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

Data highlighted the potential of napabucasin – an orally administered investigational cancer stemness inhibitor designed to inhibit CSC pathways by targeting STAT3 – to promote anti-cancer activity when used in combination with other chemotherapeutics.[i] Further clinical data was exhibited across multiple tumor types, including the company's first publication of data in advanced ovarian, lung and breast cancers. Ongoing Phase Ib extension data in metastatic pancreatic and colorectal cancers also were reported.

"The napabucasin data at ASCO this year are exciting because they underscore the potential of cancer stem cell pathway inhibition across multiple tumor types," said Tanios Bekaii-Saab, M.D., FACP, Co-Leader, GI Cancer Program, Mayo Clinic Cancer Center "Additionally, these data demonstrate the potential to combine napabucasin with current standards of care to address unmet needs, including treatment in patients who have had multiple lines of prior therapy."

An ongoing phase I advanced head and neck cancer extension study of amcasertib – an orally administered investigational agent designed to inhibit cancer stem cell pathways, including Nanog, by targeting stemness kinases – also was featured at the meeting, in a poster discussion session.

"For the fourth consecutive year at ASCO, we presented encouraging results in multiple tumor types focusing on our first-in-class compounds napabucasin and amcasertib," 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. "We are excited to share the potential impact these innovative cancer stemness inhibitors may have for patients across various tumor types as our clinical trial program continues to mature and grow."

Boston Biomedical poster sessions included:

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, Adesunloye B⁹,Grothey A², Borodyansky L¹⁰ and Li CJ¹⁰
• 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. IU Health Arnett; 10. Boston Biomedical, Inc., Cambridge, MA
• Results from this extension study demonstrated napabucasin may be combined with FOLFIRI +/- Bev and showed signs of anti-tumor activity in patients with advanced colorectal cancer who have previously been treated on FOLFIRI +/- Bev.
  
  Disease control (partial response and stable disease) was observed in 93% (n=37) of evaluable patients (n=40), with partial response in 33% (n=13) and stable disease in 60% (n=24). Among 20 patients who progressed on FOLFIRI +/- Bev previously and were evaluable for tumor assessment, disease control was observed in 90% (n=18) and tumor regression was observed in 75% (n=15) patients, of which 30% (n=6) achieved a partial response.
  
  The most common adverse events (AEs) (>30%) were grade 1/2 diarrhea, nausea and fatigue, as well as grade 1 vomiting, abdominal pain, mucositis, anorexia and alopecia. Grade 3 AEs (>3%) included diarrhea, fatigue and neutropenia. Gastrointestinal AEs were resolved with symptom medications or upon holding dose.

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. Mayo Clinic Cancer Center, Scottsdale, Arizona.
• The study demonstrated napabucasin may be combined with gemcitabine and nap-PTX and showed signs of anti-tumor activity in patients with metastatic pancreatic cancer.
  
  Among 37 patients enrolled in the study, disease control (partial response and stable disease) was observed in 76% (n=28), with tumor regression observed in 65% (n=24), a partial response achieved in 38% (n=14) and 1 patient achieved a complete response. In evaluable patients (n=30), disease control was observed in 93% (n=28) and tumor regression was seen in 80% (n=24), of which 1 patient achieved a complete response and 47% of patients (n=14) achieved a partial response.  Fifty-seven percent of patients (n=17) had a prolonged disease control (≥24 weeks).
  
  Common adverse events (AEs) (>30%) were grade 1 diarrhea, nausea, fatigue and neuropathy. Grade 3 AEs included diarrhea, nausea, fatigue, decreases in white blood cells, platelet and lymphocyte counts, neutropenia, anemia and neuropathy; grade 4 AEs, which occurred in <10% of patients (n=4), included fever (1), decrease in white blood cells (1) and lymphocyte counts (1) and neutropenia (1).

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
• The findings from the study indicated that napabucasin plus weekly paclitaxel was tolerated and showed signs of anti-cancer activity in patients with pre-treated advanced non-small cell lung cancer who had been previously treated with taxanes.
  
  Of the 27 patients enrolled in the study, the disease control rate (stable disease of at least 8 weeks, partial response or complete response) was 56%, tumor regression occurred in 44%, and a partial response was observed in 11% of patients. Median progression free survival was 4 months and median overall survival was 7.8 months. For non-squamous patients (ITT, n=22) specifically, median progression free survival was 4.3 months and median overall survival was 9.1 months. For evaluable patients (n=19), the disease control rate was 79%, tumor regression occurred in 63% of patients and a partial response was observed in 16% of patients. For evaluable non-squamous patients (n=15), the disease control rate was 87%, tumor regression occurred in 47% and a partial response was observed in 20%.  
  
