Boston Biomedical Presents Clinical Data on First-in-Class Cancer Stemness Inhibitor Napabucasin at 2017 ASCO GI Symposium

CAMBRIDGE, Mass., Jan. 21, 2017 /PRNewswire/ -- Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, today presented data from two clinical studies for its lead investigational compound, napabucasin, at the 2017 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in San Francisco.

In a Phase Ib/II study of napabucasin – an orally administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3 – colorectal cancer (CRC) patients who were FOLFIRI-naïve and those previously treated with FOLFIRI showed signs of anti-cancer activity when napabucasin was administered in combination with FOLFIRI with and without bevacizumab. Additionally, these findings demonstrated synergistic activity of napabucasin plus FOLFIRI with and without bevacizumab in patients previously treated with FOLFIRI, regardless of p-STAT3 status. Further, these data suggest napabucasin may re-sensitize chemorefractory CRC patients, including those who were previously unresponsive to FOLFIRI-based chemotherapy treatment, to treatment with FOLFIRI with and without bevacizumab.

"There remains a significant unmet need for novel treatment advances to ensure greater sustained responses and improve survival for patients with advanced colorectal cancer," said Johanna Bendell, M.D., an investigator of the Phase Ib/II Study and Director of GI Cancer Research Program at Sarah Cannon Research Institute. "We are encouraged by these study results, in which napabucasin in combination with FOLFIRI in colorectal cancer showed signs of encouraging anti-cancer activity even in FOLFIRI-pretreated patients regardless of p-STAT3 status. This underscores that targeting cancer stemness may suppress cancer relapse and metastasis."

Phase II data from a second study on napabucasin's ability to be combined with panitumumab, demonstrated encouraging anti-cancer activity in patients with K-ras wild-type metastatic colorectal cancer (mCRC), regardless of prior anti-EGFR treatment. These findings suggest napabucasin may sensitize patients to retreatment with anti-EGFR antibody therapy.

"Results from these studies for napabucasin in advanced colorectal cancer support the advancement of our clinical development program for this first-in-class cancer stemness inhibitor into a global, Phase III trial in combination with standard-of-care chemotherapy," 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 committed to ongoing research and clinical development of napabucasin with the goal of ultimately achieving better therapeutic outcomes for patients with colorectal cancer."

Highlights of the Boston Biomedical poster presentations:

Abstract #593: Cancer stemness inhibition and chemosensitization: Phase Ib/II study of cancer stemness inhibitor napabucasin (BBI-608) with FOLFIRI +/- bevacizumab (bev) administered to colorectal cancer (CRC) patients (pts)

• Bendell J¹, O'Neil BH², Starodub A³, Jonker D⁴, Halfdanarson TR⁵, Edenfield J⁶, El-Rayes, B⁷, Hubbard J⁸, Pitot H⁸, Hobday T⁸, Li Y-Z⁹, Gao Y⁹, Grothey A⁸, Borodyansky L⁹, and Li CJ⁹

• 1. Sarah Cannon Cancer Research Institute/Tennessee Oncology, Nashville, TN; 2. IU Health University Hospital, Indianapolis, IN; 3. IU Goshen Health Center, Goshen, IN; 4. The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada; 5. Mayo Clinic, Scottsdale, AZ; 6. Institute for Translational Oncology Research, Greenville, SC; 7. The Winship Cancer Institute of Emory University, Atlanta, GA; 8. Mayo Clinic, Rochester, MN; 9. Boston Biomedical, Inc., Cambridge, MA.

• In this study, both FOLFIRI-naïve and FOLFIRI-exposed colorectal cancer (CRC) patients showed signs of anti-cancer activity when napabucasin was administered in combination with FOLFIRI +/- bevacizumab. Signs of synergistic activity between napabucasin and FOLFIRI +/- bevacizumab were also observed regardless of p-STAT3 status.

Among the 63 patients enrolled, 56 patients have received RECIST evaluation. Forty-six percent of the 56 patients received prior FOLFIRI-based treatment before enrollment. Disease control (CR+PR+SD) was observed in 88% of patients (n=49), with an overall response (CR+PR) of 29% (n=16) and one patient achieved a complete response. In the p-STAT^high and p-STAT^low population, DCR and ORR were similar in evaluable pts (DCR: 84% and 92% and ORR: 26% and 32%, respectively).

