Boston Biomedical, Inc. Highlights Presentations on Investigational Agents Napabucasin and DSP-7888 (ombipepimut-S*) at ASCO 2018

CAMBRIDGE, Mass., June 1, 2018 /PRNewswire-USNewswire/ -- Boston Biomedical., Inc., an industry leader in the development of novel cancer therapeutics, today announced that it will present new research evaluating investigational compound napabucasin in the treatment of multiple cancers, including metastatic pancreatic adenocarcinoma, advanced gastric and gastroesophageal junction adenocarcinoma, and advanced thymoma and thymic carcinoma at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from June 1-5. The company will also present background on a clinical study evaluating investigational compound DSP-7888 for the treatment of glioblastoma, which recently began enrolling patients.

On June 3, updated data from a phase 1b/2 trial evaluating napabucasin in combination with nab-paclitaxel and gemcitabine in patients with metastatic pancreatic adenocarcinoma (mPDAC) will be presented (abstract #4110, NCT02231723). Trial results to date showed napabucasin was generally well-tolerated when combined with nab-paclitaxel and gemcitabine, with the majority of treatment-emergent adverse events being gastrointestinal in nature, mainly Grade 1 or 2, and manageable with supportive medication. Adverse events for these trials are consistent with those noted in previous trials and include diarrhea, fatigue, and nausea. Study investigators identified the recommended phase 2 dose of napabucasin as 240 mg twice daily in combination with nab-paclitaxel and gemcitabine.¹

Secondary measures showed that napabucasin in combination with nab-paclitaxel and gemcitabine showed signs of clinical activity in patients with mPDAC, with disease control rate (DCR) observed in 46 of 59 patients (78 percent), including two complete responses (3 percent) and 26 partial responses (44 percent), and DCR of 92 percent observed among the 50 patients evaluable by RECIST criteria. Secondary endpoints also showed a maturing median progression-free survival (PFS) of 7.06 months (95% CI: 5.68, 9.00) and overall survival (OS) of 9.59 months (8.11, 13.50) in patients with mPDAC receiving napabucasin in combination with nab-paclitaxel and gemcitabine.¹

"Pancreatic cancer continues to be one of the most difficult to treat cancers, and new innovative treatments are urgently needed for these patients," said Tanios S. Bekaii-Saab, M.D., FACP, lead author and presenter of the company's phase 1b/2 data and co-leader of the GI Cancer Program at Mayo Clinic Cancer Center. "Building off data that was shared last year, these encouraging findings demonstrate the potential of combining napabucasin with chemotherapy to improve patient outcomes in pancreatic cancer."

Additionally at ASCO, the company is presenting the efficacy and safety results from the phase 3 BRIGHTER trial, which evaluated napabucasin plus paclitaxel versus paclitaxel plus placebo in patients with pretreated advanced gastric and gastroesophageal junction adenocarcinoma, during a poster discussion on June 3 (abstract #4010, NCT02178956). The company previously reported in June 2017 that this trial did not meet its primary endpoint of extending OS compared with paclitaxel alone. No additional safety concerns were identified by the Data and Safety Monitoring Board (DSMB).²

Separately, early findings from a phase 1b trial evaluating napabucasin in advanced thymoma and thymic carcinoma, rare tumor types, are available as an online publication (abstract #e20578, NCT01325441). To date, the trial has demonstrated clinical activity and manageable side effects of napabucasin in 16 patients.³

"The data we are presenting at this year's ASCO speak to our commitment to developing therapies for patients with the highest unmet needs," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. "We are seeing some encouraging findings in our napabucasin program and are excited to share more about our evolving pipeline, including DSP-7888."

The company is also sharing a presentation on DSP-7888, an investigational cancer vaccine, which is being evaluated in several early and mid-stage trials across multiple tumor types. An overview of the trial design of the phase 2 trial will be shared in a Trial in Progress presentation at the meeting (abstract #TPS2071). The phase 2 trial of DSP-7888 in combination with bevacizumab for recurrent or progressive glioblastoma, WIZARD201G, is currently enrolling patients in an active-controlled, open label multicenter trial (NCT03149003).⁴

Presentations by Boston Biomedical, Inc. include the following:

    Abstract Title   Details                    Authors
    --------------   -------                    -------

