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

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

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) - No abstract available

P3 data • Oncology • Solid Tumor • 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) - No abstract available

P3 data • Oncology • Solid Tumor • Urothelial Cancer

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

A transpupillary approach for crosslinking Guinea pig sclera using WST11 and near-infrared light. (PubMed, Sci Rep) - "In vivo, WST-D/NIR treatment resulted in significant crosslinking compared to untreated controls (equatorial, ΔT50: 3.7, p < 0.0001; posterior, ΔT50: 3.4, p = 0.01). WST-D/NIR treatment effectively induces scleral crosslinking, with age-related differences suggesting the need for personalized treatment."

Journal • Ophthalmology

Efficacy and Safety of Padeliporfin Vascular-Targeted Photodynamic Therapy (VTP) in the ENLIGHTED Phase 3 Study for Low-Grade Upper Tract Urothelial Carcinoma (LG UTUC) (EAU 2026) - No abstract available

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

Five-year outcomes of TOOKAD® (WST-11) vascular-targeted photodynamic therapy for low-risk prostate cancer patients: Insights from a tertiary referral centre. (PubMed, BJUI Compass) - No abstract available

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ImPact Biotech Presents Updated Preliminary Data from Phase 3 ENLIGHTED Study of Padeliporfin VTP in LG UTUC at SUO 2025 (GlobeNewswire) - "Complete response (CR) observed in 70% (35/50) of patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase (ITP). Initial durability data shows all patients (100%) 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....Complete enrollment in study expected in Q1 2026, with topline data anticipated in the first half of 2026."

Enrollment status • P3 data • Urothelial Cancer

ImPact Biotech to Present Updated Interim Phase 3 Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade UTUC at SUO 2025 (GlobeNewswire) - "In addition, the Company recently delivered an encore presentation of data from the Phase 3 ENLIGHTED trial at the 17th European Multidisciplinary Congress on Urological Cancers (EMUC 2025) on November 15, 2025. The poster...featured an interim analysis that had previously been presented at ASCO 2025, showing Padeliporfin VTP induced a complete response (CR) in 73% (27/37) of evaluable patients and maintained a safe and well-tolerated profile. The interim analysis captured results from 50% of target enrollment in ENLIGHTED as of the November 5, 2024 data cutoff."

P3 data • Urothelial Cancer

ENLIGHTED Phase 3 study: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment ofLow-grade Upper Tract Urothelial Cancer (LG UTUC) (SUO 2025) - P1, P3 | "The final study outcomes are expected to support regulatory approval of a novel, organ-preserving therapy for patients with LG UTUC. "

Clinical • P3 data • Anesthesia • Fatigue • Genito-urinary Cancer • Oncology • Renal Calculi • Solid Tumor • 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 TractUrothelial cancer (LG UTUC) (EMUC 2025) - P1, P3 | "Reused with permission. This abstract was accepted as a rapid oral presentation and was presented at the 2025 ASCO Annual Meeting."

Clinical • P3 data • P3 data: top line • Genito-urinary Cancer • Oncology • Solid Tumor • 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 tracturothelial cancer (LG UTUC) (DGU 2025) - "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 in UTUC."

Clinical • P3 data • P3 data: top line • Genito-urinary Cancer • Oncology • Renal Calculi • Solid Tumor • Urothelial Cancer

Synergistic Efficacy of WST11-VTP and P-Selectin-Targeted Nanotherapy in a Preclinical Prostate Cancer Model. (PubMed, Cancers (Basel)) - " SCID (severe combined immunodeficiency) mice were engrafted with androgen-sensitive prostate tumor cells (LNCaP-AR) and treated with a combination of VTP and two different drugs linked to fucoidan nanoparticles (Enzalutamide and Paclitaxel). This approach significantly advances beyond existing VTP and nanodrug therapies by improving tumor control, ensuring sustained intra-tumoral drug concentration, and yielding superior oncological outcomes. Our results suggest that this therapy is a potential treatment option for prostate tumors treated with VTP in future clinical trials."

Journal • Preclinical • Genetic Disorders • Genito-urinary Cancer • Immunology • Oncology • Primary Immunodeficiency • Prostate Cancer • Solid Tumor

Treatment of Tumors in the Urinary Collecting System of the Kidney or Ureter Using a Light Activated Drug (WST11) (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jul 2025 | Trial primary completion date: Dec 2025 ➔ Jul 2025

Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • Urothelial Cancer

ImPact Biotech Announces Treatment of First Patient in Phase 1 Clinical Trial of Padeliporfin VTP in Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma (PDAC) (GlobeNewswire) - "ImPact Biotech...announced that the first patient has been treated in its Phase 1 trial evaluating Padeliporfin VTP in individuals with locally advanced, unresectable pancreatic ductal adenocarcinoma (PDAC) at the UCI Irvine Medical Center. The patient, who was initially assessed as ineligible for surgical resection, received a single administration of Padeliporfin VTP. Following treatment, the tumor demonstrated changes that enabled the patient to undergo a successful pancreaticoduodenectomy (Whipple procedure) which was not previously considered feasible in this case....Enrollment in the study is ongoing, and the Company expects preliminary data from the study in the second half of 2025."

