Volume 16.22 | Jun 8

Newsletter Issue
Issue 15.22 June 8, 2015
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Publications | Reviews | Science | Policy | Business | NIH | CBER | Regulatory | Events | Jobs
Scientists Demonstrate Drug-Induced Tissue Regeneration
A study shows that a primordial form of energy production that still exists in mammals can be harnessed to achieve spontaneous tissue regeneration in mice, without the need for added stem cells. [Press release from Lankenau Institute for Medical Research discussing online publication in Science Translational Medicine] Press Release | Abstract
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PUBLICATIONS (Ranked by impact factor of the journal)
Antigen-Loaded Upconversion Nanoparticles for Dendritic Cell Stimulation, Tracking, and Vaccination in Dendritic Cell-Based Immunotherapy
Antigen-loaded upconversion nanoparticles (UCNPs) were used to label and stimulate dendritic cells (DCs), which could be precisely tracked after being injected into animals and induce an antigen-specific immune response. Researchers discovered that a model antigen, ovalbumin, could be adsorbed on the surface of dual-polymer-coated UCNPs via electrostatic interaction, forming nanoparticle-antigen complexes, which are efficiently engulfed by DCs and induce DC maturation and cytokine release. [ACS Nano] Abstract | Graphical Abstract

Hydrogen Sulfide Mediates the Cardioprotective Effects of Gene Therapy with PKG-Iα
Since hydrogen sulfide (H2S) has been implicated in mediating the cardioprotective effects of the cGMP modulators tadalafil and cinaciguat, scientists tested the hypothesis that myocardial gene therapy with cyclic GMP-dependent protein kinase (PKG) exerts cardioprotection against ischemia/reperfusion injury through a mechanism involving H2S. [Basic Res Cardiol] Abstract

Time-Dependent Bladder Tissue Regeneration Using Bilayer Bladder Acellular Matrix Graft-Silk Fibroin Scaffolds in a Rat Bladder Augmentation Model
Investigators developed a bilayer scaffold comprising a porous network (silk fibroin) and an underlying natural acellular matrix (bladder acellular matrix graft) and evaluated its feasibility and potential for bladder regeneration in a rat bladder augmentation model. [Acta Biomater] Abstract

Extracellular Matrix Can Recover the Downregulation of Adhesion Molecules after Cell Detachment and Enhance Endothelial Cell Engraftment
Researchers investigated if processes involved in cell preparation could initiate downregulation of adhesion-related survival signals, and further affect cell engraftment after transplantation. [Sci Rep] Full Article

Design of Cationic Multi-Walled Carbon Nanotubes as Efficient siRNA Vectors for Lung Cancer Xenograft Eradication
Investigators established the capacity of cationic MWNT-NH3+ to deliver the apoptotic siRNA against polo-like kinase in Calu6 tumor xenografts by direct intratumoral injections. [Bioconjug Chem] Abstract

First-in-Human Case Study: Multipotent Adult Progenitor Cells for Immunomodulation after Liver Transplantation
Researchers describe the clinical course of the first patient of the Phase I, dose-escalation safety and feasibility study, MiSOT-I (Mesenchymal Stem Cells in Solid Organ Transplantation Phase I). [Stem Cells Transl Med] Abstract

Generation of Donor-Specific T Regulatory Type 1 Cells from Patients on Dialysis for Cell Therapy after Kidney Transplantation
Investigators tested the ability to generate donor-specific T regulatory type 1 cell-enriched lymphocytes from patients on dialysis on the waiting list for kidney transplantation. [Transplantation] Abstract

Immobilization of FLAG-Tagged Recombinant Adeno-Associated Virus 2 onto Tissue Engineering Scaffolds for the Improvement of Transgene Delivery in Cell Transplants
Researchers tagged the VP2 protein of type 2 adeno-associated virus with a 3xFLAG plasmid at the N-terminus and packaged a FLAG-tagged recombinant AAV2 chimeric mutant. The mutant AAVs were immobilized onto the tissue engineering scaffolds with crosslinked anti-FLAG antibodies by N-succinimidyl-3-(2-pyridyldithiol) propionate. [PLoS One] Full Article

FOXP3+ T Cells Recruited to Sites of Sterile Skeletal Muscle Injury Regulate the Fate of Satellite Cells and Guide Effective Tissue Regeneration
The authors assessed the role of the adaptive immune system in muscle regeneration after acute damage. They showed that T lymphocytes are transiently recruited into the muscle after damage and appear to exert a pro-myogenic effect on muscle repair. [PLoS One] Full Article

Increases in Plasma Tβ4 after Intracardiac Cell Therapy in Chronic Ischemic Heart Failure Is Associated with Symptomatic Improvement
To investigate whether Tβ4 is important in human cardiac disease and has a role in mediating the beneficial cardiac effects of bone-marrow-derived stem cell therapy, investigators measured serial plasma Tβ4 levels in patients enrolled on the REGENERATE-IHD cell therapy trial. [Regen Med] Abstract | Press Release

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T-Cell and Natural Killer Cell Therapies for Hematologic Malignancies after Hematopoietic Stem Cell Transplantation: Enhancing the Graft-versus-Leukemia Effect
The authors provide an overview of immunotherapeutic strategies following hematopoietic stem cell transplantation, with discussions centered on natural killer and T-cell biology. [Haematologica] Full Article

Overview of Hydrogel-Based Strategies for Application in Cardiac Tissue Regeneration
The authors review the most common approaches in hydrogel-based cardiac tissue regeneration with particular focus on the implementation of hydrogels to improve cell delivery. [Biomed Mater] Abstract

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

Going to ISSCR 2015? We’ll see you there!
Bellicum Announces ASCO Presentation Featuring its Novel CAR T Cell Co-Stimulatory Domain Designed to Improve Potency Against Solid Tumors
Bellicum Pharmaceuticals, Inc. announced the presentation of a poster highlighting the potent anti-tumor effects of CAR T cells constructed with its novel, proprietary, dual co-stimulatory domain, “MC” (MyD88/CD40). [Press release from Bellicum Pharmaceuticals, Inc. discussing research presented at the 2015 American Society for Clinical Oncology (ASCO) Annual Meeting, Chicago] Press Release

Juno’s Investigational CAR T Cell Product Candidate JCAR014 Demonstrates Encouraging Clinical Responses and Translational Insights in Patients with B-Cell Cancers
Juno Therapeutics, Inc. announced that clinical data from a chimeric antigen receptor (CAR) T cell product candidate, JCAR014, demonstrated encouraging clinical responses in patients with B-cell cancers. [Press release from Juno Therapeutics, Inc. discussing research presented at the 2015 American Society for Clinical Oncology (ASCO) Annual Meeting, Chicago] Press Release

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European Union Rejects Plea to End Animal Research
The European Commission has rejected a plea to abolish animal research across the European Union, saying that doing so would harm biomedical research. A so-called European Citizens’ Initiative signed by 1.17 million signatories formally urged the commission to scrap a 2010 directive regulating the use of animals in scientific research and to propose new rules phasing out animal research in favor of “more accurate, reliable, human-relevant methods.” [ScienceInsider] Editorial | Press Release

Sluggish Data Sharing Hampers Reproducibility Effort
An initiative that aims to validate the findings of key cancer papers is being slowed by an unexpected hurdle — problems accessing data from the original studies. [Nature News] Editorial
Celgene and bluebird bio to Develop Anti-BCMA Product Candidates; bluebird bio Regains Rights to CAR T Programs Outside of BCMA
bluebird bio, Inc. announced that its existing global collaboration agreement with Celgene Corporation has been amended and restated to focus on developing product candidates targeting B-cell maturation antigen (BCMA) during a three-year collaboration term. [bluebird bio, Inc.] Press Release

Weill Cornell Medical College and Cellectis Announce Research Alliance Advancing Drug Discovery and the Translation of Novel Immunotherapies in Leukemia
Weill Cornell Medical College and Cellectis have entered into a strategic translational research alliance to accelerate the development of a targeted immunotherapy for patients with acute myelogenous leukemia, a deadly blood cancer. [Cellectis, Inc.] Press Release

Inovio Pharmaceuticals Partners with GeneOne Life Science for MERS Immunotherapy Clinical Development
Inovio Pharmaceuticals, Inc. announced it will advance its DNA vaccine for MERS (Middle East Respiratory Syndrome) into a Phase I clinical trial in healthy volunteers in a collaboration with GeneOne Life Science Inc., an international DNA vaccine developer and manufacturer in which Inovio holds an equity interest. [Inovio Pharmaceuticals, Inc.] Press Release

Roche Announces Collaboration with Amgen on Cancer Immunotherapy Study with Investigational Medicines Talimogene Laherparepvec and Atezolizumab (MPDL3280A)
Roche announced a collaboration with Amgen on a Phase Ib study to evaluate the safety and efficacy of talimogene laherparepvec, Amgen’s investigational oncolytic immunotherapy, in combination with Roche’s investigational anti-PDL1 therapy atezolizumab, in patients with triple-negative breast cancer and colorectal cancer with liver metastases. [F. Hoffmann-La Roche Ltd.] Press Release

Baxter Ventures, Mayo Clinic and Velocity Pharmaceutical Development Announce the Formation of Vitesse Biologics, LLC, a Company Structured to Accelerate Therapeutic Innovation
Baxter Ventures, the venture arm of Baxter International Inc., Mayo Clinic and Velocity Pharmaceutical Development, LLC announced the formation of Vitesse Biologics, LLC,. Vitesse is a unique collaboration model initiated by Baxter Ventures to focus on the development of antibody and protein-based therapeutics in the areas of immunology, hematology, and oncology. [Mayo Clinic] Press Release

Seattle Genetics and Unum Therapeutics Enter into Strategic Cancer Immunotherapy Collaboration
Seattle Genetics, Inc. and Unum Therapeutics announced that the two companies have entered into a strategic collaboration and license agreement to develop and commercialize novel antibody-coupled T-cell receptor therapies for cancer. [Seattle Genetics, Inc.] Press Release

OncoSec Medical and UC Davis School of Veterinary Medicine Collaborate to Test Intratumoral Cancer Immunotherapy in Canine Soft Tissue Sarcoma
OncoSec Medical Inc. announced a collaboration with University of California, Davis School of Veterinary Medicine to test ImmunoPulse™ IL-12 as an immunotherapy in dogs with soft tissue sarcoma. [OncoSec Medical Inc.] Press Release

Azrieli Foundation Donates $10 Million for Hebrew University Research
The Azrieli Foundation, one of Canada’s largest foundations, has donated $10 million to fund innovative research at the Hebrew University of Jerusalem’s newly inaugurated Azrieli Center for Stem Cells and Genetic Research. [Hebrew University of Jerusalem] Press Release
Center for Scientific Review; Notice of Closed Meetings (FR Doc. No: 2015-13145)
Biologics PREA Reviews and Labeling Changes
Food and Drug Administration (United States)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Formal Meetings Between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants (FR Doc. No: 2015-13695)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biosimilars User Fee Cover Sheet; Form FDA 3792 (FR Doc. No: 2015-13471)

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division Level (FR Doc. No: 2015-13386)

Established Conditions: Reportable Chemistry, Manufacturing, and Controls Changes for Approved Drug and Biologic Products; Draft Guidance for Industry; Availability (FR Doc. No: 2015-13104)
NEW Nordic Life Sciences Days 2015
September 9-10, 2015
Stockholm, Sweden

NEW Stem Cell Asia Congress 2015
October 15-16, 2015
Singapore, Singapore

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.
NEW Cell Therapy GMP Manager (Paramount Recruitment)

NEW Postdoctoral Fellow – Neural Stem Cells (Children’s Hospital of Philadelphia)

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

Lead Device and Delivery Scientist (Cell Therapy Catapult)

Head of Stem Cells Immunotherapies Service Lab (NHS Blood and Transplant)

Postdoctoral Fellow – Immune Reconstitution in Hematopoietic Stem Cell Transplantation (Stanford University)

Head of Cellular Therapies Laboratory (NHS Blood and Transplant)

Postdoctoral Fellow – Immune Tolerance (Stanford University)

Postdoctoral Fellow Positions – iPSC Research and Banking (University of Magna Graecia)

Process Facilitator (Opexa Therapeutics)

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