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Yahoo
3 days ago
- Business
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ImPact Biotech Announces Treatment of First Patient in Phase 1 Clinical Trial of Padeliporfin VTP in Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma (PDAC)
– Previously inoperable patient converted to eligible for resection, underwent pancreaticoduodenectomy, following single course of treatment with Padeliporfin VTP – TEL AVIV, Israel, June 05, 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 that the first patient has been treated in its Phase 1 trial evaluating Padeliporfin VTP in individuals with locally advanced, unresectable pancreatic ductal adenocarcinoma (PDAC) at the UCI Irvine Medical Center. The patient, who was initially assessed as ineligible for surgical resection, received a single administration of Padeliporfin VTP. Following treatment, the tumor demonstrated changes that enabled the patient to undergo a successful pancreaticoduodenectomy (Whipple procedure) which was not previously considered feasible in this case. 'Dosing the first patient in this trial is an important milestone for ImPact and the clinical advancement of Padeliporfin VTP as we seek to extend promising observations from ENLIGHTED, our ongoing pivotal study in low-grade upper tract urothelial carcinoma, into patients with locally advanced PDAC,' said Dr. Eyal Morag, Chief Medical Officer of ImPact Biotech. 'PDAC is among the most challenging malignancies to treat, particularly where surgical intervention is not a viable option. The ability to undergo a Whipple procedure following treatment with Padeliporfin VTP, as has occurred with this first patient, underscores the potential of our platform to not only induce meaningful tumor regression but also open the door for curative surgical interventions for previously inoperable disease.' The ongoing Phase 1 trial is a two-part, multicenter, nonrandomized, open-label clinical study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of Padeliporfin VTP therapy, as defined by the ability to convert inoperable patients to eligible for resection, in patients with Stage III, locally advanced, unresectable PDAC. The trial is actively enrolling in UCI Irvine Medical Center and City of Hope Medical Center. Dr. Nadine Abi-Jaoudeh, Principal Investigator at UCI Irvine Medical Center, added: 'We are absolutely thrilled by this outcome. To see an inoperable patient undergo a successful pancreaticoduodenectomy after a single treatment is truly extraordinary. This result gives us renewed hope that Padeliporfin VTP may fundamentally change the treatment landscape for pancreatic cancer patients.' As in UTUC, Padeliporfin VTP treatment in PDAC involves the intravenous administration of a photosensitizing agent, Padeliporfin, followed by targeted activation using non-thermal laser light delivered via optical fibers directly to the tumor site. This approach aims to selectively ablate tumor tissue while preserving surrounding healthy structures. Enrollment in the study is ongoing, and the Company expects preliminary data from the study in the second half of 2025. About PDACPancreatic 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 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) and Phase 1 study in pancreatic ductal adenocarcinoma (PDAC), 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: and the ENLIGHTED clinical trial website (for the US): Contacts Guy SchmidtGlobal Head of Business Precision AQJohn in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
22-05-2025
- Business
- Business Upturn
ImPact Biotech Announces Late-Breaking Podium Presentation at ASCO 2025 Highlighting ENLIGHTED Study Interim Analysis
— Company to present interim update from ENLIGHTED Phase 3 Study in LG UTUC following assessment of 50% of targeted total evaluable patient enrollment — TEL AVIV, Israel, May 22, 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 that the company will present an interim analysis with updated data from the ongoing Phase 3 ENLIGHTED study evaluating Padeliporfin VTP in patients low-grade upper tract urothelial cancer (UTUC) in a late-breaking podium session at the American Society of Clinical Oncology Annual Meeting taking place May 30 – June 3, 2025 in Chicago, Illinois. 'Evaluation of Padeliporfin VTP in the ENLIGHTED study continues to steadily progress as we work to complete enrollment in the second half of 2025 and push towards potentially registrational topline results later this year,' said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. 'We believe this interim analysis, capturing 50% of the targeted enrollment of evaluable patients, will continue to support the robust value proposition for Padeliporfin VTP in UTUC as a best-in-class, paradigm shifting treatment option for patients currently underserved by the standard of care. We look forward to sharing these results and future updates as the data matures.' Podium Presentation Details: Poster Title: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the 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: LBA4513 Session Title: Bladder Cancer: Upper Tract Transitional Cell Carcinoma Session Date & Time: May 31, 2025, 1:15 PM CT About ENLIGHTED 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 follow-up visits every three months with optional VTP therapy administered on each visit 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 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: and the ENLIGHTED clinical trial website (for the US): . Contacts Global Head of Business DevelopmentGuy Schmidt [email protected]
Yahoo
22-05-2025
- Business
- Yahoo
ImPact Biotech Announces Late-Breaking Podium Presentation at ASCO 2025 Highlighting ENLIGHTED Study Interim Analysis
-- Company to present interim update from ENLIGHTED Phase 3 Study in LG UTUC following assessment of 50% of targeted total evaluable patient enrollment -- TEL AVIV, Israel, May 22, 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 that the company will present an interim analysis with updated data from the ongoing Phase 3 ENLIGHTED study evaluating Padeliporfin VTP in patients low-grade upper tract urothelial cancer (UTUC) in a late-breaking podium session at the American Society of Clinical Oncology Annual Meeting taking place May 30 – June 3, 2025 in Chicago, Illinois. 'Evaluation of Padeliporfin VTP in the ENLIGHTED study continues to steadily progress as we work to complete enrollment in the second half of 2025 and push towards potentially registrational topline results later this year,' said Eyal Morag, M.D., Chief Medical Officer of ImPact Biotech. 'We believe this interim analysis, capturing 50% of the targeted enrollment of evaluable patients, will continue to support the robust value proposition for Padeliporfin VTP in UTUC as a best-in-class, paradigm shifting treatment option for patients currently underserved by the standard of care. We look forward to sharing these results and future updates as the data matures.' Podium Presentation Details: Poster Title: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the 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: LBA4513Session Title: Bladder Cancer: Upper Tract Transitional Cell CarcinomaSession Date & Time: May 31, 2025, 1:15 PM CT 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 follow-up visits every three months with optional VTP therapy administered on each visit 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: and the ENLIGHTED clinical trial website (for the US): Contacts Global Head of Business DevelopmentGuy Precision AQJohn in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
11-04-2025
- Business
- Yahoo
ImPact Biotech Announces New Data Presentations at AUA 2025 Highlighting Safety and Efficacy of Padeliporfin VTP
- 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 - TEL AVIV, Israel, April 11, 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 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.' 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 Study Presenter: Vitaly Margulis, Professor of Urologic Oncology, University of Texas Southwestern Medical CenterPoster Number: IP-12-14Session Title: Bladder Cancer: Upper Tract Transitional Cell CarcinomaSession 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 TherapyPresenter: Jonathan Fainberg, Urologic Surgeon, Memorial Sloan Kettering Cancer CenterPodium Session Number: PD19-06Session Date and Time: April 27, 2025, 4:10 PM 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 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. 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: and the ENLIGHTED clinical trial website (for the US): Contacts Global Head of Business DevelopmentGuy Precision AQJosh
