Volume 16.15 | Apr 20

Newsletter Issue
Issue 16.15 April 20, 2015
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Publications | Reviews | Science | Policy | Business | NIH | CBER | Regulatory | Events | Jobs
Recruiting the Entire Immune System to Attack Cancer
Until now, most researchers have focused on one of two onco-immunotherapeutic strategies: attacking tumors with antibodies, which activate the innate immune system, or stimulating T cells, which form the backbone of the adaptive immune system. By combining these approaches, scientists were able to halt the growth of a very aggressive form of melanoma in mice. [Press release from the Massachusetts Institute of Technology discussing online publication in Cancer Cell] Press Release | Abstract | Graphical Abstract
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PUBLICATIONS (Ranked by impact factor of the journal)
Foxp1-Mediated Programming of Limb-Innervating Motor Neurons from Mouse and Human Embryonic Stem Cells
Scientists demonstrated that limb-innervating lateral motor column (LMC) motor neurons (MNs) can be efficiently generated from mouse and human embryonic stem cells through manipulation of the transcription factor Foxp1. Foxp1-programmed MNs exhibit features of medial and lateral LMC MNs including expression of specific motor pool markers and axon guidance receptors. [Nat Commun] Full Article

Adipose Tissue-Derived Stem Cell Therapy in Rat Cryopreserved Ovarian Grafts
Researchers aimed to evaluate adipose tissue-derived stem cells (ASCs) therapy in rat cryopreserved ovarian grafts. A single dose of rat ASCs or vehicle was injected into the bilateral cryopreserved ovaries of twelve adult female rats immediately after an autologous transplant. [Stem Cell Res Ther] Abstract | Full Article

Infusion of Endothelial Progenitor Cells Ameliorates Liver Injury in Mice after Hematopoietic Stem Cell Transplantation
Whether endothelial progenitor cell (EPC) infusion ameliorates liver sinusoidal endothelial cells injury remains unclear. Researchers aimed to evaluate the effects of EPCs on liver injury in mice after hematopoietic stem cell transplantation. [Liver Int] Abstract

Transplantation Effectiveness of Induced Pluripotent Stem Cells Is Improved by a Fibrinogen Biomatrix in an Experimental Model of Ischemic Heart Failure
Scientists investigated whether a fibrinogen biomatrix improves the transplantation effectiveness of induced pluripotent stem cells (iPSCs) in a model of myocardial infarction. iPSCs were transplanted intramyocardially into ischemic myocardium of immunodeficient mice, following permanent left coronary artery ligation. [Tissue Eng Part A] Abstract

Cell Injury-Induced Release of FGF2: Relevance to Intracerebral Mesenchymal Stromal Cell Transplantations
Scientists hypothesized that dying transplanted cells can affect surrounding tissues by releasing their active intracellular components. In transplantation-relevant mesenchymal stromal cells (MSC) injury models, MSC death coincided with the release of intracellular FGF2. [Stem Cells Dev] Abstract

Lister Strain Vaccinia Virus with Thymidine Kinase Gene Deletion Is a Tractable Platform for Development of a New Generation of Oncolytic Virus
Investigators evaluated the antitumor potency and biodistribution of different vaccinia virus strains using in vitro and in vivo models of cancer. Lister strain virus with thymidine kinase gene deletion demonstrated superior antitumor potency and cancer-selective replication in vitro and in vivo, compared with viral growth factor genes, especially in human cancer cell lines and immune-competent hosts. [Gene Ther] Abstract

Intra-Articular Delivery of Anti-Hif-2α siRNA by Chondrocyte-Homing Nanoparticles to Prevent Cartilage Degeneration in Arthritic Mice
Scientists used vectors to deliver small-interfering RNA (siRNA) and silenced hypoxia-inducible factor-2α (Hif-2α) expression to prevent cartilage degeneration in osteoarthritis-affected mice. [Gene Ther] Abstract

Engineering Cellular Resistance to HIV-1 Infection In Vivo Using a Dual Therapeutic Lentiviral Vector
Investigators utilized the humanized bone marrow, liver, thymus mouse model to characterize the in vivo efficacy of LVsh5/C46 vector to engineer cellular resistance to HIV-1 pathogenesis. [Mol Ther Nucleic Acids] Full Article

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Dental Stem Cells in Pulp Regeneration: Near Future or Long Road Ahead?
Recent advances in dental stem cell research have gained increasing insight in their regenerative potential and prospective use in the formation of viable dental tissues. [Stem Cells Dev] Abstract

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

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Investigational Personalized Cellular Therapy Tolerated Well by Patients with Advanced Mesothelioma, Ovarian and Pancreatic Cancers
Genetically modified versions of patients’ own immune cells successfully traveled to tumors they were designed to attack in an early-stage trial for mesothelioma and pancreatic and ovarian cancers. [Press release from the Perelman School of Medicine at the University of Pennsylvania discussing research presented at the American Association for Cancer Research (AACR) Annual Meeting 2015, Philadelphia] Press Release

New Combination of Immunotherapy Drugs Is Safe, Shrinks Tumors in Metastatic Melanoma Patients
Researchers have extended the reach of the immune system in the fight against metastatic melanoma, this time by combining the checkpoint inhibitor tremelimumab with an anti-CD40 monoclonal antibody drug. [Press release from University of Pennsylvania’s Abramson Cancer Center discussing research presented at the American Association for Cancer Research (AACR) Annual Meeting 2015, Philadelphia] Press Release

