ImPact Biotech Presents Additional Interim Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer

• Promising response rate in patients with low-grade upper tract urothelial cancer (UTUC); complete response (CR) observed in 77% (10/13) of patients who completed the Induction Treatment Phase
• Padeliporfin VTP safe and efficacious, consistent with prior results and reinforcing initial clinical data from ENLIGHTED
• Preliminary efficacy data presented in a poster session at ASCO; additional interim analysis expected in 2H 2024 and completion of enrollment anticipated by the end of 2024

TEL AVIV, Israel, June 02, 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 additional efficacy and safety data from ENLIGHTED (ENdoluminal LIGHT ActivatED), its ongoing pivotal Phase 3 clinical trial evaluating Padeliporfin VTP in patients with low-grade UTUC. The interim results, which demonstrate Padeliporfin VTP treatment was well-tolerated alongside further efficacy, are being presented today in a poster session at the American Society of Clinical Oncology 2024 Annual Meeting in Chicago, Illinois.

“These results emphasize the potential of Padeliporfin VTP as a viable treatment option for patients with low-grade UTUC,” said Vitaly Margulis, M.D., Professor of Urology at UT Southwestern Medical Center. “UTUC is difficult to treat, as it is not easily resectable without inflicting organ damage and current standards of care commonly require onerous treatment regimens that do not match surgery in efficacy. These results highlight Padeliporfin VTP as a compelling alternative to achieve profound efficacy, while sparing the kidney or ureter. I am encouraged by this dataset and look forward to the continued analysis of Padeliporfin VTP and its capacity to alter the treatment paradigm for patients with UTUC.”

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 clinical sites globally, 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, leading to local activation of Padeliporfin in the tumor. ITP consists of one-to-three treatments with 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 to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response.

As of January 21, 2024, the data cut-off for this presentation, 17 patients had begun treatment of which 13 had completed ITP and were evaluable for efficacy.

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

Clinical Profile:

• Ten of the 13 (77%) response-evaluable patients achieved a CR at the end of ITP.

Safety and Tolerability Profile:

• Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and preliminary Phase 3 results.
• Adverse events (AEs) observed were primarily Grade 1 or 2, mostly gastrointestinal-related. Grade 3 events were observed in 9% of patients. All AEs resolved within two to seven days.
• There were no Grade 4 or 5 serious adverse events observed.

“We are pleased to see Padeliporfin VTP making continued clinical progress in the ENLIGHTED Phase 3 study,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “This dataset underscores our conviction that Padeliporfin VTP may provide immense clinical benefit as an alternative that delivers efficacy more in line with surgical intervention than standard-of-care therapeutics but without the associated risk of organ injury or loss. We look forward to the sustained evaluation of Padeliporfin VTP as a differentiated novel treatment in low-grade UTUC and to sharing additional data as this study progresses, as we also seek to explore its potential across other unresectable solid tumors in parallel.”

ImPact continues to recruit for the ENLIGHTED study and expects to complete enrollment by the end of 2024. The Company anticipates an interim analysis from this study to be presented in 2H 2024.

In addition, ImPact plans to evaluate Padeliporfin VTP in other solid tumors, including pancreatic ductal adenocarcinoma (PDAC), high-grade UTUC and non-small cell lung cancer (NSCLC). At ASCO, the Company also presented a trials-in-progress poster featuring the design of its Phase 1 study in PDAC, which is expected to initiate patient dosing in the coming weeks. The objectives of this two-part, dose-escalation and -expansion study are as follows: in part A, to evaluate safety and tolerability of Padeliporfin VTP in locally advanced, unresectable PDAC; and in Part B, further evaluate preliminary efficacy, with responses defined by conversion from unresectable to resectable, at the recommended dose identified in Part A.

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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