Padeliporfin

– Complete response (CR) observed in 79% (26/33) of evaluable patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase (ITP) of the ENLIGHTED Phase 3 trial evaluating Padeliporfin VTP in UTUC – – Padeliporfin VTP treatment continues to be safe and efficacious, establishing profile consistent with prior results alongside additional follow-up in Maintenance Treatment Phase (MTP) – – Additional podium presentation reinforces platform applicability across solid tumors and highlights robust, long-term durability of response out to 48 months post-treatment with Padeliporfin VTP in intermediate-risk prostate cancer – TEL AVIV, Israel, April 28, 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 updated preliminary results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial cancer (UTUC), as well as long-term follow up from the PCM-204 Phase 2b trial evaluating Padeliporfin VTP in men with intermediate risk of prostate cancer. These data were presented at the American Urological Association’s 2025 Annual Meeting (AUA) on April 27, 2025 in Las Vegas, Nevada. “Positive updates from the ENLIGHTED trial continue to reinforce Padeliporfin VTP’s potential to shift the treatment paradigm as a promising non-invasive option for patients with low-grade UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We are highly encouraged by the robust complete response rate, which is in line with other minimally invasive interventions but without incurring risk of organ injury or loss. We also see potential for deepening of partial responses in a real-world setting, where retreatment may be possible beyond the number of inductions included in trial protocol. We look forward to sharing additional updates from the ENLIGHTED study, and anticipate reporting complete topline data within the year to support potential registration of Padeliporfin VTP in this indication.” Key updated preliminary results from the Phase 3 ENLIGHTED study of Padeliporfin VTP: As of November 4, 2024, the data cut-off for the poster presentation at AUA, 44 patients had begun treatment, of which 33 had completed ITP and were evaluable for efficacy. Clinical Profile: 26 of the 33 (79%) response-evaluable patients achieved a CR at the end of ITP.6 of the 33 (18%) response-evaluable patients achieved a partial response (PR) 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 previously announced preliminary Phase 3 results.Adverse events (AEs) observed were primarily Grade 1 or 2, most of which were related to the ureteroscopic procedure rather than VTP, and all resolved within two to seven days. Only one patient experienced a Grade 3 serious adverse event that was related to the VTP therapy, which resolved within two days, and there were no VTP related Grade 4 or 5 serious adverse events observed. ImPact continues to recruit for the ENLIGHTED study and expects to complete enrollment in mid-2025. Long-term follow-up from PCM-204 Phase 2b trial in intermediate-risk prostate cancer: In addition to updates from the ENLIGHTED study, the Company delivered an oral presentation on 48-month follow-up from the PCM-204 Phase 2b trial evaluating Padeliporfin VTP in men with intermediate risk prostate cancer. 46 of the 50 (92%) of patients included in the study were assessable at the 48-month follow-up interval. “We are further excited by the updates from longer-term evaluation in men with intermediate-risk prostate cancer, extending prior observations in low-risk prostate cancer for which Padeliporfin VTP has previously been approved,” Dr. Morag continued. “These data further underscore the potential of our technology’s applicability across solid tumors and, importantly, provide visibility into the durability of response to treatment with Padeliporfin VTP.” Efficacy Profile: 32 off the 46 (69%) of the evaluable men remained free from evidence of clinical disease progression at 48 months post-treatment. Functional Outcomes and Safety: Padeliporfin demonstrated minimal long-term toxicity including low impact on urinary and sexual function, consisted with the safety and tolerability profile established in the Phase 3 trial in low-risk disease. Functional outcomes at 48 months post-treatment included a non-significant mean decrease in IIEF-5 scores from baseline of -0.67 (standard deviation [SD] 4.4).IPSS demonstrated an average non-significant change of -0.34 (SD 5.1).All patients maintained pad-free urinary continence. Padeliporfin VTP (brand name Tookad) has previously been approved by the European Union, Israel, and Mexico as a treatment for low-risk prostate cancer, following demonstration of significant clinical benefit as a localized partial gland ablation (PGA) therapy when compared to active surveillance for low-risk prostate cancer. Podium and Poster Session Details: Poster Title: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): ENLIGHTED Phase 3 StudyPresenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical CenterPoster Number: IP-12-14Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma Podium Session Title: 48-Month Follow up of Results of the PCM-204 Phase 2b Trial of Partial-Gland Ablation for Men with Intermediate-Risk Prostate Cancer with Padeliporfin (WST11 or Tookad) Vascular-Targeted Photodynamic TherapyPresenter: Jonathan Fainberg, Urologic Surgeon, Memorial Sloan Kettering Cancer CenterPodium Session Number: PD19-06 About ENLIGHTEDThe 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. About ImPact BiotechImPact 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. Contacts Global Head of Business DevelopmentGuy Schmidtguy.schmidt@impactbiotech.com Precision AQJosh Rappaportjosh.rappaport@precisionaq.com

- Company to present updated preliminary results from ENLIGHTED Phase 3 Study in LG UTUC - - Additional podium presentation to provide updates from long-term evaluation of Padeliporfin VTP in intermediate-risk prostate cancer - April 11, 2025 -- 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 company will present updated preliminary results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial cancer (UTUC), as well as long-term follow up from the PCM-204 Phase 2b trial evaluating Padeliporfin VTP in men with intermediate risk of prostate cancer, at the American Urological Association’s 2025 Annual Meeting taking place April 26-29, 2025 in Las Vegas, Nevada. “We are excited for the opportunity to share positive updates from the ENLIGHTED trial, which we believe will continue to reinforce Padeliporfin VTP’s potential to shift the treatment paradigm as a promising non-invasive option for patients with low-grade UTUC,” said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. “We also look forward to presenting results from longer-term evaluation of Padeliporfin VTP in intermediate-risk prostate cancer, where our mechanism of action is already well-understood in low-risk disease. ImPact continues to progress evaluation of Padeliporfin VTP in LG UTUC and other solid tumor indications, and we anticipate completing enrollment of the ENLIGHTED trial in 2nd half of 2025.” Poster Title: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): ENLIGHTED Phase 3 Study Presenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical Center Poster Number: IP-12-14 Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma Session Date & Time: April 27, 2025, 1:00 PM Podium Session Title: 48-Month Follow up of Results of the PCM-204 Phase 2b Trial of Partial-Gland Ablation for Men with Intermediate-Risk Prostate Cancer with Padeliporfin (WST11 or Tookad) Vascular-Targeted Photodynamic Therapy Presenter: Jonathan Fainberg, Urologic Surgeon, Memorial Sloan Kettering Cancer Center Podium Session Number: PD19-06 Session Date and Time: April 27, 2025, 4:10 PM 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 over 20 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 a ureteroscope, applying laser fiber illumination for 10 minutes in the close vicinity 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 3 month follow ups, alongside potential single VTP treatment, for up to 12 months. The study’s primary objective is to assess the efficacy and response rate to Padeliporfin VTP treatment at the end of ITP, with secondary objectives evaluating safety, tolerability and duration of response. 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. The content above comes from the network. if any infringement, please contact us to modify.