  The most common adverse event (AE) (>30%) was grade 1/2 diarrhea. Grade 3 AEs included diarrhea and hyponatremia, and were reversible.

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 A^1,9, Muro K^2,9, Shitara K^3,4,9, Tebbutt NC^5,9, Bang YJ^6,9, Lordick F^7,9, Shen L.⁸, other BRIGHTER Investigators⁹, Borodyansky L¹⁰, and Li CJ¹⁰
• 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. Department of Medical Oncology, Seoul National University, Seoul, Republic of Korea; 7. University Cancer Center, University Hospital Leipzig, Germany; 8. Peking University Cancer Hospital, Beijing, China, 9. Authorship was determined by the order of regional activation and patient enrollment; 10. Boston Biomedical, Inc., Cambridge, MA
• This study will access the efficacy of napabucasin (BBI-608) plus weekly paclitaxel versus placebo plus weekly paclitaxel in patients with pretreated, advanced gastric and gastro-esophageal junction adenocarcinoma.
  
  The primary endpoint is overall survival in the general study population; secondary endpoints include progression-free survival, overall survival and progression-free survival in a predefined biomarker-positive sub-population, objective response rate, disease control rate and safety. In addition, blood, plasma and archival tissue will be assessed for pharmacokinetic and biomarker analyses and quality of life will be measured.
  
  As of February 2016, 364 patients were randomized and recruitment is ongoing.

Abstract #6018, Poster #340: A Phase I Extension Clinical Study of BBI-503, 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
• The findings indicated amcasertib (BBI-503, also known as BB503) as a monotherapy was tolerated and demonstrated signs of anti-cancer activity in patients with refractory head and neck cancer, including partial responses and prolonged disease control. 
  
  Patients were assessed for safety and preliminary activity including disease control rate, (stable disease of at least eight weeks, partial response or complete response).
  
  For evaluable non-ACC patients (n = 16), 13% achieved PR and 25% achieved disease control for ≥ 24 weeks. The 4 non-evaluable pts had clinical deterioration prior to receiving ≥80% of 1 cycle of study drug per protocol.  In the ITT non-ACC patient group (n = 20), median overall survival (mOS) was 7.7 months. For all ACC pts (ITT, n = 13), 46% had disease control for ≥ 24 weeks, 69% had survived more than 1 year, and mOS was 21.8 months. 
  
  The most common adverse events (AEs) (>30%) were grade 1 diarrhea and nausea, and grade 1/2 fatigue. Grade 3 AEs included reversible diarrhea, nausea and vomiting.

Abstract #1094, Poster #199: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BBI-608) 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
• Findings from the study demonstrated napabucasin plus weekly paclitaxel was tolerated and showed signs of anti-cancer activity in patients with heavily pretreated triple negative breast cancer who have progressed following treatment with taxane-based regimens.
  
  Of the 35 patients enrolled, median progression free survival was 2.6 months and median overall survival was 9.1 months. The disease control rate (stable disease of at least eight weeks, partial response or complete response) was 46%, the objective response rate was 11% and tumor regression occurred in 17% of patients. In evaluable patients (n=31), the disease control rate was 52%, the objective response rate was 13% and tumor regression occurred in 19% of patients.
  
  The most common adverse events (AEs) (>30%) were grade 1/2 diarrhea, and grade 1 nausea, abdominal pain, vomiting and fatigue. Related grade 3 AEs were reversible and included diarrhea, nausea, abdominal pain, vomiting, fatigue, weight loss, anorexia, dehydration, hypokalemia, anemia and neutropenia.

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
• The results of the study suggest napabucasin may be combined with weekly paclitaxel in patients with heavily pretreated platinum resistant ovarian cancer who have progressed on prior taxane-based regimens. 
  
  Of the 56 patients enrolled, disease control (stable disease of at least 8 weeks, objective partial or complete response) was observed in 48%, and objective responses were achieved in 20% of patients. Median progression free survival was 3.7 months and median overall survival was 9.9 months. In evaluable patients (n = 38), disease control rate was 71%, tumor regression occurred in 63% and the objective response rate was 29%, including 1 patient with a complete response. In patients with up to two prior lines of therapy (n=11), the objective response rate was 45%.  
  
  The most common adverse events (AEs) (>30%) included grade 1/2 diarrhea, grade 1 nausea, vomiting and abdominal pain, and grade 2 fatigue. Grade 3 AEs included diarrhea, nausea, vomiting, abdominal pain, ascites, fatigue, hypokalemia, dehydration, hypophosphatemia, hyponatremia and anemia.

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.

For general inquiries:
Boston Biomedical
617-674-6800

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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SOURCE Boston Biomedical, Inc.