ImPact Biotech Announces Treatment of First Patient in Phase 1 Clinical Trial of Padeliporfin VTP in Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma (PDAC)

–  Previously inoperable patient converted to eligible for resection, underwent pancreaticoduodenectomy, following single course of treatment with Padeliporfin VTP  –

TEL AVIV, Israel, June 05, 2025 (GLOBE NEWSWIRE) -- ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin vascular targeted photodynamic (VTP) therapy to treat a range of solid tumors, today announced that the first patient has been treated in its Phase 1 trial evaluating Padeliporfin VTP in individuals with locally advanced, unresectable pancreatic ductal adenocarcinoma (PDAC) at the UCI Irvine Medical Center.

The patient, who was initially assessed as ineligible for surgical resection, received a single administration of Padeliporfin VTP. 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.

“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.”

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, as defined by the ability to convert inoperable patients to eligible for resection, in patients with Stage III, locally advanced, unresectable PDAC. The trial is actively enrolling in UCI Irvine Medical Center and City of Hope Medical Center.

Dr. Nadine Abi-Jaoudeh, Principal Investigator at UCI Irvine Medical Center, added: “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.”

As in UTUC, Padeliporfin VTP treatment in PDAC 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.

Enrollment in the study is ongoing, and the Company expects preliminary data from the study in the second half of 2025.

About PDAC
Pancreatic ductal adenocarcinoma (PDAC) is 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.

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) and Phase 1 study in pancreatic ductal adenocarcinoma (PDAC), with earlier stage studies ongoing or planned in high-grade UTUC and non-small cell lung cancer (NSCLC). The Company has longstanding collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center and operations in the EU, Israel and the US. For more on ImPact Biotech Ltd., visit: www.impactbiotech.com and the ENLIGHTED clinical trial website (for the US): https://www.enlighted-study.com.

Contacts

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

Precision AQ
John Norton
john.norton@precisionaq.com

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