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

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

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) - P3 | "Clinical Trial Registration Number: NCT04620239 The abstract will be released to the public on May 31, 2025 at 7:00 AM CDT"

Clinical • Late-breaking abstract • P3 data • P3 data: top line • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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

Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LGUTUC): ENLIGHTED Phase 3 study (AUA 2025) - P1, P3 | "Padeliporfin VTP has shown evidence of safety and efficacy with preliminary data that is consistent with prior experience. Recruitment for the ENLIGHTED trial isongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts."

Clinical • P3 data • Anesthesia • Fatigue • Genito-urinary Cancer • Oncology • Pain • Renal Calculi • Solid Tumor • Urothelial Cancer

ImPact Biotech Announces New Data Presentations at AUA 2025 Highlighting Safety and Efficacy of Padeliporfin VTP (GlobeNewswire) - "ImPact Biotech...today announced that the company will present updated preliminary results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment in patients with low-grade upper tract urothelial cancer (UTUC), as well as long-term follow up from the PCM-204 Phase 2b trial evaluating Padeliporfin VTP in men with intermediate risk of prostate cancer, at the American Urological Association’s 2025 Annual Meeting taking place April 26-29, 2025 in Las Vegas, Nevada....ImPact continues to progress evaluation of Padeliporfin VTP in LG UTUC and other solid tumor indications, and we anticipate completing enrollment of the ENLIGHTED trial in 2nd half of 2025."

P2b data • P3 data • Trial status • Prostate Cancer • Urothelial Cancer

Selectivity and anti-tumor immune elevation by vascular-targeted photodynamic therapy of mouse orthotopic bladder cancer model. (PubMed, Photochem Photobiol) - "Vascular-targeted photodynamic therapy (VTP) with WST11 is a non-surgical tumor ablation approach that is currently being tested in a phase 3 clinical trial for the treatment of upper tract urothelial cancer...Moreover, VTP therapy prolonged the survival of mice bearing orthotopic tumors compared with the untreated control. These results suggest that VTP can selectively ablate malignant tumors in the bladder and promote a robust anti-tumor response in a mouse model that can further augment the therapeutic outcome."

Journal • Preclinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • CD4 • CD8 • ITGAM

The Safety and Efficacy of Vascular-Targeted Photodynamic Therapy in Low-Risk Prostate Cancer. (PubMed, Cancers (Basel)) - "Vascular-targeted photodynamic therapy is a safe and effective alternative to active surveillance in patients with low-risk prostate cancer."

Clinical • Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urethral Cancer • Urology

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: Dec 2024 ➔ Jun 2025

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

ENLIGHTED Phase 3 study: Efficacy and safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC) (EAU 2025) - No abstract available

Clinical • P3 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Proteomics Reveals Mechanisms of Delayed Keratoconus Progression: A Study of Corneas Following Two Light-Activated Crosslinking Treatments. (PubMed, Invest Ophthalmol Vis Sci) - "This study aims to elucidate on changes in biological pathways in rabbit corneas induced by two methods of light-activated corneal stiffening: topical application of riboflavin with dextran (RF-D) or WST11 with dextran (WST-D) followed by ultraviolet A (UVA) or near-infrared (NIR) illumination, respectively...Proteomics indicated a metabolic shift from oxidative phosphorylation to glycolysis and hypoxia after RF-D/UVA treatment. In contrast, WST-D/NIR stiffening maintained normal respiration and involved extracellular matrix remodeling."

Journal • Ophthalmology

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 | Active, not recruiting | Sponsor: Steba Biotech S.A. | Trial completion date: Nov 2024 ➔ Feb 2025

HEOR • Trial completion date • Genito-urinary Cancer • Oncology • 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 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

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

ImPact Biotech Presents Updated Interim Phase 3 Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade UTUC at SUO 2024 (GlobeNewswire) - P3 | N=100 | ENLIGHTED (NCT04620239) | Sponsor: Steba Biotech S.A. | "Key updated preliminary results from the Phase 3 ENLIGHTED study of Padeliporfin VTP: Clinical Profile: 17 of the 20 (85%) response-evaluable patients achieved a CR at the end of ITP. Safety and Tolerability Profile: Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results. Adverse events (AEs) observed were primarily Grade 1 or 2, most of which were pain related, and all resolved within two to seven days. Only one patient experienced a Grade 3 serious adverse event that was related to the VTP therapy, which resolved within two days. There were no Grade 4 or 5 serious adverse events observed."

