ImPact Biotech Announces 50% Enrollment in Phase 3 ENLIGHTED Clinical Trial of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer
2024年9月27日 - 9:00PM
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
Phase 3 ENLIGHTED (ENdoluminal LIGHT ActivatED)
trial evaluating Padeliporfin VTP in patients with low-grade
UTUC has achieved 50% patient enrollment threshold.
“We are pleased to have enrolled over 50 percent
of the patients in our Phase 3 ENLIGHTED study marking an important
milestone for ImPact Biotech,” said Eyal Morag, M.D., Chief Medical
Officer of ImPact Biotech. “With this recent progress and continued
momentum in patient recruitment, we anticipate reaching complete
enrollment by the first quarter of 2025. Based on the positive
preliminary results and encouraging advances in the study, as well
as a substantial investment commitment from the European Innovation
Council (EIC), we are well-positioned to forge ahead with the
development of Padeliporfin VTP as a potential best-in-class and
differentiated novel treatment in low-grade UTUC.”
ImPact Biotech shared interim results at the
American Society of Clinical Oncology 2024 in June in which 10 of
the 13 (77%) response-evaluable patients achieved a CR at the end
of ITP. The company is expected to share additional interim data
from the ongoing ENLIGHTED study in the fourth quarter of this
year.
The Phase 3 ENLIGHTED study is a single arm,
non-randomized, open-label, pivotal trial consisting 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.
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