CAMBRIDGE, Mass., June 5, 2017 /PRNewswire/ — Boston Biomedical, Inc., an industry leader in the development of next-generation cancer therapeutics designed to inhibit cancer stemness pathways, will present data today from a phase 1b/2 study evaluating amcasertib monotherapy in two solid tumor subpopulations – advanced adenoid cystic carcinoma (ACC) and advanced head and neck cancers – at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Amcasertib is an orally-administered investigational agent designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases.
The study results showed amcasertib prolonged survival and was well tolerated in patients with both types of cancer. Of the 14 patients enrolled with unresectable, advanced ACC, disease control rate (proportion with stable disease at eight weeks plus partial response or complete response) was observed in 86 percent, prolonged disease control of greater than six months was achieved in 57 percent, and median overall survival (mOS) was 27.8 months. Treatment was well tolerated with one case of Grade 3 diarrhea. In addition, among the 21 patients enrolled with advanced head and neck cancers, 38 percent of patients survived 12 months, and mOS was seven months. Adverse events for this study included Grade 3 diarrhea and nausea.
“We are pleased to share data results from one of our lead investigational compounds, amcasertib, in two diseases with significant unmet needs,” said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. “We are encouraged by the potential for prolonged disease control and extended survival in both advanced adenoid cystic carcinoma and head and neck cancers, and look forward to continued investigation of how amcasertib may potentially treat these cancer types.”
Head and neck cancers often originate in the mucosal lining of the mouth, nose, throat and salivary glands.1 ACC is a rare cancer that forms within the secretory glands of the head and neck.2 While this type of cancer is often found to be slow-growing, patients can experience unpredictable tumor growth spurts regardless of initial prognosis or treatment.3 Approximately 40 percent or more of ACC patients experience long-term recurrence and metastasis.4
During the annual meeting, the company also featured phase 1/2 study results of napabucasin – its most advanced orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3 – across seven tumor types in Saturday and Sunday poster sessions. Data from a phase 1b/2 study in hepatocellular cancer showed either amcasertib or napabucasin may be combined with sorafenib at full dose and encouraging anti-cancer activity was observed in patients who have not received prior systemic therapy. Also presented were phase 1/2 studies evaluating napabucasin in advanced or metastatic melanoma, ovarian, breast, lung, colorectal and pancreatic cancer. To learn more about the napabucasin data presented at ASCO, visit here.
Amcasertib Data Highlights Include:
Abstract Title and Lead Author
Poster Study Results
Monday, June 5 from 1:15 PM – 4:45 PM CDT; Hall A
Abstract #6036, Poster #24: A Phase 1b/2 Study of Amcasertib, a First-in-Class Cancer Stemness Kinase Inhibitor, in Advanced Adenoid Cystic Carcinoma
Lead Author: Gregory Michael Cote, Ph.D., M.D.; Massachusetts General Hospital
Study results exhibited tolerability and prolonged disease control in patients with unresectable ACC who received prior systemic therapy, radiation or surgery.
Of the 14 patients enrolled, disease control rate (DCR; proportion with stable disease (SD) at eight weeks, partial response (PR) or complete response (CR)) was observed in 86 percent. Prolonged disease control of greater than six months was achieved in 57 percent with 79 percent of patients surviving 12 months and median overall survival (mOS) was 27.8 months.
Treatment with amcasertib was well tolerated with Grade 3 diarrhea in one patient.
Abstract #6032, Poster #20: A Phase 1b/2 Study of Amcasertib, a First-in-Class Cancer Stemness Kinase Inhibitor in Advanced Head and Neck Cancer
Lead Author: Gregory Michael Cote, Ph.D., M.D.; Massachusetts General Hospital
Study findings suggested early signs of prolonged disease control and extended survival in 15 patients with advanced, pretreated head and neck squamous cell carcinoma and six patients with salivary or parotid gland cancers who had received prior treatment including radiation, systemic therapy or surgery.
Among the 21 patients enrolled, 38 percent survived 12 months, with a mOS of seven months and median progression-free survival of 1.9 months. In evaluable patients (n=17), the objective response rate was 12 percent and DCR (proportion with SD at eight weeks, PR or CR) was 48 percent.
Treatment with amcasertib was found to be well tolerated with five cases of Grade 3 adverse events (AEs) reported, including diarrhea and nausea.
Amcasertib is an orally-administered investigational agent designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases. Boston Biomedical, Inc. 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.
Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.5 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. In 2016, the U.S. Food and Drug Administration granted Orphan Drug Designation for napabucasin in gastric/GEJ and pancreatic cancer.
About Boston Biomedical, Inc.
Boston Biomedical, Inc. 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.
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Boston Biomedical, Inc.
For media inquiries:
1 National Cancer Institute. What are cancers of the head and neck? https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet. Accessed May 11, 2017.
2 Oral Cancer Foundation. Adenoid Cystic Carcinoma. http://oralcancerfoundation.org/facts/rare/adenoid-cystic-carcinoma. Accessed May 11, 2017.
3 Adenoid Cystic Carcinoma Organization International. What is ACC? http://www.accoi.org/faq/what-acc. Accessed May 11, 2017.
4 National Organization for Rare Disorders. Adenoid Cystic Carcinoma. https://rarediseases.org/rare-diseases/adenoid-cystic-carcinoma. Accessed May 11, 2017.
5 Li Y, Rogoff HA et al. Suppression of cancer relapse and metastasis by inhibiting cancer stemness. PNAS. 112(6):1839-44, 2015.
SOURCE Boston Biomedical, Inc.