Boston Biomedical Initiates CanStem111P: A Global Phase 3 Study Investigating Cancer Stemness Inhibitor Napabucasin in Patients With Metastatic Pancreatic Cancer

CAMBRIDGE, Mass., Feb. 21, 2017 /PRNewswire/ — Boston Biomedical, an industry leader in the development of next-generation cancer therapeutics designed to inhibit cancer stemness pathways, 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 percent 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.i,ii

“We look forward to continuing the study of napabucasin in combination with standard of care therapy in metastatic pancreatic cancer patients, which has demonstrated encouraging anti-tumor activity in earlier clinical trials,” said Chiang J. Li, M.D. FACP, President, CEO and Chief Medical Officer of Boston Biomedical, and the Head of Global Oncology for Sumitomo Dainippon Pharma Group. “Through this study, we are committed to gathering a deeper understanding of napabucasin’s therapeutic benefits and the potential of cancer stemness inhibitors for treating this devastating disease.”

Patients in CanStem111P will be randomized in a 1:1 ratio to receive either two daily doses of 240 mg napabucasin in combination with nab-paclitaxel plus gemcitabine once weekly on three of every four weeks, or only nab-paclitaxel plus gemcitabine once weekly on three of every four weeks.

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.

Further information about the study is available at www.ClinicalTrials.gov (NCT02993731).

About Cancer Stem Cells
Cancer stem cells (CSCs) possess the property of stemness – the ability to self-renew and differentiate into heterogeneous cancer cells. This allows the CSCs to act like seeds, causing a patient’s cancer to relapse or spread within the body.iii,iv Evidence suggests that these cells possess resistance to chemotherapy, radiation and targeted therapy as well as immunotherapies, so while such treatments can successfully shrink tumors, a population of CSCs may still survive.iv,v

Boston Biomedical is leading the biopharmaceutical industry in the development of novel compounds designed to target cancer stemness pathways, with the goal of addressing ongoing challenges in cancer treatment.

About Napabucasin
Napabucasin is an orally-administered, first-in-class, investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.vi

Napabucasin is currently being investigated in three phase 3 studies in advanced gastric and gastroesophageal junction (GEJ) (NCT02178956), colorectal (NCT02753127), and pancreatic cancer (NCT02993731). It is also being investigated in earlier phases in multiple solid and hematologic malignancies, including tumors of the lung, liver, pancreas and brain. In 2016, the U.S. Food and Drug Administration granted Orphan Drug Designation for napabucasin in gastric/GEJ and pancreatic cancer.

More information on napabucasin and ongoing clinical trials can be found at www.BostonBiomedical.com.

About Boston Biomedical
Boston Biomedical, Inc. (Founder, President, CEO and CMO: Chiang J. Li, M.D. FACP) was founded in November 2006 and is wholly owned by Sumitomo Dainippon Pharma Co., Ltd. Boston Biomedical’s mission is to develop the next generation of cancer therapeutics by creating drugs designed to target cancer stemness pathways. Boston Biomedical’s innovation in drug discovery has received a number of recognitions and awards in the United States, including the Frost & Sullivan 2010 North American Drug Discovery Technology Innovation of the Year Award, the National Cancer Institute (NCI) 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.

Additional information about the company and its product pipeline can be found at www.BostonBiomedical.com.

Disclaimer Regarding Forward-Looking Statements
The forward-looking statements in this press release are based on management’s assumptions and beliefs in light of information presently available, and involve both known and unknown risks and uncertainties. Any forward looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

For general inquiries:
Boston Biomedical
617-674-6800

For media inquiries:
Sara Baker
CHAMBERLAIN PR
212- 849-9474
sara.baker@inventivhealth.com

i About Pancreatic Cancer. World Pancreatic Cancer Day. http://www.worldpancreaticcancerday.org/about/ .Accessed February 7, 2017
ii World Cancer Research Fund International. Pancreatic Cancer Statistics. http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/pancreatic-cancer-statistics. Accessed February 8, 2017.
iii Gupta PB, Chaffer CL, Weinberg RA. Cancer stem cells: mirage or reality? Nat Med. 2009;15(9):1010-1012.
iv Ajani JA, Song S, Hochster HS, Steinberg IB. Cancer stem cells: the promise and the potential. Semin Oncol. 2015;42(suppl 1):S3-S17.
v Jordan CT, Guzman ML, Noble M. Cancer stem cells. N Engl J Med. 2006;355(12):1253-1261.
vi Li Y, Rogoff HA et al. PNAS. 112(6):1839-44, 2015.