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Subjects: TDS, TRI, FVT

Boston Biomedical, Inc. Announces Presentations for Investigational Agents Napabucasin and DSP-7888 (ombipepimut-S*) to be Featured at ASCO 2018


CAMBRIDGE, Mass., May 17, 2018 /PRNewswire/ -- Boston Biomedical, Inc., an industry leader in the development of novel cancer therapeutics, today announced that it will feature several studies evaluating investigational compounds napabucasin and DSP-7888 at the upcoming 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from June 1-5.

Napabucasin is currently being investigated in phase 3 studies ? CanStem303C for metastatic colorectal cancer (NCT02753127) and CanStem111P for metastatic pancreatic cancer (NCT02993731). Included in the napabucasin studies that will be presented at ASCO are data from a phase 1b/2 trial in patients with metastatic pancreatic cancer (Poster, Bekaii-Saab, 6/3, 8 a.m. - 11:30 a.m.). Boston Biomedical, Inc. will also present detailed findings from the phase 3 BRIGHTER trial evaluating the efficacy and safety of napabucasin plus paclitaxel for pretreated advanced gastric and gastroesophageal junction adenocarcinoma (Poster discussion, Shah, 6/3, 4:45 p.m. - 6 p.m.). Last year, the Company announced that the study was unblinded early after the Data and Safety Monitoring Board (DSMB) determined that the study was unlikely to reach its primary endpoint. No safety concerns were identified by the DSMB. Separately, data with napabucasin in advanced thymoma and thymic carcinoma, rare tumor types, is available as an online publication. 

DSP-7888 is being evaluated in several early and mid-stage studies across multiple tumor types. The Company will present the study design of a phase 2 study of DSP-7888 in combination with bevacizumab for recurrent or progressive glioblastoma, WIZARD201G (Poster, de Groot, 6/2, 1:15 p.m. - 4:45 p.m.), which recently began enrolling patients (NCT03149003).

"As our pipeline and clinical development program continues to evolve, we are looking forward to sharing our learnings with the scientific community at the ASCO annual meeting," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. 

Abstracts to be presented by Boston Biomedical, Inc. include the following:

Abstract Title

Details

Authors

A randomized, multicenter phase 2 study of
DSP-7888 dosing emulsion in combination with
bevacizumab (Bev) versus Bev alone in
patients with recurrent or progressive
glioblastoma

Abstract #TPS2071

June 2, 1:15-4:45 PM

Poster presentation

Hall A

John Frederick de
Groot, University
of Texas MD
Anderson Cancer
Center

The BRIGHTER trial: A phase 3 randomized
double-blind study of napabucasin (NAPA) plus
paclitaxel (PTX) versus placebo (PBO) plus
PTX in patients (pts) with pretreated advanced
gastric and gastroesophageal junction (GEJ)
adenocarcinoma

Abstract #4010

June 3, 8:00-11:00 AM

Poster presentation

Hall A

June 3, 4:45 ? 6:00 PM

Poster Discussion Session

Hall D2

Manish A. Shah,

Weill Cornell
University, New
York

Phase 1b/2 trial of cancer stemness inhibitor
napabucasin (NAPA) + nab-paclitaxel (nPTX)
and gemcitabine (Gem) in metastatic
pancreatic adenocarcinoma (mPDAC)

Abstract #4110

June 3, 8:00-11:00 AM

Poster presentation

Hall A

Tanios S. Bekaii-
Saab, Mayo
Clinic Cancer
Center

A phase 1b study of napabucasin (NAPA) +
weekly paclitaxel (PTX) in patients (pts) with
advanced thymoma and thymic carcinoma

Abstract #e20578

Online publication only

Maitri Kalra,
Indiana University

 

About Napabucasin
Napabucasin is an orally-administered investigational agent that affects multiple oncogenic cellular pathways, including inhibition of the STAT3 pathway, which has been implicated in viability of cancer cells and cancer cells with stemness phenotypes.

Napabucasin is currently being investigated in CanStem303C, a phase 3 study for metastatic colorectal cancer (NCT02753127), and CanStem111P, a phase 3 study for metastatic 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 DSP-7888 (ombipepimut-S*)
DSP-7888 is an investigational cancer peptide vaccine containing peptides that induce WT1-specific cytotoxic T lymphocytes (WT1-CTL) and helper T cells to attack WT1-expressing cancerous cells found in various types of hematologic and solid tumors. Researchers have identified that by adding helper T cell inducing peptides, improved outcomes may be achieved compared to a killer peptide treatment regimen alone.

DSP-7888 is currently being investigated in three Wizard201G monotherapy studies: a phase 1/2 study in myelodysplastic syndrome (MDS) (NCT02436252), a phase 1/2 study in pediatric patients with relapsed or refractory high grade gliomas (NCT02750891) and a phase 1 study in advanced malignancies (NCT02498665). DSP-7888 is currently being investigated in combination with bevacizumab in a phase 2 study in patients with recurrent or progressive glioblastoma (NCT03149003) and in a phase 1 study in combination with nivolumab or atezolizumab in patients with advanced solid tumors (NCT03311334). In 2017, the U.S. Food and Drug Administration granted Orphan Drug Designations for DSP-7888 in MDS and brain cancer. More information on DSP-7888 and ongoing clinical studies can be found at www.BostonBiomedical.com.

*Adegramotide/nelatimotide is also assigned as its international nonproprietary name (INN).

About Boston Biomedical, Inc.
Boston Biomedical, Inc. was founded in November 2006 and is wholly owned by Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan. Boston Biomedical is a leading developer of novel cancer therapeutics with the goal of significantly improving patient outcomes. The company's most advanced research programs are focused on investigational agents that inhibit multiple oncogenic pathways, including cancer stemness pathways, and modifying immune responses. Boston Biomedical is headquartered in Cambridge, Massachusetts, USA.

Additional information about the company and its 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.

SOURCE Boston Biomedical, Inc.


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