Immunotherapeutics

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Immunotherapeutics

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ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company, today announced an exclusive license with Annias Immunotherapeutics, a privately held Immuno-oncology company, for rights to intellectual property related to targeting antigens of cytomegalovirus (CMV) in cancer as well as methods of improving cancer vaccination. Both clinical stage cancer immunotherapy companies are focused on research and development of a potential new generation of cancer vaccines. The license includes upfront payment, milestones and royalties. This new license allows Immunomic to combine its investigational nucleic acid based immunotherapy platform, LAMP-Vax, with a patented and proprietary CMV immunotherapy platform, developed at Duke University by Drs. John H. Sampson and Duane A. Mitchell and licensed to Annias. This approach could harness the body’s immune system to recognize, attack and destroy tumor cells that express CMV, which is over-expressed in a variety of human cancers, including GBM. “We are thrilled to collaborate with Drs. Mitchell and Sampson, two giants in the field, to work toward treatment options for glioblastoma patients. GBM is an aggressive brain cancer that has devastated so many lives and for which medical advances have been so incredibly slow,” said Dr. William Hearl, CEO of Immunomic Therapeutics. “This license enables us to support and accelerate development of a potential new generation of cancer immunotherapy based on our proprietary LAMP-Vax platform not only for GBM but also for other types of cancer.” A phase II randomized clinical trial enrolling patients with newly diagnosed GBM will explore whether dendritic cell (DC) vaccines targeting the human CMV antigen pp65 expressed as fusion protein with LAMP improves survival. The clinical trial is funded by the National Cancer Institute (clinicaltrials.gov identifier: NCT02465268) and the Principal Investigator is Duane A. Mitchell, M.D., Ph.D., director of the Cancer Therapeutics and Immuno-Oncology Program at the UF Health Cancer Center and co-director of the Preston A. Wells, Jr. Center for Brain Tumor Therapy at UF. Drs. Sampson and Mitchell conducted foundational work investigating a new generation of cancer immunotherapies that targeted CMV antigens, including those specifically focused on GBM, while at Duke University. A series of Phase I studies were completed that utilized the CMV targeting concept in combination with LAMP technology and were published in Nature. Annias Immunotherapeutics exclusively licensed this patent portfolio from Duke University to develop immunotherapeutic approaches to treat cancers that contain Cytomegalovirus (CMV). Annias is currently pursuing multiple clinical development strategies towards this goal. An ongoing randomized phase I/II trial is testing the safety and efficacy of a novel multi-epitope peptide vaccine in combination with immunological pre-conditioning in patients suffering from GBM. Annias is continuing to develop all aspects of the technology outside of the field that was licensed to Immunomic. “This agreement validates the dominant patent position Annias has in the field of cancer immunotherapies that target CMV,” said Reiner Laus, MD, CEO of Annias Immunotherapeutics. “We will continue to develop our own portfolio and will further evaluate opportunities for limited out-licensing to companies that develop CMV-directed cancer immunotherapies.” Immunomic has now exclusively licensed rights to the intellectual property portfolios for the treatment of cancer, including GBM, using nucleic acid and dendritic cell vaccination approaches coupled with LAMP-based technologies. Cancer immunotherapy is widely viewed as a transformative area of cancer treatment and a burgeoning market. Immunomic’s LAMP-Vax technology is being studied in several oncology indications and has Phase I data in GBM, prostate cancer and melanoma & Phase II data in AML. The CMV approach licensed by Immunomic is detailed in “Tetanus toxoid and CCL3 improve dendritic cell migration in mice and glioblastoma patients1,” published in Nature and in Clinical Cancer Research in 2017, “Long-term Survival in Glioblastoma with Cytomegalovirus pp65-Targeted Vaccination2.” Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of the LAMP-based nucleic acid immunotherapy platforms. These investigational technologies have the potential to alter how we use immunotherapy for cancer, allergies and animal health. On the heels of two landmark deals in 2015, including an exclusive worldwide license with Astellas Pharma Inc. to explore the use of LAMP-vax for use in the prevention and treatment of allergic diseases, which resulted in over $350M in licensing revenue that year, the company has now focused on the application of LAMP technology to immuno-oncology. For information about ITI and LAMP Technology, visit www.immunomix.com or contact info@immunomix.com. Annias Immunotherapeutics, Inc., is a clinical stage immuno-oncology company focused on the development of novel immunotherapeutic approaches to treat cancers that contain Cytomegalovirus (CMV). The company’s product candidates are based on a patented and proprietary immunotherapeutic platform, which harnesses the body’s immune system to recognize and destroy tumor cells that contain CMV. Examples include Glioblastoma Multiforme (a lethal brain tumor) as well as many breast, prostate and colorectal cancers. For more information, please contact Reiner Laus, M.D. President and CEO of Annias Immunotherapeutics at info@anniasimmuno.com.


