Boston Biomedical Presents Data for Investigational Cancer Stemness Inhibitor Napabucasin in Metastatic Colorectal and Pancreatic Cancer at ESMO GI 2017

CAMBRIDGE, Mass., June 30, 2017 /PRNewswire/ — Boston Biomedical, Inc., an industry leader in the development of next-generation cancer therapeutics designed to inhibit cancer stemness pathways, featured two oral and two poster presentations evaluating napabucasin in metastatic colorectal cancer (mCRC) and pancreatic adenocarcinoma (mPDAC) at the European Society of Medical Oncology (ESMO) 19th World Congress on Gastrointestinal Cancer, held from June 28 to July 1 in Barcelona, Spain. Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3. The abstracts were simultaneously published in the ESMO GI 2017 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.

Highlighted in an oral presentation today, results of a phase 1b/2 study suggested encouraging signs of efficacy of napabucasin when combined with FOLFIRI with or without bevacizumab in 82 patients with pretreated mCRC. Among the 66 patients who received RECIST evaluation, one patient achieved complete response (CR), 13 patients achieved partial response (PR), and 41 patients achieved stable disease (SD), with 27 of these patients having tumor regression. The disease control rate (CR+PR+SD) was 83 percent and the objective response rate (CR+PR) was 21 percent.

“Innovative treatment advances are vitally needed for patients with metastatic colorectal cancer with the goal of providing greater sustained responses and improved survival,” said Johanna Bendell, M.D., lead author of the phase 1b/2 mCRC study and director of GI Cancer Research Program at Sarah Cannon Research Institute. “We are encouraged by the study results, which further support the hypothesis that targeting cancer stemness may improve outcomes in combination with chemotherapy.”

Featured in a second oral presentation today, results of a phase 1b/2 study suggested encouraging signs of anti-cancer activity of napabucasin plus nab-paclitaxel and gemcitabine in 66 patients with mPDAC. Among the 55 patients who received RECIST evaluation, the disease control rate (CR+PR+SD) was observed in 93 percent and the objective response rate (CR+PR) was observed in 55 percent, with two patients achieving CR and 28 patients attaining PR.

“As pancreatic cancer has the lowest survival rate of any major cancer, with just eight percent at five years, there is a significant unmet need for effective treatment options,” said Tanios S. Bekaii-Saab, M.D., FACP, lead author and presenter of the data for the company’s phase 1b/2 mPDAC study and co-leader of the GI Cancer Program at Mayo Clinic Cancer Center. “These data are very encouraging and support the therapeutic potential of napabucasin added to weekly nab-paclitaxel and gemcitabine in patients with advanced pancreatic cancer.”

Adverse events (AEs) for both the mCRC and mPDAC phase 1b/2 studies were consistent with previous studies and include Grade 1/2 reversible gastrointestinal AEs, including diarrhea and nausea.

The company also exhibited two posters highlighting the designs of its ongoing phase 3 studies, CanStem303C (mCRC) and CanStem111P (mPDAC), which were initiated to confirm signs of efficacy seen in the phase 1b/2 studies described above. Both studies are evaluating the efficacy and safety of napabucasin with primary endpoints of overall survival (OS).

“The data results presented at ESMO GI on investigational compound napabucasin in metastatic pancreatic and colorectal cancer underscore the potential of a novel approach for treating cancer through targeting cancer stemness pathways,” said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. “We are committed to the continued research of this first-in-class compound and look forward to the results of our pivotal studies.”

Oral Presentation Highlights:

Abstract Title and Lead
Author

Study Results

Friday, June 30, 8:10 AM – 8:20 AM CEST

Abstract LBA-002: A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin in Combination with Gemcitabine (gem) and Nab-Paclitaxel (nab-PTX) in Metastatic Pancreatic Adenocarcinoma (mPDAC) Patients (pts)

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

The results of this study showed napabucasin may be combined with nab-paclitaxel and gemcitabine. Encouraging anti-cancer activity was observed in patients with mPDAC. The results of this study are currently being confirmed in the ongoing phase 3 study, CanStem111P.

Among the 66 patients enrolled, 17 received prior perioperative systemic chemotherapy treatment. Among the 55 patients who received RECIST evaluation, the disease control rate (DCR; CR+PR+SD) was observed in 93 percent and the objective response rate (ORR; CR+PR) was observed in 55 percent.

Two patients achieved CR and 28 patients achieved PR. Maturing median progression-free survival (mPFS) and OS was greater than 7.1 months and 10.7 months, respectively.

Most common AEs were Grade 1/2 gastrointestinal events, including diarrhea, nausea and fatigue, which were resolved with dose reduction and supportive care.

Friday, June 30, 8:20 AM – 8:30 AM CEST

Abstract LBA-003: Phase 1b/II Study of Cancer Stemness Inhibitor Napabucasin in Combination with FOLFIRI +/- Bevacizumab (bev) in Metastatic Colorectal Cancer (mCRC) Patients (pts)

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

Results of this study showed napabucasin may be combined with FOLFIRI with or without bevacizumab. Encouraging anti-cancer activity was observed in patients with mCRC, including in patients previously treated with FOLFIRI with or without bevacizumab. The results of this study are currently being confirmed in the ongoing phase 3 study, CanStem303C.

Of the 82 patients enrolled, 32 patients were pretreated with FOLFIRI with or without bevacizumab. In this study, 48 patients received FOLFIRI and 34 patients received FOLFIRI plus bevacizumab in combination with napabucasin. Among the 66 patients who received RECIST evaluation, the DCR (CR+PR+SD) was observed in 83 percent and the ORR (CR+PR) was observed in 21 percent.

One patient achieved CR, 13 patients achieved PR and 41 patients achieved SD, with 27 of these patients having tumor regression.

Most common AEs were Grade 1/2 gastrointestinal events, including diarrhea, cramping, nausea and vomiting, which were resolved with dose reduction and supportive care.

Poster Presentation Highlights:

Abstract Title and Lead
Author

Study Results

Thursday, June 29, 11:10 AM – 11:40 AM CEST and 4:20 PM – 4:50 PM CEST

Abstract P-385: CanStem111P trial: A Phase III Study of Napabucasin (BBI-608) plus Nab-Paclitaxel (nab-PTX) with Gemcitabine (gem) in Adult Patients with Metastatic Pancreatic Adenocarcinoma (mPDAC)

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

Currently enrolling patients globally, this study will assess the efficacy of napabucasin plus weekly nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine alone in patients with mPDAC who have not received prior systemic anti-cancer treatment.

The primary endpoint of the study is OS, with secondary endpoints including PFS, ORR, DCR, in addition to quality of life (QOL) and safety.

Friday, June 30, 10:30 AM – 11:00 AM CEST and 4:40 PM – 5:10 PM CEST

Abstract P-383: CanStem303C: 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)

Lead Author: Axel Grothey, M.D.; Mayo Clinic Cancer Center

Currently enrolling patients globally, CanStem303C will assess the efficacy of napabucasin plus biweekly FOLFIRI (with or without bevacizumab at investigator discretion) in patients with mCRC following progression on a fluoropyrimidine and oxaliplatin (with or without bevacizumab).

The primary endpoint of the study is OS. Secondary endpoints include PFS, ORR, DCR, QOL and safety.

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

For general inquiries:
Boston Biomedical, Inc.
617-674-6800

For media inquiries:
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212-849-9474
sara.baker@inventivhealth.com

SOURCE Boston Biomedical, Inc.

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