Volume 15.35 | Sep 8

Issue 15.35 September 8, 2014
Cell Therapy News - Your Industry in an Instant
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TOP STORY
New Reprogramming Factor Cocktail Produces Therapy-Grade Induced Pluripotent Stem Cells
As scientists gained an increased understanding of the reprogramming process, they realized that myriad variables, including the ratio of reprogramming factors and the reprogramming environment, can greatly affect cell quality. Researchers have determined that the reprogramming factors themselves impact the reprogramming efficiency and the quality of the resulting cells. [Press release from the Whitehead Institute discussing online prepublication in Cell Stem Cell] Press Release | Abstract | Graphical Abstract
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PUBLICATIONS (Ranked by impact factor of the journal)
Sequential Transcriptional Changes Dictate Safe and Effective Antigen-Specific Immunotherapy
Optimization of dosing strategy is critical for effective modulation of pathogenic ​CD4+ T-cell activity. Investigators report that dose escalation is imperative for safe, subcutaneous delivery of the high self-antigen doses required for effective tolerance induction, and elicits anergic ​interleukin-10-secreting regulatory ​CD4+ T cells. [Nat Commun] Full Article | Press Release

Towards Gene Therapy for EBV-Associated Post-Transplant Lymphoproliferative Disease: Genetically Modified EBV-Specific Cytotoxic T Lymphocytes Induce Regression of Autologous EBV-Induced Lymphoproliferation Despite Immunosuppression
Investigators examined the ability of FK506-resistant EBV-cytotoxic lymphocytes to control EBV-driven tumor progression in the presence of immunosuppression in vivo in a xenogeneic mouse model. [Blood] Abstract

A Combinatorial MicroRNA Therapeutics Approach to Suppressing Non-Small Cell Lung Cancer
Researchers treated the aggressive Kras;p53 non-small cell lung cancer mouse model and demonstrated efficacy with a combination of two tumor-suppressive microRNAs. Systemic nanodelivery of miR-34 and let-7 suppressed tumor growth leading to survival advantage. [Oncogene] Abstract | Press Release

AAV Delivery of Tumor Necrosis Factor-α Short Hairpin RNA Attenuates Cold-Induced Pulmonary Hypertension and Pulmonary Arterial Remodeling
Researchers investigated whether RNA interference silencing of tumor necrosis factor-α decreases cold-induced macrophage infiltration, pulmonary hypertension, and pulmonary arterial remodeling. [Hypertension] Abstract

Sheep CD34+ Amniotic Fluid Cells Have Hematopoietic Potential and Engraft after Autologous In Utero Transplantation
Scientists studied the functional hematopoietic potential of transduced GFP+ sheep amniotic fluid stem cells, before and after autologous in utero stem cell transplantation. [Stem Cells] Abstract

Combination of Systemic Chemotherapy with Local Stem Cell Delivered S-TRAIL in Resected Brain Tumors
TRAIL induces apoptosis specifically in tumor cells and researchers have tested its efficacy by on-site delivery via engineered stem cells in mouse models of glioblastoma multiforme that mimic the clinical scenario of tumor aggressiveness and resection. [Stem Cells] Abstract

Neovascularization Capacity of Mesenchymal Stromal Cells from Critical Limb Ischemia Patients Is Equivalent to Healthy Controls
Investigators compared critical limb ischemia-mesenchymal stromal cells to healthy controls using gene expression profiling and functional assays for differentiation, senescence and in vitro and in vivo pro-angiogenic ability. [Mol Ther] Abstract

The Generation of Hybrid Nanofiber Layer with Extracellular Matrix Derived from Human Pluripotent Stem Cells, for Regenerative Medicine Applications
Scientists developed a modified protocol for the derivation of mesenchymal progenitor cells from human embryonic stem cells as well as human induced pluripotent stem cells originating from hair follicle keratinocytes. [Tissue Eng Part A] Abstract

