Tookad (padeliporfin) / Steba Biotech, ImPact Biotech - LARVOL DELTA

Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC): ENLIGHTED Phase 3 Trial (ESMO 2026) - No abstract available

P3 data • Oncology • Solid Tumor • Urothelial Cancer

Advancing treatment of low-grade upper tract urothelial carcinoma (LG UTUC) with padeliporfin vascular-targeted photodynamic therapy (VTP): The ENLIGHTED phase 3 trial. (ASCO 2026) - P1, P3 | "Padeliporfin VTP demonstrates favorable preliminary efficacy, durable responses, and a safety profile consistent with prior experience. Enrollment is ongoing, and final outcomes are anticipated to support regulatory approval of an organ-preserving therapy for LG UTUC."

P3 data • Oncology • Renal Calculi • Solid Tumor • Urothelial Cancer

ImPact plans to present interim data from the Phase 3 ENLIGHTED trial in LG-UTUC at the ESMO Congress taking place from October 23-27, 2026 in Madrid (GlobeNewswire)

P3 data • Urothelial Cancer

ENLIGHTED phase 3 study: Interim results of efficacy and safety of padeliporfin vascular targeted photodynamic therapy (VTP) in the treatment of low-grade upper tract urothelial cancer (LG UTUC). (ASCO 2025) - P1, P3 | "Padeliporfin VTP has demonstrated efficacy and safety aligned with previous findings. Recruitment in ENLIGHTED trial is ongoing, with results anticipated to support the approval of a new therapy offering clinical benefits and organ-sparing alternative for pts."

Clinical • Late-breaking abstract • P3 data • P3 data: top line • Anesthesia • Fatigue • Genito-urinary Cancer • Oncology • Pain • Renal Calculi • Solid Tumor • Urothelial Cancer

The ENLIGHTED Phase 3 Trial: Advancing Treatment of Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) with Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) (AUA 2026) - P3 | "Padeliporfin VTP demonstrated a favorable preliminary safety and efficacy profile consistent with prior experience. Recruitment is ongoing and final outcomes are expected to support regulatory approval of an organ‑preserving therapy for LG UTUC."

P3 data • Oncology • Renal Calculi • Solid Tumor • Urothelial Cancer

ImPact Biotech…announced the completion of treatment for all required patients enrolled in its Phase 3 ENLIGHTED trial evaluating Padeliporfin VTP in patients with low-grade upper tract urothelial carcinoma (LG-UTUC) (GlobeNewswire) - "Completion of treatment, along with a positive pre-NDA meeting held with the U.S. Food and Drug Administration (FDA) in April 2026, supports the Company's planned reporting of topline data and anticipated NDA submission in 2027....Following ImPact’s positive pre-NDA meeting in April 2026, 'the FDA acknowledged the clinical considerations around the potential clinical meaningfulness of Padeliporfin-VTP as a treatment option for low-grade UTUC including the potential clinical value of durable CR in the treated area'....Additionally, the Company has engaged in discussions with the FDA regarding a potential expanded access program (EAP) for eligible patients with LG-UTUC in the US."

FDA event • FDA filing • P3 data: top line • Trial status • Urothelial Cancer

ENLIGHTED Phase 3 Trial of Non-Thermal, Drug-Activated Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) (AUA 2026) - P1, P3 | "More recently, mitomycin C gel (Jelmyto) became the first approved pharmacologic therapy for LG UTUC, representing an important advance in organ-sparing care. Enrollment is planned for 100 patients; as of February 1, 2026, 81 patients have been treated and 63 have completed PRE. The most recent DSMB review on October 30, 2025 recommended continuation of the study as planned.By integrating a drug-activated, vascular-targeted, non-thermal mechanism, Padeliporfin VTP has the potential to expand organ-sparing treatment options for LG UTUC and influence future clinical practice."

P3 data • Oncology • Solid Tumor • Urology • Urothelial Cancer

CLIN1601 PCM204t: Study of the Efficacy, Safety and Quality of Life After TOOKAD® Soluble (VTP) for Intermediate Risk Prostate Cancer. (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Steba Biotech S.A. | Active, not recruiting ➔ Completed

HEOR • Trial completion • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Impact Biotech Ltd | Trial primary completion date: May 2026 ➔ Aug 2026

Trial primary completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Feasibility and Pathologic Outcomes of Peripheral Lung Vascular Targeted Photodynamic Therapy in a Normal Porcine Lung Model. (PubMed, CHEST Pulm) - "We then infused the photosensitizer WST11 after which we immediately performed illumination of the optical fibers...Posttreatment radiology and pathology support measurable ablation fields and expected post-VTP changes. Our preclinical evidence provides early rationale for the study of safety and feasibility of bronchoscopic VTP ablation of peripheral lung cancers in humans."

