Boston Biomedical Announces Orphan Drug Designation for Napabucasin in Pancreatic Cancer

CAMBRIDGE, Mass., Nov. 14, 2016 /PRNewswire/ -- Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, 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.

"Receiving another Orphan Drug Designation for napabucasin is an important regulatory milestone achieved by Boston Biomedical and an exciting step towards the clinical advancement of this first-in-class therapy," 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. "Pancreatic cancer has a five year survival rate of 7% and few viable treatment options. This designation represents our determination to address an unmet need and potentially bring a new treatment to those with this difficult-to-treat 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.ⁱ In 2016, it is estimated that over 53,000 people in the U.S. will be diagnosed with pancreatic cancer.ⁱⁱ

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, fifty-seven percent 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.ⁱⁱⁱ

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 their body.^iv,v Evidence suggests that these cells possess resistance to conventional chemotherapy and radiation, so while such treatments can successfully shrink tumors, a population of CSCs may still survive.^v,vi

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 challenge in cancer treatment.

About Napabucasin
Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.^vii

Napabucasin is currently being investigated in three Phase III studies in advanced gastric and GEJ (NCT02178956), colorectal (NCT02753127) and lung cancer (NCT02826161). It is also being investigated in earlier phases in multiple solid and hematologic malignancies, including tumors of the liver, pancreas and brain. 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
[email protected]

ⁱ FDA. "Developing Products for Rare Diseases & Conditions." Accessed on November 11, 2016. Available at: http://www.fda.gov/forindustry/developingproductsforrarediseasesconditions/ucm2005525.htm
ⁱⁱ National Cancer Institute: Surveillance, Epidemiology, and End Results Program. "SEER Stat Fact Sheets: Pancreas Cancer." Accessed on November 4, 2016. Available at: http://seer.cancer.gov/statfacts/html/pancreas.html
ⁱⁱⁱ Boston Biomedical. "A Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) in combination with Gemcitabine and nab-Paclitaxel (nab-PTX) in patients (pts) with metastatic pancreatic cancer." Accessed on November 11, 2016. Available at: http://www.bostonbiomedical.com/wp-content/uploads/Abst4128-BBI608-118-ASCO2016.pdf.
^iv Gupta PB, Chaffer CL, Weinberg RA. Cancer stem cells: mirage or reality? Nat Med. 2009;15(9):1010-1012.
^v Ajani JA, Song S, Hochster HS, Steinberg IB. Cancer stem cells: the promise and the potential. Semin Oncol. 2015;42(suppl 1):S3-S17.
^vi Jordan CT, Guzman ML, Noble M. Cancer stem cells. N Engl J Med. 2006;355(12):1253-1261.
^vii Li Y, Rogoff HA et al. PNAS. 112(6):1839-44, 2015.

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SOURCE Boston Biomedical, Inc.

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