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 Poster Study Results
Author
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Saturday, June 3 from 8:00 AM - 11:30 AM CDT; Hall A
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Abstract #9052, Poster 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.
#378: A Phase 1b/2 Study
of Napabucasin with
Weekly Paclitaxel in
Advanced, Previously
Treated Non-Squamous
Non-Small Cell Lung
Cancer
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.
Lead Author: Carlos
Becerra, M.D.; U.S.
Oncology Research, TOPS
Phase I Program
Treatment was well tolerated with Grade 3
adverse events (AEs) including diarrhea and
fatigue.
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Currently enrolling patients globally,
CanStem303C will assess the efficacy of
napabucasin plus biweekly FOLFIRI (plus
bevacizumab at investigator discretion) in
Abstract #TPS3619, Poster patients with previously treated mCRC.
#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)
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.
Lead Author: Axel Grothey,
M.D.; Mayo Clinic Cancer
Center
--------------------------
Abstract #3529, Poster 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.
#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)
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.
Lead Author: Johanna C. Bendell, M.D.; Sarah Cannon Research Institute
and Tennessee Oncology, PLLC
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 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.
#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)
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.
Lead Author: Tanios S.
Bekaii-Saab, M.D.; Mayo
Clinic Cancer Center
AEs included Grade 1 diarrhea, nausea,
fatigue, neuropathy, Grade 2 alopecia, and
Grade 3 neutropenia.
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Abstract #TPS4148, Poster 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.
#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)
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.
Lead Author: Tanios S.
Bekaii-Saab, M.D.; Mayo
Clinic Cancer Center
------------------------
Abstract #4077, Poster 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.
#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)
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).
Lead Author: Bassel F. El-Rayes, M.D.; Winship Cancer Institute
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
---------------------------------------------------
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
Abstract #5548, Poster on prior taxane-based regimens.
#370: A Phase 1b/2 Study
of Napabucasin with
Weekly Paclitaxel in
Advanced, Previously
Treated Platinum
Resistant Ovarian Cancer
A total of 98 patients were enrolled in the
study and treatment was well tolerated. Grade
3 AEs included diarrhea and vomiting.
Lead Author: Carlos
Becerra, M.D.; U.S.
Oncology Research, TOPS
Phase I Program
---
Findings from this study suggest clinical
safety of napabucasin plus weekly paclitaxel
and encouraging anti-cancer activity in
patients with previously treated advanced
Abstract #9553, Poster melanoma.
#161: A Phase 1b Study of Napabucasin plus Weekly Paclitaxel in
Patients with 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.
Lead Author: William Jeffery Edenfield, M.D.; Greenville Health System
Cancer Institute
---------------------------------------------------------------------- ----------------------------------------------------------------------
Sunday, June 4 from 8:00 AM - 11:30 AM CDT; Hall A
--------------------------------------------------
Abstract #1084, Poster 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.
#76A: Phase 2 Study of Napabucasin with Weekly Paclitaxel in Previously
Treated 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.
Lead Author: William Jeffery Edenfield, M.D.; Greenville Health System
Cancer Institute
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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
(1)Li Y, Rogoff HA et al. PNAS. 112(6):1839-44, 2015.
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