^
    3d
    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, Steba Biotech S.A. | Trial completion date: Nov 2024 --> Feb 2025
    Trial completion date • HEOR
    |
    Tookad (padeliporfin)
    7d
    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, 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
    |
    Tookad (padeliporfin)
    2ms
    Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov)
    P1, N=36, Recruiting, Impact Biotech Ltd | Suspended --> Recruiting
    Enrollment open
    |
    Tookad (padeliporfin)
    3ms
    Lisavanbulin (BAL101553), a novel microtubule inhibitor, plus radiation in patients with newly diagnosed, MGMT promoter unmethylated glioblastoma. (PubMed, Neurooncol Adv)
    This multicenter phase 1 study sought to determine the MTD of oral Lisavanbulin in combination with standard RT (60 Gy/30 fractions) but without temozolomide in patients with newly diagnosed MGMT promoter unmethylated GBM (uGBM). Avanbulin exposures increased in a relatively dose-proportional manner with increasing oral dose of Lisavanbulin from 4 to 15 mg. Lisavanbulin in combination with RT was considered safe up to the highest predefined oral dose level of 15 mg daily.
    Journal
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • MGMT (6-O-methylguanine-DNA methyltransferase)
    |
    IDH1 mutation
    |
    temozolomide • lisavanbulin (BAL101553)
    3ms
    Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov)
    P1, N=36, Suspended, 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 suspension • Trial primary completion date
    |
    Tookad (padeliporfin)
    4ms
    Spatial Analysis of Tumor-Infiltrating Lymphocytes in mRCC Patients Treated with Pexa-Vec (Thymidine Kinase-Deactivated Vaccinia Virus plus GM-CSF) and cemiplimab (REGN2810; Anti-PD-1) (EORTC-NCI-AACR 2024)
    AI-powered spatial analysis suggests that combination therapy with Pexa-vec and cemiplimab enhances the immune response, evidenced by increased TIL densities in the tumor microenvironment.Table 1: Changes in TIL Densities from Pre- to Post-TreatmentMeasureCohortPre-Treatment (mm²)(Median, IQR)Post-Treatment (mm²)(Median, IQR)p-value isTILOverall (n = 18)87.53 (179.37-114.65)214.02 (257.50-389.74)0.0040 Arm A (n = 9)41.30 (257.13-81.61)190.17 (830.30-389.34)0.0078 Arm B (n = 9)165.43 (180.52-147.69)390.17 (340.11-387.14)0.1641iTILOverall (n = 18)88.89 (129.08-116.99)161.11 (376.62-321.79)0.0237 Arm A (n = 9)56.42 (125.56-101.70)157.44 (421.03-469.55)0.0273 Arm B (n = 9)96.27 (57.33-132.29)154.92 (194.87-184.03)0.3716sTILOverall (n = 18)100.91 (291.38-193.61)219.37 (370.85-466.27)0.0599 Arm A (n = 9)35.59 (257.13-67.38)140.55 (286.46-157.15)0.0391 Arm B (n = 9)303.37 (171.24-319.84)353.58 (189.15-735.39)0.4961
    Clinical • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker
    |
    CSF2 (Colony stimulating factor 2)
    |
    Lunit SCOPE IO
    |
    Libtayo (cemiplimab-rwlc) • Pexa-Vec (pexastimogene devacirepvec)
    4ms
    Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=30, Recruiting, Impact Biotech Ltd | Active, not recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Tookad (padeliporfin)
    4ms
    VB-111 in Surgically Accessible Recurrent/Progressive GBM (clinicaltrials.gov)
    P2, N=15, Terminated, Dana-Farber Cancer Institute | Active, not recruiting --> Terminated; Trial stopped at request of VBL Therapeutics, as they are no longer pursuing their VB-111 development program.
    Trial termination
    |
    Avastin (bevacizumab) • ofranergene obadenovec (VB-111)
    5ms
    Targeting vascular disrupting agent-treated tumor microenvironment with tissue-penetrating nanotherapy. (PubMed, Sci Rep)
    Notably, treatment with a combination of CA4P, iRGD, and polymersomes loaded with a novel anthracycline Utorubicin (UTO-PS) resulted in a significant decrease in the overall tumor burden in PC-bearing mice, while avoiding overt toxicities. Our results indicate that VDA-treated tumors can be targeted therapeutically using iRGD-potentiated nanotherapy and warrant further studies on the sequential targeting of VDA-induced molecular signatures.