Journal • Preclinical • Immunology • Lung Cancer • Oncology • Solid Tumor • Systemic Inflammatory Response Syndrome

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (clinicaltrials.gov) - P3 | N=89 | Active, not recruiting | Sponsor: Steba Biotech S.A. | Completed ➔ Active, not recruiting | Trial completion date: Jul 2026 ➔ Aug 2028

Enrollment closed • Trial completion date • Genito-urinary Cancer • Kidney Cancer • Oncology • Solid Tumor • Urothelial Cancer

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (clinicaltrials.gov) - P3 | N=89 | Completed | Sponsor: Steba Biotech S.A. | Recruiting ➔ Completed | Trial completion date: Jan 2029 ➔ Jul 2026 | Trial primary completion date: Mar 2026 ➔ Jul 2026

Trial completion • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Kidney Cancer • Oncology • Solid Tumor • Urothelial Cancer

Phase I light-dose escalation study in locally advanced pancreatic ductal adenocarcinoma: Intra-arterial (IA) padeliporfin vascular-targeted photodynamic therapy (VTP). (ASCO 2026) - P1 | "The study comprises two parts: part A with 3+3 light dose escalation schema; part B (expansion cohort) with the RP2D/MTD, derived in Part A. As of 28 October 2025, Cohort 1 of Part A with an LPD of 200mW/cm have been completed without DLTs. Enrolment to cohort 2, with LPD 400mW/cm, began in November 2025."

Metastases • P1 data • Oncology • Pancreatic Ductal Adenocarcinoma

ImPact has completed enrollment in ENLIGHTED with topline data expected in 2026 (GlobeNewswire) - "...The Company is on track to submit an NDA in low-grade UTUC in 2027."

Enrollment closed • FDA filing • P3 data: top line • Urothelial Cancer

ImPact Biotech Presents Updated Data from Phase 1 Trial of Padeliporfin VTP in LA-PDAC…at ASCO 2026 (GlobeNewswire) - "As of April 24, 2026, the data cut-off for the poster presentation at ASCO, seven patients had completed treatment across the 200 mW/cm and the 400 mW/cm dose levels without clinically significant dose-limiting toxicities (DLTs) and were evaluable for potential surgery....5 of the 7 (71%) patients underwent successful surgery following Padeliporfin VTP treatment, including 4 of the 7 patients (57%) with R0 margins....Padeliporfin VTP was well-tolerated with no complications observed related to arterial injury, thrombosis, ischemia, or significant VTP-related morbidity."

P1 data • Pancreatic Ductal Adenocarcinoma

ImPact Biotech Presents Updated Data from…Phase 3 ENLIGHTED Trial in LG-UTUC at ASCO 2026 (GlobeNewswire) - "As of April 20, 2026, the data cut-off for the poster presentation at ASCO, Padeliporfin VTP demonstrated a consistent efficacy profile with 50 of the 72 (70%) response-evaluable patients achieving a CR at the end of Primary Response Evaluation (PRE). 18 of the 21 (85.7%) response-evaluable patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date, reaching a current median duration of response in the treated area of 23.9 months based on available follow-up. Padeliporfin VTP treatment was well-tolerated and has demonstrated a consistent and acceptable safety profile to date."

P3 data • Urothelial Cancer

ImPact Biotech Presents Updated Data from Phase 3 ENLIGHTED Trial of Padeliporfin VTP in LG-UTUC at AUA 2026 (GlobeNewswire) - "Complete response (CR) observed in 70% (50/72) of evaluable patients with low-grade upper tract urothelial cancer (UTUC) who completed Primary Response Evaluation (PRE). Updated durability data shows 85.7% (18/21) of patients who completed the Maintenance Treatment Phase (MTP) sustained CRs in the treated area for at least 12 months as of the data cutoff date. Padeliporfin VTP treatment continues to be safe and well-tolerated, establishing profile consistent with prior results alongside additional follow-up in MTP....Additional updates...will be presented at the American Society for Clinical Oncology (ASCO) Annual Meeting..."

