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    DRUG CLASS:

    Immunostimulant

    Related drugs:
    1d
    Characterization of shared neoantigens landscape in Mismatch Repair Deficient Endometrial Cancer. (PubMed, NPJ Precis Oncol)
    A high coverage emerged from the comparative analysis of the EC FSPs with the content of the previously validated NOUS-209 vaccine. We obtained pieces of evidence of FSPs translation as expressed proteins from Ribo-seq, supporting the potential as the target of vaccination. The development of a nAgs-based vaccine strategy in MMRd EC may be further explored.
    Journal • Mismatch repair
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    MLH1 (MutL homolog 1)
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    MSI-H/dMMR
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    NOUS-209
    1d
    Telomerase-based vaccines: a promising frontier in cancer immunotherapy. (PubMed, Cancer Cell Int)
    While DNA vaccines demonstrate promising immunogenicity, peptide vaccines, such as UV1, UCPVax, and Vx-001, have shown clinical efficacy in certain cancer types. Accordingly, we discuss the mechanisms of action, preclinical and clinical data, and the potential of these vaccines to elicit robust and durable anti-tumor immune responses. This review highlights the potential of telomerase-based vaccines as a promising strategy for cancer treatment and identifies areas for future research.
    Review • Journal
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    TERT (Telomerase Reverse Transcriptase)
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    UCPVax • UV1 • Vx-001
    3d
    A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older (clinicaltrials.gov)
    P1/2, N=1158, Not yet recruiting, Sanofi Pasteur, a Sanofi Company
    New P1/2 trial
    3d
    Assessing the Safety, Immune Response, and Early Efficacy of a Candida Vaccine in Women with Recurrent Vulvovaginal Candidiasis: a Randomized Controlled Study (clinicaltrials.gov)
    P1/2, N=251, Recruiting, LimmaTech Biologics AG | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    3d
    Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery (clinicaltrials.gov)
    P1, N=29, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Surgery
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    Tecentriq (atezolizumab) • irinotecan • autogene cevumeran (RG6180)
    3d
    Combination of UCPVax Vaccine and Atezolizumab for the Treatment of Human Papillomavirus Positive Cancers (VolATIL) (clinicaltrials.gov)
    P2, N=47, Completed, Centre Hospitalier Universitaire de Besancon | Active, not recruiting --> Completed | Trial completion date: Oct 2025 --> Nov 2024 | Trial primary completion date: Sep 2024 --> Mar 2024
    Trial completion • Trial completion date • Trial primary completion date
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    Tecentriq (atezolizumab) • UCPVax
    4d
    A Study to Investigate Cardiac Troponin Levels After mRNA-1273.712 Vaccine in Participants 12 Through 30 Years of Age (clinicaltrials.gov)
    P4, N=1000, Active, not recruiting, ModernaTX, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    4d
    Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran (clinicaltrials.gov)
    P=N/A, N=15196685, Completed, ModernaTX, Inc. | Active, not recruiting --> Completed | N=10000000 --> 15196685
    Trial completion • Enrollment change
    4d
    A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Participants in Japan (clinicaltrials.gov)
    P2/3, N=186, Not yet recruiting, Takeda
    New P2/3 trial
    4d
    C4591068: Estimated Vaccine Effectiveness and Durability of Pfizer/BioNTech 2024-2025 COVID-19 Vaccine (clinicaltrials.gov)
    P=N/A, N=22692, Active, not recruiting, Pfizer | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    4d
    Secondary Databased Post-marketing Surveillance Study of BNT162b2 (clinicaltrials.gov)
    P=N/A, N=10890000, Not yet recruiting, Pfizer
    New trial
    4d
    A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults (clinicaltrials.gov)
