On May 17, 2018 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director President and CEO: Hiroshi Nomura) reported 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) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 1 to June 5, 2018 (Press release, Sumitomo Dainippon Pharma, MAY 17, 2018, View Source [SID1234526742]).

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【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.
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【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. DSP7888 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.
Contact: Public & Investor Relations Group, Corporate Governance
Sumitomo Dainippon Pharma Co., Ltd.
TEL: +81-6-6203-1407 (Osaka); +81-3-5159-3300 (Tokyo)

On May 17, 2018 Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported it has initiated ALX148 combination dosing with targeted antibody therapies in its Phase 1 clinical program in patients with advanced solid tumors and lymphoma (Press release, Alexo Therapeutics, MAY 17, 2018, View Source [SID1234526778]). The Company will present updated data on ALX148 at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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Poster Presentation Information
Title: A Phase 1 Study of ALX148, a CD47 Blocker, Alone and in Combination with Established Anti-Cancer Antibodies in Patients with Advanced Malignancy and Non-Hodgkin Lymphoma
Session Name: Developmental Therapeutics-Immunotherapy
Session Date: June 04, 2018
Presentation Time: 8:00am – 11:30am CT
Abstract Number: 3068

"The initiation of ALX148 combination cohorts marks the next important milestone in Alexo’s development," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of Alexo Therapeutics. "ALX148 is designed to enhance the efficacy of antibody-based therapies, while avoiding the dose-limiting toxicities that have been seen with other CD47-targeted approaches in the clinic. ALX148 is generally well tolerated in patients with advanced tumors and exhibits favorable pharmacokinetics and CD47 target occupancy at doses evaluated. No maximum tolerated dose of ALX148 was reached. With broad therapeutic potential across many types of cancer, we are eager to now be evaluating ALX148 in combination with select anti-cancer therapeutic antibodies."

The ALX148 Phase 1 clinical trial is a two-part study that evaluates the safety, pharmacokinetics, and pharmacodynamics of ALX148. Enrollment to the single-agent dose escalation phase is complete and the combination therapy portion in which ALX148 is administered with approved anti-cancer antibodies is ongoing. Clinical data will be presented at the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. For more information about the Phase 1 study, please visit clinicaltrials.gov, identifier number NCT03013218.

About ALX148
ALX148 is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and specifically binds CD47 and blocks its interaction with SIRPα, thus inhibiting a key immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 bridges innate and adaptive immunity to enhance anti-tumor response in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells. ALX148 is currently being investigated in a Phase 1 study in combination with checkpoint inhibitors and targeted anti-cancer antibodies (NCT03013218)

On May 17, 2018 NantHealth, Inc. (NASDAQ-GS: NH), a next-generation, evidence-based, personalized healthcare company, reported that its management will be presenting at the Bank of America Merrill Lynch 2018 Health Care Conference on Thursday, May 17, 2018, at 11:20 a.m. PT in Las Vegas (Press release, NantHealth, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349532 [SID1234526743]).

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On May 17, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported two data presentations supporting plans for rapid development of avapritinib, a selective KIT and PDGFRα inhibitor, in patients with gastrointestinal stromal tumors (GIST) and systemic mastocytosis (SM) (Press release, Blueprint Medicines, MAY 17, 2018, View Source;p=RssLanding&cat=news&id=2349637 [SID1234526761]).

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Data from a retrospective natural history study of previously treated patients with advanced PDPGFRα D842V-driven GIST will be presented in a poster session at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois on June 1-5, 2018. In addition, updated data from Blueprint Medicines’ Phase 1 EXPLORER trial of avapritinib in patients with advanced SM will be presented in a poster session at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden on June 14-17, 2018.

