Volume 16.00 | Jan 5

Newsletter Issue
Issue 16.00 January 5, 2015
Cell Therapy News - Your Industry in an Instant
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Publications | Reviews | Science | Policy | Business | NIH | CBER | Regulatory | Events | Jobs
Report on Remission in Patients with MS Three Years after Stem Cell Transplant
Three years after a small number of patients with multiple sclerosis (MS) were treated with high-dose immunosuppressive therapy and then transplanted with their own hematopoietic stem cells, most of the patients sustained remission of active relapsing-remitting MS and had improvements in neurological function. [JAMA Neurol] Press Release | Full Article | Editorial
Free Nature Reviews Immunology Poster: The Immune Response to HIV
PUBLICATIONS (Ranked by impact factor of the journal)
Lineage-Negative Progenitors Mobilize to Regenerate Lung Epithelium after Major Injury
Scientists define the regenerative role of previously uncharacterized, rare lineage-negative epithelial stem/progenitor cells present within normal distal lung. [Nature] Abstract

Inducible RNAi In Vivo Reveals that the Transcription Factor BATF Is Required to Initiate but Not Maintain CD8+ T-Cell Effector Differentiation
Scientists demonstrate that lentivirus-transduced progenitor cells could reconstitute normal hematopoiesis and develop into naive CD8+ T cells that were indistinguishable from wild-type naive T cells. This experimental system enabled induction of efficient gene knockdown in vivo without subsequent manipulation. [Proc Natl Acad Sci USA] Abstract

Combination Therapy with Anti-CTLA-4 and Anti-PD-1 Leads to Distinct Immunologic Changes In Vivo
Although both PD-1 and CTLA-4 dampen the T cell activation, the in vivo effects of these drugs in humans remain to be clearly defined. To better understand biologic effects of therapy, investigators analyzed blood/tumor tissue from 45 patients undergoing single or combination immune checkpoint blockade. [J Immunol] Abstract

RNAi-Mediated Gene Silencing of St6Galnac I Suppresses the Metastatic Potential in Gastric Cancer Cells
The authors investigated the effects of suppression of ST6GalNAc I on gastric cancer in vitro and in vivo. They evaluated the effect of ST6GalNAc I siRNA treatment in a peritoneal dissemination mouse model. [Gastric Cancer] Abstract

Impact of Natural IgM Concentration on Gene Therapy with Adenovirus Type 5 Vectors
Scientists show that polyreactive natural IgM antibodies bind to type 5 adenovirus and that inhibition of liver transduction by IgM depends on Kupffer cells. By manipulating IgM concentration in vivo, they demonstrate that IgM inhibits liver transduction in a concentration-dependent manner. [J Virol] Abstract

Chronic Spinal Cord Lesions Respond Positively to Transplants of Mesenchymal Stem Cells
Researchers investigated whether transplantation of mesenchymal stem cells in mice during the chronic stage of spinal cord injury has benefits in terms of morphological and functional outcomes. [Restor Neurol Neurosci] Abstract

Single and Multiple Dose MultiStem® (Multi-Potent Adult Progenitor Cell) Therapy Prophylaxis of Acute GvHD in Myeloablative Allogeneic Hematopoietic Cell Transplantation: A Phase I Trial
Researchers conducted a multi-center, Phase I dose escalation study evaluating safety of the allogeneic multipotent adult progenitor cell stromal product administered as an adjunct therapy to 36 patients after myeloablative allogeneic hematopoietic cell transplantation. [Biol Blood Marrow Transplant] Abstract

HLA-E Polymorphism and Clinical Outcome after Allogeneic Hematopoietic Stem Cell Transplantation in Egyptian Patients
Investigators evaluated the clinical impact of human leukocyte antigen-E (HLA)-E alleles on transplantation in a group of Egyptian patients. HLA-E genotyping was analyzed in eighty-eight recipients of stem cell transplantation using polymerase chain reaction-restriction fragment length polymorphism. [Hum Immunol] Abstract

Free Wallchart: Small Molecules, Big Impact in PSC Research
Clinical Applications of Naturally Derived Biopolymer-Based Scaffolds for Regenerative Medicine
The authors highlight biopolymer-based scaffolds used in clinical applications for the regeneration and repair of native tissues, with a focus on bone, skeletal muscle, peripheral nerve, cardiac muscle, and cornea substitutes. [Ann Biomed Eng] Abstract

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

Learn more about the new smartphone app for human blood cell frequencies
BrainStorm Announces Final Analysis of Phase IIa ALS Study Showing Nearly All Subjects Experienced Clinical Benefit from NurOwn™
BrainStorm Cell Therapeutics Inc. announced positive final results from its Phase IIa clinical trial of NurOwn™ in amyotrophic lateral sclerosis (ALS) patients, which enrolled 14 subjects at Hadassah Medical Center in Jerusalem. [BrainStorm Cell Therapeutics Inc. (PR Newswire Association LLC)] Press Release

Athersys Finishes Enrollment of Phase II Study of MultiStem® Cell Therapy for Ischemic Stroke
Athersys, Inc. announced that it has concluded patient enrollment of its Phase II clinical study involving administration of Athersys’ MultiStem® cell therapy to ischemic stroke patients. [Athersys, Inc.] Press Release

From our sponsor: Learn about assays for cord blood. Download the free technical bulletin.
Questions Linger over Stress-Induced Stem Cells
The latest investigation into a debunked method of generating stem cells has left researchers grappling with questions about what went wrong in a laboratory at the RIKEN research institute in Japan. The final report from the independent investigation bolstered suspicions that the stem cells—which were supposedly generated by applying stress to ordinary adult cells in an acid bath—were actually embryonic stem cells that had been introduced to the samples. [Nature News] Editorial

India’s Major Science Funders Join Open-Access Push
Two of India’s major science funding agencies are joining the push to make the results of the research they fund freely available to the public. India’s Ministry of Science & Technology announced it will require researchers who receive even just part of their funding from its biotechnology and science and technology departments to deposit copies of their papers in publicly accessible depositories. [ScienceInsider] Editorial

Overhaul of Dutch Funding Agency Triggers Uproar
A government plan to radically reform the Netherlands Organisation for Scientific Research, a major research funding agency in the Netherlands, is causing an uproar among scientists. Many say that the attempt to streamline the agency—which a 2013 evaluation called a “disorderly patchwork”—is a threat to basic science and will give nonscientists too much power in the distribution of research grants. [ScienceInsider] Editorial
Amgen and Kite Pharma Announce Strategic Cancer Immunotherapy Collaboration to Advance the Application of Novel Chimeric Antigen Receptor (CAR) T Cell Therapies
Amgen and Kite Pharma announced that the two companies have entered into a strategic research collaboration and license agreement to develop and commercialize the next generation of novel CAR T cell immunotherapies based on Kite’s engineered autologous cell therapy platform and Amgen’s extensive array of cancer targets. [Kite Pharma, Inc.] Press Release

Selecta and Skolkovo Foundation Collaboration to Develop a Synthetic Vaccine Particle in the Field of Immuno-Oncology
Selecta Biosciences announced that it has been awarded a $3.2 million grant from Skolkovo Foundation in support of Selecta’s program to develop an synthetic vaccine particle immunotherapy to treat cancers caused by infections with Human Papilloma Virus, such as cervical, head and neck cancers. [Selecta Biosciences, Inc.] Press Release

Osiris Announces a Strategic Partnership with Stryker for Marketing Osiris’ Viable Bone Matrix
Osiris Therapeutics, Inc. announced that it has entered into an exclusive, worldwide partnership with Stryker Corporation for the commercialization and development of Osiris’ viable bone matrix tissue form. [Osiris Therapeutics, Inc.] Press Release

