ImPact Biotech Presents Preliminary Phase 3 Results from ENLIGHTED Study of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer

• Encouraging response rate shown; CR in 67% (6/9) of patients who completed the Induction Treatment Phase

• Padeliporfin VTP generally well-tolerated, consistent with prior results and reinforcing differentiated organ-sparing profile

• Preliminary data presented in a podium session at AUA; additional interim results to be presented at ASCO

TEL AVIV, Israel, May 06, 2024 (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 positive preliminary results from ENLIGHTED (ENdoluminal LIGHT ActivatED), its ongoing pivotal Phase 3 clinical trial evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial cancer (UTUC). As of the cut-off date, Padeliporfin VTP treatment was well-tolerated and demonstrated clinical benefit and in all evaluable patients, consistent with the profile established with prior results. The preliminary results were presented in a podium presentation by Professor Ronald P. Kaufman Jr., M.D., an investigator in the ENLIGHTED study, during the American Urology Association (AUA) 2024 Annual Meeting in San Antonio, Texas.

“UTUC is notoriously hard to resect and current standards of care commonly require treatments which may be challenging,” said Dr. Kaufman, Professor of Urology at Albany Medical College. “I’m encouraged by these early results, which highlight Padeliporfin VTP as a compelling treatment alternative which provides a kidney sparing option, with selective tumor ablation and responses that are so far achieved with a safe, minimally invasive procedure. I look forward to continued evaluation of this exciting investigational product exploring its potential impact on the treatment landscape.”

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. Across 29 global sites, ImPact is targeting enrollment of up to 100 patients with new or recurrent low-grade, non-invasive UTUC of the kidney or ureter. The study consists of two parts – an Induction Treatment Phase (ITP) and Maintenance Treatment Phase (MTP) – across which Padeliporfin, a photosensitizing drug, is administered intravenously and VTP therapy is performed, via an outpatient endoscopy which applies a laser fiber illumination for 10 minutes in the proximity of the tumor, to locally activate Padeliporfin in the tumor. ITP consists of one-to-three courses of VTP therapy at four-week intervals or until a complete response (CR) is achieved; MTP follows with standard-of-care treatment alongside VTP therapy administered every three months for up to 12 months. The study’s primary objective is to assess the response rate at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

As of October 31, 2023, the data cut-off for this presentation, 12 patients had begun treatment of which nine had completed ITP.

Key preliminary results from the Phase 3 ENLIGHTED study of Padeliporfin VTP:

Clinical Profile:

• Six of the nine (67%) response-evaluable patients achieved a CR at the end of ITP.

Safety and Tolerability Profile:

• Padeliporfin VTP was well-tolerated and safety profile is consistent with the previous data obtained from the Phase 1 study.
• Adverse events (AEs) observed were mostly Grade 1 or 2, with Grade 3 events in three patients. All events were resolved within two days and there were no Grade 4 or 5 serious adverse events observed.

“We were excited to present a first look at our Phase 3 results for Padeliporfin VTP at AUA. Importantly, these preliminary results from ENLIGHTED reinforce proof-of-concept data from the Phase 1 study, showing Padeliporfin VTP offers strong potential as a safe and effective, kidney-sparing alternative for endoscopic management of UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We believe this represents important differentiation as a potential novel treatment in low-grade UTUC, compared to available endoscopic and therapeutic options, and we look forward to sharing additional data at ASCO in the coming weeks.”

In addition, ImPact will present a poster containing updated interim data, from a cut-off date beyond the presentation at AUA, at the American Society for Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, in Chicago, Illinois. The Company continues to recruit patients for the ENLIGHTED study and expects to complete enrollment by the end of 2024.

ImPact also plans to evaluate Padeliporfin VTP in other solid tumors, including pancreatic ductal adenocarcinoma (PDAC), high-grade UTUC and non-small cell lung cancer (NSCLC). The Company expects to initiate a Phase 1 study in PDAC in the coming weeks and plans to share design of this study in a trials-in-progress poster session at ASCO.

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) with earlier stage studies ongoing or planned in high-grade UTUC, pancreatic ductal adenocarcinoma (PDAC) 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.

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