adegramotide/nelatimotide (DSP-7888) / Sumitomo Pharma - LARVOL DELTA

Phase 1/2 clinical trial of Ombipepimut-S in Japanese pediatric patients with recurrent/refractory diffuse intrinsic pontine glioma, Glioblastoma, or high-grade glioma (ISPNO 2024) - "Ombipepimut-S exhibited antitumor activity, and this cancer immunotherapy appeared to be preferably initiated when the patient's immunity is relatively preserved immediately after the completion of standard therapy for primary disease or before the tumor recurs or relapses."

Clinical • P1/2 data • Brain Cancer • CNS Tumor • Diffuse Intrinsic Pontine Glioma • Glioblastoma • Glioma • Nephrology • Oncology • Pediatrics • Solid Tumor • Wilms Tumor • WT1

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 | Sponsor: Sumitomo Pharma America, Inc. | Phase classification: P1b/2 ➔ P1/2 | Completed ➔ Terminated; Sponsor's decision to terminate development of the program.

Checkpoint inhibition • Combination therapy • Metastases • Phase classification • Trial termination • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • HLA-A • HLA-B • MSI

Ombipepimut dosing emulsion (ODE) + bevacizumab (bev) vs bev alone in patients (pts) with recurrent or progressive glioblastoma (rGBM). (ASCO 2023) - P3 | "The data in pts with KPS 60 or 70 suggested benefit with ODE + bev that was consistent across different endpoints and that warrants further validation. Clinical trial information: NCT03149003. >Progression free survival: PFS; overall response rate: ORR; disease control rate: DCR using mRANO by central review."

Clinical • Brain Cancer • CNS Tumor • Glioblastoma • Nephrology • Oncology • Solid Tumor • Wilms Tumor • IDH1 • WT1

PHASE 1/2 STUDY OF DSP-7888 IN PEDIATRIC PATIENTS WITH MALIGNANT GLIOMA (SNO 2018) - ": DSP-7888 is well tolerated at 3.5 mg/body for pts with pediatric malignant glioma. Survival results in DIPG pts exceeded in comparison with historical controls. Moreover, some GBM pts shows encouraging sign of long survival."

Clinical • P1/2 data • Brain Cancer • Oncology • Solid Tumor

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 | Sponsor: Sumitomo Pharma Oncology, Inc. | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • HLA-A • MGMT

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 | Sponsor: Sumitomo Pharma Oncology, Inc. | Active, not recruiting ➔ Completed | N=84 ➔ 47

Checkpoint inhibition • Combination therapy • Enrollment change • Trial completion • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • HLA-A • HLA-B • MSI

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 | Sponsor: Sumitomo Pharma Oncology, Inc. | Trial completion date: Feb 2024 ➔ Nov 2022 | Trial primary completion date: Aug 2023 ➔ Oct 2022

Checkpoint inhibition • Combination therapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • HLA-A • HLA-B • MSI

Preliminary safety and efficacy of DSP-7888 plus nivolumab (NIV) or pembrolizumab (PEM) in patients (pts) with advanced solid tumors (ASTs): A phase (Ph) 1b/2 open-label study (AACR 2022) - P1b/2 | "DSP-7888 + NIV or PEM was generally tolerable at 10.5 mg ID (most common TEAE was ISR) and showed evidence of preliminary antitumor activity. An expansion cohort in ovarian cancer is enrolling.Table. Safety and Efficacy (N=13a) >"

Clinical • P1/2 data • Oncology • Ovarian Cancer • Solid Tumor • Wilms Tumor • WT1

[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) - P1b/2 | "This study is currently recruiting patients. Research Funding: Boston Biomedical, Inc."

Checkpoint inhibition • Clinical • Combination therapy • IO biomarker • P1/2 data • Gynecologic Cancers • Immune Modulation • Inflammation • Oncology • Ovarian Cancer • Solid Tumor • PD-L1

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 • Hematological Disorders • Hematological Malignancies • Immune Modulation • Inflammation • Oncology • Solid Tumor • Wilms Tumor • CD4 • CD8 • IFNG • WT1

Sumitomo Pharma Oncology Presents New Data from Investigational Pipeline of Novel Cancer Therapeutics at AACR Annual Meeting 2022 (PRNewswire) - "Sumitomo Pharma Oncology, Inc...announced it will present new clinical and preclinical data on a range of investigational agents from the company's pipeline at the American Association for Cancer Research (AACR) Annual Meeting, held April 8-13, 2022, in New Orleans, LA. The data that will be presented at the meeting includes Phase 1 clinical data evaluating the potential anti-cancer activity of the cyclin dependent kinase 9 (CDK9) inhibitor oral TP-1287, the WT1 immunotherapeutic cancer vaccine DSP-7888 plus nivolumab (NIV) or pembrolizumab (PEM), and the activin receptor-like kinase-2 (ALK2) inhibitor oral TP-0184."