    P2, N=10016, Recruiting, CyanVac LLC
    New P2 trial
    4d
    CLAUDE: EO2040 in Combination With Nivolumab, for Treatment of Patients With Minimal Residual Disease of Colorectal Cancer (clinicaltrials.gov)
    P2, N=1, Terminated, Enterome | Completed --> Terminated; the study recruitment is significantly behind expectations as only one single patient has started treatment
    Trial termination • Minimal residual disease • Circulating tumor DNA
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    Opdivo (nivolumab)
    5d
    Extension Safety and Immunogenicity Study of GPNV-001 (clinicaltrials.gov)
    P1/2, N=60, Completed, GPN Vaccines | Recruiting --> Completed
    Trial completion
    5d
    A Phase Ib Study of JMKX000197 Injection in the Treatment of Malignant Pleural Effusion (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, Jemincare
    New P1 trial
    5d
    A Study on the Immune Response and Safety of an Investigational Chickenpox Vaccine When Given to Healthy Children 12 to 15 Months of Age (clinicaltrials.gov)
    P3, N=1840, Not yet recruiting, GlaxoSmithKline
    New P3 trial
    5d
    A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1468 in Healthy Adults ≥50 Years of Age (clinicaltrials.gov)
    P1/2, N=659, Active, not recruiting, ModernaTX, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    5d
    Immunologic Responses to a Live Attenuated Oral Cholera Vaccine (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, Emory University | Recruiting --> Active, not recruiting | N=50 --> 34
    Enrollment closed • Enrollment change
    5d
    A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults (clinicaltrials.gov)
    P1, N=60, Suspended, University Hospital Tuebingen | Recruiting --> Suspended
    Trial suspension
    5d
    A Strain Change Study for SARS-CoV-2 rS Vaccines (clinicaltrials.gov)
    P3, N=60, Active, not recruiting, Novavax | Not yet recruiting --> Active, not recruiting | Phase classification: P2/3 --> P3 | N=100 --> 60 | Trial completion date: Feb 2025 --> Jun 2025
    Enrollment closed • Phase classification • Enrollment change • Trial completion date
    5d
    Dose Escalation Trial of CD40.HIVRI.Env Vaccine Combined or Not With a DNA-HIV-PT123 HIV-1 Vaccine in Healthy Volunteers (clinicaltrials.gov)
    P1, N=72, Completed, ANRS, Emerging Infectious Diseases | Active, not recruiting --> Completed
    Trial completion
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    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    5d
    Serum cytokines as a biomarker for immune checkpoint inhibitor toxicity in patients with pleural mesothelioma. (PubMed, Front Immunol)
    Patients with pleural mesothelioma treated with nivolumab and ipilimumab with or without UV1 vaccine in the NIPU study were included. Elevated levels of certain cytokines, both before and after onset of treatment, correlate with specific irAEs in PM patients receiving ICIs. These cytokines may be used as biomarkers to predict and detect irAES.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    TNFA (Tumor Necrosis Factor-Alpha) • IL2RA (Interleukin 2 receptor, alpha) • CCL4 (Chemokine (C-C motif) ligand 4) • CCL11 (C-C Motif Chemokine Ligand 11) • IL4 (Interleukin 4) • IL16 (Interleukin 16)
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • UV1
    5d
    A High-Throughput Immune-Oncology Screen Identifies Immunostimulatory Properties of Cytotoxic Chemotherapy Agents in TNBC. (PubMed, Cancers (Basel))
    Four chemotherapy agents were chosen as priority hits for mechanistic follow-up due to their ability to enhance T-cell-mediated cytotoxicity at multiple doses and multiple time points: paclitaxel, bleomycin sulfate, ispinesib, and etoposide. Based on the ability to increase tumor cell susceptibility to T-cell-mediated cytotoxicity while minimizing T-cell toxicity, bleomycin was identified as the most promising lead candidate. Overall, the results of these studies provide mechanistic insight into potential new chemotherapy partners to enhance anti-PD-1 efficacy in TNBC patients.
