On December 5, 2017 Medidata (NASDAQ:MDSO), the leading global provider of cloud-based technology and data analytics for clinical research, reported that CytomX Therapeutics, Inc., a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, will expand its partnership to include Medidata Regulated Content Management (RCM) solutions, eTMF Archive and SOP Management (Press release, CytomX Therapeutics, DEC 5, 2017, View Source [SID1234522418]).

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"We’ve created a seamless offering with the Medidata platform that can facilitate everything during clinical research, from data collection and management to compliance"
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With the addition of Medidata RCM, CytomX will now manage regulated and nonregulated content in a single, unified platform. Accessible through the Medidata Clinical Cloud, CytomX will integrate standard operating procedure (SOP) management and electronic trial master file (eTMF) archive to manage all content, data and workflows.

CytomX is also currently using Medidata Rave, the world’s leading solution for capturing, managing and reporting patient data and Medidata Balance, randomization and trial supply management (RTSM) application, for its oncology research studies.

"We’ve created a seamless offering with the Medidata platform that can facilitate everything during clinical research, from data collection and management to compliance," said Mike Capone, chief operating officer at Medidata. "Medidata’s industry difference is that we enable our customers to take control of their data, helping them meet regulatory requirements and ensure efficient clinical trials."

On December 5, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will update data from its completed pilot study1 of NY‑ESO SPEAR T-cell therapy in multiple myeloma patients in the setting of autologous stem cell transplant (ASCT) presented at the annual ASH (Free ASH Whitepaper) meeting at the Georgia World Congress Center in Atlanta, Ga (Press release, Adaptimmune, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321280 [SID1234522387]).

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During an oral presentation, Dr. Edward Stadtmauer, University of Pennsylvania Abramson Cancer Center, will present an update on all twenty-five multiple myeloma patients treated in Adaptimmune’s pilot study in the setting of ASCT. The data cut-off for the abstract was through July 2017, the data cut-off for the oral presentation was August 16, 2017.

Oral Presentation 845: Phase I/IIa Study of Genetically Engineered NY-ESO-1 SPEAR T-Cells Administered Following Autologous Stem Cell Transplant in HLA-a*02+ Patients with Advanced Multiple Myeloma: Long Term Follow‑up (NCT01352286)

Session: 703. Adoptive Immunotherapy: Gene Engineered T cells for Hematologic Malignancies

Time: Monday, December 11, 2017: 5:30 PM (EST)

Location: Bldg. B, Level 2, B206 (Georgia World Congress Center)

Result highlights from the abstract include:

Overall response rate (ORR) at day 100 was 76% (1 stringent complete response [sCR]; 12 very good partial response [VGPR]; 6 partial response [PR])
At year 1, 13 patients were progression free (52%) of which 11 were responders (1 sCR; 1 CR; 8 VGPR; 1 PR)
Three patients remain disease progression-free at 39, 56, and 61 months post T-cell infusion
Median progression free survival (PFS) was ~13 months (range 3-61 months)
Eleven of 25 patients (44%) are alive, and median survival was ~35 months (range 6-68 months)
Autologous GvHD (24%) was reported in 6 patients (3 G3, 3 ≤G2); all resolved with corticosteroids and supportive therapy
No fatal adverse events have been reported

On December 5, 2017 BioLineRx presented Corporate Presentation (Presentation, BioLineRx, DEC 5, 2017, View Source [SID1234522388]).

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Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On December 5, 2017 BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that on this date it hosts its investor breakfast meeting at the Convene Conference Center near Grand Central in New York, NY (Press release, BioLineRx, DEC 5, 2017, View Source;p=RssLanding&cat=news&id=2321125 [SID1234522378]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Philip Serlin, Chief Executive Officer of BioLineRx, stated, "This annual event gives us the opportunity to directly meet with our investors for updates on our progress: steady advancements on our multiple clinical programs in stem cell mobilization, combination immunotherapies and acute myeloid leukemia (AML), as well as our new and novel immuno-oncology therapy. And we are pleased to feature a presentation by Dr. John DiPersio, Chief, Division of Oncology at Washington University School of Medicine, an internationally-renowned hematologist and expert on the role of CXCR4 in stem-cell mobilization and hematological malignancies. There remains a large, unmet need for cancer therapies and we remain focused on advancing programs that improve upon current treatments and the standard of care."

In addition to the keynote presentation by Dr. DiPersio on bone marrow transplantation and the role of CXCR4 in cancer, additional topics for discussion at the ongoing BioLineRx investor breakfast meeting include: (i) presentation on BL-8040 clinical development plans in immuno-oncology combinations and AML, as well as on the upcoming GENESIS Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation in multiple myeloma patients; (ii) presentation of AGI-134, the Company’s novel immuno-oncology project; and (iii) an overview of the Company’s plans and expected milestones for 2018.

BioLineRx is hosting a live webcast of the investor breakfast today between 9:00-10:30 am ET. To access the webcast, please go to the breakfast event page on BioLineRx’s website. An audio replay of the meeting will also be available for approximately three months following the meeting on the breakfast event page.