– Updated data across two dose levels of 200 mW/cm and 400 mW/cm in LA-PDAC trial show 71% (5/7) patients resected following VTP with a consistent and well-tolerated safety profile –
– Early clinical observations of Padeliporfin VTP in LA-PDAC support advancement of the program with potential for accelerated registrational pathway, strengthened by robust efficacy and durability data in LG-UTUC –
– Complete response (CR) observed in 70% of evaluable patients with LG-UTUC who completed Primary Response Evaluation (PRE); 85.7% patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months –
– Additional data from Phase 1 trial in LA-PDAC expected through 2026; NDA submission of Padeliporfin VTP in LG-UTUC expected in 2027 following topline results –
TEL AVIV, Israel, May 30, 2026 (GLOBE NEWSWIRE) — ImPact Biotech, a clinical-stage biotechnology company focused on developing Padeliporfin Vascular Targeted Photodynamic therapy (VTP) to treat a range of solid tumors, today announced updated data from the ongoing Phase 1 trial of Padeliporfin VTP treatment in patients with unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) and from ENLIGHTED, the Company’s ongoing Phase 3 study in patients with low-grade upper tract urothelial carcinoma (UTUC). These data will be shared during two poster presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 29-June 2, 2026, in Chicago, IL.
“Today’s presentations underscore the continued clinical progress across both our expanding development efforts in LA-PDAC and our pivotal Phase 3 ENLIGHTED study in LG-UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “The updated early Phase 1 results in LA-PDAC, including successful resection outcomes observed to date, are encouraging and support initial validation of our VTP platform and its potential broader application in difficult-to-treat solid tumors. Given the substantial unmet need and large addressable patient population in LA-PDAC, we believe Padeliporfin VTP may offer a differentiated therapeutic option with the potential to convert these patients to surgically resectable candidates.”
“In parallel, updated data from the ENLIGHTED trial continue to demonstrate compelling complete response rates, encouraging durability, and a favorable tolerability profile, reinforcing Padeliporfin VTP’s potential to offer a clinically meaningful, organ-sparing treatment option for patients with low-grade UTUC,” continued Dr. Morag. “We look forward to pursuing strategic opportunities for the potential commercialization of Padeliporfin VTP in LG-UTUC, while advancing clinical development in both indications.”
Key updated results from the Phase 1 study of Padeliporfin VTP in LA-PDAC:
The Phase 1 LA-PDAC trial is a three part dose-escalation and expansion study evaluating Padeliporfin VTP in patients with vascular encasement deeming them ineligible for surgical resection. As of April 24, 2026, the data cut-off for the poster presentation at ASCO, seven patients had completed treatment across the 200 mW/cm and the 400 mW/cm dose levels without clinically significant dose-limiting toxicities (DLTs) and were evaluable for potential surgery.
Efficacy Profile:
- 5 of the 7 (71%) patients underwent successful surgery following Padeliporfin VTP treatment, including 4 of the 7 patients (57%) with R0 margins.
Safety and Tolerability Profile:
- Padeliporfin VTP was well-tolerated with no complications observed related to arterial injury, thrombosis, ischemia, or significant VTP-related morbidity.
Early clinical observations of Padeliporfin in LA-PDAC support advancement of the program, showing potential to convert patients with unresectable stage III LA tumors to surgically resectable candidates. Subject to future discussions with the U.S. Food and Drug Administration (FDA), the Company believes this program may have potential to move directly into a registrational study.
Key updated results from the Phase 3 ENLIGHTED study of Padeliporfin VTP:
The Phase 3 ENLIGHTED study is a single arm, non-randomized, open-label, pivotal trial evaluating Padeliporfin VTP for the treatment of low-grade UTUC. As of April 20, 2026, the data cut-off for the poster presentation at ASCO, Padeliporfin VTP demonstrated a consistent efficacy profile with 50 of the 72 (70%) response-evaluable patients achieving a CR at the end of Primary Response Evaluation (PRE). 18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, reaching a current median duration of response in the treated area of 23.9 months based on available follow-up. Padeliporfin VTP treatment was well-tolerated and has demonstrated a consistent and acceptable safety profile to date.
ImPact has completed enrollment in ENLIGHTED with topline data expected in 2026. Following positive ongoing discussions with the FDA, including a recent Type C meeting which confirmed the proposed registrational pathway and streamlined package requirements allowing ImPact to leverage supplemental non-clinical modules from a prior NDA submission for Padeliporfin VTP in advanced localized prostate cancer, the Company is on track to submit an NDA in low-grade UTUC in 2027. ImPact is pursuing strategic partnering opportunities to support the commercialization of this program.
ASCO Presentation Details:
Poster Title: Phase I Light-Dose Escalation Study in Locally Advanced Pancreatic Ductal Adenocarcinoma: Intra-Arterial (IA) Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP)
Presenter: Nadine Abi-Jaoudeh, M.D., Professor of Clinical Radiology, University of California Irvine
Poster Number: 236a
Session Title: Gastrointestinal Cancer: Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date & Time: Saturday, May 30, 2026 at 9:00 AM CT
Poster Title: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP): The ENLIGHTED Phase 3 Trial
Presenter: Vitaly Margulis, M.D., Professor of Urologic Oncology, University of Texas Southwestern Medical Center
Poster Number: 115a
Session Title: Genitourinary Cancer: Kidney and Bladder
Session Date & Time: Sunday, May 31, 2026 at 9:00 AM CT
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 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 Phase 1 light dose escalation study in unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC) and a pivotal Phase 3 study in low-grade upper tract urothelial carcinoma (UTUC) 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
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Guy Schmidt
guy.schmidt@impactbiotech.com