News Article | April 17, 2017
Site: www.eurekalert.org

Bottom Line: A vaccine targeting cytomegalovirus (CMV) antigen pp65, combined with high-dose chemotherapy (temozolomide), improved both progression-free survival and overall survival for a small group of glioblastoma (GBM) patients. Journal in Which the Study was Published: Clinical Cancer Research, a journal of the American Association for Cancer Research. Author: Lead author of the study is Kristen Batich, MD, PhD, a researcher in the lab of senior author John Sampson, MD, PhD, chair of the Department of Neurosurgery at Duke University. Background: The typical median survival for GBM patients is less than 15 months. To overcome these poor numbers, the researchers took advantage of CMV's affinity for GBM, with the viral proteins being expressed in roughly 90 percent of these tumors. Building on previous research, they used CMV as a proxy for GBM, targeting the virus with pp65-specific dendritic cells to spotlight the tumor for the immune system. How the Study Was Conducted and Results: The cohort of 11 patients who received this combination therapy demonstrated a median progression-free survival of 25.3 months and a median overall survival of 41.1 months, and three patients remain progression-free more than seven years after diagnosis, Batich explained. "The clinical outcomes in GBM patients who received this combination were very striking," Batich said. Previous work had shown that TMZ generates profound lymphopenia or the loss of immune cells, which offers a unique opportunity to retrain the immune system, Batich explained. The researchers administered dose-intensified temozolomide (TMZ) as a strategy to further enhance the immune response. "The dose-intensified temozolomide induces a strong state of lymphopenia," said Batich. "With that comes an opportune moment to introduce an antigen-specific vaccine, which redirects the immune system to put all hands on deck and fight that target." One of the noteworthy results from the study was the excellent response rate despite the high proportion of regulatory T cells, which dampen the immune response and rebounded sharply following TMZ administration. This finding may actually be cause for optimism, Batich noted. "If we could preclude this regulatory T-cell rebound, it could have additionally enhancing effects on the pp65 vaccine response," said Batich. Limitations: Though the survival results are quite encouraging, the authors caution that this was a single-arm study without a control group. In addition, the cohort was quite small. Though the outcomes far outpaced historical controls, a more robust trial will be needed to confirm these results. In addition, the team wants to better understand the mechanisms that underlie the strong response rate and refine this combination therapy to produce even better results. "We want to understand why some patients do better than others," said Batich. Funding & Disclosures: This study was funded by the National Institutes of Health. Sampson holds stock ownership and is on the board of directors with Annias Immunotherapeutics; serves as a consultant and advisory board member for Celldex Therapeutics; reports honoraria for Celldex Therapeutics, Bristol-Myers Squibb, and Brainlab; and a co-inventor on a patent describing the immunologic targeting of CMV antigens in cancer. Batich is a co-inventor on a patent for improving the immunogenicity of dendritic cell vaccines. Founded in 1907, the American Association for Cancer Research (AACR) is the world's first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes more than 37,000 laboratory, translational, and clinical researchers; population scientists; other health care professionals; and patient advocates residing in 108 countries. The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, biology, diagnosis, and treatment of cancer by annually convening more than 30 conferences and educational workshops, the largest of which is the AACR Annual Meeting with more than 21,900 attendees. In addition, the AACR publishes eight prestigious, peer-reviewed scientific journals and a magazine for cancer survivors, patients, and their caregivers. The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration, and scientific oversight of team science and individual investigator grants in cancer research that have the potential for near-term patient benefit. The AACR actively communicates with legislators and other policymakers about the value of cancer research and related biomedical science in saving lives from cancer. For more information about the AACR, visit http://www. . To interview Kristen Batich, contact Julia Gunther at julia.gunther@aacr.org or 215-446-6896.


