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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


THERADIAG (Paris:ALTER) (ISIN : FR0004197747, Mnémonique : ALTER), société spécialisée dans le diagnostic in vitro et le théranostic, annonce aujourd’hui que le conseil d’administration, réuni le 28 février 2017, a coopté Dominique Costantini, MD et Dominique Takizawa au sein de son Conseil d’Administration. « Nous sommes heureux d’accueillir Dominique Costantini et Dominique Takizawa en qualité d’administratrices indépendantes de Theradiag. Leurs compétences complémentaires en immunologie, dans le domaine des biotechs et en finance apporteront à la société de nouveaux atouts indéniables pour accompagner sa stratégie de développement. A l’heure où Theradiag poursuit son développement international notamment au travers d’accords de partenariats avec des acteurs majeurs de la pharma et du diagnostic, leur éclairage et leurs conseils seront précieux. » commente Gérard Tobelem, Président du Conseil d’Administration de Theradiag. Dotée d’une expérience de plus de 20 ans dans l’industrie pharmaceutique, Dominique Costantini a accompagné de nombreuses innovations thérapeutiques au plan international dans le domaine de l’oncologie. Au cours de sa carrière, elle a occupé des postes de management au sein de HMR (aujourd’hui Sanofi) où elle a dirigé les activités médico-marketing de mise sur le marché (notamment en immunologie, endocrinologie, infectiologie et oncologie). En 1997, Dominique Costantini a co-fondé BioAlliance Pharma, société de biotechnologie spécialisée en oncologie et dans les soins de support, dont elle fut Directrice générale jusqu’en 2011. A ce titre, elle a piloté l’introduction en bourse de la société sur Euronext (2005) et est à l’origine de nombreux partenariats industriels internationaux (Europe, Etats-Unis, Chine, Japon, Corée). Elle y a par ailleurs mené l’enregistrement de produits en Europe et aux Etats-Unis et à ce jour, BioAlliance Pharma (renommée Onxeo en 2014) est la seule société de biotechnologie française à avoir obtenu l’enregistrement de trois médicaments auprès de la FDA (Beleodaq®, Livatag® et Validive®). En 2012, Dominique Costantini a co-fondé et pris la Direction générale d’OSE Pharma, une société de biotechnologie développant des produits d’immunothérapie contre les cancers au stade invasif. En mai 2016, elle a mené la fusion d’OSE Pharma avec Effimune pour co-fonder OSE Immunotherapeutics, biotech spécialisée dans l’activation et la régulation immunitaire en immuno-oncologie, dans les maladies auto-immunes et en transplantation, dont elle est Directrice générale et Administrateur. Dominique Costantini est médecin (Paris V), spécialisée en immunologie. Dominique Takizawa est Secrétaire générale de l’Institut Mérieux depuis 2006. Ayant rejoint le groupe Mérieux en 2001, elle a été notamment associée au développement stratégique du groupe, en particulier lors des opérations de fusion-acquisition, dans la gestion des relations avec les actionnaires et les investisseurs. Dominique Takizawa a géré des opérations de marché et a notamment accompagné l’introduction en bourse de la société bioMérieux. Auparavant, elle a occupé les fonctions de Directeur financier auprès de différentes sociétés, dont Pasteur-Mérieux Connaught (aujourd’hui Sanofi Pasteur) et Rhône Mérieux/Mérial, en particulier lors d'évolutions stratégiques majeures. Dominique Takizawa est également Administrateur et Présidente du comité d’audit des sociétés cotées en bourse April et Adocia. Dominique Takizawa est diplômée d’HEC (École des Hautes Études Commerciales) et titulaire du DECF (Diplôme d’Études Comptables et Financières). A propos de Theradiag Forte de son expertise dans la distribution, le développement et la fabrication de tests de diagnostic in vitro, Theradiag innove et développe des tests de théranostic (alliance du traitement et du diagnostic), qui mesurent l’efficacité des biothérapies dans le traitement des maladies auto-immunes, du cancer et du SIDA. Theradiag participe ainsi au développement de la « médecine personnalisée », favorisant l’individualisation des traitements, la mesure de leur efficacité et la prévention des résistances médicamenteuses. Theradiag commercialise la gamme Lisa Tracker®, marquée CE, une solution complète de diagnostic multiparamétrique pour la prise en charge des patients atteints de maladies auto-immunes et traités par biothérapies. Via sa filiale Prestizia, Theradiag développe également de nouveaux marqueurs de diagnostic grâce à la plateforme microARN, pour la détection et le suivi du cancer du rectum et du VIH/SIDA. La société est basée à Marne-la-Vallée et Montpellier et compte plus de 75 collaborateurs. Pour de plus amples renseignements sur Theradiag, visitez notre site web : www.theradiag.com


