Boston Biomedical Announces First Clinical Data for Investigational WT1 Cancer Peptide Vaccine, DSP-7888, at ASH Annual Meeting & Exposition

CAMBRIDGE, Mass., Dec. 6, 2016 /PRNewswire/ -- Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, featured two posters on data for DSP-7888, a novel investigational cancer peptide vaccine, at the 2016 American Society of Hematology (ASH) Annual Meeting and Exposition, held from December 3 to 6, in San Diego. These include the first clinical data for the compound, from a Phase I/II trial in adult patients with myelodysplastic syndrome (MDS) who progressed on or after first-line azacitidine (AZA) treatment.

DSP-7888 contains the peptides to induce WT1 (Wilms' tumor gene 1)-specific cytotoxic T lymphocytes (CTL) and helper T cells, which attack WT1-expressing cancerous cells found in various types of hematologic and solid cancers. In the Phase I portion of the study, DSP-7888 was well tolerated in MDS patients, and CTL induction and delayed type hypersensitivity (DTH) were detected; the data also demonstrated preliminary signs of clinical activity. The Phase II portion of the trial is currently ongoing to evaluate the efficacy and safety in higher-risk MDS patients after AZA failure.

"DSP-7888 is the third compound in our portfolio to move into clinical investigation, signifying our growing pipeline of first-in-class agents for the potential treatment of cancers with a high unmet need," said Chiang J. Li, M.D. FACP, President, CEO and Chief Medical Officer of Boston Biomedical, and the Head of Global Oncology for Sumitomo Dainippon Pharma Group. "We are encouraged by the data at ASH, which show signs of preliminary activity in patients with MDS, and by the preclinical data exploring the potential synergistic effect of DSP-7888 with PD-1 checkpoint inhibition."

Highlights from the two data posters at ASH follow below:

Abstract #4335: Preliminary Results from a Phase 1/2 Study of DSP-7888, a Novel WT1 Peptide-Based Vaccine, in Patients with Myelodysplastic Syndrome (MDS)

• Miyakoshi S¹, Usuki K², Matsumura I³, Ueda Y⁴, HiromiI^{5, 6}, Miyamoto T⁵, Origuchi M⁷, Tagashira S⁷, Naoi I⁷, Naoe T⁸, Kizaki M⁹, Heike Y¹⁰, Akashi K¹¹, Miyazaki Y¹²
• 1. Department of Hematology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo; 2. Department of Hematology, NTT Medical Center Tokyo, Tokyo; 3. Department of Hematology and Rheumatology, Kindai University Hospital, Osaka, Japan; 4. Department of Hematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan; 5. Department of Hematology/Oncology, Kyushu University Hospital, Fukuoka, Japan; 6. Department of Hematology National Hospital Organization Kyushu Medical Center, Fukuoka, Japan; 7. Sumitomo Dainippon Pharma Co., Ltd., Tokyo; 8. National Hospital Organization Nagoya Medical Center, Nagoya, Japan; 9. Department of Hematology, Saitama Medical Center, Saitama, Japan; 10. Laboratory for Joint Research and Development, St Luke's International Hospital, Tokyo; 11. Department of Medicine and Biosystemic Science Faculty of Medicine, Kyushu University, Fukuoka, Japan; 12. Department of Hematology, Atomic Bomb Disease and Hibakusha Medicine Unit, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan
• The findings from the study demonstrated that DSP-7888 was tolerated in patients with MDS who progressed on or after first-line AZA. Of the 12 patients enrolled in the study, eight patients showed stable disease (SD) including three patients with hematological improvements (HIs) and the disease control rate (SD plus any HI) was 66.7%. WT1-specific CTL induction was observed in five patients and delayed type hypersensitivity was detected in eight patients. Seven high-risk AZA failure patients were enrolled and the current survival time in this population is 6.8 to 15.5 months.
• The most common adverse events (AEs) were injection site reactions (100%), of which half (6) became Grade 3. Other serious AEs included pyrexia (1) and myocarditis (1).

Abstract #4715: DSP-7888, a Novel Cocktail Design of WT1 Peptide Vaccine, and its Combinational Immunotherapy with Immune Checkpoint-Blocking Antibody against PD-1

• Goto M¹, Nakamura M¹, Suginobe N¹, Takasu H¹, Takanashi Y¹, Ban H¹, Li CJ²
• 1. DSP Cancer Institute, Sumitomo Dainippon Pharma Co., Ltd., Tokyo; 2. Boston Biomedical, Inc., Cambridge, MA
• Additional preclinical findings shared at the meeting exhibited a potential synergic effect between DSP-7888 and anti-PD-1 antibodies. The results demonstrated that the helper peptide included in DSP-7888 enhanced the response of CTL induction, contributing to lasting cytotoxic activities in the tumor immunosuppressive environment. Furthermore, the in vitro treatment with anti-PD-1 antibodies improved the activity of DSP-7888 induced CTLs.

About DSP-7888  
DSP-7888 is an investigational cancer peptide vaccine containing the peptides which induce WT1 (Wilms' tumor gene 1)-specific cytotoxic T lymphocytes and helper T cells, which attack WT1-expressing cancerous cells found in various types of hematologic and solid cancers. By adding a helper T cell-inducing peptide, improved efficacy over that observed with a killer peptide alone treatment regimen may be achieved.

DSP-7888 is currently being investigated in three monotherapy studies: a Phase I/II study in myelodysplastic syndrome (NCT02436252), a Phase I/II study in diffuse intrinsic pontine glioma, glioblastoma, or grade III or IV glioma (NCT02750891) and a Phase I study in advanced malignancies (NCT02498665). More information on DSP-7888 and ongoing clinical trials can be found at www.BostonBiomedical.com.

About Boston Biomedical   
Boston Biomedical, Inc. (Founder, President, CEO and CMO: Chiang J. Li, M.D. FACP) 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.

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SOURCE Boston Biomedical, Inc.

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