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Controversy Awaits as House Republicans Roll Out Long-Awaited Bill to Revamp U.S. Research Policy
The science committee in the U.S. House of Representatives took a major step in its two-year effort to reshape federal research policy, introducing a long-awaited and controversial bill that covers the National Science Foundation, the National Institute of Standards and Technology, research at the Department of Energy, and federal science education policy. [ScienceInsider] Editorial

Withholding Results from Clinical Trials Is Unethical, Says WHO
The movement to ensure that clinical trial results don’t end up in drawers has found an important global ally. The World Health Organization (WHO) issued a call to make results from every clinical study publicly available within a year. [ScienceInsider] Editorial
CiRA and Takeda Enter Ten-Year Collaboration on iPS Cell Research
Center for iPS Cell Research Application (CiRA) of Kyoto University and Takeda Pharmaceutical Company Limited announced that they will work together to develop clinical applications of induced pluripotent stem cells in areas such as heart failure, diabetes mellitus, neurological disorders and cancer immunotherapy. [Takeda Pharmaceutical Company Limited.] Press Release

REGiMMUNE Announces Collaboration with JDRF and Pfizer Inc. for Type 1 Diabetes Prevention and Treatment Promoting Regulatory T-Cells
REGiMMUNE Corporation and JDRF announced a partnership, along with financial assistance and scientific expertise from Pfizer Inc., for a research collaboration to develop an antigen-specific immunotherapy utilizing RGI’s proprietary αGalCer/liposome platform for immunological tolerance for the treatment of type 1 diabetes. [REGiMMUNE Corporation] Press Release

Argos Therapeutics Licenses Arcelis® Technology Platform to Lummy HK for Development of Personalized Immunotherapies to Treat Cancer in China
Argos Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, and Lummy (Hong Kong) Co. Ltd. announced they have entered into a license agreement. [Argos Therapeutics, Inc.] Press Release

CheckMate-057, a Pivotal Phase III Opdivo (Nivolumab) Lung Cancer Trial, Stopped Early
Bristol-Myers Squibb Company announced that an open-label, randomized Phase III study evaluating Opdivo versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer was stopped early because an assessment conducted by the independent data monitoring committee concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. [Bristol-Myers Squibb Company] Press Release

Athersys Announces Results from Phase II Study of MultiStem® Cell Therapy for Treatment of Ischemic Stroke
Athersys, Inc. announced interim results from its exploratory Phase II clinical study of the intravenous administration of MultiStem® cell therapy to treat patients who have suffered an ischemic stroke. With respect to the primary and secondary endpoints, the cell therapy did not show a difference at 90 days compared to placebo. [Athersys, Inc.] Press Release

AstraZeneca Announces Updated Progression Free Survival Data for Investigational Non-Small Cell Lung Cancer Medicine AZD9291
AstraZeneca announced latest data from the ongoing AURA study of AZD9291 in patients with advanced epidermal growth factor receptor mutation positive non-small cell lung cancer, who also have the T790M resistance mutation. [AstraZeneca] Press Release

ReNeuron Files Application to Commence Phase I/II Clinical Trial in the US with Its Stem Cell Therapy Candidate for the Blindness-Causing Disease, Retinitis Pigmentosa
ReNeuron Group plc announced that it has filed an investigational new drug application with the US FDA to commence a Phase I/II clinical trial with its human retinal progenitor cell therapy candidate for retinitis pigmentosa. [ReNeuron Group plc] Press Release

Isarna Initiates First-in-Human Phase I Trial for ISTH0036 to Treat Advanced Glaucoma
Isarna Therapeutics announced the initiation of a Phase I clinical trial with ISTH0036, an antisense oligonucleotide selectively targeting transforming growth factor beta to treat advanced glaucoma. [Isarna Therapeutics] Press Release

RepliCel Life Sciences Receives Approval to Conduct Clinical Trial for Patients with Chronic Achilles Tendinosis
RepliCel Life Sciences Inc. announced that it has received approval from the University of British Columbia Clinical Research Ethics Board to conduct a Phase I/II clinical trial at the UBC Hospital. The trial will investigate the potential of RepliCel’s tendon repair product, RCT-01, to treat chronic tendon injury. [RepliCel Life Sciences Inc.] Press Release
List of Environmentally Responsive Human Genes Selected for Use In Screening Large Numbers of Substances Using Toxicogenomic Approaches (FR Doc. No: 2015-08529)
2015 Biological License Application Supplement Noteworthy Approvals
Food and Drug Administration (United States)

Agency Information Collection Activities: Proposed Collection; Comment Request; User Fee Cover Sheet; Form FDA 3397 (FR Doc. No: 2015-08618)

Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; Guidance for Industry and Food and Drug Administration Staff; Availability (FR Doc. No: 2015-08363)
NEW Cell Therapy Bioprocessing & Commercialization
September 30-October 1, 2015
Alexandria, United States

NEW 2nd Annual World Congress of Smart Materials (WCSM-2016)
March 4-6, 2016
Singapore, Singapore

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.
NEW Director – Clinical Trial Operations (BioRestorative Therapies, Inc.)

NEW Director – Cell Therapy Manufacturing (BioRestorative Therapies, Inc.)

Scientist – Reprogramming and Pluripotent Stem Cell Biology (STEMCELL Technologies Inc.)

Scientist – Liver Cell Biology (STEMCELL Technologies Inc.)

Professor – Gene Therapy (University of Massachusetts)

Research Scientist – Cell and Gene Therapy Group (Biogen Idec)

Research Associate – Cell Culture Specialist (Tisch MS Research Center of New York)

Postdoctoral Positions – Developmental Biology (Joslin Diabetes Center)

Cell and Gene Therapy Formulation Scientist (Stelfox)

Associate Director, Center for Gene Therapy (City of Hope)

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