ImPact's Light-Activated Therapy Aims to Disrupt Cancer Care

TEL AVIV, Israel – December 04, 2025 – In the world of oncology, innovation is often measured not just by survival rates, but by the quality of life preserved. A new therapy presented this week is making waves by promising both. At the Society of Urologic Oncology's annual meeting in Phoenix, Israeli firm ImPact Biotech unveiled compelling data for Padeliporfin VTP, a novel treatment that uses laser light to destroy tumors, potentially saving patients from the life-altering removal of a kidney.

The updated preliminary results from the Phase 3 ENLIGHTED study are turning heads. For patients with low-grade upper tract urothelial cancer (LG UTUC), a rare and difficult-to-treat malignancy, the data offers a significant ray of hope. This isn't just another incremental improvement; it’s a potential paradigm shift in how we approach localized solid tumors.

A New Standard of Efficacy

The data presented by ImPact Biotech is striking. In the study, 70% of evaluable patients who completed the initial treatment phase saw their tumors disappear entirely—a "complete response" in clinical terms. The overall response rate, including those with partial tumor reduction, was an impressive 88%. These figures are significant in a field where effective, non-invasive options are scarce.

Perhaps more importantly, the treatment shows signs of remarkable durability. For the cohort of patients who have completed the full maintenance treatment phase, 100% have remained cancer-free in the treated area for at least 12 months. This sustained response is a critical metric for any new cancer therapy, suggesting that the effects of Padeliporfin VTP are not fleeting.

"We continue to see significant efficacy, with complete responses achieved in 70% of patients, and consistent established safety with similar observations to date," said Dr. Eyal Morag, Chief Medical Officer of ImPact Biotech, in the company's official announcement. He emphasized the durability data, noting, "this first look at the program’s durability profile shows complete responses were sustained in patients for over twelve months."

Crucially, the therapy has been well-tolerated. Most side effects were mild, procedure-related, and resolved quickly. This favorable safety profile is a core part of its value proposition, especially when compared to the alternative.

The Innovation: Precision Ablation Through Light

Padeliporfin VTP (Vascular Targeted Photodynamic therapy) represents a sophisticated fusion of drug and device. The mechanism is elegant in its targeted approach. First, patients receive an intravenous infusion of Padeliporfin, a photosensitizing agent. The drug circulates harmlessly throughout the body until it is activated.

The activation happens during a minimally invasive outpatient procedure. A urologist guides a thin, flexible fiber-optic laser through a ureteroscope directly to the tumor site in the upper urinary tract. The laser then emits a specific wavelength of non-thermal light for approximately 10 minutes. This light activates the Padeliporfin molecules circulating in the tumor's blood vessels, triggering a cascade that rapidly cuts off the tumor's blood supply and causes selective cell death, or ablation. Because the light is precisely targeted, the damage is confined to the tumor, leaving surrounding healthy kidney tissue unharmed.

This design is the key to its "organ-sparing" potential. It is a form of focal therapy that aims to eradicate the cancer without the collateral damage associated with traditional treatments.

Disrupting a Challenging Treatment Landscape

To understand the disruptive potential of Padeliporfin VTP, one must consider the current standard of care for LG UTUC. This cancer affects the lining of the kidneys or the ureters, the tubes that carry urine to the bladder. While often low-grade, it has a high rate of recurrence. For many patients, the definitive treatment has been a radical nephroureterectomy—the complete surgical removal of the affected kidney and ureter.

While effective at removing the cancer, this surgery results in an immediate and permanent loss of kidney function, which can lead to chronic kidney disease and increased cardiovascular risks. For a disease that affects around 6,000 to 8,000 new patients annually in the U.S., the cumulative impact is significant. While less invasive ablative techniques and the 2020 approval of the topical chemotherapy gel Jelmyto have provided alternatives, a substantial unmet need remains for a highly effective, durable, and minimally invasive organ-sparing option.

Padeliporfin VTP is positioned to fill this gap. By offering a treatment that can be performed as an outpatient procedure and avoids the need for major surgery, it could fundamentally change the treatment algorithm for thousands of patients, prioritizing both cancer control and long-term quality of life.

A Calculated Strategy for Market Entry

ImPact Biotech is not just relying on strong clinical data; it is executing a deliberate strategy to bring this innovation to market. The company has secured Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA) for Padeliporfin VTP in UTUC. These designations are granted to therapies that address serious conditions with unmet medical needs, allowing for expedited regulatory review and development support.

The company's foundation is bolstered by strong academic collaborations with the Weizmann Institute of Science and Memorial Sloan Kettering Cancer Center, two world-renowned research institutions. Furthermore, a recent €13.5 million investment commitment from the European Innovation Council (EIC) provides both financial validation and the necessary capital to push the ENLIGHTED study across the finish line.

With enrollment in the pivotal trial expected to be complete in the first quarter of 2026 and topline data anticipated in the first half of that year, the path to potential regulatory approval is becoming clearer. If the final data confirms these promising interim results, ImPact Biotech could be on track to introduce a major disruptor to the urologic oncology market.

The potential of Padeliporfin VTP may extend far beyond UTUC. ImPact Biotech is actively exploring its use in other hard-to-treat solid tumors, having already received FDA clearance to begin studies in locally advanced pancreatic cancer and non-small cell lung cancer. This suggests that the company views VTP not as a single-indication product, but as a broad therapeutic platform. This light-activated, precision-focused approach could represent a new pillar in minimally invasive oncology, offering a future where destroying cancer no longer requires sacrificing the vital organs that surround it.