TEL AVIV, Israel | An Israeli-developed cancer technology is being tested against one of medicineโs most difficult challenges: pancreatic tumors that cannot be surgically removed because they surround major blood vessels.
Tel Aviv-based ImPact Biotechโs Padeliporfin Vascular Targeted Photodynamic therapy, or VTP, is being evaluated in a first-in-human U.S. Phase 1 clinical trial involving patients with locally advanced pancreatic ductal adenocarcinoma considered unresectable because of tumor encasement around major arteries.
UCI Health, one of two American cancer centers participating in the study, reported this month that six patients had received the treatment and four subsequently underwent surgery to remove remaining tumor tissue. Three of those four patients had no cancer cells detected at their surgical margins.
The findings are preliminary and come from an early-stage clinical trial primarily designed to evaluate safety and determine an appropriate treatment dose. They do not establish that the therapy is effective and will require confirmation in larger studies.
But for patients whose tumors have previously been considered impossible to operate on, the possibility of converting an unresectable cancer into one that surgeons can remove represents a potentially important clinical development.
Targeting Tumors Around Major Arteries
Pancreatic cancer is particularly difficult to treat when a tumor wraps around major abdominal arteries.
Removing the tumor surgically can then risk catastrophic damage to the vessels, leaving patients without an operation that might otherwise offer their best chance for long-term survival.
The ImPact Biotech treatment approaches the problem from inside the affected blood vessel.
Patients are first given padeliporfin, a light-sensitive drug. Physicians then position a catheter containing a laser illumination device within the artery surrounding the tumor.
The drug is activated using precisely delivered, non-thermal laser light.
That illumination causes a photochemical reaction within the tumorโs blood vessels, damaging the tumor vasculature and ultimately destroying tumor tissue surrounding the artery.
UCI Health delivers the treatment in two five-minute illumination periods.
Physicians then allow approximately two weeks for the treatment effect to develop before assessing whether the remaining tumor can be removed surgically.
โWe use the light-sensitive drug padeliporfin to destroy pancreatic tumors encasing major arteries in the abdomen,โ trial leader Dr. Nadine Abi-Jaoudeh of UCI Health said.
Once the blood vessels are sufficiently cleared of tumor, she said, patients may become eligible for surgery.
Early Results Require Caution
The trial is prospective, multicentre, non-randomized and open-label.
Its primary purpose is to examine safety and determine the appropriate light dose for further study, while preliminary efficacy is being assessed by determining whether patients initially judged inoperable can subsequently undergo surgery.
UCI Healthโs September update said six patients had been treated, with four proceeding to surgery.
Earlier data released by ImPact Biotech at the American Society of Clinical Oncology meeting in May included seven evaluable patients across two dose levels. Five of those seven, or 71 percent, underwent surgery after treatment, including four patients whose resections produced negative surgical margins.
The differing patient totals reflect data reported at different stages of the developing trial and should not be interpreted as mature efficacy results.
The trial is expected to enroll up to 30 participants and is currently listed as accepting patients at the University of California, Irvine and City of Hope in California.
No randomized comparison with standard treatment has yet been completed.
A Major Challenge in Pancreatic Cancer
The potential importance of the approach stems from the poor prognosis associated with pancreatic cancer.
UCI Health says about half of pancreatic cancer patients have localized disease when evaluated, but approximately two-thirds of those patients cannot undergo surgery.
For some, the problem is not that the cancer has spread throughout the body.
Instead, the tumor has grown around critical arteries in a way that makes conventional surgery too dangerous.
Abi-Jaoudeh said patients with localized cancers who cannot undergo surgery can have survival outcomes comparable to those whose cancer has metastasized.
โThis is a significant finding because patients with localized cancers who cannot undergo surgery have similarly low survival rates as patients with metastasized pancreatic cancer,โ she said of the early results.
The goal of Padeliporfin VTP is therefore not simply to shrink a tumor.
It is to selectively eliminate enough cancer around key vessels to change the patientโs surgical status.
Israeli Company Reaches Separate Phase 3 Milestone
The pancreatic cancer trial is not the only major clinical program underway for ImPact Biotech.
The Israeli company announced Sept. 9 that all 91 required patients had completed treatment in its Phase 3 ENLIGHTED trial evaluating Padeliporfin VTP for low-grade upper tract urothelial carcinoma, a cancer affecting the lining of the kidney or ureter.
The international study spans 29 clinical sites.
In that application, physicians deliver padeliporfin intravenously and activate it using a laser fiber positioned near the tumor during ureteroscopy.
The company said it expects to present additional interim data at the European Society for Medical Oncology Congress in October and is working toward a U.S. regulatory submission in 2027.
ImPact said written feedback following an April meeting with the U.S. Food and Drug Administration supported a potential path toward submitting a New Drug Application next year.
That does not amount to FDA approval or a guarantee that the therapy will ultimately be authorized.
One Technology, Multiple Solid Tumors
The significance of the two programs is that ImPact Biotech is using the same underlying platform against very different solid tumors.
In upper tract urothelial cancer, the company is already conducting a pivotal Phase 3 study.
In pancreatic cancer, development remains considerably earlier, with researchers still establishing safety, dosing and preliminary evidence of whether the treatment can make otherwise unresectable disease operable.
That distinction is essential.
A handful of successful surgeries cannot demonstrate that the approach will improve survival or work in a broader population.
But early conversion of patients from inoperable to operable status provides researchers with a clinical signal worth investigating.
For an Israeli biotechnology company, it also represents another example of Israeli medical innovation moving from laboratory development into advanced clinical testing in the United States.
If larger trials eventually confirm that Padeliporfin VTP can safely clear tumor tissue from around major arteries and allow more pancreatic cancer patients to undergo potentially curative surgery, the technology could address one of the most difficult problems in oncology.
For now, the evidence remains early.
But in a disease where losing the possibility of surgery can dramatically alter a patientโs prognosis, four patients reaching the operating room after receiving an experimental Israeli-developed treatment is a development that warrants close attention.
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