Boston Biomedical, Inc. today announced the presentation of new data from a phase 1 study evaluating DSP-7888, an investigational WT1 cancer peptide vaccine, in patients with advanced malignancies.
CAMBRIDGE, Mass., Nov. 8, 2019 /PRNewswire/ -- Boston Biomedical Inc. today announced the presentation of new data from a phase 1 study evaluating DSP-7888, an investigational WT1 cancer peptide vaccine, in patients with advanced malignancies. Findings from the phase 1 study investigating the safety, tolerability, and determination of the recommended phase 2 dose of DSP-7888 in patients with recurrent or progressive advanced malignancies will be presented in a poster presentation at the Society for Immunotherapy of Cancer's (SITC) 34th Annual Meeting, held in National Harbor, Maryland, on November 6-10, 2019. Patients enrolled in the study have progressed on standard therapy, were intolerant to standard therapy, or were patients for whom no standard therapy existed for their cancer. "The data presented at the SITC Annual Meeting demonstrate our unwavering commitment to advancing a pipeline of novel cancer therapeutics to address unmet patient needs," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. "We are excited to share more about the progress of our pipeline, including DSP-7888, with the scientific community." Findings from the multicenter, open-label, dose-escalation study showed that DSP-7888 was well tolerated, with no dose-limiting toxicities identified in patients with advanced malignancies. In this study, 24 patients received escalating doses of intradermal (n=10) or subcutaneous (n=14) DSP-7888. Of the 24 patients, four had stable disease and 21 patients were evaluable for WT1-specific cytotoxic T-lymphocyte (CTL) detection. In the evaluable population, WT1-specific CTL induction was observed in six of nine intradermal patients (66.7%) and five of 12 subcutaneous patients (41.7%). An intradermal dose of 10.5 mg was determined as the recommended phase 2 dose, consistent with the findings of a separate phase 1/2 study of DSP-7888 in patients with myelodysplastic syndrome. The most frequently observed adverse event was Grade 1 or 2 injection site reaction.1 "We believe the WT1 antigen is a promising target for immunotherapy, as it is expressed across a range of cancer types and plays a key role in the proliferation, differentiation and apoptotic process of cells," said Alexander Spira, MD, PhD, FACP, lead author, and Director of Virginia Cancer Specialists Research Institute. "The findings from this study support the continuation of evaluating DSP-7888 in advanced cancers." The company will also present background information on an ongoing phase 1/2 clinical study evaluating DSP-0509, an investigational toll-like receptor (TLR) 7 agonist, for the treatment of solid tumors. Below are the details for the Boston Biomedical presentations:
About DSP-7888 (ombipepimut-S*) DSP-7888 is currently being investigated in combination with bevacizumab in a phase 2 trial in patients with recurrent or progressive glioblastoma (NCT03149003) and in a phase 1/2 trial in combination with nivolumab or pembrolizumab in patients with advanced solid tumors (NCT03311334). DSP-7888 is currently being investigated in two monotherapy studies: a phase 1/2 trial in myelodysplastic syndrome (MDS) (NCT02436252) and a phase 1/2 trial in pediatric patients with relapsed or refractory high grade gliomas (NCT02750891). In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for DSP-7888 in MDS and brain cancer. *Adegramotide/nelatimotide is also assigned as the international nonproprietary name (INN). About DSP-0509 About Boston Biomedical, Inc. Headquartered in Cambridge, Massachusetts, Boston Biomedical, Inc. is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan. Boston Biomedical works closely with its parent company, Sumitomo Dainippon Pharma, and Tolero Pharmaceuticals, also a wholly owned subsidiary, to expedite the discovery, development and commercialization of novel treatment options. Additional information about the company and its pipeline can be found at www.BostonBiomedical.com. Disclaimer Regarding Forward-Looking Statements References: SOURCE Boston Biomedical, Inc. |