– Initial data from first cohort in LA-PDAC show 66% (2/3) patients resected following VTP at lowest light dose with a consistent and well-tolerated safety profile –
– LA-PDAC program represents large market opportunity in highest unmet need patients, with potential for accelerated registrational pathway; additional results from Phase 1 trial expected in 2026 –
– Topline data from Phase 3 ENLIGHTED trial and NDA expected in 2026 for Padeliporfin VTP in low-grade UTUC; Company to pursue strategic partnering opportunities for commercialization –
TEL AVIV, Israel, April 13, 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 positive preliminary results from the Company’s ongoing Phase 1 study of Padeliporfin VTP treatment in patients with unresectable locally advanced pancreatic ductal adenocarcinoma (LA-PDAC). These data will be shared in a late-breaking podium presentation at the Society of Interventional Radiology (SIR) 2026 Annual Meeting taking place April 11-15, 2026 in Toronto, Canada. Early clinical observations of Padeliporfin in LA-PDAC support advancement of the program, while the Company is pursuing strategic partnering opportunities to support the commercialization of its low-grade upper tract urothelial carcinoma (UTUC) program.
“These initial results from our ongoing trial in LA-PDAC spotlight the emerging clinical profile behind our strategic advancement of this program. At the lowest dose, Padeliporfin VTP has so far not only demonstrated a well-tolerated profile – consistent with the robust body of data generated across indications – but, importantly, also shown promising signs of clinical efficacy highlighting its potential to convert patients with unresectable tumors to become eligible for surgery,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “For such a large, high-need set of patients with limited treatment options aside from surgery, Padeliporfin VTP has the potential to expand the treatable population by selectively ablating the tumor near major arteries to safely allow for resection of the residual tumor tissue. We are strongly encouraged by the initial responses from the first cohort and look forward to providing additional updates on the program this year.”
The Phase 1 LA-PDAC trial is a two-part dose-escalation and expansion study evaluating Padeliporfin VTP in patients with vascular encasement deeming them ineligible for surgical resection. The primary objective in Part A of this trial is to assess safety and determine the optimal light dose to progress into Part B for further evaluation. Secondary objectives are to assess preliminary efficacy, as patients are evaluated following treatment to determine eligibility for pancreaticoduodenectomy (Whipple procedure).
As of December 4, 2025, the data cut-off for the podium presentation at SIR, three patients had completed follow-up from initial treatment in the lowest dose cohort (200 mW/cm) and were evaluable for potential surgery.
Key preliminary results from the Phase 1 study of Padeliporfin VTP in LA-PDAC:
Clinical Profile:
- 2 of the 3 (66%) patients successfully underwent surgery following Padeliporfin VTP treatment with low light dose of 200 mW/cm, with the third patient remaining ineligible for surgery due to a mesenteric tumor spread unrelated to the VTP procedure.
Safety and Tolerability Profile:
- Padeliporfin VTP was well-tolerated with no complications observed related to arterial injury, thrombosis, ischemia, or other VTP-related morbidity, consistent with previous data obtained from prior clinical studies.
- No select treatment-related adverse effects (sTRAE) or dose-limiting toxicities (DLT) were observed in any patients.
ImPact has completed patient enrollment in the second cohort of the Phase 1 dose-escalation study and expects to report additional data throughout 2026. Subject to future discussions with the U.S. Food and Drug Administration (FDA), the Company believes the program may have potential to move directly into a registrational study.
“Given PDAC’s large addressable market and potential for an efficient development path forward, this program represents a compelling near-term opportunity for ImPact,” said Barak Palatchi, Chief Executive Officer of ImPact Biotech. “The significant platform potential demonstrated by Padeliporfin VTP across several indications has enabled us to strategically pursue opportunities with the greatest potential for patient impact and long-term value. While we continue to generate promising and validating results with our late-stage UTUC program, we believe that advancing this program with the right strategic partner, supported by a commercial infrastructure and resources to accelerate launch, will maximize its impact for patients and allow our team and resources to focus on what we do best.”
Topline data from the Phase 3 ENLIGHTED trial in low-grade upper tract urothelial carcinoma (UTUC) and submission of a new drug application (NDA) for Padeliporfin VTP to the FDA are anticipated in 2026.
Presentation Details:
Title: Intra-Arterial (IA) Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP): Ongoing Multicenter, Phase I Light Dose Escalation Study in Unresectable Locally Advanced Pancreatic Ductal Adenocarcinoma (LA-PDAC)
Presenter: Nadine Abi-Jaoudeh, M.D., Professor of Radiology, University of California, Irvine
Session Title: Late-breaking Abstracts 2
Session Date & Time: Monday, April 13, 2026, 4:21 PM ET
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 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
Global Head of Business Development
Guy Schmidt
guy.schmidt@impactbiotech.com
