Print（PDF/97KB） May 17, 2018 R&D

Sumitomo Dainippon Pharma announces the Clinical Data will be presented at ASCO 2018

Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura) announced today that a total of 6 presentations including clinical study results and designs for investigational anti-cancer agents napabucasin (BBI608), DSP-7888 and TP-0903 will be made at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from June 1 to June 5, 2018.

*The abstracts are now available on the official website of ASCO.
(http://abstracts.asco.org/214/IndexView_214.html)

Napabucasin: Study result of BRIGHTER Study

Abstract number	Title of presentation	Date and Time, Location	Study number	Cancer Type
4010	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.	June 3, 2018 8：00 AM-11：30 AM, Hall A 4:45 PM-6:00 PM, Hall D2 (Poster Discussion)	BRIGHTER Study： NCT02178956	gastric and gastro-esophageal junction (GEJ) adeno-carcinoma

Napabucasin: Study results of Phase 1 and 1/2 study, 2 presentations

Abstract number	Title of presentation	Date and Time, Location	Study number	Cancer Type
4110	Phase 1b/2 trial of cancer stemness inhibitor napabucasin (NAPA) + nab-paclitaxel (nPTX) and gemcitabine (Gem) in metastatic pancreatic adenocarcinoma (mPDAC).	June 3, 2018 8：00 AM-11：30 AM, Hall A	118 Study: NCT02231723	pancreatic adeno-carcinoma
e20578	A Phase 1b Study of Napabucasin (NAPA) + Weekly Paclitaxel (PTX) in Patients (pts) with Advanced Thymoma and Thymic Carcinoma.	Online publication only	201Study: NCT01325441	thymoma and thymic carcinoma

(Reference) Napabucasin: Study result of investigator-initiated clinical study, 1 presentation

Abstract number	Title of presentation	Date and Time, Location	Study number	Cancer Type
3530	Multicenter phase I/II trial of BBI608 and pembrolizumab combination in patients with metastatic colorectal cancer (SCOOP Study): EPOC1503	June 3, 2018 8：00 AM-11：30 AM, Hall A	SCOOP Study: NCT02851004	colorectal cancer

* This trial is investigator-initiated clinical study conducted by National Cancer Center Hospital East, Japan.

DSP-7888: Study design of Phase 2 study, 1 presentation

Abstract number	Title of presentation	Date and Time, Location	Study number	Cancer Type
TPS2071	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.	June 2, 2018 1：15 PM-4：45 PM, Hall A	NCT03149003	glioblastoma

TP-0903: Study design of Phase 1 study, 1 presentation

Abstract number	Title of presentation	Date and Time, Location	Study number	Cancer Type
TPS2612	A phase 1a / 1b first-in-human, open-label, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study of oral TP-0903, a potent inhibitor of AXL kinase, administered daily for 21 days to patients with advanced solid tumors.	June 4, 2018 8：00 AM-11：30 AM, Hall A	NCT02729298	solid tumors

(Reference)

【About napabucasin】
Napabucasin is an orally administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3. By inhibiting pathways involved in the maintenance of cancer stemness, it may provide a new therapeutic option against the challenges in cancer treatment such as treatment resistance, recurrence and metastasis. Napabucasin has been shown to inhibit STAT3 pathways, Nanog pathways and β-catenin pathways in pre-clinical studies.

【About DSP-7888】
DSP-7888 is a therapeutic cancer peptide vaccine derived from Wilms' tumor gene 1 (WT1) protein. DSP-7888 is a vaccine containing peptides that induces WT1-specific cytotoxic T lymphocytes (CTLs) and helper T cells. DSP-7888 is expected to become a treatment option for patients with various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1-specific CTLs that attack WT1-expressing cancer cells. By adding a helper T cell-inducing peptide, improved efficacy over that observed with a CTL-inducing peptide alone may be achieved. DSP-7888 is expected to be an option for a wide range of patients.

【About TP-0903】
TP-0903 is an AXL receptor tyrosine kinase inhibitor, which is known to be involved in acquiring resistance to conventional agents and developing metastatic capacity in cancer cells. TP-0903 may have anti-cancer activities on various cancer types through blocking transition from epithelial to mesenchymal phenotype by inhibiting AXL. TP0903 has been shown to inhibit AXL signaling and reverse the mesenchymal to epithelial phenotype in pre-clinical studies.

* These agents have not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of cancer or any other disorder.