Sirnaomics and Partner Submit IND to CFDA
Sirnaomics, Inc. and its affiliate Suzhou Sirnaomics Pharmaceutics, Co. Ltd., together with its partner Guangzhou Xiangxue Pharmaceutical, Co. Ltd., have formally submitted an Investigational New Drug (IND) Application to the China Food and Drug Administration (CFDA) for STP705, an anti-fibrosis RNA interference therapeutic for prevention and treatment of human skin hypertrophic scars. [Sirnaomics, Inc.] Press Release

Bristol-Myers Squibb Receives Accelerated Approval of Opdivo (Nivolumab) from the U.S. Food and Drug Administration
Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration approved Opdivo injection, for intravenous use. Opdivo is a human programmed death receptor-1 blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor. [Bristol-Myers Squibb Company] Press Release

Tekmira Establishes Manufacturing and Clinical Trial Agreement to Provide TKM-Ebola-Guinea for Clinical Studies in West Africa
Tekmira Pharmaceuticals Corporation, a developer of RNA interference therapeutics, announced that the company has entered into a manufacturing and clinical trial agreement with the University of Oxford to provide the new TKM-Ebola-Guinea therapeutic product for clinical studies in West Africa. [Tekmira Pharmaceuticals Corporation]
Press Release

Philanthropists John and Leslie Malone Propel Regenerative Medicine with $42.5 Million Gift
Philanthropists John and Leslie Malone have committed a record $42.5 million to Colorado State University to develop regenerative medical therapies for animals and people. [Colorado State University] Press Release

Grant Supports Research on Potential Immunotherapy Treatment for Neuroblastoma
A Baylor College of Medicine and Texas Children’s Cancer Center researcher was one of three inaugural recipients of the Bio-therapeutics Impact Award from the nonprofit organization Alex’s Lemonade Stand. Dr. Leonid Metelitsa received the $1.5 million, three-year grant for his research on a new form of cancer immunotherapy to treat neuroblastoma, one of the most common solid tumors in children. [Baylor College of Medicine] Press Release

Locate Therapeutics Appoints Chairman to Its Board of Directors
Locate Therapeutics Ltd. announced the appointment of Ian Wilding as Chairman of the Board of Directors. Dr. Wilding has previously founded, managed and developed a number of successful bioscience start-up companies, including Pharmaceutical Profiles. [Locate Therapeutics Ltd.] Press Release
National Center for Advancing Translational Sciences; Notice of Meetings (FR Doc. No: 2014-30619)

Prospective Grant of Start-Up Exclusive Commercialization License: Anti-Tyrosine Kinase-Like Orphan Receptor 1 Immunotoxins for the Treatment of Human Cancers (FR Doc. No: 2014-30259)
Tissue Notices, Proposed and Final Rules
Food and Drug Administration (United States)

Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (FR Doc. No: 2014-30528)

Advisory Committees; Filing of Closed Meeting Reports (FR Doc. No: 2014-30460)

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring (FR Doc. No: 2014-30452)

Vaccines and Related Biological Products Advisory Committee; Notice of Meeting (FR Doc. No: 2014-29860)
NEW 4th International Conference on Immunochemotherapy
April 16-17, 2015
Philadelphia, United States

NEW BIT’s 5th Annual Symposium of Drug Delivery Systems
October 20-22, 2015
Beijing, China

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.
NEW Postdoctoral Fellow – Radiation Therapy and Immunotherapy (Georgia Regents University Cancer Center)

PhD Student – Experimental Leukemia Research (University Children’s Hospital Basel)

Postdoctoral Position – Gene Therapy (EB-House Austria)

Manager – Cell Processing Facility (Fred Hutchinson Cancer Research Center)

Cell Therapy Senior Manager (taylorollinson Ltd.)

Mesenchymal Stem Cell (MSC) Laboratory Technician (California Cryobank)

Clinical Laboratory Scientist – Umbilical Cord Blood Processing (California Cryobank)

Postdoctoral Researcher – Chromatin and Epigenetic Regulation (Van Andel Research Institute)

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.)

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

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