February 27, 2017 4:44 AM ET

Biotechnology

Company Overview of Boston Biomedical, Inc.

Company Overview

Boston Biomedical, Inc. focuses on the research and development of cancer therapeutics. Its product pipeline comprises BBI608 is an orally-administered investigational agent designed to inhibit cancer stem cell pathways by targeting STAT3; and BBI503, an orally-administered investigational agent designed to inhibit Nanog and other cancer stem cell pathways by targeting kinases. The company was founded in 2006 and is based in Cambridge, Massachusetts. As of April 24, 2012, Boston Biomedical, Inc. operates as a subsidiary of Sumitomo Dainippon Pharma Co., Ltd.

640 Memorial Drive

Cambridge, MA 02139

United States

Founded in 2006

Phone:

617-674-6800

Fax:

617-674-8661

Key Executives for Boston Biomedical, Inc.

Founder, Chief Executive Officer, President and Chief Medical Officer
Age: 51
Chief Commercial Officer and Executive Vice President
Age: 57
Vice President of Product Development & Business Affairs
Compensation as of Fiscal Year 2016.

Boston Biomedical, Inc. Key Developments

Boston Biomedical Initiates Dosing of the First Patient in A New Global Phase 3 Study, CanStem111P

Boston Biomedical has initiated dosing of the first patient in a new global phase 3 study, CanStem111P. The study will investigate napabucasin an orally administered, first-in-class, investigational agent designed to inhibit cancer stemness pathways by targeting STAT3 in combination with standard of care (nab-paclitaxel plus gemcitabine) in patients with metastatic pancreatic cancer. Pancreatic cancer is the seventh leading cause of cancer-related deaths, with only up to 10% of people diagnosed surviving five years.i Approximately 330,000 people are diagnosed with pancreatic cancer worldwide each year and that number is expected to rise to 418,000 by 2020. A total of 1,132 patients with metastatic pancreatic cancer who have not been previously treated with systemic chemotherapy or investigational agents will be enrolled in the study. The primary endpoint of the study is overall survival. Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), safety and quality of life. Overall survival, PFS, ORR and DCR analyses will be conducted in the general study population as well as in biomarker-positive patients.

Boston Biomedical Presents Clinical Data on First-in-Class Cancer Stemness Inhibitor Napabucasin at 2017 ASCO GI Symposium

Boston Biomedical presented data from two clinical studies for its lead investigational compound, napabucasin, at the 2017 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco. In a Phase Ib/II study of napabucasin – an orally administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3 – colorectal cancer (CRC) patients who were FOLFIRI-naïve and those previously treated with FOLFIRI showed signs of anti-cancer activity when napabucasin was administered in combination with FOLFIRI with and without bevacizumab. Additionally, these findings demonstrated synergistic activity of napabucasin plus FOLFIRI with and without bevacizumab in patients previously treated with FOLFIRI, regardless of p-STAT3 status. Further, these data suggest napabucasin may re-sensitize chemorefractory CRC patients, including those who were previously unresponsive to FOLFIRI-based chemotherapy treatment, to treatment with FOLFIRI with and without bevacizumab. Phase II data from a second study on napabucasin's ability to be combined with panitumumab, demonstrated encouraging anti-cancer activity in patients with K-ras wild-type metastatic colorectal cancer (mCRC), regardless of prior anti-EGFR treatment. These findings suggest napabucasin may sensitize patients to retreatment with anti-EGFR antibody therapy.

Boston Biomedical Announces Orphan Drug Designation for Napabucasin in Pancreatic Cancer

Boston Biomedical announced that its lead investigational compound, napabucasin, has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in the treatment of pancreatic cancer. This is the second Orphan Drug Designation for napabucasin, an orally administered agent designed to inhibit cancer stemness pathways by targeting STAT3; the first designation was for gastric cancer including gastroesophageal junction (GEJ) cancer. The FDA's Orphan Drug Designation program provides special status and development incentives for drugs and biologics which are intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. In 2016, it is estimated that over 53,000 people in the U.S. will be diagnosed with pancreatic cancer. Phase Ib data for napabucasin in metastatic pancreatic cancer (NCT02231723) were previously presented at the American Society of Clinical Oncology 2016 annual meeting. These data showed that napabucasin may be combined with gemcitabine and nab-PTX and showed signs of anti-tumor activity in patients with metastatic pancreatic cancer. Of the 37 patients enrolled in the study, 57% of patients (17 of 30 evaluable patients) had prolonged disease control (=24 weeks).iii Common adverse events (AEs) identified in this clinical trial were grade 1 diarrhea, nausea, fatigue and neuropathy, which were reversible and manageable with symptom medications.

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