Boston Biomedical Presents Data Suggesting Anti-Cancer Activity of Investigational Stemness Inhibitor Napabucasin in Seven Tumor Types at ASCO 2017

CAMBRIDGE, Mass., June 3, 2017 /PRNewswire/ — Boston Biomedical, Inc., an industry leader in the development of next-generation cancer therapeutics designed to inhibit cancer stemness pathways, will present phase 1b/2 clinical data evaluating napabucasin, an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3, at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Presented today and tomorrow (June 4), these study results show anti-cancer activity in advanced or metastatic disease in seven tumor types: colorectal cancer (mCRC), pancreatic cancer (mPDAC), non-squamous non-small cell lung cancer, ovarian cancer, breast cancer, hepatocellular cancer, and melanoma.

Today, results of a phase 1b/2 study in 82 patients with mCRC suggest anti-cancer activity of napabucasin when combined with FOLFIRI with or without bevacizumab. In addition, results of a phase 1b/2 study evaluating napabucasin plus nab-paclitaxel and gemcitabine in 66 patients with mPDAC exhibited anti-cancer activity, including achieving complete response in two patients and partial response in 28 patients. Adverse events for these studies are consistent with previous studies and include nausea and diarrhea. The results of these studies are now being confirmed in two phase 3 studies, CanStem111P (mPDAC) and CanStem303C (mCRC).

“We are excited to feature the most robust data set to date on investigational compound napabucasin at ASCO, which continue to underscore its promise in potentially treating advanced cancers with high unmet needs,” said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. “We continue to explore napabucasin’s ability to inhibit cancer stemness pathways in a broad range of tumor types and advance our clinical development portfolio while we are also looking ahead to potential regulatory filings.”

Updated data in advanced ovarian cancer and the company’s first results in advanced melanoma will be presented in poster sessions this afternoon. Data in previously treated metastatic breast cancer will be shared during a poster session tomorrow, June 4.

Data Highlights Include:

Abstract Title and Lead
Author

Poster Study Results

Saturday, June 3 from 8:00 AM – 11:30 AM CDT; Hall A

Abstract #9052, Poster
#378:
A Phase 1b/2 Study of Napabucasin with Weekly Paclitaxel in Advanced, Previously Treated Non-Squamous Non-Small Cell Lung Cancer

Lead Author: Carlos Becerra, M.D.; U.S. Oncology Research, TOPS Phase I Program

Results from this study show napabucasin may be combined with weekly paclitaxel and patients with heavily pretreated non-squamous non-small cell lung cancer exhibited encouraging signs of anti-cancer activity.

Among the 23 patients enrolled, the objective response rate (ORR) was 26 percent, disease control rate (DCR; proportion with stable disease (SD) at eight weeks plus partial response (PR)) was 65 percent and tumor regression, including PR, occurred in 61 percent. The median progression-free survival (mPFS) was 5.8 months with 30 percent of patients free of progression at least 24 weeks; median overall survival (mOS) was 9.6 months with 43 percent of patients surviving at least 52 weeks. In evaluable patients (n=22), ORR was 27 percent, DCR was 68 percent, and tumor regression, including PR, occurred in 64 percent.

Treatment was well tolerated with Grade 3 adverse events (AEs) including diarrhea and fatigue.

Abstract #TPS3619, Poster
#241b:
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 (plus bevacizumab at investigator discretion) in patients with previously treated mCRC.

The primary endpoint of the study is OS. Secondary endpoints include progression-free survival (PFS), ORR, DCR, safety and quality of life. OS, PFS, ORR and DCR analyses will be conducted in the general study population as well as in patients with baseline phospho-STAT3 status and/or ß-catenin biomarkers.

Abstract #3529, Poster
#152:
BBI608-246: A Phase 1b/II Study of Cancer Stemness Inhibitor Napabucasin (BBI-608) 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 (bev). Encouraging anti-cancer activity was observed in patients with mCRC, including in patients previously treated with FOLFIRI. The results are currently being confirmed in the phase 3 study, CanStem303C.

Of the 82 patients enrolled, 48 received FOLFIRI and 34 received FOLFIRI plus bev in combination with napabucasin. The DCR (CR, PR and SD) was 67 percent and ORR was 17 percent. In evaluable patients (n=66), DCR was observed in 83 percent with one complete response (CR). PR was achieved in 20 percent, 66 percent experienced tumor regression, and 41 patients had SD.

Most common AEs included Grade 1/2 diarrhea, cramping, nausea, vomiting, fatigue and anorexia with Grade 4 diarrhea in one patient and 27 patients with Grade 3 AEs including: diarrhea, fatigue, hypokalemia, hyponatremia, hypophosphatemia, dehydration, electrolyte imbalance, abdominal pain, vomiting, and weight loss.

