On November 30, 2018 QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) and NeoGenomics, Inc. (NASDAQ: NEO) reported a master service agreement to accelerate the availability of innovative companion diagnostics that enable precision medicine for cancer patients (Press release, Qiagen, NOV 30, 2018, View Source [SID1234531758]). The partnership between QIAGEN and NeoGenomics, a leading provider of cancer-focused genetic testing services, will ensure Day-One patient access to FDA-approved molecular tests paired with newly approved drugs for cancer.

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Building on the U.S. Food and Drug Administration’s modernized regulatory approach to advanced diagnostics, especially next-generation sequencing (NGS) tests, the collaboration with NeoGenomics will allow QIAGEN and pharmaceutical partners to streamline the development and launch of targeted drugs and companion diagnostics to guide treatment decisions. The partnership offers flexible pathways leading to introduction of FDA-approved companion diagnostics simultaneously with launch of new therapies.

QIAGEN and NeoGenomics will discuss their efforts to expedite access for precision medicine solutions at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting and Exposition from December 1-4, 2018, in San Diego.

"As a leading provider of oncology testing for both clinical trials and patient care, NeoGenomics is uniquely positioned to assist pharmaceutical and biotech companies to develop and commercialize companion diagnostic tests. Our collaboration with QIAGEN will ensure that patients have access to the most advanced companion diagnostics to target new cancer medicines, as soon as those medicines are approved. We are excited to work with QIAGEN to deploy cutting edge technologies to remain at the forefront of precision medicine" said Douglas M. VanOort, Chairman and CEO of NeoGenomics.

"We are excited to collaborate with NeoGenomics to ensure immediate availability of QIAGEN companion diagnostics during clinical trials and upon approval by the FDA, supporting synchronized launches of new oncology drugs, to make a difference for patients," said Peer Schatz, CEO of QIAGEN. "Together with our Pharma partners, we are now planning to provide investigational use only (IOU) tests to NeoGenomics and other labs, enabling them to verify, set up and run our companion diagnostics in clinical trials and in anticipation of regulatory approval. The companion diagnostic services can be promoted by NeoGenomics through their national commercial teams starting with their FDA approval, facilitating the rapid adoption of innovative targeted therapies which can deliver meaningful benefits to patients. We look forward to discussing this approach further at ASH (Free ASH Whitepaper) 2018, and demonstrating our rapidly evolving Sample to Insight solutions to the world’s top hematology and oncology experts."

NeoGenomics has a national footprint and broad customer reach in cancer-related genetic testing services and one of the most comprehensive oncology-focused test menus. The master service agreement provides a flexible framework with multiple options for co-development, verification, setup, and launch of new companion diagnostics, including next-generation sequencing tests, for biomarker profiling paired with new targeted drugs.

As QIAGEN collaborates with pharma and biotech partners, co-development progresses from drug discovery and creation of a biomarker test, to clinical development evaluating the proposed drug and test, to validation for clinical use and then commercialization of the new drug and companion diagnostic. Commercial alignment and launch readiness for companion diagnostics at the time of drug approval have become increasingly important for QIAGEN´s pharmaceutical partners. For more information, please visit View Source

On November 30, 2018 Crescendo Biologics Ltd (Crescendo), the drug developer of novel, targeted T-cell enhancing therapeutics, reported that Takeda Pharmaceutical Company Limited (Takeda), has exercised an option under its existing, multi-target collaboration and license agreement (Press release, Crescendo Biologics, NOV 30, 2018, View Source [SID1234531757]). Takeda has taken an exclusive licence to Humabodies directed to one of its oncology targets.

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This licence option exercise comes substantially earlier than planned and marks the highly successful delivery and further pre-clinical evaluation by Takeda of Humabody leads meeting its stringent criteria.

Dr Peter Pack, CEO of Crescendo, commented:

"The team at Crescendo has made great progress on our Humabody programmes, working closely with the Takeda team. To date, we have met all the technical milestones on time or earlier than planned, which is proof of our excellent collaboration. We are delighted that the option to license has been taken by Takeda ahead of schedule and look forward to further future successes."

Chris Arendt, Head, Oncology Drug Discovery Unit & Immunology Unit, Takeda, commented:

"At Takeda, we continue to research diverse modalities to bring transformative treatments to patients with cancer. Our decision to exercise the licence was based on the quality of the Humabody leads and the potential we see to develop improved and differentiated immuno-oncology therapies."