    Journal
    |
    NRP1 (Neuropilin 1)
    7ms
    Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) (clinicaltrials.gov)
    P4, N=43, Terminated, Boston Scientific Corporation | N=100 --> 43 | Trial completion date: Jun 2027 --> Apr 2024 | Active, not recruiting --> Terminated; Enrollment challenges and a difficult insurance coverage landscape
    Enrollment change • Trial completion date • Trial termination
    7ms
    An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst (clinicaltrials.gov)
    P4, N=10, Terminated, University of Edinburgh | N=120 --> 10 | Unknown status --> Terminated
    Enrollment change • Trial termination
    7ms
    Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Impact Biotech Ltd | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    Tookad (padeliporfin)
    8ms
    Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) (clinicaltrials.gov)
    P4, N=100, Active, not recruiting, Boston Scientific Corporation | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2024 --> Apr 2024
    Enrollment closed • Trial primary completion date
    9ms
    Tumor vascular disrupting agent 5,6-dimethylxanthenone-4-acetic acid (DMXAA): Suppresses macrophage capping protein beyond STING activation. (PubMed, Biochim Biophys Acta Mol Basis Dis)
    Our study has originally uncovered a novel cross-species pathway underlying the antitumor vascular disruption of DMXAA extends beyond STING activation. This finding deepens our understanding of the multifaceted actions of flavonoid VDAs in animal models and in clinical settings, and may provide insights for the precise therapy of DMXAA based on the biomarker CapG protein.
    Journal
    |
    STING (stimulator of interferon response cGAMP interactor 1)
    9ms
    VB-111 in Surgically Accessible Recurrent/Progressive GBM (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Mar 2024 --> Aug 2024
    Trial primary completion date
    |
    Avastin (bevacizumab) • ofranergene obadenovec (VB-111)
    9ms
    VOS: Outcomes of Different Treatment Options in Chronic Venous Disease (clinicaltrials.gov)
    P=N/A, N=2000, Not yet recruiting, Universitaire Ziekenhuizen KU Leuven
    New trial
    9ms
    UCM301: ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED) Study (clinicaltrials.gov)
    P3, N=100, Recruiting, Steba Biotech S.A. | Trial primary completion date: Feb 2024 --> Dec 2024
    Trial primary completion date
    |
    Tookad (padeliporfin)
    10ms
    Assessing the Efficacy of Repeat, Monthly Treatments of Cutaneous Neurofibromas (cNFs) (clinicaltrials.gov)
    P1, N=10, Not yet recruiting, Massachusetts General Hospital
    New P1 trial
    10ms
    Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Impact Biotech Ltd | Trial completion date: Dec 2026 --> Dec 2027 | Initiation date: Oct 2023 --> May 2024 | Trial primary completion date: Mar 2025 --> May 2026
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    Tookad (padeliporfin)
    10ms
    Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Impact Biotech Ltd | Trial completion date: Oct 2025 --> Oct 2026 | Initiation date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2024 --> Apr 2025
    Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    |
    Tookad (padeliporfin)
    10ms
    Reshaping the tumor microenvironment of cold soft-tissue sarcomas with oncolytic viral therapy: a phase 2 trial of intratumoral JX-594 combined with avelumab and low-dose cyclophosphamide. (PubMed, Mol Cancer)
    Analysis of sequential tissue biopsies and plasma samples revealed an increase in CD8 density and upregulation of immune-related protein biomarkers, including CXCL10.Intra-tumoral administration of JX-594 in combination with cyclophosphamide and avelumab is safe and capable of modulating the TME in cold STS. However, the limited efficacy observed warrants further research to define the therapeutic potential of oncolytic viruses, particularly in relation to specific histological subtypes of STS.