P3 data • Urothelial Cancer

Integrating padeliporfin vascular-targeted photodynamic therapy with enfortumab vedotin and immune checkpoint blockade in urothelial cancer models (AACR 2026) - P1, P3 | "Vascular-targeted photodynamic therapy (VTP) has demonstrated efficacy in the ongoing phase III trial for low-grade upper tract urothelial carcinoma (UTUC), achieving a 78% complete response rate (NCT0420239). Flow cytometric analyses of patient PBMCs and preclinical data using the MB49 bladder cancer model demonstrated CD8⁺ T cell-driven immune modulation, leading us to hypothesize that VTP may complement EV and anti-PD1 by converting immune-desert tumors into more inflamed, treatment-responsive phenotypes. UCC14 and an MB49 high-Nectin-4 model are currently being evaluated to determine whether combining VTP with EV and/or Pembro enhances immune infiltration and response durability, providing translational rationale for integrating VTP with EV+Pembro in UTUC."

Checkpoint block • Checkpoint inhibition • IO biomarker • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD8 • HER-2 • TACSTD2

ImPact Biotech Announces Upcoming Data Presentations for Padeliporfin VTP at AUA and ASCO 2026 (GlobeNewswire) - "Company to present updated data from the Phase 3 ENLIGHTED trial of Padeliporfin VTP in LG UTUC with topline data expected in 2026; Additional preliminary data from the Phase 1 trial in LA-PDAC to be presented at ASCO; initial data from first cohort show promising signs of efficacy with a well-tolerated safety profile."

P1 data • P3 data: top line • Pancreatic Ductal Adenocarcinoma • Urothelial Cancer

A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Disorder • Oncology • Solid Tumor

Topline data from the Phase 3 ENLIGHTED trial in low-grade upper tract urothelial carcinoma (UTUC) and submission of a new drug application (NDA) for Padeliporfin VTP to the FDA are anticipated in 2026. (The Manila Times)

FDA filing • P3 data: top line • Urothelial Cancer

ImPact Biotech Presents Preliminary Data from Phase 1 Study of Padeliporfin VTP in LA-PDAC at SIR 2026… (The Manila Times) - "2 of the 3 (66%) patients successfully underwent surgery following Padeliporfin VTP treatment with low light dose of 200 mW/cm, with the third patient remaining ineligible for surgery due to a mesenteric tumor spread unrelated to the VTP procedure...Padeliporfin VTP was well-tolerated with no complications observed related to arterial injury, thrombosis, ischemia, or other VTP-related morbidity, consistent with previous data obtained from prior clinical studies....ImPact has completed patient enrollment in the second cohort of the Phase 1 dose-escalation study and expects to report additional data throughout 2026."

P1 data • Trial status • Pancreatic Ductal Adenocarcinoma

aPD1 treatment of urothelial cancers is synergistically enhanced by activating anti tumor immunity using vascular targeted photodynamic therapy (AACR 2024) - "The treatment success of low grade UTUC by vascular targeted photodynamic therapy (VTP) with WST11 (Padeliporfin) in phase I clinical trials led the FDA to approve Phase 3 trial in a fast track, orphan drug designation for low grade UTUC (ENLIGHT)... These observations indicate that elevating the content of anti-tumor immune cells in the tumor microenvironment by VTP in combination with ICI synergistically enhances the therapeutic effect providing a much higher complete cure compared with the individual therapies. The cure rate extent strongly depends on the synchronization of the two modalities providing guidelines for the clinical management of HG-UTUC treatment."

IO biomarker • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD8

Combination of gemcitabine and local tumor ablation WST-11 vascular-targeted photodynamic therapy displays superior efficacy compared to either monotherapy in a urothelial cancer model (AACR 2025) - P1 | "Assessment of systemic anti-tumor responses using a bilateral tumor model, re-challenge in surviving mice and host immune effect in Rag1-/- (lacking T-cell and B-cell populations) mice bearing MB49 suggests that there is a long-term systemic immune modulation and antitumor activity enforced by the combination of VTP and gemcitabine. Additional analyses by flow cytometry and immunohistochemistry suggests that the combination of gemcitabine and VTP induces both innate and adaptive immune responses."

Clinical • Monotherapy • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD8 • RAG1

ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (clinicaltrials.gov) - P3 | N=100 | Recruiting | Sponsor: Steba Biotech S.A. | Trial primary completion date: Jun 2025 ➔ Mar 2026

Trial primary completion date • Genito-urinary Cancer • Kidney Cancer • Oncology • Solid Tumor • Urothelial Cancer