Takeda’s option is part of the existing multi-target collaboration and licence agreement announced in October 2016 where Takeda received the right to develop and commercialise Humabody-based therapeutics resulting from the collaboration. Under the agreement, Crescendo is eligible to receive clinical development, regulatory and sales-based milestone payments of up to $754 million plus royalties on Humabody-based product sales by Takeda.

On November 30, 2018 Turnstone Biologics, a clinical-stage immuno-oncology company leading the next generation of oncolytic viral therapies, reported its pre-clinical data today supporting the development of a new Vaccinia therapeutic platform at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Tumor Immunology and Immunotherapy Meeting in Miami (Press release, Turnstone Biologics, NOV 30, 2018, View Source [SID1234531756]). This platform was developed by Dr. John Bell and his colleagues at The Ottawa Hospital Research Institute and the University of Ottawa, and engineered to be potent, highly selective and immune-stimulatory. Furthermore, the versatility of the platform enables additional therapeutic agents to be encoded in the virus and produced at tumor sites. This single platform virus has the potential to create a portfolio of diverse products. Turnstone has exclusively licensed this technology.

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This proprietary Vaccinia virus can be delivered systemically and is designed to target and kill cancer cells throughout the body, modulate the tumor microenvironment and stimulate both innate and adaptive immune responses. The virus also contains a very large transgene capacity, allowing for the insertion of multiple therapeutic agents. These agents will be produced selectively at tumor sites as the virus replicates only in the tumor cells, effectively enabling a local combination therapy from a single therapeutic promoting cancer cell killing. Turnstone is conducting IND-enabling studies on TBio-6517, its lead product candidate from this platform, consisting of the Vaccinia virus expressing three potent immune modulators, and anticipates initiating clinical studies in 2019.

"The decades-long search for immunotherapies and combinations that are safe and effective for a range of cancers has proven challenging," said Dr. Bell. "While previous Vaccinia therapies have shown promise, we believe that we have selected and designed significant improvements into this platform, potentially allowing us to safely and effectively combine multiple modes of action into a single therapy."

"This is an exciting time for Turnstone as we unveil another novel viral immunotherapy platform technology in our continued pursuit to develop transformative technologies that advance the treatment of cancer," said Mike Burgess, MBChB, Ph.D., President, Research and Development at Turnstone Biologics. "We are rapidly advancing our lead candidate from this proprietary platform, TBio-6517, to the clinic with the goal of achieving effective and durable outcomes for a greater number of cancer patients."

The oral presentation entitled "Utilizing Novel Oncolytic Vaccinia Virus for Selective Expression of Immunotherapeutic Proteins in Metastatic Tumors" includes key proof-of-concept data:

Cancer Cell Selectivity: The Turnstone Vaccinia virus was shown to rapidly kill more than 80% of cancer cells across multiple cell lines while sparing normal cells, exhibiting high tumor specificity in mouse models.
Potent Oncolytic Activity: The Turnstone Vaccinia virus replicated in human lung, sarcoma, melanoma, ovarian, gastic and thymic tumor explants, and showed efficacy with improved safety in the HT29 colon cancer tumor model.
Transgene Expression: TBio-6517 demonstrated selective expression of its three encoded immunomodulators at the sites of tumors in preclinical models, with no evidence for exposure in the peripheral blood.

On November 30, 2018 Eureka Therapeutics, Inc., a clinical stage biopharmaceutical company with the goal of curing cancer by developing novel T-cell therapies that harness the evolutionary power of the immune system, reported that five abstracts, including four oral presentations and one poster discussion, highlighting clinical programs in multiple myeloma and NHL using binding domains developed by Eureka, have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 1-4 in San Diego, California (Press release, Eureka Therapeutics, NOV 30, 2018, View Source [SID1234531755]).

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The data presented at this meeting underscores the potential potency of antibodies generated from Eureka’s proprietary E-ALPHA discovery platform, which includes the human BCMA and CD19 binding domains used in the CAR-T and ARTEMIS T-cell therapies presented at ASH (Free ASH Whitepaper). The E-ALPHA platform comprises a highly diverse human-derived antibody phage library, containing over 100 billion clones with unique antibody sequences, and a robust workflow to develop highly specific antibodies against target antigens.

"We are pleased to be working with Eureka on our multiple myeloma programs," said Eric Smith, M.D., Ph.D., Director of Translational Development, Cellular Therapeutics Center at Memorial Sloan Kettering Cancer Center (MSK) and co-inventor of CARs for the targeting of multiple myeloma. "Working with Eureka to identify fully-human BCMA and other multiple myeloma targeted binding domains has the potential to avoid host anti-CAR immunity that may develop when using murine derived antibodies as binders. We look forward to continue working with Eureka on developing the next generation of T-cell therapies."

