and converting unresectable disease to resectable is an active area of clinical investigation. Neoadjuvant chemotherapy and chemoradiotherapy have both been explored as conversion strategies, and a handful of targeted and immunotherapy approaches are in earlier development.
Padeliporfin already has a Phase 3 programme running in low-grade upper tract urothelial carcinoma, giving ImPact some regulatory experience with the platform. Applying VTP to PDAC, where the pancreas sits in close proximity to major vasculature, represents a meaningfully different technical and clinical challenge. The Phase 1 dataset of twelve patients is small, and the absence of a comparator arm means the resection rate cannot yet be benchmarked against current conversion rates in this population. Longer-term outcomes, including overall survival and recurrence data from the resected patients, will be required before the signal observed here can be interpreted with confidence.
The company's next disclosures are likely to include a regulatory agency meeting outcome and the design of Part B, both of which will be closely watched by observers interested in ablative and photodynamic approaches to solid tumour treatment.