    P2 data • Journal • Oncolytic virus • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10)
    |
    Bavencio (avelumab) • cyclophosphamide • Pexa-Vec (pexastimogene devacirepvec)
    10ms
    Varithena Versus Endothermal Ablation of the Great Saphenous Vein (VERITAS) (clinicaltrials.gov)
    P4, N=100, Recruiting, Boston Scientific Corporation | Trial completion date: Nov 2026 --> Jun 2027 | Trial primary completion date: Feb 2024 --> Sep 2024
    Trial completion date • Trial primary completion date
    11ms
    Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas (clinicaltrials.gov)
    P1, N=30, Recruiting, Massachusetts General Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    12ms
    VB-111 (ofranergene obadenovec) in combination with nivolumab in patients with microsatellite stable colorectal liver metastases: a single center, single arm, phase II trial. (PubMed, J Immunother Cancer)
    In patients with MSS CLM, VB-111 and nivolumab did not improve overall response rate or survival but were tolerated with minimal toxicities. While challenging to distinguish between antiviral or antitumor, correlative studies demonstrated an immune response with activation and proliferation of CD8 T cells systemically that was poorly sustained.
    P2 data • Journal • Combination therapy
    |
    CD8 (cluster of differentiation 8) • TNFA (Tumor Necrosis Factor-Alpha) • IL10 (Interleukin 10)
    |
    Opdivo (nivolumab) • ofranergene obadenovec (VB-111)
    12ms
    Light-enhanced VEGF/rGel induce immunogenic cell death and increase the antitumor activity of αCTLA4 treatment. (PubMed, Front Immunol)
    VEGF/rGel-PCI describes a novel concept for ICI enhancement which induces a rapid CD8+ dependent tumor eradication in both CT26 and MC38 tumors. The concept is based on the combination of intracellular ROS generation and vascular targeting using a plant derived toxin and will be developed towards clinical utilization.
    Journal
    |
    CD8 (cluster of differentiation 8) • HMGB1 (High Mobility Group Box 1) • HSP90AA1 (Heat Shock Protein 90 Alpha Family Class A Member 1Heat Shock Protein 90 Alpha Family Class A Member 1)
    1year
    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, Memorial Sloan Kettering Cancer Center | Completed --> Active, not recruiting | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Tookad (padeliporfin)
    1year
    Identification and validation of microtubule depolymerizing agent, CYT997, as a potential drug candidate for hepatocellular carcinoma. (PubMed, Liver Int)
    CYT997 is a potentially efficacious and non-toxic drug candidate for HCC therapy. Its ability to down-regulate GPC3, β-catenin, and c-Myc highlights a novel mechanism of action.
    Journal
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • MAP2K1 (Mitogen-activated protein kinase kinase 1) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • GPC3 (Glypican 3) • CDKN1A (Cyclin-dependent kinase inhibitor 1A) • CCNB1 (Cyclin B1)
    |
    sorafenib • lexibulin (CYT997)
    1year
    Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Massachusetts General Hospital
    New P1 trial
    1year
    Dosing and Tolerability of Deoxycholic Acid Versus Polidocanol in the Treatment of Neurofibromatosis Type 1 Cutaneous Neurofibromas (clinicaltrials.gov)
    P1, N=20, Recruiting, Massachusetts General Hospital
    New P1 trial
    |
    NF1 (Neurofibromin 1)
    1year
    Exploratory Evaluation of [11C]MPC6827 (clinicaltrials.gov)
    P1, N=40, Recruiting, Columbia University | Trial primary completion date: Sep 2023 --> Sep 2024
    Trial primary completion date
    1year
    A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=34, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Oncolytic virus • Checkpoint inhibition
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS wild-type • RAS wild-type
    |
    Imfinzi (durvalumab) • Vectibix (panitumumab) • Imjudo (tremelimumab-actl) • Pexa-Vec (pexastimogene devacirepvec)
    1year
    VB-111 in Surgically Accessible Recurrent/Progressive GBM (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Dana-Farber Cancer Institute | Trial completion date: Jan 2024 --> Jun 2024 | Trial primary completion date: Oct 2023 --> Mar 2024
    Trial completion date • Trial primary completion date
    |
    Avastin (bevacizumab) • ofranergene obadenovec (VB-111)
    1year
    Sclerotherapy as a primary or salvage procedure for aneurysmal bone cysts: A single-center experience. (PubMed, World J Orthop)
    Percutaneous sclerotherapy with polidocanol appears to be a safe alternative for treatment of aneurysmal bone cysts. In our series of both primary and recurrent cysts, it showed the ability to achieve healing or stable disease in 22 of 23 cases (96%). Further studies are needed to decide if this provides a long-lasting effect.