P1 data • P1/2 data • Preclinical • Oncology • Solid Tumor

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 | Sponsor: Sumitomo Dainippon Pharma Oncology, Inc | Recruiting ➔ Active, not recruiting

Checkpoint inhibition • Combination therapy • Enrollment closed • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • HLA-A • HLA-B • MSI

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 | Sponsor: Sumitomo Dainippon Pharma Oncology, Inc | Recruiting ➔ Active, not recruiting | N=338 ➔ 236

Combination therapy • Enrollment change • Enrollment closed • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • HLA-A • MGMT

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 • Journal • P1/2 data • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Myelodysplastic Syndrome • Neutropenia • Oncology • Solid Tumor • Wilms Tumor • WT1

Sumitomo Dainippon Pharma Oncology Provides Update on Phase 3 WIZARD 201G Study of Ombipepimut-S Emulsion (DSP-7888) in Patients with Recurrent or Progressive Glioblastoma (PRNewswire) - P3, N=338; WIZARD 201G (NCT03149003); Sponsor: Sumitomo Dainippon Pharma Oncology, Inc; "Sumitomo Dainippon Pharma Oncology...announced that the Phase 3 WIZARD 201G study will terminate following its second interim analysis after determining there is a low probability of meeting the primary endpoint of overall survival at the final analysis....The study's primary endpoint was overall survival with an adaptive design and two planned interim analyses. The overall safety profile was generally tolerable. The most common adverse events occurring in patients in the Ombipepimut-S Emulsion in combination with bevacizumab arm were injection site reactions, hypertension, headache and fatigue. Final data and analyses of this study will be published for the oncology community."

P3 data • Trial termination • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

[VIRTUAL] RESULTS FROM A RANDOMIZED TRIAL OF DSP-7888, A NOVEL WT1 PEPTIDE-BASED VACCINE, MAINTENANCE THERAPY IN PATIENTS WITH RHABDOMYOSARCOMA (RMS) AND NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMA (NRSTS) (SIOP 2021) - "In our study, DSP-7888 peptide vaccine as maintenance therapy for RMS/NRSTS patients in remission showed increased EFS and was well tolerated. A clinical trial with larger sample size is needed to validate these results."

Clinical • Late-breaking abstract • Immunology • Oncology • Rhabdomyosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Multicenter, open-label, phase 1 study of DSP-7888 Dosing Emulsion (DSP-7888) in patients with advanced malignancies (SITC 2019) - P1, P1/2; "DSP-7888 was well tolerated, with no DLTs, in patients with advanced malignancies, supporting further evaluation of DSP-7888. The 10.5 mg ID dose was identified as a dose level and route of administration for further evaluation."

Clinical • P1 data

PHASE 1/2 STUDY OF DSP-7888 IN PATIENTS WITH HIGHER-RISK (HR) MYELODYSPLASTIC SYNDROMES (MDS) AFTER FAILURE OF AZACITIDINE (AZA) THERAPY (EHA 2019) - P1/2; "Of the 42 patients, 37 were evaluable for WT1 reactive immune response and the results are shown in the Table.Conclusion DSP-7888 was tolerable and showed signs of clinical activity in patients with HR-MDS; those who had a positive immune response showed a significantly longer OS than those who were negative. Identifying the optimal population for treatment with DSP-7888 is important for further investigations."

Clinical • P1/2 data • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Renal Cell Carcinoma

A randomized, multicenter phase 2 study of DSP-7888 dosing emulsion in combination with bevacizumab (Bev) versus Bev alone in patients with recurrent or progressive glioblastoma. (ASCO 2018) - P2; "In part 2, new patients are randomized to one of the 2 treatment arms. Treatment continues in the absence of clear progression, clinical neurologic deterioration, or until 150 deaths have occurred."

Clinical • Combination therapy • P2 data • Renal Cell Carcinoma

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; Sponsor: Sumitomo Dainippon Pharma Oncology, Inc; Active, not recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • HLA-A • MGMT

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; Active, not recruiting; Sponsor: Sumitomo Dainippon Pharma Oncology, Inc; Phase classification: P2 ➔ P3; N=219 ➔ 338; Trial completion date: Jan 2021 ➔ Nov 2023; Trial primary completion date: Oct 2020 ➔ Sep 2022

Clinical • Combination therapy • Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Multicenter, Open-Label, Phase I Study of DSP-7888 Dosing Emulsion in Patients with Advanced Malignancies. (PubMed, Target Oncol) - P1 | "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 • Journal • P1 data • Oncology • Solid Tumor • Wilms Tumor • WT1

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; Sponsor: Sumitomo Dainippon Pharma Oncology, Inc; Trial completion date: May 2022 ➔ Feb 2024; Trial primary completion date: Nov 2021 ➔ Aug 2023

Checkpoint inhibition • Clinical • Combination therapy • Trial completion date • Trial primary completion date • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Fallopian Tube Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Immune Modulation • Inflammation • Lung Cancer • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • MSI

Sumitomo Dainippon Pharma Oncology Announces First Patient Dosed in Phase 2 Dose-Expansion Portion of Study Evaluating Investigational WT1 Immunotherapeutic Cancer Vaccine DSP-7888 (ombipepimut-S) in Patients with Ovarian Cancer (PRNewswire) - "Sumitomo Dainippon Pharma Oncology...announced the first patient has been dosed in the Phase 2 expansion portion of the study evaluating DSP-7888, an investigational immunotherapeutic cancer vaccine that targets Wilms Tumor 1 (WT1), in combination with checkpoint inhibitor pembrolizumab, in patients with platinum-resistant ovarian cancer (PROC). The Phase 1b/2 open-label, multicenter study consists of two parts. The Phase 1b portion evaluated the safety and tolerability of the combination of DSP-7888 with a PD-1 checkpoint inhibitor in adult patients with solid tumors. Based on the known high prevalence of WT1 in ovarian cancer and the findings from the Phase 1b portion of this study, the Phase 2 part will evaluate the antitumor activity of DSP-7888 in combination with pembrolizumab in patients with PROC."

Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer

Investigator-initiated Clinical Trial (Phase II) of Cancer Vaccine "DSP-7888" for Acute Myeloid Leukemia Patients. (clinicaltrials.gov) - P2; N=100; Recruiting; Sponsor: Osaka University

Clinical • New P2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology