ImPact Biotech has achieved a significant milestone in its Phase 1 clinical trial of Padeliporfin vascular targeted photodynamic (VTP) therapy for locally advanced, unresectable pancreatic ductal adenocarcinoma (PDAC), with the first treated patient successfully undergoing surgical resection after being initially deemed inoperable.
The patient, who was initially assessed as ineligible for surgical resection, received a single administration of Padeliporfin VTP at UCI Irvine Medical Center. Following treatment, the tumor demonstrated changes that enabled the patient to undergo a successful pancreaticoduodenectomy (Whipple procedure) which was not previously considered feasible in this case.
Clinical Trial Design and Mechanism
The ongoing Phase 1 trial is a two-part, multicenter, nonrandomized, open-label clinical study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Padeliporfin VTP therapy. The primary efficacy endpoint is defined by the ability to convert inoperable patients to eligible for resection in patients with Stage III, locally advanced, unresectable PDAC.
Padeliporfin VTP treatment involves the intravenous administration of a photosensitizing agent, Padeliporfin, followed by targeted activation using non-thermal laser light delivered via optical fibers directly to the tumor site. This approach aims to selectively ablate tumor tissue while preserving surrounding healthy structures.
Clinical Significance and Expert Commentary
"Dosing the first patient in this trial is an important milestone for ImPact and the clinical advancement of Padeliporfin VTP as we seek to extend promising observations from ENLIGHTED, our ongoing pivotal study in low-grade upper tract urothelial carcinoma, into patients with locally advanced PDAC," said Dr. Eyal Morag, Chief Medical Officer of ImPact Biotech. "PDAC is among the most challenging malignancies to treat, particularly where surgical intervention is not a viable option. The ability to undergo a Whipple procedure following treatment with Padeliporfin VTP, as has occurred with this first patient, underscores the potential of our platform to not only induce meaningful tumor regression but also open the door for curative surgical interventions for previously inoperable disease."
Dr. Nadine Abi-Jaoudeh, Principal Investigator at UCI Irvine Medical Center, emphasized the extraordinary nature of the outcome: "We are absolutely thrilled by this outcome. To see an inoperable patient undergo a successful pancreaticoduodenectomy after a single treatment is truly extraordinary. This result gives us renewed hope that Padeliporfin VTP may fundamentally change the treatment landscape for pancreatic cancer patients."
Addressing Significant Unmet Medical Need
Pancreatic ductal adenocarcinoma represents one of the most challenging oncological conditions, serving as the third-leading cause of cancer deaths with a five-year survival rate of approximately 10% - the lowest among all solid tumors. At diagnosis, only about 20% of patients have resectable or borderline resectable disease, while the remaining 80% present with unresectable tumors that are either locally advanced or have distant metastases.
Patients with unresectable tumors have limited therapeutic options and while prognoses have improved significantly in the last decade, only about 5% of patients will survive for 10 years or more following diagnosis. Therapeutic options for treatable patients remain limited and underscore significant unmet need for innovative treatments that can improve survival and quality of life.
Trial Progress and Timeline
The trial is actively enrolling at UCI Irvine Medical Center and City of Hope Medical Center. Enrollment in the study is ongoing, and the Company expects preliminary data from the study in the second half of 2025.
ImPact Biotech's Padeliporfin VTP platform is currently being evaluated across multiple indications, including a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) and the current Phase 1 study in PDAC, with earlier stage studies ongoing or planned in high-grade UTUC and non-small cell lung cancer (NSCLC).