    Journal
    over1year
    Local Sustained Chemotherapy of Pancreatic Cancer Using Endoscopic Ultrasound-Guided Injection of Biodegradable Thermo-Sensitive Hydrogel. (PubMed, Int J Nanomedicine)
    A drug delivery system was developed, consisting of gemcitabine (GEM) and thermo-sensitive hydrogel (PLGA-PEG-PLGA, PPP)...The therapeutic effects of GEM/PPP hydrogel on xenograft mice were compared with those of GEM, ethanol and polidocanol using the precisely targeted EUS-FNI technology...The combination of GEM/PPP hydrogel and EUS-FNI technology provides an optimal approach of precise chemotherapy for pancreatic cancer, builds a bridge for clinical translation of basic research, and brings great hope for innovation of minimally invasive treatment modalities. The first-hand EUS image data obtained in this study also serves as a crucial reference for future clinical trials.
    Journal
    |
    gemcitabine
    over1year
    Pexa-vec (thymidine kinase-deactivated vaccinia virus plus GM-CSF) in combination with cemiplimab (REGN2810; ANTI-PD-1) for metastatic or unresectable renal cell carcinoma REN026: Results from a phase II study (ESMO 2023)
    The most common treatment-related adverse event was pyrexia, with a Grade ≥ 3 of 13.3% in Arm A, 0% in Arm B,0% in Arm C, and 3.6% in Arm D. No Grade 5 events occurred in any of the study arms. Table: 1885P Summary of efficacy results Conclusions The combination immunotherapy of IV PV and cemiplimab demonstrated an acceptable safety profile and encouraging efficacy of ORR and survival with durable responses in patients with metastatic or unresectable RCC, regardless of previous ICI treatment.
    P2 data • Combination therapy • Metastases
    |
    CSF2 (Colony stimulating factor 2)
    |
    CSF2 expression
    |
    Libtayo (cemiplimab-rwlc) • Pexa-Vec (pexastimogene devacirepvec)
    over1year
    VB-111 in Surgically Accessible Recurrent/Progressive GBM (clinicaltrials.gov)
    P2, N=15, Active, not recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Jun 2023 --> Oct 2023
    Trial primary completion date
    |
    Avastin (bevacizumab) • ofranergene obadenovec (VB-111)
    over1year
    Padeliporfin VTP Treatment for Unresectable Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Steba Biotech S.A.
    New P1 trial • Metastases
    |
    Tookad (padeliporfin)
    over1year
    Padeliporfin VTP Using Robotic Assisted Bronchoscopy in Peripheral Lung Cancer (clinicaltrials.gov)
    P1, N=36, Not yet recruiting, Steba Biotech S.A.
    New P1 trial
    |
    Tookad (padeliporfin)
    over1year
    Study of FGFR2 status in gastric cancer by immunohistochemistry and fluorescent in situ hybridization (PubMed, Arkh Patol)
    Clone EPR24075-418 showed the best result in assessing the expression of FGFR2: the correlation with FISH results in reaction 3+ was 100%. Due to the high heterogeneity of FGFR2 expression, it is recommended to either examine the material of the primary tumor and metastasis, or evaluate a large volume of the primary tumor.
    Journal
    |
    FGFR2 (Fibroblast growth factor receptor 2)
    |
    FGFR2 amplification • FGFR2 expression • FGFR2b expression
    |
    crolibulin (EPC2407)
    over1year
    The microtubule-targeted agent lisavanbulin (BAL101553) shows anti-tumor activity in lymphoma models. (PubMed, Am J Cancer Res)
    Due to its unique binding to the colchicine site of tubulin, differently from other MTAs, avanbulin has previously shown activity in solid tumor cell lines. Half of the cell lines tested showed an induction of apoptosis already in the first 24 h of treatment, the other half in the first 48 h. EB1 showed expression in DLBCL clinical specimens, opening the possibility for a cohort of patients that could potentially benefit from treatment with lisavanbulin. These data show the basis for further preclinical and clinical evaluation of lisavanbulin in the lymphoma field.
    Journal
    |
    lisavanbulin (BAL101553)
    over1year
    To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer (clinicaltrials.gov)
    P2, N=10, Terminated, SynCore Biotechnology Co., Ltd. | N=37 --> 10
    Enrollment change • Metastases
    |
    SB01