ImPact Biotech News
6 articles
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ImPact Biotech Announces 50% Enrollment in Phase 3 ENLIGHTED Clinical Trial of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer
ImPact Biotech announced that its Phase 3 ENLIGHTED trial for Padeliporfin VTP in treating low-grade UTUC has reached 50% patient enrollment. The company expects to complete enrollment by Q1 2025. Interim results showed a 77% complete response rate among evaluable patients. The European Innovation Council has made a substantial investment commitment to support the trial. ImPact Biotech collaborates with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center.
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ImPact Biotech to Present at Oppenheimer Private Life Sciences Company Showcase
ImPact Biotech, a clinical-stage biotechnology company specializing in Padeliporfin vascular targeted photodynamic (VTP) therapy for solid tumors, announced that its management will present a corporate overview at the Oppenheimer Private Life Sciences Company Showcase on October 1st, 2024, in New York, NY. The presentation will be delivered by CEO Barak Palatchi. The company is also hosting one-on-one meetings at the conference. ImPact Biotech is currently evaluating its VTP therapy in a pivotal Phase 3 study for low-grade upper tract urothelial carcinoma (UTUC) and has ongoing or planned studies for other cancers. The company collaborates with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center.
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ImPact Biotech Presents Preliminary Phase 3 Results from ENLIGHTED Study of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer
ImPact Biotech announced positive preliminary results from its Phase 3 ENLIGHTED clinical trial evaluating Padeliporfin VTP for treating low-grade upper tract urothelial cancer (UTUC). The treatment showed a 67% complete response rate in patients who completed the Induction Treatment Phase and was well-tolerated. These results were presented at the American Urology Association (AUA) 2024 Annual Meeting. The company plans to continue recruiting patients and expects to complete enrollment by the end of 2024. ImPact Biotech also aims to evaluate Padeliporfin VTP in other solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC).
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ImPact Biotech Receives FDA Clearance of IND Application for Padeliporfin VTP in Pancreatic Cancer
ImPact Biotech announced that its Investigational New Drug (IND) application for Padeliporfin Vascular Targeted Photodynamic (VTP) therapy has been cleared by the FDA to begin a Phase 1 study in patients with unresectable pancreatic adenocarcinoma (PDAC). The study, expected to start in the first half of 2024, aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the therapy. This clearance reflects the broad potential of Padeliporfin VTP across various solid tumors. The company is also conducting studies in upper tract urothelial cancer and plans to evaluate the therapy in non-small cell lung cancer.
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Impact Biotech collaborates with Maastricht University to advance padeliporfin VTP research for pathological myopia
Impact Biotech Ltd. has entered into a collaboration with Maastricht University to advance research on using padeliporfin vascular targeted photodynamic (VTP) therapy to treat pathological myopia, also known as myopic macular degeneration. This partnership aims to arrest the progression of this eye condition, leveraging Impact Biotechs VTP therapy platform.
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FDA grants orphan drug designation to ImPact’s focal cancer therapy
The FDA has granted orphan drug designation to ImPact Bios padeliporfin VTP for treating locally advanced pancreatic cancer. The company, headquartered in Israel, plans to submit an IND application and start a Phase I trial later in 2023. Orphan drug designation provides benefits such as tax credits for US-based clinical trials and FDA recommendations on necessary studies. The therapy involves using padeliporfin activated by non-thermal laser light to target tumors. ImPact Bio is a spin-off from Steba Biotech, which initially developed the treatment.
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