This report provides a comprehensive overview of the size of the regenerative medicine market, segmentation of the market (stem cells, tissue engineering and CAR-T therapy), key players and the vast potential of therapies that are in clinical trials.  Kelly Scientific analysis indicates that the global regenerative medicine market was worth $18.9 billion in 2016 and will grow to over $53.7 billion by 2021. Within this market, the stem cell industry will grow significantly. Regenerative medicine's main objective is to heal and replace organs/cells that have been damaged by age, trauma or disease. Congenital defects can also be addressed with regenerative medicine. Therefore, it's market encompasses dermal wounds, cardiovascular disease, specific cancer types and organ replacement. To that end, regenerative medicine is a broader field and manipulates the body's immune system and regeneration potential to achieve its requirement. Financially speaking, investment into this space is dominated by grants, private investors and publicly traded stocks. Looking forward, the regenerative medicine market is promising for a number of robust reasons including: Key Topics Covered: 1.0 Report Synopsis 2.0 Introduction 2.1 Gurdon and Yamanaka Share the Nobel Prize 2.2 Stem Cell Clinical Trials: Initiated in 2010 2.3 Types of Stem Cells 2.4 Adult (Tissue) Stem Cells 2.5 Pluripotent Stem Cells 2.6 Somatic Cell Nuclear Transfer (SCNT) 2.7 Induced pluripotent Stem Cells (iPSC) 2.8 Mesenchymal Cells 2.9 Hematopoietic Stem and Progenitor Cells 2.10 Umbilical Cord Stem Cells 2.11 Heart Stem Cells 2.12 Mammary Stem Cells 2.13 Neural Stem Cells 2.14 Stem Cell Applications in Retinal Repair 2.15 Liver Stem Cells 2.16 Gut Stem Cells 2.16 Pancreatic Stem Cells 2.17 Epidermal Stem Cells 3.0 Stem Cells and Clinical Trials 3.1 Introduction 3.2 Pluripotent Stem Cells 3.3 Limbal Stem Cells 3.4 Neural Stem Cells 3.5 Endothelial Stem or Progenitor Cells 3.6 Placental Stem Cells 3.7 Why Do Stem Cell Clinical Trials Fail? 3.8 What is the Future of Stem Cell Trials? 3.9 Cutting Edge Stem Cell Clinical Trials 3.10 Ocata Therapeutics Current Stem Cell Trials 3.11 CHA Biotech Current Stem Cell Trials 3.12 Pfizer Current Stem Cell Trials 3.13 GSK Current Stem Cell Trials 3.14 Bayer Current Stem Cell Trials 3.15 Mesoblast International Current Stem Cell Trials 3.16 Millennium Pharmaceutical Current Stem Cell Trial 3.17 AstraZeneca Current Stem Cell Trials 3.18 Merck Current Stem Cell Trials 3.19 Chimerix Current Stem Cell Trials 3.20 Eisai Current Stem Cell Trials 3.21 SanBio Current Stem Cell Trials 3.22 Celgene Current Stem Cell Trials 3.23 StemCells Current Stem Cell Trials 3.24 Genzyme (Sanofi) Current Stem Cell Trials 3.25 Teva Current Stem Cell Trials 3.26 MedImmune Current Stem Cell Trials 3.27 Janssen Current Stem Cell Trials 3.28 Seattle Genetics Current Stem Cell Trials 3.29 Baxter Healthcare Current Stem Cell Trials 3.30 InCyte Corp Current Stem Cell Trials 4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing 4.1 Introduction 4.2 Case Study: Genentech and Stem Cell Technology 4.3 3D Sphere Culture Systems 4.4 Stem Cells and High Throughput Screening 4.5 Genetic Instability of Stem Cells 4.6 Comprehensive in Vitro Proarrhythmia Assay (CiPA) & Cardiomyocytes 4.8 Coupling Precise Genome Editing (PGE) and iPSCs 4.9 Stem Cells & Toxicity Testing 4.10 Stem Cell Disease Models 4.11 Defining Human Disease Specific Phenotypes 4.12 Advantages of Stem Cell Derived Cells & Tissues for Drug Screening 5.0 Stem Cell Biomarkers 5.1 Pluripotent Stem Cell Biomarkers 5.2 Mesenchymal Stem Cell Biomarkers 5.3 Neural Stem Cell Biomarkers 5.4 Hematopoietic Stem Cell Biomarkers 6.0 Manufacturing Stem Cell Products 6.1 Manufacturing Strategies For Stem Cell Products 6.2 BioProcess Economics for Stem Cell Products 6.3 Capital Investment 6.4 Cost of Goods 6.5 Bioprocess Economic Drivers & Strategies 6.6 hPSC Expansion & Differentiation using Planar Technology 6.7 hPSC Expansion using 3D Culture 6.8 Microcarrier Systems 6.9 Aggregate Suspension 6.10 Bioreactor Based Differentiation Strategy 6.11 Integrated hPSC Bioprocess Strategy 6.12 GMP Regulations and Stem Cell Products 7.0 Investment & Funding 7.1 What do Investors Want from Cell & Gene Therapy Companies? 7.2 What Makes a Good Investment? 7.3 What Types of Companies do Not Get Investment? 7.4 Global Funding 7.5 Cell & Gene Therapy Investment Going Forward 7.6 What Cell & Gene Companies are the Most Promising in 2017? 7.7 Insights into Investing in Cell and Gene Therapy Companies 8.0 Regenerative Medicine Market Analysis & Forecast to 2021 8.1 Market Overview 8.2 Global Frequency Analysis 8.3 Economics of Regenerative Medicine 8.4 Market Applications & Opportunities for Regenerative Therapies 8.5 Global Financial Landscape 8.6 Regenerative Medicine Clinical Trial Statistics 8.7 Regenerative Medicine Market Forecast to 2021 8.8 Regenerative Medicine Geographic Analysis and Forecast to 2021 8.9 Regenerative Medicine Geographical Location of Companies 8.10 Regenerative Medicine Technology Breakdown of Companies 8.11 Commercially Available Regenerative Medicine Products 8.12 Major Regenerative Medicine Milestones 9.0 Stem Cell Market Analysis & Forecast to 2021 9.1 Autologous & Allogenic Cell Market Analysis 9.2 Stem Cell Market by Geography 9.3 Stem Cell Market Forecast by Therapeutic Indication 9.4 Stem Cell Reagent Market Trends 