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    DRUG:

    adegramotide/nelatimotide (DSP-7888)

    i
    Other names: DSP-7888, DSP 7888, WT1 protein-derived peptide vaccine
    Associations

    News

    Trials
    Company:
    Sumitomo Pharma
    Drug class:
    Wilms tumor 1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    1m
    A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=47, Terminated, Sumitomo Pharma America, Inc. | Phase classification: P1b/2 --> P1/2 | Completed --> Terminated; Sponsor's decision to terminate development of the program.
    Phase classification • Trial termination • Combination therapy • Checkpoint inhibition • Metastases
    |
    MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-B (Major Histocompatibility Complex, Class I, B)
    |
    MSI-H/dMMR • HLA-A*02 • HLA-A*24
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
    over1year
    WIZARD201G: A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (clinicaltrials.gov)
    P3, N=221, Completed, Sumitomo Pharma Oncology, Inc. | Active, not recruiting --> Completed
    Trial completion • Combination therapy
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02 • HLA-A*24:02
    |
    Avastin (bevacizumab) • adegramotide/nelatimotide (DSP-7888)
    over1year
    A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1b/2, N=47, Completed, Sumitomo Pharma Oncology, Inc. | Active, not recruiting --> Completed | N=84 --> 47
    Trial completion • Enrollment change • Combination therapy • Checkpoint inhibition • Metastases
    |
    MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-B (Major Histocompatibility Complex, Class I, B)
    |
    MSI-H/dMMR • HLA-A*02
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
    over1year
    A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1b/2, N=84, Active, not recruiting, Sumitomo Pharma Oncology, Inc. | Trial completion date: Feb 2024 --> Nov 2022 | Trial primary completion date: Aug 2023 --> Oct 2022
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-B (Major Histocompatibility Complex, Class I, B)
    |
    MSI-H/dMMR • HLA-A*02
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
    over1year
    Mechanism of action of DSP-7888 (adegramotide/nelatimotide) Emulsion, a peptide-based therapeutic cancer vaccine with the potential to turn up the heat on non-immunoreactive tumors. (PubMed, Clin Transl Oncol)
    DSP-7888 Emulsion can promote both cytotoxic and helper T-cell-mediated immune responses against WT1-positive tumors. Adegramotide enhances CTL numbers, and the CTLs induced by treatment with both nelatimotide and adegramotide are capable of functioning within the immunosuppressive tumor microenvironment. The ability of anti-PD-1 to enhance the antitumor activity of DSP-7888 Emulsion in mice implanted with WT1-positive tumors suggests the potential for synergy.
    Journal
    |
    CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • WT1 (WT1 Transcription Factor) • CD4 (CD4 Molecule)
    |
    WT1 expression • WT1 positive
    |
    adegramotide/nelatimotide (DSP-7888)
    2years
    A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1b/2, N=84, Active, not recruiting, Sumitomo Dainippon Pharma Oncology, Inc | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Checkpoint inhibition
    |
    MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A) • HLA-B (Major Histocompatibility Complex, Class I, B)
    |
    MSI-H/dMMR • HLA-A*02
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
    over2years
    WIZARD201G: A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (clinicaltrials.gov)
    P3, N=236, Active, not recruiting, Sumitomo Dainippon Pharma Oncology, Inc | Recruiting --> Active, not recruiting | N=338 --> 236
    Enrollment closed • Enrollment change • Combination therapy
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    HLA-A*02
    |
    Avastin (bevacizumab) • adegramotide/nelatimotide (DSP-7888)
    over2years
    Phase 1/2 Study Evaluating the Safety and Efficacy of DSP-7888 Dosing Emulsion in Myelodysplastic Syndromes. (PubMed, Cancer Sci)
    In the efficacy analysis set, comprising patients with higher-risk MDS after azacitidine failure in the phase 1 and phase 2 parts (n=42), the disease control rate was 19.0%, and median overall survival (OS) was 8.6 (90% CI, 6.8─10.3) months. Median OS was 10.0 (90% CI, 7.6-11.4) months in patients with a WT1-specific immune response (IR) (n=33) versus 4.1 (90% CI, 2.3-8.1) months in those without a WT1-specific IR (n=9) (P=0.0034). The acceptable safety and clinical activity findings observed support the continued development of DSP-7888 dosing emulsion.
    Clinical • P1/2 data • Journal
    |
    WT1 (WT1 Transcription Factor)
    |
    azacitidine • adegramotide/nelatimotide (DSP-7888)
    almost3years
    WIZARD201G: A Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy (clinicaltrials.gov)
    P3, N=338, Recruiting, Sumitomo Dainippon Pharma Oncology, Inc | Active, not recruiting --> Recruiting
    Enrollment open
    |
    MGMT (6-O-methylguanine-DNA methyltransferase) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    Avastin (bevacizumab) • adegramotide/nelatimotide (DSP-7888)
    3years
    Multicenter, Open-Label, Phase I Study of DSP-7888 Dosing Emulsion in Patients with Advanced Malignancies. (PubMed, Target Oncol)
    DSP-7888 Dosing Emulsion was well tolerated, with no dose-limiting toxicities, in patients with recurrent or advanced malignancies. Higher WT1-specific CTL induction activity was noted with ID compared with SC administration; because of this, the ID route was selected for further evaluation in the clinical program.
    Clinical • P1 data • Journal
    |
    WT1 (WT1 Transcription Factor)
    |
    adegramotide/nelatimotide (DSP-7888)
    over3years
    A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1b/2, N=104, Recruiting, Sumitomo Dainippon Pharma Oncology, Inc | Trial completion date: May 2022 --> Feb 2024 | Trial primary completion date: Nov 2021 --> Aug 2023
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
    almost4years
    A Study of DSP-7888 in Pediatric Patients With Relapsed or Refractory High Grade Gliomas (clinicaltrials.gov)
    P1/2, N=18, Completed, Sumitomo Dainippon Pharma Co., Ltd. | Active, not recruiting --> Completed | N=30 --> 18 | Trial completion date: Apr 2020 --> Jan 2020 | Trial primary completion date: Apr 2020 --> Jan 2020
    Clinical • Trial completion • Enrollment change • Trial completion date • Trial primary completion date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • WT1 (WT1 Transcription Factor)
    |
    PD-L1 expression
    |
    adegramotide/nelatimotide (DSP-7888)
    4years
    [VIRTUAL] A phase Ib/II, multicenter, open-label study of DSP-7888 dosing emulsion in combination with immune checkpoint inhibitors (CPI) nivolumab or pembrolizumab in adult patients (pts) with advanced solid tumors, including platinum-resistant ovarian cancer (PROC). (ASCO 2020)
    This study is currently recruiting patients. Research Funding: Boston Biomedical, Inc.
    Clinical • P1/2 data • Combination therapy • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)
    over4years
    A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1b/2, N=84, Recruiting, Boston Biomedical, Inc | Trial completion date: Nov 2020 --> May 2022 | Trial primary completion date: Aug 2020 --> Nov 2021
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
    |
    MSI (Microsatellite instability) • HLA-A (Major Histocompatibility Complex, Class I, A)
    |
    MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • adegramotide/nelatimotide (DSP-7888)