The accepted abstracts are listed below and are now available online on the ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conference websites, respectively: View Source and View Source

2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting

Presentation Title: A retrospective natural history study of patients (pts) with PDGFRα D842V mutant advances gastrointestinal stromal tumor (GIST) previously treated with a tyrosine kinase inhibitor (TKI)
Session Title: Sarcoma
Session Date & Time: Saturday, June 2, 2018 from 8:00 a.m. – 11:30 a.m. CT (9:00 a.m. – 12:30 p.m. ET)
Abstract Number: 11533
Poster Board Number: 278
Location: Hall A, McCormick Place

23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper)

Presentation Title: Avapritinib (BLU-285), a Selective KIT Inhibitor, is Associated with High Response Rate and Tolerable Safety Profile in Advanced Systemic Mastocytosis (AdvSM): Results of a Phase 1 Study
Session Title: Myeloproliferative neoplasms – Clinical
Session Date & Time: Friday, June 15, 2018 from 17:30 – 19:00 CEST (11:30 a.m. – 1:00 p.m. ET)
Abstract Number: PF612
Location: Poster Area, Stockholmsmässan

On May 17, 2018 Obsidian Therapeutics, Inc., a biotechnology company dedicated to the development of next-generation cell and gene therapies with pharmacologic operating systems, reported that the company presented preclinical data on its regulated IL12 and IL15 programs at the Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) in Chicago, IL (Press release, Obsidian Therapeutics, MAY 17, 2018, View Source [SID1234526779]).

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Obsidian is developing CAR-T therapies that incorporate Destabilizing Domains (DDs) to regulate expression of immune cytokines, thereby providing pharmacologic control over these potent but potentially toxic molecules. DDs are small, fully-human protein domains that confer conditional stability to a fused payload protein that is engineered into a cell or gene therapy product. IL12 and IL15 are two important immune cytokines that play important roles in tumor response to adoptive cell therapy but which require precise control to optimize their therapeutic benefit.

"IL12 and IL15 are critical factors that promote CAR-T cell expansion, persistence, and penetration into solid tumors," said Vipin Suri, Ph.D., Vice President of Discovery of Obsidian. "However, unregulated expression of these cytokines by CAR-T or other adoptively-transferred cells can potentially compromise safety and efficacy. Obsidian’s technology allows the treating physician to control expression of IL12 and IL15 via the use of safe, FDA-approved small-molecule drugs, and the preclinical data we present today demonstrate the elegance and effectiveness of this approach."

Highlights of the two preclinical presentations follow:

Abstract number 113: Exogenous In Vitro and In Vivo Regulation of Interleukin-12 Secretion from T Cells Using Destabilizing Domain Technology
Presenter: Dexue Sun

Session: Cancer – Immunotherapy, Cancer Vaccines I

Construction of a single-chain regulated IL12 using a DD derived from FKBP
Demonstration of small molecule-regulated expression of IL12 in a variety of cell types including primary human T cells
Use of different promoters to tune expression level of the regulated cytokine
Demonstration of in vivo regulation of IL12 in adoptively transferred T cells
Development of a CD19 CAR construct co-expressing regulated IL12, with in vitro data showing effective performance of the regulated cytokine cassette
Abstract number 133: Dose dependent exogenous regulation of membrane bound Interleukin-15-Interleukin-15 receptor alpha fusion protein for adoptive T-cell therapy
Presenter: Christopher Reardon
Session: Cancer – Targeted Gene & Cell Therapy I

Design of regulated membrane-bound IL15-IL15 Receptor Alpha (mbIL15) fusion construct incorporating DDs for pharmacologic control with small molecule ligands
Construction of mbIL15-DD construct incorporating human DDs, regulated by FDA-approved small-molecule drugs
Dose- and time-dependent regulation of mbIL15 expression in multiple cell types
Regulation of mbIL15 expression on primary human T cells in vivo
About Destabilizing Domains

Obsidian uses Destabilizing Domains (DDs) to enable pharmacologic regulation of protein activity for next-generation cell and gene therapies. Obsidian’s DDs are small, fully-human protein domains that confer conditional stability to a fused payload protein. In the absence of a specific small-molecule ligand, the fusion protein is rapidly degraded, whereas in the presence of the ligand, the fusion protein becomes stable and functional. Obsidian uses this approach to equip engineered cells with controllable functions that can be precisely tuned by the administration of non-immunosuppressive, small-molecule medicines that are readily available and dispensed by the treating physician.