ImPact Biotech, based in Ness Ziona, Israel, develops padeliporfin vascular targeted photodynamic therapy (VTP): an intravenous drug derived from bacteriochlorophyll that stays inactive until a laser fibre lights up the tumour, when it produces radicals that block the tumour's blood vessels and kill it within hours, sparing the surrounding organ. Its EIC Accelerator project, IMPACT, receives an EU contribution of €2,498,731 and runs from December 2024 to November 2026, according to CORDIS. It supports the pivotal Phase 3 trial of padeliporfin in low-grade upper tract urothelial carcinoma (UTUC), a cancer of the kidney lining and ureter usually treated by removing the kidney.
The EIC report notes that padeliporfin already has EMA approval for low-grade prostate cancer and completed a Phase 1 trial in UTUC, according to CORDIS. The Phase 3 trial, ENLIGHTED, sponsored by the related company Steba Biotech, started in March 2021 and lists 89 enrolled patients, according to ClinicalTrials.gov. In September 2026 ImPact announced completion of treatment for all required patients, 91 by its count, with interim data due at the ESMO congress in October 2026, and said FDA feedback from a pre-NDA meeting in April supports a new drug application in 2027, according to ImPact Biotech. In April 2026 it had expected topline data and the NDA in 2026.
Company file
- Legal entity
- ImPact Biotech Ltd, Ness Ziona
- Related company
- Steba Biotech S.A., sponsor of the Phase 3 trial
- Drug
- Padeliporfin, with laser and fibre device
- Lead indication
- Low-grade upper tract urothelial carcinoma
- Other programmes
- Pancreatic, lung, oesophageal cancer
- US designations
- Orphan drug in UTUC; Fast Track
- EIC funding
- Blended finance, €2.5M grant
Where ImPact Biotech Stands Now
ImPact is looking for a partner to commercialise its UTUC programme and is advancing padeliporfin in locally advanced pancreatic cancer, where two of three patients in the first low-dose cohort could have their tumours surgically removed after treatment, according to ImPact Biotech. It is also discussing an expanded access programme with the FDA. Its funding and accounts are not public.
"The completion of treatment for all required patients in the Phase 3 ENLIGHTED trial represents a major milestone."
Eyal Morag, chief medical officer of ImPact Biotech, September 2026The Technology: A Drug Switched On by Light
UTUC patients are often elderly, with an average age of 73, and up to half already have impaired kidney function, the EIC report says, so removing a kidney can push them towards dialysis. Padeliporfin is activated with a laser and fibre device directly at the tumour, can be repeated, and is designed to preserve the organ. The report cites excess costs of about €220,840 per patient over five years after surgery.
What the EIC Award Promised, and What the Record Shows
The project runs until November 2026, so it is too early to judge it. The EIC funded the final stage of a trial that was already four years old when the project began. Treatment is complete, but the efficacy results that decide approval were not public at the end of September 2026, and the company's own timeline for filing moved back by a year within five months.
- Phase 3 treatment completeDeliveredSeptember 2026.
- Topline efficacy dataPendingInterim at ESMO.
- FDA filingSlipped2026 to 2027.
- Commercial partnerSoughtNot announced.
The Money
The award was blended finance. No EIC Fund investment or other financing round has been announced, and ImPact's search for a commercialisation partner indicates it will not market the UTUC drug alone.
What Cannot Be Checked
Questions for the EIC
Whether the EIC Fund invested, what the Phase 3 complete response rate is, why the NDA moved to 2027, and whether a European marketing application is planned are not public.
Why Europe Should Care
An organ-sparing option for kidney-lining cancer would reduce the renal failure and costs the EIC report associates with surgery. The drug's prostate approval came through the EMA, but the company's regulatory path for UTUC runs first through the FDA.
What the award promised
A validated pivotal Phase 3 trial and preparation for market entry.
What the record shows
Treatment complete, results pending, US filing now 2027.
The Verdict
Close to the finish, results unknown
ImPact has finished treating its Phase 3 patients. Everything now depends on data it has yet to publish.
ImPact Biotech and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.