P3 data • Urothelial Cancer

Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC): ENLIGHTED Phase 3 study (SUO 2024) - P1, P3 | "Recruitment for the ENLIGHTED trial is ongoing with results expected to provide basis for approval of a new therapy that clinically benefits patients . "

Clinical • P3 data • Anesthesia • Fatigue • Genito-urinary Cancer • Infectious Disease • Nephrology • Oncology • Pain • Renal Calculi • Solid Tumor • Urothelial Cancer

ENLIGHTED Phase 3 study: Efficacy and Safety of Padeliporfin Vascular Targeted Photodynamic Therapy (VTP) for Treatment of Low-grade Upper Tract Urothelial Cancer (LG UTUC) (EMUC 2024) - P1, P3 | "Conclusions Padeliporfin VTP has shown evidence of safety and efficacy with preliminary data that is consistent with prior experience. Recruitment for the ENLIGHTED trial is ongoing with results expected to provide basis for approval of a new therapy that clinically benefits pts."

Clinical • P3 data • Anesthesia • Fatigue • Genito-urinary Cancer • Oncology • Pain • Renal Calculi • Solid Tumor • Urothelial Cancer

ImPact Biotech Presents Updated Interim Phase 3 Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade UTUC at EMUC 2024 (GlobeNewswire) - "Padeliporfin VTP was well-tolerated with a safety profile consistent with the previous data obtained from the Phase 1 study and previously announced preliminary Phase 3 results. Adverse events (AEs) observed were primarily Grade 1 or 2, most of which were pain related, and all resolved within two to seven days. Only one patient experienced a Grade 3 serious adverse event that was related to the VTP therapy, which resolved within two days. There were no Grade 4 or 5 serious adverse events observed...ImPact continues to recruit for the ENLIGHTED study. As previously announced in September, the Company has exceeded 50% enrollment in the study and expects to complete enrollment by early 2025."

P3 data • Oncology • Solid Tumor • Urothelial Cancer

Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Impact Biotech Ltd | Suspended ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Solid Tumor

ImPact Biotech to Present Updated Interim Phase 3 Data from ENLIGHTED Study of Padeliporfin VTP in Low Grade UTUC at EMUC 2024 (GlobeNewswire) - "ImPact Biotech...announced an abstract including interim results from ENLIGHTED, the Company’s ongoing Phase 3 study of Padeliporfin VTP treatment of patients with low-grade upper tract urothelial cancer (UTUC), will be presented at the 16th European Multidisciplinary Congress on Urological Cancers (EMUC 2024) taking place November 7 – 10, 2024, in Lisbon, Portugal."

P3 data • Urothelial Cancer

Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov) - P1 | N=36 | Suspended | Sponsor: Impact Biotech Ltd | Trial completion date: Dec 2027 ➔ Dec 2028 | Not yet recruiting ➔ Suspended | Trial primary completion date: May 2026 ➔ May 2027

Trial completion date • Trial primary completion date • Trial suspension • Lung Cancer • Oncology • Solid Tumor

ImPact Biotech Announces 50% Enrollment in Phase 3 ENLIGHTED Clinical Trial of Padeliporfin VTP in Low Grade Upper Tract Urothelial Cancer (GlobeNewswire) - "ImPact Biotech...today announced that the Phase 3 ENLIGHTED (ENdoluminal LIGHT ActivatED) trial evaluating Padeliporfin VTP in patients with low-grade UTUC has achieved 50% patient enrollment threshold....With this recent progress and continued momentum in patient recruitment, we anticipate reaching complete enrollment by the first quarter of 2025....The company is expected to share additional interim data from the ongoing ENLIGHTED study in the fourth quarter of this year."

Enrollment status • P3 data • Genito-urinary Cancer • Urothelial Cancer