Boston Biomedical Announces Presentations for Investigational First-in-Class Cancer Stemness Inhibitors Napabucasin and Amcasertib in Multiple Tumor Types at ASCO 2017

CAMBRIDGE, Mass., May 18, 2017 /PRNewswire/ — Boston Biomedical, Inc., an industry leader in the development of next-generation cancer therapeutics designed to inhibit cancer stemness pathways, today announced it will feature 11 clinical data poster presentations on investigational compounds evaluating napabucasin and amcasertib in nine different tumor types at the upcoming 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held from June 2-6, in Chicago.

Clinical data results from phase 1 and 2 studies assessing napabucasin – the company’s most advanced orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3 – showed encouraging anti-cancer activity in multiple tumor types, including updated data for advanced ovarian and non-squamous non-small cell lung cancers. For the first time, data in advanced melanoma will be presented. Further, the company will present updated metastatic colorectal cancer (mCRC) and pancreatic cancer data, which support the ongoing napabucasin, phase 3 clinical trials: CanStem303C (mCRC) and CanStem111P (metastatic pancreatic cancer).

In addition, results of a phase 1b/2 study investigating either napabucasin or amcasertib in combination with sorafenib in hepatocellular carcinoma will be presented. Amcasertib is an orally-administered investigational agent designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases, which is currently being investigated in phase 1 and 2 clinical studies.

“We are excited to share new clinical data results for our investigational first-in-class cancer stemness pathway inhibitors – napabucasin and amcasertib – at the 2017 ASCO Annual Meeting,” said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. “These data highlight the depth and potential of our growing clinical development pipeline and reinforce our continued commitment to advancing novel treatment options for cancers with a high unmet need.”

Planned poster sessions include:

Abstract Details

Lead Author

Poster Session

Saturday, June 3 from 8:00 AM – 11:30 AM CDT; Hall A

Abstract #9052, Poster #378: A Phase 1b/2 Study of Napabucasin with Weekly Paclitaxel in Advanced, Previously Treated Non-Squamous Non-Small Cell Lung Cancer

Carlos Becerra, M.D.; U.S. Oncology Research, TOPS Phase I Program

Lung Cancer –
Non-Small Cell
Metastatic

Abstract #TPS3619, Poster #241b: CanStem303: A Phase III Study of Napabucasin (BBI-608) in Combination with 5-Fluorouracil (5-FU), Leucovorin, Irinotecan (FOLFIRI) in Adult Patients with Previously Treated Metastatic Colorectal Cancer (mCRC)

Axel Grothey, M.D.; Mayo Clinic Cancer Center

Gastrointestinal
(Colorectal)
Cancer

Abstract #3529, Poster #152: BBI608-246: A Phase 1b/II Study of Cancer Stemness Inhibitor Napabucasin (BBI-608) in Combination with FOLFIRI +/- Bevacizumab (bev) in Metastatic Colorectal Cancer (mCRC) Patients (pts)

Johanna C. Bendell, M.D.; Sarah Cannon Research Institute and Tennessee Oncology, PLLC

Gastrointestinal
(Colorectal)
Cancer

Abstract #4106, Poster #98: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BBI-608) in Combination with Gemcitabine (gem) and Nab-Paclitaxel (nabPTX) in Metastatic Pancreatic Adenocarcinoma (mPDAC) Patients (pts)

Tanios S. Bekaii-Saab, M.D.; Mayo Clinic Cancer Center

Gastrointestinal
(Noncolorectal)
Cancer

Abstract #4077, Poster #69: BBI608-503-103HCC: A Phase Ib/II Clinical Study of Napabucasin (BBI608) in Combination with Sorafenib or Amcasertib (BBI503) in Combination with Sorafenib(Sor) in Adult Patients with Hepatocellular Carcinoma (HCC)

Bassel F. El-Rayes, M.D.; Winship Cancer Institute

Gynecologic
Cancer

Abstract #TPS4148, Poster #131b: CanStem111P trial: A Phase III Study of Napabucasin (BBI-608) plus Nab-Paclitaxel (nab-PTX) with Gemcitabine (gem) in Adult Patients with Metastatic Pancreatic

Tanios S. Bekaii-Saab, M.D.; Mayo Clinic Cancer Center

Gastrointestinal
(Noncolorectal)
Cancer

Saturday, June 3 from 1:15 PM – 4:45 PM CDT; Hall A

Abstract #5548, Poster #370: A Phase 1b/2 Study of Napabucasin with Weekly Paclitaxel in Advanced, Previously Treated Platinum Resistant Ovarian Cancer

Carlos Becerra, M.D.; U.S. Oncology Research, TOPS Phase I Program

Gynecologic
Cancer

Abstract #9553, Poster #161: A Phase 1b Study of Napabucasin plus Weekly Paclitaxel in Patients with Advanced Melanoma

William Jeffery Edenfield, M.D.; Greenville Health System Cancer Institute

Melanoma/Skin
Cancers

Sunday, June 4 from 8:00 AM – 11:30 AM CDT; Hall A

Abstract #1084, Poster #76: A Phase 2 Study of Napabucasin with Weekly Paclitaxel in Previously Treated Metastatic Breast Cancer

William Jeffery Edenfield, M.D.; Greenville Health System Cancer Institute

Breast Cancer—
Metastatic

Monday, June 5 from 1:15 PM – 4:45 PM CDT; Hall A

Abstract #6032, Poster #20: A Phase 1b/2 Study of Amcasertib, a First-in-Class Cancer Stemness Kinase Inhibitor in Advanced Head & Neck Cancer

Gregory Michael Cote, Ph.D., M.D.; Massachusetts General Hospital

Head and Neck
Cancer

Abstract #6036, Poster #24: A phase 1b/2 study of Amcasertib, a First-in-Class Cancer Stemness Kinase Inhibitor, in Advanced Adenoid Cystic Carcinoma

Gregory Michael Cote; Ph.D., M.D.; Massachusetts General Hospital

Head and Neck
Cancer

About Napabucasin
Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.i Napabucasin is currently being investigated in multiple phase 3 studies, including 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 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.

About Amcasertib
Amcasertib is an orally-administered investigational agent designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases. Boston Biomedical is currently investigating amcasertib in nine phase 1 and 2 clinical trials in solid tumors, hepatobiliary cancer, gastrointestinal stromal tumors, urological malignancies, ovarian cancer and hepatocellular carcinoma.

About Boston Biomedical
Boston Biomedical 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 Li Y, Rogoff HA et al. PNAS. 112(6):1839-44, 2015.