    Journal • PD(L)-1 Biomarker • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • HMGB1 (High Mobility Group Box 1)
    |
    paclitaxel • etoposide IV • bleomycin • ispinesib (SB-715992)
    7d
    A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults (clinicaltrials.gov)
    P1/2, N=1429, Completed, GlaxoSmithKline | Active, not recruiting --> Completed
    Trial completion
    7d
    Immunogenicity and Safety Study of Self-amplifying MRNA COVID-19 Vaccine Administered with Influenza Vaccines in Adults (clinicaltrials.gov)
    P3, N=1499, Completed, Arcturus Therapeutics, Inc. | Active, not recruiting --> Completed
    Trial completion
    7d
    Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell) (clinicaltrials.gov)
    P3, N=8000, Not yet recruiting, Sinovac Biotech Co., Ltd
    New P3 trial
    7d
    Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia (clinicaltrials.gov)
    P2, N=54, Active, not recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting --> Active, not recruiting | N=100 --> 54
    Enrollment closed • Enrollment change
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    CD4 (CD4 Molecule)
    |
    Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
    7d
    Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov)
    P3, N=1630, Not yet recruiting, Sanofi Pasteur, a Sanofi Company
    New P3 trial
    7d
    A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer. (clinicaltrials.gov)
    P1/2, N=18, Completed, Ultimovacs ASA | Active, not recruiting --> Completed
    Trial completion
    |
    Leukine (sargramostim) • UV1
    7d
    A Phase I/IIa Study of UV1 Vaccine in Patients With Prostate Cancer (clinicaltrials.gov)
    P1/2, N=22, Completed, Ultimovacs ASA | Active, not recruiting --> Completed
    Trial completion • Metastases
    |
    Leukine (sargramostim) • UV1
    7d
    Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma (clinicaltrials.gov)
    P1/2, N=12, Completed, Ultimovacs ASA | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    Yervoy (ipilimumab) • Leukine (sargramostim) • UV1
    7d
    Evaluation of Full Versus Fractional Doses of COVID-19 Vaccines Given as a Booster in Adults in Australia - Mongolia, Indonesia, Australia Coronavirus (MIACoV). (clinicaltrials.gov)
    P3, N=13, Terminated, Murdoch Childrens Research Institute | Completed --> Terminated; Due to the small number of participants
    Trial termination
    7d
    A Study to Investigate Multiple Sclerosis Relapse Prevention With mRNA-1195 Compared With Placebo in Participants Aged 18 to ≤55 Years (clinicaltrials.gov)
    P2, N=180, Not yet recruiting, ModernaTX, Inc.
    New P2 trial
    7d
    POX-MVA-045: Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections (clinicaltrials.gov)
    P2, N=460, Recruiting, Bavarian Nordic | Not yet recruiting --> Recruiting
    Enrollment open
    7d
    Efficacy, Immunogenicity, and Safety of V503 in Chinese Males (V503-052) (clinicaltrials.gov)
    P3, N=8100, Active, not recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Nov 2024 --> May 2029
    Trial primary completion date
    |
    Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant)
    7d
    MELODY-1: A Phase 1b Trial to Evaluate Safety of MB097 in Combination With Pembrolizumab in Melanoma Patients (clinicaltrials.gov)
    P1, N=40, Recruiting, Microbiotica Ltd | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab)
    8d
    A Study of Dengue Tetravalent Vaccine (TDV) in Healthy Subjects in Japan (clinicaltrialsregister.eu)
    P3, N=186, Takeda
    New P3 trial
    10d
    Immunogenicity of Influenza Vaccinations (clinicaltrials.gov)
    P4, N=605, Active, not recruiting, Duke University | Recruiting --> Active, not recruiting | Trial primary completion date: May 2025 --> Dec 2024
    Enrollment closed • Trial primary completion date
    10d
    Lot Consistency Study of COVID-19 and Influenza Combination Vaccine (clinicaltrials.gov)
    P2/3, N=1925, Not yet recruiting, Novavax | Trial completion date: May 2025 --> May 2026 | Initiation date: Nov 2024 --> Feb 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial initiation date • Trial primary completion date
    10d
    Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Pilot Study in adults aged 18 years and over. (ACTRN12621001543875)
    P=N/A, N=3000, Completed, Metro North Hospital and Health Service | Active, not recruiting --> Completed
    Trial completion • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • NCAM1 (Neural cell adhesion molecule 1) • IL10 (Interleukin 10) • CD27 (CD27 Molecule) • IL5 (Interleukin 5) • B3GAT1 (Beta-1,3-Glucuronyltransferase 1)
    10d
    Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Program: Mixed Dose 1 and 2 Study (ACTRN12621001524886)
    P=N/A, N=2000, Completed, Metro North Hospital and Health Service | Active, not recruiting --> Completed
    Trial completion • IO biomarker
    |
    CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD69 (CD69 Molecule) • IL2 (Interleukin 2) • NCAM1 (Neural cell adhesion molecule 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • IL10 (Interleukin 10) • CCR7 (Chemokine (C-C motif) receptor 7) • CD27 (CD27 Molecule) • CCL2 (Chemokine (C-C motif) ligand 2) • GZMB (Granzyme B) • IL18 (Interleukin 18) • IL17A (Interleukin 17A) • IL1A (Interleukin 1, alpha) • IL23A (Interleukin 23 Subunit Alpha) • PRF1 (Perforin 1) • B3GAT1 (Beta-1,3-Glucuronyltransferase 1) • IL33 (Interleukin 33)
    |
    CD8 expression
    10d
    A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza. (clinicaltrials.gov)
    P3, N=8798, Completed, BioNTech SE | Active, not recruiting --> Completed
    Trial completion