Influence of Delivery Method on Neuroprotection by Bone Marrow Mononuclear Cell Therapy following Ventral Root Reimplantation with Fibrin Sealant
Researchers compared the local injection of mononuclear cells to the spinal cord lateral funiculus with the alternative approach of local delivery with fibrin sealant after ventral root avulsion and reimplantation. [PLoS One] Full Article

Free Cell Stem Cell Poster: Directed Differentiation of ESCs/iPSCs
 
REVIEWS
Similar Effect of Autologous and Allogeneic Cell Therapy for Ischemic Heart Disease: Systematic Review and Meta-Analysis of Large Animal Studies
The authors conducted a systematic literature search to identify publications describing controlled pre-clinical trials of unmodified stem cell therapy in large animal models of myocardial ischemia. [Circ Res] Abstract

Visit our reviews page to see a complete list of reviews in the cell, gene and immunotherapy research field.

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SCIENCE NEWS
Novel Immunotherapy Vaccine Decreases Recurrence in HER2 Positive Breast Cancer Patients
A new breast cancer vaccine candidate, GP2, provides further evidence of the potential of immunotherapy in preventing disease recurrence. This is especially the case for high-risk patients when it is combined with a powerful immunotherapy drug. [Press release from The University of Texas MD Anderson Cancer Center discussing research presented at the 2014 American Society of Clinical Oncology’s Breast Cancer Symposium, San Francisco] Press Release

Ascend Biopharmaceuticals Clinical Trial Program Update
Ascend Biopharmaceuticals plans to begin a Phase II clinical trial on ASN-002, an injectable immunotherapy for basal cell carcinoma, by 2015. Ascend has also announced plans to begin a Phase Ib study on a therapeutic cancer vaccine for breast cancer, ASN-004, in the second half of 2015. [Ascend Biopharmaceuticals Ltd.]
Press Release

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POLICY
Japan’s Researchers Face Increased Ethics Oversight
Scientists in Japan applying for government grants will soon be getting new mandatory reading material: a manual for promoting research integrity. The manual is being developed by the country’s three major funding agencies and the Science Council of Japan, the nation’s largest organization of researchers. [ScienceInsider] Editorial

Australian Gene-Patent Case Dismissed
An Australian federal court has thrown out a lawsuit challenging a patent on the cancer-associated gene BRCA1. The decision is the latest setback for patient advocates who argue that the patent limits genetic-testing options for Australian cancer patients. [Nature News] Editorial

RIKEN to Investigate STAP Papers Yet Again
RIKEN announced a new investigation into two papers reporting a sensational but now-discredited way of making stem cells. A brief announcement on RIKEN’s website states that the committee will look into issues concerning the papers and related cell lines that have emerged since a previous committee probing for research misconduct completed its work. [ScienceInsider] Editorial
 
BUSINESS
Ludwig Cancer Research and Cancer Research Institute Collaborate on Evaluation of VentiRx’s Investigational Immunotherapy
The nonprofits Ludwig Cancer Research and the Cancer Research Institute (CRI) announced an agreement with VentiRx Pharmaceuticals Inc. to conduct a clinical trial with motolimod (VTX-2337) combined with other immunotherapy agents available to Ludwig and CRI through other industry partnerships. [Ludwig Institute for Cancer Research Ltd.] Press Release

Allergopharma and S-TARget Therapeutics Conclude Licensing Agreement
Allergopharma, the Merck Allergy Business Unit, and S-TARget therapeutics have signed an exclusive licensing agreement. The main focus of this cooperation is the use of S-TARget S-TIR™ technology and the associated development of a new generation of products for the causal treatment of allergies. [Merck KGaA] Press Release

Merck Receives Accelerated Approval of KEYTRUDA® (Pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. [Merck & Co., Inc.] Press Release

Cynata Initiates European Regulatory Process
Cynata Therapeutics Ltd announced that it has formally initiated a Scientific Advice procedure with the European Medicines Agency (EMA). This important interaction represents the first step in formal engagement with the EMA, the body responsible for issuing therapeutic product approvals in the EU. [Cynata Therapeutics Ltd.]
Press Release