P1 data • Trial status • Pancreatic Ductal Adenocarcinoma

ImPact Biotech Presents Interim Analysis from Phase 3 ENLIGHTED Study of Padeliporfin VTP in LG UTUC at ASCO 2025 (GlobeNewswire) - P3 | N=100 | ENLIGHTED (NCT04620239) | Sponsor; Steba Biotech S.A. | "Complete response (CR) observed in 73% (27/37) of evaluable patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase (ITP); Padeliporfin VTP treatment continues to be safe and well-tolerated, establishing profile consistent with prior results alongside additional follow-up in Maintenance Treatment Phase (MTP); Interim analysis follows evaluation of 50% of target enrollment in study; completion of enrollment anticipated in 2H25 with topline data by year end; ImPact continues to recruit for the ENLIGHTED study and expects to complete enrollment in the second half of 2025. The company anticipates the presentation of topline ENLIGHTED data in 2025."

P3 data • Urothelial Cancer

ImPact Biotech Announces Late-Breaking Podium Presentation at ASCO 2025 Highlighting ENLIGHTED Study Interim Analysis (GlobeNewswire) - "ImPact Biotech...announced that the company will present an interim analysis with updated data from the ongoing Phase 3 ENLIGHTED study evaluating Padeliporfin VTP in patients low-grade upper tract urothelial cancer (UTUC) in a late-breaking podium session at the American Society of Clinical Oncology Annual Meeting....'Evaluation of Padeliporfin VTP in the ENLIGHTED study continues to steadily progress as we work to complete enrollment in the second half of 2025 and push towards potentially registrational topline results later this year'..."

Enrollment status • Late-breaking abstract • P3 data • Urothelial Cancer

aPD1 treatment synergistically enhanced by vascular-targeted photodynamic therapy with metastasis inhibition in urothelial cancers (IMMUNOLOGY 2025) - "Vascular-targeted photodynamic therapy (VTP) with WST11 shows promise in low-grade UTUC, leading to FDA fast-track approval for Phase 3 trials... Enhancing anti-tumor immune cells via VTP timing boosts cure rates with ICI, offering guidance for clinical HG-UTUC treatment.Keywords: Animals Rodent; Cells Dendritic Cells Natural Killer Cells T Cells, Cytotoxic; Molecules Nitric Oxide; Processes Cytotoxicity"

Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD4 • CD8 • FOXP3

Key updated preliminary results from the Phase 3 ENLIGHTED study of Padeliporfin VTP (GlobeNewswire) - P3 | N=100 | ENLIGHTED (NCT04620239) | Sponsor: Steba Biotech S.A. | "Complete response (CR) observed in 79% (26/33) of evaluable patients with low-grade upper tract urothelial cancer (UTUC) who completed the Induction Treatment Phase (ITP) of the ENLIGHTED Phase 3 trial evaluating Padeliporfin VTP in UTUC; Padeliporfin VTP treatment continues to be safe and efficacious, establishing profile consistent with prior results alongside additional follow-up in Maintenance Treatment Phase (MTP); ImPact continues to recruit for the ENLIGHTED study and expects to complete enrollment in mid-2025."

P3 data • Trial status • Urothelial Cancer

Long-term follow-up from PCM-204 Phase 2b trial in intermediate-risk prostate cancer (GlobeNewswire) - P2b | N=50 | "32 off the 46 (69%) of the evaluable men remained free from evidence of clinical disease progression at 48 months post-treatment; Padeliporfin demonstrated minimal long-term toxicity including low impact on urinary and sexual function, consisted with the safety and tolerability profile established in the Phase 3 trial in low-risk disease. Functional outcomes at 48 months post-treatment included a non-significant mean decrease in IIEF-5 scores from baseline of -0.67 (standard deviation [SD] 4.4). IPSS demonstrated an average non-significant change of -0.34 (SD 5.1). All patients maintained pad-free urinary continence."

P2b data • Prostate Cancer

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

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 2025 ➔ Feb 2026 | Trial primary completion date: Feb 2025 ➔ Feb 2026

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

Intravesical Vascular-Targeted Photodynamic Therapy of Urothelial Carcinomas Derived from the Oncopig Model (AUA 2025) - "VTP procedure included infusion of Padeliporfin (WST11) followed by laser illumination of tumor lesions using a frontal laser fiber at a light dose of 191 mW/cm2... Vascular-targeted photodynamic therapy shows effective ablation of urothelial carcinomas in the Oncopig model, supporting its potential for targeted intravesical cancer treatment."

Bladder Cancer • Oncology • Sarcoma • Solid Tumor • Urothelial Cancer • KRAS

48 MONTH FOLLOW UP OF RESULTS OF THE PCM-204 PHASE 2B TRIAL OF PARTIAL-GLAND ABLATION FOR MEN WITH INTERMEDIATE-RISK PROSTATE CANCER WITH PADELIPORFIN (WST11 OR TOOKAD) VASCULAR-TARGETED PHOTODYNAMIC THERAPY (AUA 2025) - "These positive trial results show that WST11-VTP is effective for PGA of intermediate-risk prostate cancer with minimal long-term toxicity including low impact on urinary and sexual function, consistent with the Phase 3 trial results in low-risk disease. Continued follow-up to the protocol defined 5-year endpoint is pending with final 5-year results expected by early 2025. Based on the presented data, this therapy bears consideration for approval as a conservative therapeutic option for selected cases of intermediate risk disease."

P2b data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor