Volume 16.05 | Feb 9

Newsletter Issue
Issue 16.05 February 9, 2015
Cell Therapy News - Your Industry in an Instant
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Publications | Reviews | Science | Policy | Business | NIH | CBER | Regulatory | Events | Jobs
 
TOP STORY
Human Embryonic Stem Cell-Derived Oligodendrocyte Progenitors Remyelinate the Brain and Rescue Behavioral Deficits following Radiation
Scientists demonstrate the efficient derivation and prospective isolation of human oligodendrocyte progenitors, which, upon transplantation, migrate throughout the major white matter tracts resulting in both structural and functional repair. [Cell Stem Cell] Abstract | Graphical Abstract | Press Release
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PUBLICATIONS (Ranked by impact factor of the journal)
Polymeric Nanoparticles for Non-Viral Gene Therapy Extend Brain Tumor Survival In Vivo
Tumor-bearing rats were treated with poly(beta-amino ester)/herpes simplex virus type I thymidine kinase infusion via convection-enhanced delivery in combination with systemic administration of ganciclovir. [ACS Nano]
Abstract | Press Release

Humoral Immune Response against Non-Targeted Tumor Antigens after Treatment with Sipuleucel-T and Its Association with Improved Clinical Outcome
Investigators evaluated humoral antigen spread after treatment with sipuleucel-T, an immunotherapy for asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer, designed to target prostatic acid phosphatase. [Clin Cancer Res] Abstract

Bone Engineering of Maxillary Sinus Bone Deficiencies Using Enriched CD90+ Stem Cell Therapy: A Randomized Clinical Trial
The aim of this Phase I/II randomized, controlled, clinical trial was to evaluate reconstruction of bone deficiencies of the maxillary sinus with transplantation of autologous cells enriched with CD90+ stem cells and CD14+ monocytes. [J Bone Miner Res] Abstract

Adoptive T Cell Immunotherapy for Treatment of Ganciclovir-Resistant Cytomegalovirus Disease in a Renal Transplant Recipient
Scientists describe a case of ganciclovir-resistant cytomegalovirus (CMV) disease in a renal transplant recipient manifested by thrombotic microangiopathy-associated glomerulopathy. Adoptive T cell immunotherapy using CMV-specific T cells from a donor bank was used as salvage therapy. [Am J Transplant] Abstract

The Combination of ISCOMATRIX Adjuvant and TLR Agonists Induces Regression of Established Solid Tumors In Vivo
ISCOMATRIX adjuvant is able to induce both tumor Ag-specific cellular and Ab responses to protect mice against tumor challenge, but this is insufficient to result in regression of established solid tumors. Investigators used B16-OVA melanoma, Panc-OVA pancreatic, and TRAMP-C1 prostate cancer mouse tumor models to test therapeutic efficacy of ISCOMATRIX vaccines combined with other immune modulators. [J Immunol] Abstract

Inclusion of an IgG1-Fc Spacer Abrogates Efficacy of CD19 CAR T Cells in a Xenograft Mouse Model
Whereas most protocols use permanently reprogrammed T cells, the authors developed a platform for transient chimeric antigen receptor (CAR) expression by mRNA electroporation. They investigated therapy with transiently redirected T cells in vitro and in a xenograft mouse model. [Gene Ther] Abstract

Harnessing the Clustered Regularly Interspaced Short Palindromic Repeat (CRISPR)/CRISPR-Associated Cas9 System to Disrupt the Hepatitis B Virus
Scientists studied the effects of the CRISPR/CRISPR-associated Cas9 system that was targeted to the surface antigen-encoding region of hepatitis B virus, both in a cell culture system and in vivo. [Gene Ther] Abstract

Chimerism-Based Pre-Emptive Immunotherapy with Fast Withdrawal of Immunosuppression and Donor Lymphocyte Infusions after Allogeneic Stem Cell Transplantation for Pediatric Hematologic Malignancies
Researchers prospectively studied post-transplant chimerism-based immunotherapy using fast withdrawal of immunosuppression and donor lymphocyte infusions in children with early post-transplant mixed chimerism. [Biol Blood Marrow Transplant] Abstract

