Boston Biomedical Announces Clinical Data on First-in-Class Investigational Cancer Stem Cell Pathway Inhibitors Napabucasin and Amcasertib in Multiple Cancer Types at ASCO 2016

CAMBRIDGE, Mass., May 18, 2016 /PRNewswire/ -- Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stem cell (CSC) pathways, will feature clinical data on investigational compounds napabucasin (BBI-608) and amcasertib (BBI-503) in multiple tumor types at the 2016 American Society of Clinical Oncology annual meeting, held from June 3 to June 7, in Chicago.

Data to be exhibited underscore the potential of napabucasin – an orally administered investigational cancer stemness inhibitor designed to inhibit CSC pathways by targeting STAT3 – to enhance anti-cancer activity when used in combination with other chemotherapeutics.ⁱ Data will be shared across multiple tumor types, including the company's first results in ovarian, lung and breast cancers. Updated data in colorectal and pancreatic cancers from ongoing phase Ib extension studies will also be provided.

Also the first data in head and neck cancer from an ongoing phase I extension study of amcasertib – an orally administered investigational agent designed to inhibit cancer stem cell pathways, including Nanog, by targeting stemness kinases – will be shared at the meeting, both in poster format as well as in a poster discussion session.

"Boston Biomedical is pleased to share new clinical data on first-in-class cancer stemness inhibitors napabucasin and amcasertib at this year's ASCO annual meeting," said Chiang J. Li, M.D. FACP, the President, CEO and Chief Medical Officer of Boston Biomedical, and the Head of Global Oncology for Sumitomo Dainippon Pharma Group. "These findings support the potential for napabucasin and amcasertib to address a broad range of tumor types, which ultimately could lead to a new approach in treating cancer through targeting CSC pathways"

Planned poster sessions include:

Saturday, June 4 from 8:00 a.m. – 11:30 a.m. [Gastrointestinal (Colorectal) Cancer], Hall A

• Abstract #3564, Poster #261: Phase Ib extension study of cancer stemness inhibitor BB608 (Napabucasin) administered in combination with FOLFIRI +/- Bevacizumab (Bev) in patients (pts) with advanced colorectal cancer (CRC)
  • O'Neil BH¹, Hubbard JM², Starodub A³, Jonker D⁴, Edenfield WJ⁵, El-Rayes B⁶, Halfdanarson TR², Ramanathan R⁷, Pitot H², Britten C⁸, Grothey A², Borodyansky L⁹ and Li CJ⁹
  • 1. IU Health University Hospital, Indianapolis, IN; 2. Mayo Clinic, Rochester, MN; 3. IU Goshen Health Center; 4. The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; 5. Institute for Translational Oncology Research, Greenville, SC; 6. The Winship Cancer Institute of Emory University, Atlanta, GA; 7. Mayo Clinic, Scottsdale, AZ; 8. MUSC Hollings Cancer Center, Charleston, SC; 9. Boston Biomedical, Inc., Cambridge, MA

Saturday, June 4 from 8:00 a.m. – 11:30 a.m. [Gastrointestinal (Noncolorectal) Cancer], Hall A

• Abstract #4128, Poster #120: 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 
  • El-Rayes B¹, Shahda S², Starodub A³, O'Neil BH², Hanna W⁴, Shaib W¹, Oh C⁵, Li YZ⁵, Borodyansky L⁵, Li CJ⁵ and Bekaii-Saab T⁶
  • 1. The Winship Cancer Institute of Emory University, Atlanta, GA; 2. IU Health University Hospital, Indianapolis, IN; 3. IU Health Goshen Center for Cancer Care, Goshen, IN; 4. University of Tennessee Medical Center, Knoxville, TN; 5. Boston Biomedical, Inc., Cambridge, MA; 6. The Ohio State University Wexler Medical Center, Columbus, OH.

Saturday, June 4 from 8:00 a.m. – 11:30 a.m. (Lung Cancer, Non-Small Cell Metastatic), Hall A

• Abstract #9093, Poster #416: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Non-Small Cell Lung Cancer
  • Becerra C¹, Spira A¹, Conkling P¹, Richey S¹, Hanna W², Cote G³, Heist R³, Langleben A⁴, Laurie S⁵, Edenfield WJ⁶, Kossler K⁷, Hume S⁷, Li Y⁷, Hitron M⁷, Li CJ⁷
  • 1. US Oncology Research, TOPS Phase I Program, Woodlands, TX; 2. University of Tennessee Medical Center, Knoxville, TN; 3. Massachusetts General Hospital, Boston, MA; 4. St. Mary's Hospital, McGill University, Montreal, QC; 5. Ottawa Hospital Research Institute, Ottawa, ON; 6. Institute for Translational Oncology Research, Greenville Hospital System/University Medical Center, Greenville, SC; 7. Boston Biomedical, Inc., Cambridge, MA

Saturday, June 4 from 8:00 a.m. – 11:30 a.m. [Gastrointestinal (Noncolorectal) Cancer], Hall A

