Boston Biomedical Inc. Initiates Two Studies Evaluating WT1 Cancer Peptide Vaccine DSP-7888 (ombipepimut-S*)

CAMBRIDGE, MA, USA I April 25, 2018 I Boston Biomedical, Inc., an industry leader in the development of next-generation cancer therapeutics, today announced that it has initiated dosing of the first patient in each of two clinical studies evaluating DSP-7888, an investigational cancer peptide vaccine. One study is in combination with checkpoint inhibitors for multiple tumor types, and the other is in combination with bevacizumab in glioblastoma. DSP-7888 is hypothesized to induce Wilms' tumor gene 1 (WT1)-specific cytotoxic T lymphocytes (CTL) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic cancers and solid tumors. WT1 has been a focus of cancer vaccine researchers since the National Cancer Institute ranked it as the number one priority target for cancer immunotherapy.1

"Despite significant advances in cancer treatment, there remains a need for new, effective treatment options for many patients," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. "We are exploring the potential of DSP-7888 to elicit an anti-tumor response in a number of high unmet need tumor types."

The multicenter, open-label, phase 1b study of DSP-7888 in combination with checkpoint inhibitors, known as WIZARD101CI, is targeted to enroll approximately 84 patients who will receive either DSP-7888 in combination with nivolumab or in combination with atezolizumab. The primary endpoints of the study are determination of safety, tolerability, and recommended phase 2 dose. Secondary endpoints include duration of response, disease control rate, progression-free survival (PFS) at six months, median PFS, survival at 12 months and overall survival (OS). This study will be conducted in patients with advanced solid tumors including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, renal cell carcinoma, and urothelial cancer. Further information about this study is available at www.ClinicalTrials.gov (NCT03311334).

The multicenter, global phase 2 study of DSP-7888 in combination with bevacizumab in glioblastoma, known as WIZARD201G, is targeted to enroll approximately 200 patients with recurrent or progressive glioblastoma following treatment with first-line therapy consisting of surgery and radiation with or without chemotherapy. Patients will receive either DSP-7888 in combination with bevacizumab or bevacizumab alone. The primary endpoint of the study is OS, with secondary endpoints including survival at 12 months, PFS at six months, median PFS, response rate (complete response + partial response), duration of response, and adverse event profile. Further information about this study is available at www.ClinicalTrials.gov (NCT03149003).

DSP-7888 is also being investigated in early phase studies in patients with pediatric high grade gliomas, myelodysplastic syndrome, and other malignant tumors. In 2017, the U.S. Food and Drug Administration granted DSP-7888 Orphan Drug Designation in myelodysplastic syndrome and brain cancer.

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

About DSP-7888
DSP-7888 is an investigational cancer peptide vaccine containing peptides that induce WT1-specific CTL and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that by adding helper T cell inducing peptides, improved outcomes may be achieved compared to a killer peptide treatment regimen alone.2

DSP-7888 is currently being investigated in three monotherapy studies: a phase 1/2 study in myelodysplastic syndrome (MDS) (NCT02436252), a phase 1/2 study in pediatric patients with relapsed or refractory high grade gliomas (NCT02750891), and a phase 1 study in advanced malignancies (NCT02498665). DSP-7888 is currently being investigated in combination with bevacizumab in a phase 2 study in patients with recurrent or progressive glioblastoma (NCT03149003), and in a phase 1 study in combination with nivolumab or atezolizumab in patients with advanced solid tumors (NCT03311334). In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for DSP-7888 in MDS and brain cancer. More information on DSP-7888 and ongoing clinical studies can be found at www.BostonBiomedical.com.

About Boston Biomedical, Inc.
Boston Biomedical, Inc. was founded in November, 2006 and is wholly owned by Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan. Boston Biomedical is a leading developer of next-generation cancer therapeutics designed to inhibit cancer stemness pathways and modify immune responses. Boston Biomedical's innovation in drug discovery has received a number of recognitions and awards in the U.S., including the Frost & Sullivan 2010 North American Drug Discovery Technology Innovation of the Year Award, the National Cancer Institute cancer stem cell initiative grant award in 2010, and the 2011 Biotech Pioneer Award at the Alexandria Oncology Summit. The company also received the "Company To Watch" award in the 10th Annual Team Massachusetts Economic Impact Awards in 2013. Boston Biomedical is headquartered in Cambridge, Massachusetts, USA.

1 Cheever, M., Allison, J.P., Ferris, A.S., Finn, O.J., Hastings, B.M., Hecht, T.T. (2009) The Prioritization of Cancer Antigens: A National Cancer Institute Pilot Project for the Acceleration of Translational Research. Clinical Cancer Research. http://clincancerres.aacrjournals.org/content/15/17/5323.full-text.pdf. Accessed April 2018.
2 Goto, M., Nakamura, M., Suginobe, N., Takasu, H., Takanashi, Y., Ban, H. and Li, C. (2016) DSP-7888, a Novel Cocktail Design of WT1 Peptide Vaccine, and Its Combinational Immunotherapy with Immune Checkpoint-Blocking Antibody Against PD-1.  Blood. http://www.bloodjournal.org/content/128/22/4715. Accessed April 2018.

SOURCE: Boston Biomedical

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