ImPact Biotech and the EIC Accelerator: Light-Activated Cancer Drug

30 September 2026908 words5 min

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.

91Phase 3 patients treated, company figure
2021Phase 3 start, before the EIC award
2 of 3Pancreatic patients made operable
2027US drug application, revised

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 record

A Phase 3 trial nearing its readout

The ENLIGHTED Phase 3 trial began in 2021, before the EIC award, and finished treating patients in 2026. The planned US new drug application moved from 2026 to 2027.

  1. Mar 2021ENLIGHTED Phase 3 startsSponsor Steba Biotech
  2. Mar 2024EIC Accelerator cut-offIMPACTblended finance
  3. Dec 2024EIC project starts€2.5M EU contribution
  4. Apr 2026Pre-NDA meeting with FDATopline and NDA expected in 2026
  5. Apr 2026Pancreatic cancer Phase 1 data2 of 3 patients resected
  6. Sep 2026Treatment completed91 patients; NDA now 2027
  7. Nov 2026EIC project endsTopline data pending

ImPact Biotech, ClinicalTrials.gov and CORDIS.

"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 2026

The 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.

The trial

Patients in the ENLIGHTED Phase 3 trial

ImPact Biotech says 91 patients were treated. The ClinicalTrials.gov record lists 89 enrolled.

ImPact Biotech, September 2026; ClinicalTrials.gov NCT04620239. Patients.

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 by ImPact's account, 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.

  1. Phase 3 treatment completeDeliveredSeptember 2026.
  2. Topline efficacy dataPendingInterim at ESMO.
  3. FDA filingSlipped2026 to 2027.
  4. Commercial partnerSoughtNot announced.

The schedule

Expected year of the US drug application

In April 2026 ImPact expected topline data and an NDA in 2026. In September 2026 it moved the NDA to 2027.

ImPact Biotech releases, April and September 2026. Year.

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.

Industry

HealthBiopharmaceuticals

Focus
  • Small molecules
Technologies
  • Energy-based therapy
Keywords
  • Upper tract urothelial cancer
  • Pancreatic cancer
  • Organ preservation
  • Oncology
  • Photodynamic therapy