• Abstract #TPS4144, Poster #129b: The BRIGHTER trial: A phase III randomized double-blind study of BBI-608 + weekly paclitaxel versus placebo (PBO) + weekly paclitaxel in patients (pts) with pretreated advanced gastric and gastro-esophageal junction (GEJ) adenocarcinoma
  • Shah MA^1,8, Muro K^2,8, Shitara K^3,4,8, Tebbutt NC^5,8, Bang YJ^6,8, Lordick F^7,8, Borodyansky L^8,9, other BRIGHTER Investigators⁸ and Li CJ^8,9
  • 1. New York-Presbyterian Hospital Weill Cornell Medical School, New York, NY; 2. Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan; 3. Department of Gastroenterology GI Oncology Division, National Cancer Center Hospital East, Chiba, Japan; 4. Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, Chiba, Japan; 5, Austin Health, Heidelberg, Victoria, Australia; 6. Seoul National University Hospital, Seoul, Republic of Korea; 7. University Cancer Center, University Hospital Leipzig, Leipzig, Germany; 8. Authorship was determined by the order of regional activation and patient enrollment; 9. Boston Biomedical, Inc., Cambridge, MA

Saturday, June 4 from 1:00 p.m. – 4:30 p.m. (Head and Neck Cancer), Hall A; Saturday, June 4 from 4:45 p.m. – 6:00 p.m. (Poster Discussion Session), S406

• Abstract #6018, Poster #340: Phase I Extension Clinical Study of BB503, a First-in-Class Cancer Stemness Kinase Inhibitor, in Adult Patients with Advanced Head and Neck Cancer
  • Cote G¹, Chau N², Spira A³, Edenfield WJ⁴, Richards D³, Richey S³, Laurie S⁵, Wilks S³, Braiteh F³, Wang K⁶, Li Y⁶, Rogoff H⁶, Hitron M⁶, Li CJ⁶
  • 1. Massachusetts General Hospital, Boston, MA; 2. Dana-Farber Cancer Institute, Boston, MA; 3. US Oncology Research, TOPS Phase I Program, Woodlands, TX; 4. Institute for Translational Oncology Research, Greenville Hospital System/University Medical Center, Greenville, SC; 5. Ottawa Hospital Research Institute, Ottawa, ON; 6. Boston Biomedical, Inc., Cambridge, MA

Sunday, June 5 from 8:00 a.m. – 11:30 a.m. (Breast Cancer, Triple Negative / Cytotoxics /Local Therapy), Hall A

• Abstract #1094, Poster #199: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Advanced Triple Negative Breast Cancer
  • Becerra C¹, Braiteh F¹, Spira A¹, Langleben A², Panasci L², Vukelja S¹, Hinshaw I¹, Goodwin R³, Panella T⁴, Edenfield WJ⁵, Kossler K⁶, Hume S⁶, Li Y⁶, Hitron MJ⁶, Li CJ⁶
  • 1. US Oncology Research, TOPS Phase I Program, Woodlands, TX; 2. McGill University, Montreal, QC; 3. Ottawa Hospital Research Institute, Ottawa, ON; 4. University of Tennessee Medical Center, Knoxville, TN; 5. Institute for Translational Oncology Research, Greenville Hospital System/University Medical Center, Greenville, SC; 6. Boston Biomedical, Inc., Cambridge, MA

Monday, June 6 from 1:00 p.m. – 4:30 p.m. (Gynecologic Cancer), Hall A

• Abstract #5578, Poster #401: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BB608) Combined with Weekly Paclitaxel in Platinum Resistant Ovarian Cancer
  • Garcia A¹, Hays J², Cote G³, Becerra C⁴, Langleben A⁵, Lau S⁵, Roman L¹, McCormick C⁴, Richards D⁴, Braiteh F⁴, Yimer H⁴, Richey S⁴, Spira A⁴, Edenfield JW⁶, Kossler K⁷, Hume S⁷, Li Y⁷, Hitron MJ⁷, Li CJ⁷
  • 1. University of Southern California, Los Angeles, CA; 2. The Ohio State University Comprehensive Cancer Center, Columbus, OH; 3. Massachusetts General Hospital, Boston, MA; 4. US Oncology Research, TOPS Phase I Program, Woodlands, TX; 5. McGill University, Montreal, QC; 6. Institute for Translational Oncology Research, Greenville Hospital System/University Medical Center, Greenville, SC; 7. Boston Biomedical, Inc., Cambridge, MA

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 stem cell 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 document are based on management's assumptions and beliefs in light of information presently available, and involve both known and unknown risks and uncertainties. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

ⁱ Li Y, Rogoff HA, Keates, S, Gao Y, Murikipudi S, Mikule K, Leggett D, Wei L, Pardee A, Li CJ. Suppression of Cancer Relapse and Metastasis by Inhibiting Cancer Stemness. PNAS. 2015;112(6):1839-1844.

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