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DRUG:

adegramotide/nelatimotide (DSP-7888)

i
Other names: DSP-7888, DSP 7888, WT1 protein-derived peptide vaccine
Associations
Company:
Sumitomo Pharma
Drug class:
Wilms tumor 1 inhibitor
Associations
7ms
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)
almost2years
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)
almost2years
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)
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 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)
2years
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)
over2years
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)
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=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)
almost3years
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
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WT1 (WT1 Transcription Factor)
|
azacitidine • adegramotide/nelatimotide (DSP-7888)
over3years
Enrollment open
|
MGMT (6-O-methylguanine-DNA methyltransferase) • HLA-A (Major Histocompatibility Complex, Class I, A)
|
Avastin (bevacizumab) • adegramotide/nelatimotide (DSP-7888)
over3years
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)
4years
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)
over4years
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)
over4years
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)
almost5years
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)