On October 21, 2021 Sumitomo Dainippon Pharma Oncology, Inc., a clinical-stage company focused on research and development for novel cancer therapeutics, reported the first patient has been dosed in a Phase 1 study evaluating its investigational agent DSP-0390, an emopamil-binding protein (EBP) inhibitor, for the treatment of patients with recurrent high-grade glioma (Press release, Sumitomo Dainippon Pharma, OCT 21, 2021, View Source [SID1234591740]).
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High grade gliomas are the most common type of malignant brain tumor and cause significant morbidity and mortality.1 Preclinical studies have shown DSP-0390 may have anti-tumor activity that may help address this persistent unmet medical need.
"Dosing the first patient in this study represents another important milestone for SDP Oncology and broadens our fight against brain tumors along with our investigational agent WT1 immunotherapeutic cancer vaccine," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "We look forward to generating data to guide the development of DSP-0390 with the goal of developing meaningful treatments for patients with brain cancer."
The primary objective of the first-in-human, open-label, dose-escalation study is to assess the safety and tolerability of DSP-0390 in patients with recurrent high-grade glioma. The trial will also determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE). The secondary objective is to characterize the pharmacokinetic (PK) profile of DSP-0390.
Following the completion of the dose-escalation portion of the trial, the study will move into a Part 2 expansion to evaluate whether there is preliminary antitumor activity of DSP-0390 and establish the recommended Phase 2 dose (RP2D) in recurrent World Health Organization (WHO) Grade III or IV malignant glioma.
The trial is being conducted in the United States and Japan. Additional information, including comprehensive inclusion and exclusion criteria, can be accessed at www.ClinicalTrials.gov (NCT05023551).
About DSP-0390
DSP-0390 is an emopamil-binding protein (EBP) inhibitor, that is currently being investigated in a Phase 1 study in patients with recurrent high-grade glioma (NCT05023551). EBP is an endoplasmic reticulum membrane protein involved in cholesterol biosynthesis.2 Since most cancer cells are characterized by an upregulation of the various pathways responsible for their biosynthesis and the demand for cholesterol to support cell proliferation is high,3,4,5 the inhibition of EBP by DSP-0390 therefore is expected to lead to disruption of cholesterol homeostasis and induce cell death in cancer cells.6,7 Moreover, as EBP is reported to be highly expressed in several types of cancer and correlates with an aggressive phenotype of certain types of cancers, DSP-0390 has the potential to have anti-tumor activity in these cancers.8,9