10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2021 10.1 Geographical Analysis and Forecast to 2021 10.2 Geographical Analysis by Company Share 10.3 Tissue Engineering Clinical Indication Analysis & Forecast to 2021 11.0 Biobanking Market Analysis 11.1 Increasing Number of Cord Blood Banks Globally 11.2 Global Biobanking Company Sector Analysis & Breakdown 11.3 Allogenic Versus Autologous Transplant Frequency 11.4 Biobanking Market Analysis & Forecast to 2021 11.5 Major Global Players 12.0 Global Access & Challenges of the Regenerative Medicine Market 12.1 Regenerative Medicine Market in the USA 12.2 Regenerative Medicine in Japan 12.3 Regenerative Medicine in China 12.4 Regenerative Medicine in South Korea 13.0 Cell and CAR T Therapy 13.1 Challenges Relating to Cell therapy and Chimeric Antigen Receptor T Cells in Immunotherapy 13.2 Regulations Pertaining to Immunotherapy, including Adoptive Cell Therapy (CAR-T and TCR) Immunotherapy Regulation in the USA 13.3 Regulations for Cell Therapy & Immunotherapy in Japan 13.4 European Regulation and Cell Therapy & Immunotherapeutics 13.5 Manufacturing of Immunotherapies 13.6 Supply Chain & Logistics 13.7 Pricing & Cost Analysis 14.0 Company Profiles 14.1 Astellas Institute for Regenerative Medicine (Ocata Therapeutics) 14.2 Athersys 14.3 Baxter International (Baxalta, Shire) 14.4 Caladrius Biosciences (NeoStem) 14.5 Cynata Therapeutics 14.6 Cytori Therapeutics 14.7 MEDIPOST 14.8 Mesoblast 14.9 NuVasive 14.10 Osiris Therapeutics 14.11 Plasticell 14.12 Pluristem Therapeutics 14.13 Pfizer 14.14 StemCells Inc 14.15 STEMCELL Technologies 14.16 Takara Bio 14.17 Tigenix 15.0 SWOT Industry Analysis 15.1 What has Strengthened the Industry Thus Far? 15.2 Allogenic and Autologous Stem Cell Industry SWOT Analysis 15.3 What are the Main Driving Forces of this Space? 15.4 Restraints of the Regenerative Medicine Industry as a Whole 15.5 Industry Opportunities Within this Sector 15.6 USA SWOT Analysis 15.7 UK SWOT Analysis 15.8 South Korea SWOT Analysis 15.9 China SWOT Analysis 15.10 Japan SWOT Analysis 15.11 Singapore SWOT Analysis For more information about this report visit http://www.researchandmarkets.com/research/jh2432/global To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-regenerative-medicine-market-analysis--forecast-2017-2021---research-and-markets-300452299.html


News Article | May 16, 2017
Site: www.eurekalert.org

Summer is approaching, and for many allergy sufferers this means it is time to start fearing bee stings. "Allergic reactions to insect venoms are potentially life-threatening, and constitute one of the most severe hypersensitivity reactions," explains PD Dr. Simon Blank, research group leader at the Center of Allergy & Environment (ZAUM), a joint undertaking by the Helmholtz Zentrum München and the TUM. This is where allergen-specific immunotherapy, commonly known as allergy shots, can help. The treatment involves injecting very small doses of the venom under the patient's skin. The idea is to force the body to become accustomed to the poison and consequently to put an end to the immune system's excessive reaction. According to Blank and his team, however, it may be necessary to improve the procedure. "We now know that bee venom is a cocktail of many different substances. In particular, there are five components that are especially relevant for allergy sufferers," Blank explains. "In our current investigation of commercial preparations, however, we were able to show that these so-called major allergens are not present everywhere at sufficient levels, and some allergens are seriously underrepresented!" While some preparations contained uniform levels of all venom components, in others up to three of the five allergens were present at levels that were too low, according to the authors. The scientists cannot concretely state exactly what this means for the therapeutic success. "So far, studies have not been able to prove how significant this is for the treatment. Because more than six percent of the patients are sensitized only against these three allergens, however, their underrepresentation could affect the treatment success, at least for these patients." Consequently, if patients react to specific allergens in bee venom but these are possibly not found in the preparations at sufficient levels, the question that must be asked is what good does immunotherapy against bee stings do for the individual. ZAUM Director Prof. Dr. Carsten Schmidt-Weber sees it like this: "The vast majority of patients benefit from such a treatment. A desirable objective that results from this work, however, would be for patients to receive a customized treatment in the future. This would be a preparation with exactly the allergens to which the particular patient actually reacts." Due to costs and the relatively small number of patients, however, such developments are still a long way off. For their analysis, the researchers first produced antibodies against the five individual bee venom allergens in order to be able to detect these substances. Specifically, this involved proteins Api m 1, 2, 3, 5 and 10. The abbreviation Api m comes from the Latin term for the honey bee, Apis mellifera. Its venom is correspondingly called apitoxin. The researchers then tested the content of these components in four different preparations for allergen immunotherapy, while also examining different batches. Some preparations contained sufficient levels of all allergens, but some did not. Specific studies are needed to provide findings regarding the effects on the treatment. Recently, however, a different study (Frick et al., JACI 2016) was able to show that sensitization principally with respect to Api m 10 constitutes an increased risk for the failure of the immunotherapy. The study did not examine if this is associated with a low content of Api m 10 in the preparations. Blank, S. et al. (2017): Component-resolved evaluation of the content of major allergens in therapeutic extracts for specific immunotherapy of honeybee venom allergy. Human Vaccines and Immunotherapeutics, DOI: 10.1080/21645515.2017.1323603 The Helmholtz Zentrum München, the German Research Center for Environmental Health, pursues the goal of developing personalized medical approaches for the prevention and therapy of major common diseases such as diabetes and lung diseases. To achieve this, it investigates the interaction of genetics, environmental factors and lifestyle. The Helmholtz Zentrum München is headquartered in Neuherberg in the north of Munich and has about 2,300 staff members. It is a member of the Helmholtz Association, a community of 18 scientific-technical and medical-biological research centers with a total of about 37,000 staff members. The Center of Allergy & Environment (ZAUM) in Munich is a joint undertaking by the Helmholtz Zentrum München and the Technical University of Munich (TUM). This cooperation, which is the only one of its kind in the German research landscape, is dedicated to interdisciplinary basic research and forms a link between clinicians at the hospital and clinical research staff at the university. Thanks to this approach, findings about the mechanisms that lie behind allergies are translated into preventive and therapeutic measures. The development of effective, individually tailored treatments enables better care to be provided for allergy-sufferers. Technical University of Munich (TUM) is one of Europe's leading research universities, with more than 500 professors, around 10,000 academic and non-academic staff, and 40,000 students. Its focus areas are the engineering sciences, natural sciences, life sciences and medicine, com-bined with economic and social sciences. TUM acts as an entrepreneurial university that promotes talents and creates value for society. In that it profits from having strong partners in science and industry. It is represented worldwide with a campus in Singapore as well as offices in Beijing, Brussels, Cairo, Mumbai, San Francisco, and São Paulo. Nobel Prize winners and inventors such as Rudolf Diesel, Carl von Linde, and Rudolf Mößbauer have done research at TUM. In 2006 and 2012 it won recognition as a German "Excellence University." In international rankings, TUM regularly places among the best universities in Germany. The Institute of Allergy Research (IAF) investigates the molecular mechanisms behind the development of allergies, which are on the rise around the world. Through intensive cooperation among scientists and clinicians on individual approaches to prevention, the IAF is working to halt this epidemiological spread. In the therapeutic area, the institute's scientists want to develop new approaches specifically targeted at the patients. The IAF works with the Technische Universität München in the joint Center of Allergy & Environment (ZAUM) facility. The IAF is also a member of the Cluster Allergy and Immunity (CAI) and the German Center for Lung Research (DZL). PD Dr. Simon Blank, Helmholtz Zentrum München - German Research Center for Environmental Health, Institute of Allergy Research & Center of Allergy and Environment, Ingolstädter Landstr. 1, 85764 Neuherberg - Tel. +49 89 4140 2625 - E-mail: simon.blank@helmholtz-muenchen.de


Dublin, May 12, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Regenerative Medicine Market Analysis & Forecast to 2021 - Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries" report to their offering. Current regenerative medicine market is worth $18.9 billion globally, and will hit over $53 billion by 2021 According to the report ‘due to the dominance of the bone and joint reconstruction market, the US currently has the biggest space, followed by Europe. However, due to recent positive legislation in Japan and Europe, the stem cell arena will grow more substantially in these regions over the next five years. By 2021, it is possible that Europe will surpass the US market with respect to stem cell applications, and this will become more likely if the Trump Administration restricts legislation and funding’. The regenerative medicine market has massive scope and can be applied to a wide range of diseases and indications including neurological, autoimmune, cardiovascular, diabetes, musculoskeletal, ocular, orthopedic and wound healing. To that end, the expanse of market opportunities is large as are the patient populations globally. Kelly indicates that ‘this study has extensively profiled all major players in the market, analyzed their financials, pipeline products and business strategy going forward. It is the most comprehensive analysis on the market, and stakeholders wanting to gain a significant insight would greatly benefit from this information’. Financial forecasts to 2021 are included with respect to: Interestingly, the report also takes a detailed look at the CAR-T industry and its impact on the healthcare space. The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? The report also addresses the following key points: Key stakeholder questions are answered in this 680 page analysis including: Key Topics Covered: 1.0 Report Synopsis 1.1 Objectives of Report 1.2 Executive Summary 1.2 Key Questions Answered in this Report 1.3 Data Sources and Methodology 2.0 Introduction 2.1 Gurdon and Yamanaka Share the Nobel Prize 2.2 Stem Cell Clinical Trials: Initiated in 2010 2.3 Types of Stem Cells 2.4 Adult (Tissue) Stem Cells 2.5 Pluripotent Stem Cells 2.6 Somatic Cell Nuclear Transfer (SCNT) 2.7 Induced pluripotent Stem Cells (iPSC) 2.8 Mesenchymal Cells 2.9 Hematopoietic Stem and Progenitor Cells 2.10 Umbilical Cord Stem Cells 2.11 Heart Stem Cells 2.12 Mammary Stem Cells 2.13 Neural Stem Cells 2.14 Stem Cell Applications in Retinal Repair 2.15 Liver Stem Cells 2.16 Gut Stem Cells 2.16 Pancreatic Stem Cells 2.17 Epidermal Stem Cells 3.0 Stem Cells and Clinical Trials 3.1 Introduction 3.2 Pluripotent Stem Cells 3.3 Limbal Stem Cells 3.4 Neural Stem Cells 3.5 Endothelial Stem or Progenitor Cells 3.6 Placental Stem Cells 3.7 Why Do Stem Cell Clinical Trials Fail? 3.8 What is the Future of Stem Cell Trials? 3.9 Cutting Edge Stem Cell Clinical Trials 3.10 Ocata Therapeutics Current Stem Cell Trials 3.11 CHA Biotech Current Stem Cell Trials 3.12 Pfizer Current Stem Cell Trials 3.13 GSK Current Stem Cell Trials 3.14 Bayer Current Stem Cell Trials 3.15 Mesoblast International Current Stem Cell Trials 3.16 Millennium Pharmaceutical Current Stem Cell Trial 3.17 AstraZeneca Current Stem Cell Trials 3.18 Merck Current Stem Cell Trials 3.19 Chimerix Current Stem Cell Trials 3.20 Eisai Current Stem Cell Trials 3.21 SanBio Current Stem Cell Trials 3.22 Celgene Current Stem Cell Trials 3.23 StemCells Current Stem Cell Trials 3.24 Genzyme (Sanofi) Current Stem Cell Trials 3.25 Teva Current Stem Cell Trials 3.26 MedImmune Current Stem Cell Trials 3.27 Janssen Current Stem Cell Trials 3.28 Seattle Genetics Current Stem Cell Trials 3.29 Baxter Healthcare Current Stem Cell Trials 3.30 InCyte Corp Current Stem Cell Trials 4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing 4.1 Introduction 4.2 Case Study: Genentech and Stem Cell Technology 4.3 3D Sphere Culture Systems 4.4 Stem Cells and High Throughput Screening 4.5 Genetic Instability of Stem Cells 4.6 Comprehensive in Vitro Proarrhythmia Assay (CiPA) & Cardiomyocytes 4.8 Coupling Precise Genome Editing (PGE) and iPSCs 4.9 Stem Cells & Toxicity Testing 4.10 Stem Cell Disease Models 4.11 Defining Human Disease Specific Phenotypes 4.12 Advantages of Stem Cell Derived Cells & Tissues for Drug Screening 5.0 Stem Cell Biomarkers 5.1 Pluripotent Stem Cell Biomarkers 5.2 Mesenchymal Stem Cell Biomarkers 5.3 Neural Stem Cell Biomarkers 5.4 Hematopoietic Stem Cell Biomarkers 6.0 Manufacturing Stem Cell Products 6.1 Manufacturing Strategies For Stem Cell Products 6.2 BioProcess Economics for Stem Cell Products 6.3 Capital Investment 6.4 Cost of Goods 6.5 Bioprocess Economic Drivers & Strategies 6.6 hPSC Expansion & Differentiation using Planar Technology 6.7 hPSC Expansion using 3D Culture 6.8 Microcarrier Systems 6.9 Aggregate Suspension 6.10 Bioreactor Based Differentiation Strategy 6.11 Integrated hPSC Bioprocess Strategy 6.12 GMP Regulations and Stem Cell Products 7.0 Investment & Funding 7.1 What do Investors Want from Cell & Gene Therapy Companies? 7.2 What Makes a Good Investment? 7.3 What Types of Companies do Not Get Investment? 7.4 Global Funding 7.5 Cell & Gene Therapy Investment Going Forward 7.6 What Cell & Gene Companies are the Most Promising in 2017? 7.7 Insights into Investing in Cell and Gene Therapy Companies 8.0 Regenerative Medicine Market Analysis & Forecast to 2021 8.1 Market Overview 8.2 Global Frequency Analysis 8.3 Economics of Regenerative Medicine 8.4 Market Applications & Opportunities for Regenerative Therapies 8.5 Global Financial Landscape 8.6 Regenerative Medicine Clinical Trial Statistics 8.7 Regenerative Medicine Market Forecast to 2021 8.8 Regenerative Medicine Geographic Analysis and Forecast to 2021 8.9 Regenerative Medicine Geographical Location of Companies 8.10 Regenerative Medicine Technology Breakdown of Companies 8.11 Commercially Available Regenerative Medicine Products 8.12 Major Regenerative Medicine Milestones 9.0 Stem Cell Market Analysis & Forecast to 2021 9.1 Autologous & Allogenic Cell Market Analysis 9.2 Stem Cell Market by Geography 9.3 Stem Cell Market Forecast by Therapeutic Indication 9.4 Stem Cell Reagent Market Trends 10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2021 10.1 Geographical Analysis and Forecast to 2021 10.2 Geographical Analysis by Company Share 10.3 Tissue Engineering Clinical Indication Analysis & Forecast to 2021 11.0 Biobanking Market Analysis 11.1 Increasing Number of Cord Blood Banks Globally 11.2 Global Biobanking Company Sector Analysis & Breakdown 11.3 Allogenic Versus Autologous Transplant Frequency 11.4 Biobanking Market Analysis & Forecast to 2021 11.5 Major Global Players 12.0 Global Access & Challenges of the Regenerative Medicine Market 12.1 Regenerative Medicine Market in the USA 12.2 Regenerative Medicine in Japan 12.3 Regenerative Medicine in China 12.4 Regenerative Medicine in South Korea 13.0 Cell and CAR T Therapy 13.1 Challenges Relating to Cell therapy and Chimeric Antigen Receptor T Cells in Immunotherapy 13.2 Regulations Pertaining to Immunotherapy, including Adoptive Cell Therapy (CAR-T and TCR) Immunotherapy Regulation in the USA 13.3 Regulations for Cell Therapy & Immunotherapy in Japan 13.4 European Regulation and Cell Therapy & Immunotherapeutics 13.5 Manufacturing of Immunotherapies 13.6 Supply Chain & Logistics 13.7 Pricing & Cost Analysis 14.0 Company Profiles 14.1 Astellas Institute for Regenerative Medicine (Ocata Therapeutics) 14.2 Athersys 14.3 Baxter International (Baxalta, Shire) 14.4 Caladrius Biosciences (NeoStem) 14.5 Cynata Therapeutics 14.6 Cytori Therapeutics 14.7 MEDIPOST 14.8 Mesoblast 14.9 NuVasive 14.10 Osiris Therapeutics 14.11 Plasticell 14.12 Pluristem Therapeutics 14.13 Pfizer 14.14 StemCells Inc 14.15 STEMCELL Technologies 14.16 Takara Bio 14.17 Tigenix 15.0 SWOT Industry Analysis For more information about this report visit http://www.researchandmarkets.com/research/ml94n2/global


Dublin, May 12, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Regenerative Medicine Market Analysis & Forecast to 2021 - Stem Cells, Tissue Engineering, BioBanking & CAR-T Industries" report to their offering. Current regenerative medicine market is worth $18.9 billion globally, and will hit over $53 billion by 2021 According to the report ‘due to the dominance of the bone and joint reconstruction market, the US currently has the biggest space, followed by Europe. However, due to recent positive legislation in Japan and Europe, the stem cell arena will grow more substantially in these regions over the next five years. By 2021, it is possible that Europe will surpass the US market with respect to stem cell applications, and this will become more likely if the Trump Administration restricts legislation and funding’. The regenerative medicine market has massive scope and can be applied to a wide range of diseases and indications including neurological, autoimmune, cardiovascular, diabetes, musculoskeletal, ocular, orthopedic and wound healing. To that end, the expanse of market opportunities is large as are the patient populations globally. Kelly indicates that ‘this study has extensively profiled all major players in the market, analyzed their financials, pipeline products and business strategy going forward. It is the most comprehensive analysis on the market, and stakeholders wanting to gain a significant insight would greatly benefit from this information’. Financial forecasts to 2021 are included with respect to: Interestingly, the report also takes a detailed look at the CAR-T industry and its impact on the healthcare space. The CAR-T industry is addressing unmet needs in specific relapsed cancers, however does early clinical trial data support a blockbuster status for this upcoming therapy? The report also addresses the following key points: Key stakeholder questions are answered in this 680 page analysis including: Key Topics Covered: 1.0 Report Synopsis 1.1 Objectives of Report 1.2 Executive Summary 1.2 Key Questions Answered in this Report 1.3 Data Sources and Methodology 2.0 Introduction 2.1 Gurdon and Yamanaka Share the Nobel Prize 2.2 Stem Cell Clinical Trials: Initiated in 2010 2.3 Types of Stem Cells 2.4 Adult (Tissue) Stem Cells 2.5 Pluripotent Stem Cells 2.6 Somatic Cell Nuclear Transfer (SCNT) 2.7 Induced pluripotent Stem Cells (iPSC) 2.8 Mesenchymal Cells 2.9 Hematopoietic Stem and Progenitor Cells 2.10 Umbilical Cord Stem Cells 2.11 Heart Stem Cells 2.12 Mammary Stem Cells 2.13 Neural Stem Cells 2.14 Stem Cell Applications in Retinal Repair 2.15 Liver Stem Cells 2.16 Gut Stem Cells 2.16 Pancreatic Stem Cells 2.17 Epidermal Stem Cells 3.0 Stem Cells and Clinical Trials 3.1 Introduction 3.2 Pluripotent Stem Cells 3.3 Limbal Stem Cells 3.4 Neural Stem Cells 3.5 Endothelial Stem or Progenitor Cells 3.6 Placental Stem Cells 3.7 Why Do Stem Cell Clinical Trials Fail? 3.8 What is the Future of Stem Cell Trials? 