Sumitomo Dainippon Pharma announces the data of an investigational WT1 cancer peptide vaccine, DSP-7888 will be presented at the ASH 2016

Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; "Sumitomo Dainippon Pharma") announced today that clinical data of an investigational WT1 cancer peptide vaccine, DSP-7888 will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego from December 3 to 6, 2016. Planned poster sessions include: 1. Abstract #4335, [637. Myelodysplastic Syndromes―Clinical Studies: Poster III] Preliminary Results from a Phase 1/2 Study of DSP-7888, a Novel WT1 Peptide-Based Vaccine, in Patients with Myelodysplastic Syndrome (MDS) Presenter: S. Miyakoshi (Department of Hematology, Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology, Tokyo, Japan) Monday, December 5 from 6:00 p.m. - 8:00 p.m. (local time), Hall GH The abstract is now available on the official website of ASH (URL: https://ash.confex.com/ash/2016/webprogram/Paper89176.html) 【Highlights of the abstract】 In phase 1 portion, azacitidine (the first-line treatment option) failure higher-risk (7 patients) and transfusion-dependent lower-risk (5 patients) MDS patients (total 12 patients) were enrolled in 3.5 or 10.5 mg/body cohorts. Safety and tolerability were evaluated, and delayed type hypersensitivity (DTH), WT1-specific CTL induction and expression of WT1 mRNA in peripheral blood and bone marrow cells were also examined. DSP-7888 was well-tolerated in MDS patients and dose-dependent toxicity was not observed except for ISR, although ISR was observed in all patients. Disease control rate (PR+SD) was observed in 66.6 % and CTL induction, one of the secondary clinical activities, was observed in 50% of the 12 evaluable patients. 2. Abstract #4715, [802. Chemical Biology and Experimental Therapeutics: Poster III] DSP-7888, a Novel Cocktail Design of WT1 Peptide Vaccine, and Its Combinational Immunotherapy with Immune Checkpoint-Blocking Antibody Against PD-1 Note: This data is non-clinical evaluation. Presenter: M. Goto (DSP Cancer Institute, Sumitomo Dainippon Pharma Co., Ltd., Japan) Monday, December 5 from 6:00 p.m. - 8:00 p.m. (local time), Hall GH The abstract is now available on the official website of ASH (URL: https://ash.confex.com/ash/2016/webprogram/Paper89006.html) Reference Information (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. DSP-7888 induces the WT1 specific cytotoxic T lymphocytes (CTLs), 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. A phase 2 study in patients with MDS who had received and not responded to azacitidine, and a phase 2 study in pediatric patients with relapsed or refractory high grade glioma are currently ongoing in Japan. A phase 1 study in patients with solid tumors and hematologic malignancies is ongoing in the U.S.

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