CAMBRIDGE, Mass., May 17, 2018 — Boston Biomedical, Inc., an industry leader in the development of novel cancer therapeutics, today announced that it will feature several studies evaluating investigational compounds napabucasin and DSP-7888 at the upcoming 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from June 1-5.
Napabucasin is currently being investigated in phase 3 studies – CanStem303C for metastatic colorectal cancer (NCT02753127) and CanStem111P for metastatic pancreatic cancer (NCT02993731). Included in the napabucasin studies that will be presented at ASCO are data from a phase 1b/2 trial in patients with metastatic pancreatic cancer (Poster, Bekaii-Saab, 6/3, 8 a.m. – 11:30 a.m.). Boston Biomedical, Inc. will also present detailed findings from the phase 3 BRIGHTER trial evaluating the efficacy and safety of napabucasin plus paclitaxel for pretreated advanced gastric and gastroesophageal junction adenocarcinoma (Poster discussion, Shah, 6/3, 4:45 p.m. – 6 p.m.). Last year, the Company announced that the study was unblinded early after the Data and Safety Monitoring Board (DSMB) determined that the study was unlikely to reach its primary endpoint. No safety concerns were identified by the DSMB. Separately, data with napabucasin in advanced thymoma and thymic carcinoma, rare tumor types, is available as an online publication.
DSP-7888 is being evaluated in several early and mid-stage studies across multiple tumor types. The Company will present the study design of a phase 2 study of DSP-7888 in combination with bevacizumab for recurrent or progressive glioblastoma, WIZARD201G (Poster, de Groot, 6/2, 1:15 p.m. – 4:45 p.m.), which recently began enrolling patients (NCT03149003).
“As our pipeline and clinical development program continues to evolve, we are looking forward to sharing our learnings with the scientific community at the ASCO annual meeting,” said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc.
Abstracts to be presented by Boston Biomedical, Inc. include the following:
|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
June 2, 1:15-4:45 PM
|John Frederick de Groot, University of Texas MD Anderson Cancer Center|
|The BRIGHTER trial: A phase 3 randomized double-blind study of napabucasin (NAPA) plus paclitaxel (PTX) versus placebo (PBO) plus PTX in patients (pts) with pretreated advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma
June 3, 8:00-11:00 AM
June 3, 4:45 – 6:00 PM
Poster Discussion Session
|Manish A. Shah,
Weill Cornell University, New York
|Phase 1b/2 trial of cancer stemness inhibitor napabucasin (NAPA) + nab-paclitaxel (nPTX) and gemcitabine (Gem) in metastatic pancreatic adenocarcinoma (mPDAC)
June 3, 8:00-11:00 AM
|Tanios S. Bekaii-Saab, Mayo Clinic Cancer Center|
|A phase 1b study of napabucasin (NAPA) + weekly paclitaxel (PTX) in patients (pts) with advanced thymoma and thymic carcinoma
Online publication only
|Maitri Kalra, Indiana University
Napabucasin is an orally-administered investigational agent that affects multiple oncogenic cellular pathways, including inhibition of the STAT3 pathway, which has been implicated in viability of cancer cells and cancer cells with stemness phenotypes.
Napabucasin is currently being investigated in CanStem303C, a phase 3 study for metastatic colorectal cancer (NCT02753127) and CanStem111P, a phase 3 study for metastatic pancreatic cancer (NCT02993731). It is also being investigated in earlier phases in multiple solid and hematologic malignancies. In 2016, the U.S. Food and Drug Administration granted Orphan Drug Designation for napabucasin in pancreatic cancer.
About DSP-7888 (ombipepimut-S*)
DSP-7888 is an investigational cancer peptide vaccine containing 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 by adding helper T cell inducing peptides, improved outcomes may be achieved compared to a killer peptide treatment regimen alone.
DSP-7888 is currently being investigated in three Wizard201G 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.
*Adegramotide/nelatimotide is also assigned as its international nonproprietary name (INN).
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 novel cancer therapeutics with the goal of significantly improving patient outcomes. The company’s most advanced research programs are focused on investigational agents that inhibit multiple oncogenic pathways, including cancer stemness pathways, and modifying immune responses. Boston Biomedical is headquartered in Cambridge, Massachusetts, USA.
Additional information about the company and its pipeline can be found at www.BostonBiomedical.com.
Disclaimer Regarding Forward-Looking Statements
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