3.9 Cutting Edge Stem Cell Clinical Trials 3.10 Ocata Therapeutics Current Stem Cell Trials 3.11 CHA Biotech Current Stem Cell Trials 3.12 Pfizer Current Stem Cell Trials 3.13 GSK Current Stem Cell Trials 3.14 Bayer Current Stem Cell Trials 3.15 Mesoblast International Current Stem Cell Trials 3.16 Millennium Pharmaceutical Current Stem Cell Trial 3.17 AstraZeneca Current Stem Cell Trials 3.18 Merck Current Stem Cell Trials 3.19 Chimerix Current Stem Cell Trials 3.20 Eisai Current Stem Cell Trials 3.21 SanBio Current Stem Cell Trials 3.22 Celgene Current Stem Cell Trials 3.23 StemCells Current Stem Cell Trials 3.24 Genzyme (Sanofi) Current Stem Cell Trials 3.25 Teva Current Stem Cell Trials 3.26 MedImmune Current Stem Cell Trials 3.27 Janssen Current Stem Cell Trials 3.28 Seattle Genetics Current Stem Cell Trials 3.29 Baxter Healthcare Current Stem Cell Trials 3.30 InCyte Corp Current Stem Cell Trials 4.0 Stem Cells, Disruptive Technology, Drug Discovery & Toxicity Testing 4.1 Introduction 4.2 Case Study: Genentech and Stem Cell Technology 4.3 3D Sphere Culture Systems 4.4 Stem Cells and High Throughput Screening 4.5 Genetic Instability of Stem Cells 4.6 Comprehensive in Vitro Proarrhythmia Assay (CiPA) & Cardiomyocytes 4.8 Coupling Precise Genome Editing (PGE) and iPSCs 4.9 Stem Cells & Toxicity Testing 4.10 Stem Cell Disease Models 4.11 Defining Human Disease Specific Phenotypes 4.12 Advantages of Stem Cell Derived Cells & Tissues for Drug Screening 5.0 Stem Cell Biomarkers 5.1 Pluripotent Stem Cell Biomarkers 5.2 Mesenchymal Stem Cell Biomarkers 5.3 Neural Stem Cell Biomarkers 5.4 Hematopoietic Stem Cell Biomarkers 6.0 Manufacturing Stem Cell Products 6.1 Manufacturing Strategies For Stem Cell Products 6.2 BioProcess Economics for Stem Cell Products 6.3 Capital Investment 6.4 Cost of Goods 6.5 Bioprocess Economic Drivers & Strategies 6.6 hPSC Expansion & Differentiation using Planar Technology 6.7 hPSC Expansion using 3D Culture 6.8 Microcarrier Systems 6.9 Aggregate Suspension 6.10 Bioreactor Based Differentiation Strategy 6.11 Integrated hPSC Bioprocess Strategy 6.12 GMP Regulations and Stem Cell Products 7.0 Investment & Funding 7.1 What do Investors Want from Cell & Gene Therapy Companies? 7.2 What Makes a Good Investment? 7.3 What Types of Companies do Not Get Investment? 7.4 Global Funding 7.5 Cell & Gene Therapy Investment Going Forward 7.6 What Cell & Gene Companies are the Most Promising in 2017? 7.7 Insights into Investing in Cell and Gene Therapy Companies 8.0 Regenerative Medicine Market Analysis & Forecast to 2021 8.1 Market Overview 8.2 Global Frequency Analysis 8.3 Economics of Regenerative Medicine 8.4 Market Applications & Opportunities for Regenerative Therapies 8.5 Global Financial Landscape 8.6 Regenerative Medicine Clinical Trial Statistics 8.7 Regenerative Medicine Market Forecast to 2021 8.8 Regenerative Medicine Geographic Analysis and Forecast to 2021 8.9 Regenerative Medicine Geographical Location of Companies 8.10 Regenerative Medicine Technology Breakdown of Companies 8.11 Commercially Available Regenerative Medicine Products 8.12 Major Regenerative Medicine Milestones 9.0 Stem Cell Market Analysis & Forecast to 2021 9.1 Autologous & Allogenic Cell Market Analysis 9.2 Stem Cell Market by Geography 9.3 Stem Cell Market Forecast by Therapeutic Indication 9.4 Stem Cell Reagent Market Trends 10.0 Tissue Engineering Tissue Engineering Market Analysis and Forecast to 2021 10.1 Geographical Analysis and Forecast to 2021 10.2 Geographical Analysis by Company Share 10.3 Tissue Engineering Clinical Indication Analysis & Forecast to 2021 11.0 Biobanking Market Analysis 11.1 Increasing Number of Cord Blood Banks Globally 11.2 Global Biobanking Company Sector Analysis & Breakdown 11.3 Allogenic Versus Autologous Transplant Frequency 11.4 Biobanking Market Analysis & Forecast to 2021 11.5 Major Global Players 12.0 Global Access & Challenges of the Regenerative Medicine Market 12.1 Regenerative Medicine Market in the USA 12.2 Regenerative Medicine in Japan 12.3 Regenerative Medicine in China 12.4 Regenerative Medicine in South Korea 13.0 Cell and CAR T Therapy 13.1 Challenges Relating to Cell therapy and Chimeric Antigen Receptor T Cells in Immunotherapy 13.2 Regulations Pertaining to Immunotherapy, including Adoptive Cell Therapy (CAR-T and TCR) Immunotherapy Regulation in the USA 13.3 Regulations for Cell Therapy & Immunotherapy in Japan 13.4 European Regulation and Cell Therapy & Immunotherapeutics 13.5 Manufacturing of Immunotherapies 13.6 Supply Chain & Logistics 13.7 Pricing & Cost Analysis 14.0 Company Profiles 14.1 Astellas Institute for Regenerative Medicine (Ocata Therapeutics) 14.2 Athersys 14.3 Baxter International (Baxalta, Shire) 14.4 Caladrius Biosciences (NeoStem) 14.5 Cynata Therapeutics 14.6 Cytori Therapeutics 14.7 MEDIPOST 14.8 Mesoblast 14.9 NuVasive 14.10 Osiris Therapeutics 14.11 Plasticell 14.12 Pluristem Therapeutics 14.13 Pfizer 14.14 StemCells Inc 14.15 STEMCELL Technologies 14.16 Takara Bio 14.17 Tigenix 15.0 SWOT Industry Analysis For more information about this report visit http://www.researchandmarkets.com/research/ml94n2/global

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