On May 17, 2018 Boston Biomedical, Inc., an industry leader in the development of novel cancer therapeutics, reported that it will feature several studies evaluating investigational compounds napabucasin and DSP-7888 at the upcoming 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago from June 1-5 (Press release, Boston Biomedical, MAY 17, 2018, View Source [SID1234526762]).
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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 (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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.