The most common adverse events (AEs) included 1/2 diarrhea, nausea, vomiting, anorexia and fatigue. Grade 3 AEs included diarrhea, fatigue, dehydration, electrolyte imbalance, nausea, vomiting, abdominal pain and weight loss, which were resolved with dose reduction and supportive care.

Abstract #677: BBI608-224: A phase Ib/II study of cancer stemness inhibitor napabucasin (BBI-608) administered with panitumumab in K-ras wild-type (wt) patients (pts) with metastatic colorectal cancer (mCRC)

• Larson TG¹, Ciombor K², Becerra CHR¹, Hubbard JM³, Edenfield WJ⁴, Shao S⁵, Grothey A³, Walsh E⁷, Borodyansky L⁷, Ortuzar W⁷, Khan W⁷, Xu B⁷, Li W⁷, Li Y⁷, Li CJ⁷ and Bekaii-Saab T⁶

• 1. US Oncology Research, TOPS Phase I Program; 2. Ohio State University Wexner Medical Center, Columbus, OH; 3. Mayo Clinic, Rochester, MN; 4. Institute for Translational Oncology Research, Greenville Hospital System/University Medical Center, Greenville, SC; 5. Northwest Cancer Specialist, Portland OR; 6. Mayo Clinic, Scottsdale AZ; 7. Boston Biomedical, Inc., Cambridge, MA

• Results from the Phase II study showed encouraging anti-cancer activity, regardless of prior anti-EGFR exposure, suggesting that napabucasin may sensitize patients to repeat anti-EGFR therapy.

Among the 72 heavily pretreated CRC pts enrolled in the study, 48 patients were evaluable by RECIST and 84.5% of patients had failed three or more lines of therapies. Disease control rate (DCR) was observed in 54% of evaluable patients (n=26), with partial response in two patients and stable disease in 24 patients. Of the 37 patients previously treated with anti-EGFR therapy, DCR was observed in 54% (n=20) compared with DCR of 54.5% observed in six out of 11 anti-EGFR naïve patients receiving a scan. 

Among all 54 patients who had received prior anti-EGFR antibody therapy and who had failed three or more lines of prior therapies before enrollment into this study, intent-to-treat (ITT)-based median overall survival was 9.1 months. Among all 18 patients who were anti-EGFR-naïve and who had failed two or three more lines of chemotherapy before enrollment into this study, ITT-based median overall survival was 13.3 months.      

Adverse events (AEs) were consistent with those observed in the Phase I portion of the study. The most common AEs included grade 1/2 diarrhea, nausea, abdominal cramps and vomiting.  

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 the body.^i,ii Evidence suggests that these cells possess resistance to chemotherapy, radiation and targeted therapy as well as immunotherapies, so while such treatments can successfully shrink tumors, a population of CSCs may still survive.^ii,iii

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 challenges in cancer treatment.

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

Napabucasin is currently being investigated in four Phase III studies in advanced gastric and gastroesophageal junction (GEJ) (NCT02178956), colorectal (NCT02753127), lung (NCT02826161), and pancreatic cancer (NCT02993731). It is also being investigated in earlier phases in multiple solid and hematologic malignancies, including tumors of the lung, 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.

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
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For media inquiries:
Sara Baker
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[email protected]

ⁱ Gupta PB, Chaffer CL, Weinberg RA. Cancer stem cells: mirage or reality? Nat Med. 2009;15(9):1010-1012.
ⁱⁱ Ajani JA, Song S, Hochster HS, Steinberg IB. Cancer stem cells: the promise and the potential. Semin Oncol. 2015;42(suppl 1):S3-S17.
ⁱⁱⁱ Jordan CT, Guzman ML, Noble M. Cancer stem cells. N Engl J Med. 2006;355(12):1253-1261.
^iv Li Y, Rogoff HA et al. PNAS. 112(6):1839-44, 2015.

SOURCE Boston Biomedical, Inc.

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