Anti-CD40-Induced Inflammatory E-Cadherin+ Dendritic Cells Enhance T Cell Responses and Antitumor Immunity in Murine Lewis Lung Carcinoma
In agonistic CD40 antibody-mediated inflammatory responses, a novel subset of E-cadherin+ dendritic cells (DCs) has been identified, and little is known about the role of these DCs in tumor immunity. Scientists investigated the effect of anti-CD40-mediated inflammatory E-cadherin+ DCs in murine Lewis lung carcinoma. [J Exp Clin Cancer Res] Abstract | Full Article

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REVIEWS
Stem Cells for Amyotrophic Lateral Sclerosis Modeling and Therapy: Myth or Fact?
The authors discuss how stem cells have been useful in modeling amyotrophic lateral sclerosis (ALS) and address critical topics concerning their therapeutic use, such as administration protocols, injection site, cell type to be administered, type of transplantation (autologous vs. allogeneic) among other issues with particular implications for ALS therapy. [Cytometry A] Abstract

The Potential Use of Cell-Based Therapies in the Treatment of Oral Diseases
The utility of living cells to treat diseases was first proved in hematopoietic stem cell transplantation for leukemia patients. The potential of cell-based therapy for oral diseases is discussed. [Oral Dis] 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
IOmet Pharma to Present Data on Pre-Clinical Cancer Immunotherapy Programs
IOmet Pharma will present data on its preclinical IDO, TDO and IDO/TDO Dual Inhibitor programs. IOmet has identified multiple, distinct novel chemical series of potent, IDO-selective, TDO-selective and dual-acting IDO/TDO inhibitors. [Press release from IOmet Pharma Ltd. discussing research to be presented at the Keystone Tumor Immunology Symposium, Banff] Press Release

Compugen to Present Cancer Immunotherapy Targets
Compugen Ltd. announced that it will present aspects of its immune checkpoint related research. They will discuss Compugen’s discovery approach in identifying 11 novel immune checkpoint candidates for cancer immunotherapy. [Press release from Compugen Ltd. discussing research to be presented at the Keystone Tumor Immunology Symposium, Banff] Press Release

Cell Culture World Congress 2015
 
POLICY
U.K. Parliament Approves Controversial Three-Parent Mitochondrial Gene Therapy
The United Kingdom’s House of Commons voted overwhelmingly to allow British researchers to pursue a new fertility treatment that could prevent certain kinds of genetic diseases. The technique, called mitochondrial DNA replacement therapy, could allow women who carry disease-causing mutations in their mitochondrial genes to give birth to genetically related children free of mitochondrial disease. [ScienceInsider] Editorial

NIH Proposal to Create Grant for Aging Scientists Hits a Nerve
A seemingly innocuous idea from the National Institutes of Health (NIH) for nudging aging scientists to retire is being blasted in the blogosphere. NIH’s proposal — an “emeritus” award that senior scientists would use to pass their work on to younger colleagues and wind down their labs — is unnecessary and could take funding away from younger and midcareer scientists, many commenters argued. [ScienceInsider] Editorial

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BUSINESS
Cord Blood Registry and China Cord Blood Corporation Enter into Strategic Collaboration
Cord Blood Registry® and China Cord Blood Corporation China’s first and largest umbilical cord blood bank, entered into a memorandum of understanding regarding their strategic collaboration in China and the United States. [Cord Blood Registry®] Press Release

Cynata Partners with UWA Centre for Cell Therapy and Regenerative Medicine
Cynata Therapeutics Ltd. announced that it has commenced a study to test the potential therapeutic efficacy of its Cymerus™ mesenchymal stem cells in an animal model of lung fibrosis. [Cynata Therapeutics Ltd.]
Press Release

Valeant Enters into Amended Agreement to Remain Lead Bidder in Acquisition of Dendreon and Its Leading Immunotherapy Treatment, PROVENGE® (Sipuleucel-T)
Valeant Pharmaceuticals International, Inc. announced that it entered into an amended and restated “stalking horse” asset purchase agreement to acquire the world-wide rights to Dendreon’s PROVENGE® product and certain other assets of Dendreon Corporation. [Valeant Pharmaceuticals International, Inc.] Press Release

