Phase 3 study launches of padeliporfin ImPACT for UTUC

The first patient has been diagnosed in the pivotal phase 3 ENLIGHTED trial exploring padeliporfin Immune Photo Activated Cancer Therapy (ImPACT) for the treatment of patients with low-grade upper tract urothelial cancer (UTUC), according to Steba Biotech, the developer of the investigational treatment.¹

The padeliporfin ImPACT platform involves the intravenous delivery and activation of the photosensitive drug padeliporfin. Once the drug is in the patient, it is “activated by a non-thermal light delivery system that uses a lower energy laser light channeled through optical fibers.”² The minimally invasive approach enables targeted ablation of the tumor. The treatment was initially explored in prostate cancer and is now being investigated in UTUC and other solid tumors.

“The treatment of UTUC remains a clinical challenge with limited options available to effectively help our patients while avoiding the risk of significant morbidity. This study will work closely with investigators in the United States, Europe, and Israel with the goal of confirming the safety and efficacy of padeliporfin ImPACT as a promising new therapy for treating patients with urothelial cancers involving the upper urinary tract,” Jonathan Coleman, MD, principal investigator of ENLIGHTED and urologic surgeon at Memorial Sloan Kettering Cancer Center, stated in a press release.

The open-label, single-arm ENLIGHTED trial is enrolling patients with low-grade UTUC in either the ureter or the kidney. Treatment will comprise 2 phases, induction and maintenance. The target enrollment is 100 patients. Follow-up will last 1 to 5 years after treatment. The primary end point is the number of patients with absence of UTUC tumors in the entire ipsilateral calyces’ renal pelvis and ureter. This outcome measure will be assessed endoscopically. The investigators anticipate that data for the primary end point will be available in 2022.

Padeliporfin ImPACT previously received FDA Fast Track and Orphan Drug designations for the treatment of patients with UTUC. The designations are designed to expedite the review and development of novel treatments that will fill an unmet medical need.

Overall, about 6000 to 8000 new cases of low-grade UTUC occur annually in the United States. Despite some breakthroughs, there remains a high unmet need for novel UTUC treatments.

“The successful initiation of the pivotal trial for padeliporfin ImPACT is an important milestone in our ambitious new development program. Our aim is to unlock the potential of our novel oncology platform, padeliporfin ImPACT, on solid tumors with high unmet medical need. Targeting diseases such as UTUC, where surgery is either impossible or clinically undesirable could be very beneficial for patients living with these conditions. The ENLIGHTED trial is 1 of 2 clinical and 5 preclinical programs that we are advancing this year,” Dr. David Perry, head of Research and Development, Steba, stated in the press release.

References

1. Steba Biotech Treats First Patient in Pivotal ENLIGHTED Study of Padeliporfin ImPACT in Low Grade Upper Tract Urothelial Cancer. Published online April 20, 2020. Accessed April 20, 2020. https://bit.ly/3x9tHDF

2. Steba biotech. A Novel Treatment Path. Accessed March 8, 2021. https://www.stebabiotech.com/technology-innovation.