"We are delighted that data involving Eureka’s assets are being reported in many presentations at ASH (Free ASH Whitepaper) – in particular the exciting clinical data from the BCMA/multiple myeloma programs that we developed in collaboration with Memorial Sloan Kettering in 2012 and licensed to Juno Therapeutics (now Celgene) in 2016," said Dr. Cheng Liu, President and Chief Executive Officer of Eureka Therapeutics. "In addition, the updated data from the 21-patient proof-of-concept study of our ARTEMIS T-cell therapy (ET190L1 ARTEMIS) for CD19-positive r/r NHL continues to show that our ARTEMIS T-cells have been well tolerated with no observed cytokine release syndrome (CRS) or neurotoxicity, validating the potential of our ARTEMIS platform to deliver safer T-cell therapy than the currently available CAR-T therapies."

The accepted abstracts are listed below and are now available on the ASH (Free ASH Whitepaper) website.

Multiple Myeloma

CAR T Cell Therapy Targeting G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D), a Novel Target for the Immunotherapy of Multiple Myeloma
Author: Eric L. Smith, MD, PhD
Abstract #589
Oral Session: 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Development of Novel Immunotherapeutic Approaches in Multiple Myeloma
Monday, December 3, 2018: 7:00 AM, Ballroom 20D
Clinical Responses and Pharmacokinetics of MCARH171, a Human-Derived BCMA Targeted CAR T Cell Therapy in Relapsed/Refractory Multiple Myeloma: Final Results of a Phase I Clinical Trial
Author: Sham Mailankody, MBBS
Abstract #959
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapies in Plasma Cell Disorders
Monday, December 3, 2018: 5:30 PM, Ballroom 20A
JCARH125, Anti-BCMA CAR T-cell Therapy for Relapsed/Refractory Multiple Myeloma: Initial Proof of Concept Results from a Phase 1/2 Multicenter Study (EVOLVE)
Author: Sham Mailankody, MBBS
Abstract #957
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapies in Plasma Cell Disorders
Monday, December 3, 2018: 5:00 PM, Ballroom 20A
Fully Human BCMA Targeted Chimeric Antigen Receptor T Cells Administered in a Defined Composition Demonstrate Potency at Low Doses in Advanced Stage High Risk Multiple Myeloma
Author: Damian J. Green, MD
Abstract #1011
Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Immunotherapy
Monday, December 3, 2018: 6:45 PM, Ballroom 20D
Non-Hodgkin Lymphoma

ET190L1-ARTEMIS T Cell Therapy Results in Durable Disease Remissions with No Cytokine Release Syndrome or Neurotoxicity in Patients with Relapsed and Refractory B-Cell Lymphoma
Author: Zhitao Ying, MD, PhD
Abstract #1689
Poster Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster I
Saturday, December 1, 2018, 6:15 PM-8:15 PM, Hall GH
About E-ALPHA Antibody Discovery Platform
Eureka’s proprietary E-ALPHA antibody discovery platform is composed of a highly diverse human-derived antibody phage library, containing over 100 billion clones with unique antibody sequences, and a robust workflow with specificity screens designed to develop highly specific antibodies against target antigens. The E-ALPHA platform is designed to enable Eureka to rapidly discover, iterate upon and improve our antibodies. Eureka’s E-ALPHA platform enables Eureka to develop highly specific antibodies for both conventional targets, such as cell surface markets, and T-cell receptor targets, such as intracellular peptides displayed by the major histocompatibility complex, with the goal of addressing solid tumors.

About ARTEMIS T-cell Receptor Platform
Eureka’s proprietary ARTEMIS T-cell receptor platform was designed to create potentially safer and more effective T-cell therapies. In pre-clinical studies against CD19-positive malignancies, Eureka’s ARTEMIS T-cells matched the cancer killing potency of currently available CAR-T therapies but with a dramatic reduction in the levels of inflammatory cytokines released. Cytokine release syndrome (CRS) and neurotoxicity are serious side effects associated with currently available CAR-T therapies.

On November 30, 2018 bluebird bio, Inc. (Nasdaq: BLUE) reported that the company will host a live webcast of an investor and analyst event being held on Monday, December 3, 2018, during the 60th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, bluebird bio, NOV 30, 2018, View Source [SID1234531754]). Speaker presentations will begin at 8:30 p.m. PST (11:30 p.m. EST) and will review the company’s data being presented at the ASH (Free ASH Whitepaper) meeting.

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To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the event.