Cellular Biomedicine Group (CBMG) Acquiring Chinese PLA General Hospital’s CAR-T (CD19/CD20/CD30/EGFR) Immuno-Oncology Technology and Clinical Data
CBMG announced its acquisition of Chinese PLA General Hospital’s chimeric antigen receptor T cell (CAR-T) therapy, its recombinant expression vector CD19, CD20, CD30 and human epidermal growth factor receptor’s immuno-oncology patents, and Phase I/II clinical data of the aforementioned therapies and manufacturing knowledge. [Cellular Biomedicine Group Inc.] Press Release

Dicerna Pharmaceuticals Announces First Patient Dosed in Phase Ib/II Clinical Trial of DCR-MYC, an Investigational RNAi Therapeutic Targeting the MYC Oncogene, in Patients with Advanced Hepatocellular Carcinoma
Dicerna Pharmaceuticals, Inc. announced that the first patient has been dosed in a global Phase Ib/II clinical trial of DCR-MYC, an investigational Dicer substrate short interfering RNA therapeutic, in patients with advanced hepatocellular carcinoma. [Dicerna Pharmaceuticals, Inc.] Press Release

Juno Therapeutics Establishes Manufacturing Presence in Washington State
Juno Therapeutics, Inc. announced that it has entered into a lease agreement for a facility in Bothell, Washington to manufacture the company’s cell therapy products. The facility will support Juno’s planned JCAR015 multicenter clinical trial, additional clinical programs in Juno’s pipeline, and the company’s first commercial products. [Juno Therapeutics, Inc.] Press Release

Cellular Dynamics Manufactures cGMP HLA “Superdonor” Stem Cell Lines to Enable Cell Therapy with Genetic Matching
Cellular Dynamics International, Inc. announced that it has manufactured, under current Good Manufacturing Practices (cGMP), stem cell lines from two HLA (human leukocyte antigens) “superdonors.” [Cellular Dynamics International, Inc.] Press Release

Cord Blood Registry Announces Formation of Scientific & Medical Advisory Board
Cord Blood Registry® (CBR®) announced the establishment of a Scientific and Medical Advisory Board (SMAB). Composed of internationally renowned stem cell experts, the SMAB will provide input and guidance to help advance CBR’s mission to expand the scope of newborn stem cell therapies that may be available to patients and their families. [Cord Blood Registry®] Press Release
 
NIH
Center for Scientific Review; Notice of Closed Meetings (FR Doc. No: 2015-01981)
 
CBER
Summary Basis for Regulatory Action – Hizentra
 
REGULATORY
Food and Drug Administration (United States)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export of Food and Drug Administration Regulated Products: Export Certificates (FR Doc. No: 2015-02348)

Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions; Section 351(k) Biosimilar Applications (FR Doc. No: 2015-02025)
 
EVENTS
NEW Regenerative Medicine & Stem Cell (RMSC) 2015
March 19-21, 2015
Busan, South Korea

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.
 
JOB OPPORTUNITIES
NEW Research Associate, Pluripotent Stem Cell Biology (STEMCELL Technologies Inc.)

NEW Senior Process Development Engineer (Sangamo BioSciences, Inc.)

NEW Director – Vector Production (Sangamo BioSciences, Inc.)

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

Scientist – PSC Biology and Bioengineering (STEMCELL Technologies Inc.)

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.)

Postdoctoral Fellow – Targeted Gene Editing in Hematopoietic Stem Cells (University Medical Center Freiburg)

Postdoctoral Fellow – Vascular Bioengineering (University of Pittsburgh)

Assistant/Associate Professor – Gastroenterology (North Carolina State University College of Veterinary Medicine)

Postdoctoral Position – Immunology Animal Models (The Technical University of Denmark)

Postdoctoral Position – Inflammatory Bowel Disease (The Technical University of Denmark)

Postdoctoral Fellow – Wnt Signaling in Development and Disease (Van Andel Research Institute)

Cell Therapy Manufacturing Scientist (SLS Services Ltd.)

Postdoctoral Fellowship – CNS Inflammation (Rutgers University)


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