Abstract #4106, Poster
#98:
A Phase Ib/II Study of Cancer Stemness Inhibitor Napabucasin (BBI-608) 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 are currently being confirmed in the phase 3 study, CanStem111P.

Among the 66 patients enrolled, DCR (CR, PR and SD) was observed in 77 percent, with a total ORR of 45 percent, CR in two patients and 28 patients achieving PR. mPFS and OS was greater than 7.1 months and greater than 10.7 months, respectively. In evaluable patients (n=55), DCR was 93 percent, with a total ORR of 55 percent, including two patients achieving CR and 51 percent achieving PR.

AEs included Grade 1 diarrhea, nausea, fatigue, neuropathy, Grade 2 alopecia, and Grade 3 neutropenia.

Abstract #TPS4148, Poster
#131b:
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, this study will assess the efficacy of napabucasin plus weekly standard of care treatment (nab-paclitaxel and gemcitabine) versus weekly standard of care treatment alone in adult patients with mPDAC who have been diagnosed more than six weeks prior to study randomization and have not received prior treatment with chemotherapy or any investigational agents.

The primary endpoint of the study is OS, with secondary endpoints including PFS, ORR, DCR, in addition to safety and quality of life. OS, PFS, ORR and DCR analyses will be conducted in the general study population as well as in biomarker-positive patients.

Abstract #4077, Poster
#69:
BBI608-503-103HCC: A Phase Ib/II Clinical Study of Napabucasin (BBI608) in Combination with Sorafenib or Amcasertib (BBI503) in Combination with Sorafenib(Sor) in Adult Patients with Hepatocellular Carcinoma (HCC)

Lead Author: Bassel F. El-Rayes, M.D.; Winship Cancer Institute

Results from this study suggest either napabucasin or amcasertib may be combined with sorafenib. Encouraging signs of anti-tumor activity were observed in patients with hepatocellular carcinoma who have not received prior systemic chemotherapy.

The 27 patients enrolled in the study were divided into two treatment arms to receive napabucasin plus sorafenib (Arm One, n=14) or amcasertib plus sorafenib (Arm Two, n=13). Intent-to-treat patients had a DCR (CR, PR and SD) of 64 percent in Arm One and 61 percent in Arm Two. mPFS was 7.5 months in Arm One and 3.4 months in Arm Two. DCR among evaluable patients was 100 percent in Arm One (n=9) and for Arm Two (n=8).

The most common AEs were attributed to sorafenib and included rash, palmar-plantar erythrodysesthesia, Grade 1/2 diarrhea, nausea, abdominal cramps and vomiting.

Saturday, June 3 from 1:15 PM – 4:45 PM CDT; Hall A

Abstract #5548, Poster
#370:
A Phase 1b/2 Study of Napabucasin with Weekly Paclitaxel in Advanced, Previously Treated Platinum Resistant Ovarian Cancer

Lead Author: Carlos Becerra, M.D.; U.S. Oncology Research, TOPS Phase I Program

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.

A total of 98 patients were enrolled in the study and treatment was well tolerated. Grade 3 AEs included diarrhea and vomiting.

Abstract #9553, Poster
#161:
A Phase 1b Study of Napabucasin plus Weekly Paclitaxel in Patients with Advanced Melanoma

Lead Author: William Jeffery Edenfield, M.D.; Greenville Health System Cancer Institute

Findings from this study suggest clinical safety of napabucasin plus weekly paclitaxel and encouraging anti-cancer activity in patients with previously treated advanced melanoma.

12 patients were enrolled after having received a median of three prior lines of therapy. Treatment was well tolerated with Grade 3 AEs including diarrhea, abdominal pain and fatigue.

Sunday, June 4 from 8:00 AM – 11:30 AM CDT; Hall A

Abstract #1084, Poster
#76A:
Phase 2 Study of Napabucasin with Weekly Paclitaxel in Previously Treated Metastatic Breast Cancer

Lead Author: William Jeffery Edenfield, M.D.; Greenville Health System Cancer Institute

Findings from this study suggest clinical safety and tolerability of napabucasin plus weekly paclitaxel and signs of anti-cancer activity in patients with heavily pretreated metastatic breast cancer.

50 patients were enrolled, including 34 with triple-negative disease. Patients were heavily pretreated, having received a median of five prior lines of systemic therapy. Treatment was well tolerated with Grade 3 AEs including diarrhea and one patient with Grade 4 diarrhea.

About Napabucasin
Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.1 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 Amcasertib
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.

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:
Sara Baker
CHAMBERLAIN PR
212-849-9474
sara.baker@inventivhealth.com

RELATED LINKS
http://www.bostonbiomedical.com

1Li Y, Rogoff HA et al. PNAS. 112(6):1839-44, 2015.

SOURCE Boston Biomedical, Inc.