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

As of April 1, 2022 Sumitomo Dainippon Pharma Oncology (SDP Oncology) will be known as Sumitomo Pharma Oncology (SMP Oncology). Moving forward, all new publications and press releases will reflect our updated company name.

CAMBRIDGE, Mass., Dec. 14, 2021 /PRNewswire/ -- Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage biopharmaceutical company focused on research and development for novel cancer therapeutics, today 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. This study evaluated the safety and efficacy of Ombipepimut-S Emulsion (DSP-7888)*, an investigational WT1 immunotherapeutic cancer vaccine, in combination with bevacizumab versus bevacizumab alone in patients with recurrent or progressive glioblastoma (GBM) following initial therapy.

"Patients with recurrent or progressive glioblastoma have a high unmet medical need and we intended to develop a new treatment option for this population," said Patricia S. Andrews, CEO and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "We are disappointed with the results of this Phase 3 trial and would like to express gratitude to the trial's participants, investigators, and staff for their efforts and contributions to the study. SDP Oncology is committed to continuing our pursuit of advancing our pipeline to bring forward innovative treatments for patients with cancer."

The multicenter, open-label, randomized Phase 3 WIZARD 201G study evaluated the efficacy and safety of Ombipepimut-S Emulsion in combination with bevacizumab versus bevacizumab alone at 185 events in the second interim analysis of a pivotal trial with an enrollment planned for 338 patients. Patients were randomized one-to-one in the study. 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.

The study of Ombipepimut-S Emulsion in combination with checkpoint inhibitors in solid tumors with an expansion arm in platinum-resistant ovarian cancer (NCT03311334) will continue as planned.

*Adegramotide/nelatimotide is assigned as the international nonproprietary name (INN).

About Ombipepimut-S Emulsion (DSP-7888)

Ombipepimut-S Emulsion (DSP-7888) is an investigational WT1 immunotherapeutic cancer vaccine containing two peptides that induce WT1-specific cytotoxic T-lymphocytes (WT1-CTL) and helper T-cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that adding a peptide to induce helper T cells may improve outcomes compared to a treatment regimen based on a killer peptide alone.1

Ombipepimut-S Emulsion is in a Phase 1/2 study (estimated enrollment number of patients: 84; NCT03311334) in the United States in combination with nivolumab or pembrolizumab in patients with advanced solid tumors with a Phase 2 expansion arm in platinum-resistant ovarian cancer in combination with pembrolizumab. In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for Ombipepimut-S Emulsion in brain cancer and in myelodysplastic syndrome (MDS).

About Glioblastoma

Glioblastoma multiforme (GBM) is the most aggressive form of primary brain cancer.2 In 2018, approximately 11,000 men and women in the U.S. were diagnosed with GBM.3 GBM is a highly infiltrative form of cancer and is not surgically curable, which leads to a high recurrence rate and poor prognosis. The overall 5-year survival rate is approximately 5.7%.3 Treatment barriers to GBM include its ability to create an immunosuppressive tumor microenvironment (TME) that is further protected by the confines of the blood-brain-barrier.4

About Sumitomo Dainippon Pharma Oncology

Sumitomo Dainippon Pharma Oncology, Inc., is a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. As a global oncology organization with teams in the U.S. and Japan, SDP Oncology is relentlessly committed to advancing purposeful science by transforming new discoveries into meaningful treatments for patients with cancer. SDP Oncology's robust and diverse pipeline of preclinical and advanced-stage assets spans multiple areas, including oncogenic pathways, survival mechanisms and novel protein interactions, which aim to address unmet clinical needs in oncology.

For more information, visit www.sdponcology.com.

About Sumitomo Dainippon Pharma

Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China and other Asian countries. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at www.ds-pharma.com.

Disclaimer Regarding Forward-Looking Statements

This press release contains "forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. The forward-looking statements in this press release are based on management's assumptions and beliefs in light of information presently available and involve both known and unknown risks and uncertainties. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

References

1. Goto M, Nakamura M, Suginobe N, et al. DSP-7888, a novel cocktail design of WT1 peptide vaccine, and its combinational immunotherapy with immune checkpoint-blocking antibody against PD-1. Blood. 2016;128(22):4715.

2. Seyed-Mostafa Razavi, Karen E Lee, et al. Immune evasion strategies of glioblastoma. Frontiers in Surgery. 2016;10.3389/fsurg.2016.00011

3. Software: Surveillance Research Program, National Cancer Institute SEER*Stat software (www.seer.cancer.gov/seerstat) version 8.3.9. Data: Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER Research Data, 18 Registries, Nov 2020 Sub (2000-2018) - Linked To County Attributes - Time Dependent (1990-2018) Income/Rurality, 1969-2019 Counties, National Cancer Institute, DCCPS, Surveillance Research Program, released April 2021, based on the November 2020 submission.

4. Woroniecka K, Chongsathidkiet P, Rhodin K, et al. T-Cell exhaustion signatures vary with tumor type and are severe in glioblastoma. Clinical Cancer Research. 2018;10.1158/1078-0432.CCR-17-1846

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