    A randomized,      John Frederick de Groot,
     multicenter      recurrent or               University of Texas MD
     phase 2 study    progressive                Anderson Cancer Center
     of DSP-7888      glioblastoma
     dosing emulsion
     in combination
     with
     bevacizumab
     (Bev) versus
     Bev alone in
     patients with

                     June 2, 1:15-4:45 PM
                     Abstract #TPS2071
                     Poster presentation

                     Hall A
    ---              ------

    The BRIGHTER     Abstract #4010
     trial: A phase   patients (pts)
     3 randomized     with pretreated
     double-blind     advanced
     study of         gastric and
     napabucasin      gastroesophageal
     (NAPA) plus      junction (GEJ)
     paclitaxel       adenocarcinoma
     (PTX) versus
     placebo (PBO)
     plus PTX in                                Manish A. Shah,

                     June 3, 8:00-11:00 AM       Weill Cornell University,
                                                 New York

                     Poster presentation

                     Hall A

                     June 3, 4:45 - 6:00 PM

                     Poster Discussion Session

                     Hall D2
    ---              -------

    Phase 1b/2         Tanios S. Bekaii-Saab,
     trial of cancer  pancreatic                 Mayo Clinic Cancer Center
     stemness         adenocarcinoma
     inhibitor        (mPDAC)
     napabucasin
     (NAPA) + nab-
     paclitaxel
     (nPTX) and
     gemcitabine
     (Gem) in
     metastatic

                     June 3, 8:00-11:00 AM
                     Abstract #4110
                     Poster presentation

                     Hall A


    ---

    A phase 1b study                             Maitri Kalra, Indiana
     of napabucasin                              University
     (NAPA) + weekly
     paclitaxel
     (PTX) in
     patients (pts)
     with advanced
     thymoma and
     thymic
     carcinoma       Abstract #e20578

                     Online publication only
    ---              -----------------------

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 trial for metastatic colorectal cancer (NCT02753127) and CanStem111P, a phase 3 trial for metastatic pancreatic cancer (NCT02993731). It is also being investigated in earlier phase trials in multiple solid and hematologic malignancies. In 2016, the U.S. Food and Drug Administration granted Orphan Drug Designation for napabucasin in pancreatic cancer. More information on napabucasin and ongoing clinical trials can be found at www.BostonBiomedical.com.

About DSP-7888 (ombipepimut-S*)
DSP-7888 is an investigational cancer vaccine containing two peptides that induces 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 monotherapy studies: a phase 1/2 trial in myelodysplastic syndrome (MDS) (NCT02436252), a phase 1/2 trial in pediatric patients with relapsed or refractory high grade gliomas (NCT02750891), and a phase 1 trial in advanced malignancies (NCT02498665). DSP-7888 is currently being investigated in combination with bevacizumab in a phase 2 trial in patients with recurrent or progressive glioblastoma (NCT03149003) and in a phase 1 trial 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 trials can be found at www.BostonBiomedical.com.

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

About Boston Biomedical, Inc.
Boston Biomedical, Inc. 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. Headquartered in Cambridge, Massachusetts, Boston Biomedical, Inc. is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., a pharmaceutical company based in Japan.

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.

¹ Saab T et al. Phase 1b/2 trial of cancer stemness inhibitor napabucasin (NAPA) + nab-paclitaxel (nPTX) and gemcitabine (Gem) in metastatic pancreatic adenocarcinoma (mPDAC) [abstract]. In: American Society of Clinical Oncology; 2018 June 1-5; McCormick Place, Chicago, Illinois (IL). Abstract 4110.

² Shah MA et al. 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]. In: American Society of Clinical Oncology; 2018 June 1-5; McCormick Place, Chicago, Illinois (IL). Abstract 4010.

³ Kalra M et al. A phase 1b study of napabucasin (NAPA) + weekly paclitaxel (PTX) in patients (pts) with advanced thymoma and thymic carcinoma [abstract]. In: American Society of Clinical Oncology. 2018 June 1-5. McCormick Place, Chicago, Illinois (IL). Abstract e20578.

⁴ de Groot F et al. 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]. In: American Society of Clinical Oncology. 2018 June 1-5. McCormick Place, Chicago, Illinois (IL). Abstract TPS2071.

CONTACT: For general inquiries: Boston Biomedical, Inc., 617-674-6800, or For media inquiries: Rachel Newman, Spectrum™, 404-865-3603, mediainquiries@bostonbiomedical.com