Advanced Cell Technology Announces Issuance of Patent Covering Dendritic Cells Manufacturing from Renewable Stem Cell Sources
Advanced Cell Technology, Inc. announced that the US Patent and Trademark Office has issued U.S. patent 8,822,218 covering methods of manufacturing dendritic cells using a highly scalable processing involving a readily renewable stem cell source as the starting materials. [Advanced Cell Technology, Inc.] Press Release

Amgen Submits Marketing Authorization Application for Talimogene Laherparepvec to the European Medicines Agency
Amgen announced the submission of a Marketing Authorization Application to the European Medicines Agency via the centralized procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic. Talimogene laherparepvec is an investigational oncolytic immunotherapy administered as an intralesional injection that is designed to initiate a systemic anti-tumor immune response. [Amgen Inc.] Press Release

Bristol-Myers Sues Merck over Cancer Immunotherapy Patent
Bristol-Myers Squibb Co. accused Merck & Co. of infringing a new U.S. patent for a novel method of cancer-fighting that uses a patient’s own immune system to fight the disease. [Bloomberg L.P.] Article

FDA Removes Partial Clinical Hold on OncoMed’s Ipafricept
OncoMed Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the company’s ipafricept Phase I clinical trials. Ipafricept (Fzd8-Fc, OMP-54F28) is a first-in-class fusion protein that inhibits a key signaling pathway in cancer, the Wnt pathway. [OncoMed Pharmaceuticals, Inc.] Press Release

Cellular Biomedicine Group Launches Clinical Research Study for Cartilage Defect Stem Cell Therapy
Cellular Biomedicine Group Inc. announced the launch of a study on human adipose derived mesenchymal progenitor cell therapy for cartilage defects resulting from osteoarthritis or sports injury. [Cellular Biomedicine Group Inc.] Press Release
 
NIH
Center for Scientific Review; Notice of Closed Meetings (FR Doc. No: 2014-21132)
 
CBER
Evicel Application Device
 
REGULATORY
Food and Drug Administration (United States)

Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction (FR Doc. No: 2014-21266)

European Medicines Agency (European Union)

Medicines Regulators to Work Together Internationally to Find Innovative Solutions to Facilitate Evaluation of and Access to Potential New Medicines to Counter Ebola Outbreaks
 
EVENTS
NEW Clinical Applications of Stem Cells (CASC) 2015
February 26-27, 2015
Singapore, Singapore

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.
 
JOB OPPORTUNITIES
NEW PhD Opportunities – Cell Therapies (Cooperative Research Centre for Cell Therapy Manufacturing)

Postdoctoral Fellow – Cardiac Differentiation of Pluripotent Stem Cells (Stanford University)

Postdoctoral Fellow – Cardiac Animal Surgery (Stanford University)

Postdoctoral Position – Transplantation Aspects of Hepatocytes Derived from Human Pluripotent Stem Cells (INSERM UMR 1064)

Associate Research Fellow – Cell Therapy Manufacturing Process (Pfizer, Inc.)

Research Associate – Gene Therapy Center (University of Massachusetts)

Postdoctoral Fellow – Induced Pluripotent Stem Cell Based Therapeutics (Fred Hutchinson Cancer Research Center)

Postdoctoral Fellow – New Combination Immune Therapies for Cancer (Massachusetts General Hospital)

Postdoctoral Position – Scaffolding and Drug Delivery for Regenerative Medicine Applications (Ospedale Niguarda)

Scientist – Pluripotent Stem Cell Media Development, High Throughput Screening (STEMCELL Technologies Inc.)

Scientist – Cell Culture Support Products (STEMCELL Technologies Inc.)

Scientist – Liver Cell Biology (STEMCELL Technologies Inc.)

Scientist – Immunology/Cell Separation (STEMCELL Technologies Inc.)


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