OSE Immunotherapeutics SA (Paris:OSE) (ISIN: FR0012127173; Mnémo: OSE) announced today that the company has been invited to present its SIRP-α antagonist OSE-172 (Effi-DEM), and its main preclinical results at the 24th Molecular Med TRI-CON 2017 Meeting, session “Cancer Immunotherapy” in San Francisco (CA) on February 20-22, 2017. OSE-172 (Effi-DEM) is a humanized monoclonal antibody targeting SIRP-α expressed on suppressive cells involved in the tumor micro-environment (Myeloid cells, named Myeloid Derived Suppressive Cells and Tumor Associated Macrophages). OSE-172 is an antagonist of SIRP-α which transforms these suppressive cells into effector cells, in particular it inhibits macrophages M2 pro-tumorigenic cells and increases M1 anti-tumorigenic cells. In addition, OSE-172 does not bind human T-cells (does not bind SIRP-γ expressed on T-cells), allowing strong effector T-cell proliferation. This original mechanism of action provides reduction of tumor growth in various solid tumor models through such an immune-cell transformation in the tumor micro-environment. As an example, the combination of OSE-172 with anti-PD-L1 is very effective allowing effector macrophages and T-cells to work together at tumor level. “Our vision is to become a leader with our SIRP-α antagonist in the very attractive and competitive new field of myeloid suppressive cells and tumor associated macrophages. The interest of the blockade on such cells is today increasing as these cells are involved in the limits of action related to T-cell checkpoint inhibitors”, said Bernard Vanhove, COO of OSE Immunotherapeutics, in charge of R&D and International scientific collaborations. FOR MORE INFORATION ON THE 24TH MOLECULAR MED TRI-CON 2017 MEETING, SESSION “CANCER IMMUNOTHERAPY”: http://www.triconference.com/Cancer-Immunotherapy/ February 20-22, 2017 - Moscone North Convention Center, San Francisco Session: TARGETING MACROPHAGE CHECKPOINTS FOR NEW IMMUNOTHERAPIES AND COMBINATIONS Targeting SIRPα to Control Myeloid-Derived Suppressor Cells and Tumor-Associated Macrophages Bernard Vanhove, Ph.D., COO, OSE Immunotherapeutics ABOUT OSE IMMUNOTHERAPEUTICS Our ambition is to become a world leader in activation and regulation immunotherapies OSE Immunotherapeutics is a biotechnology company focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology, auto-immune diseases and transplantation. The company has a balanced portfolio of first-in-class products with a diversified risk profile ranging from clinical phase 3 registration trials to R&D: In immuno-oncology: The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter global agreements at different stages of development with major pharmaceutical players. Immunotherapy is a highly promising and growing market. By 2023 Immunotherapy of cancer could represent nearly 60% of treatments against less than 3% at present * and the projected market is estimated at $67 billion in 2018 **. There are more than 80 autoimmune diseases that represent a significant market including major players in the pharmaceutical industry with sales towards $10 billion for the main products. The medical need is largely unmet and requires the provision of new innovative products involved in the regulation of the immune system. Click and follow us on Twitter and Linkedln Forward-looking statements This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 8 June 2016 under the number R.16-052, the consolidated financial statements and the management report for the fiscal year 2015, as well as the Merger Document registered with the AMF on 26 April 2016 under number E.16-026, all available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Anti-CD22 Immunotherapeutics in: October 2016 R&D and Business Tracker for Antibody-Drug Conjugates" report to their offering. Anti-CD22 Immunotherapeutics in: October 2016 R&D and Business Tracker for Antibody-Drug Conjugates This pdf report contains information about Antibody-Drug Conjugates (ADCs) released during the month of October 2016. This issue forms part of the subscription service R&D and Bus


OSE-172 est un antagoniste de SIRP-α qui transforme ces cellules suppressives en cellules effectrices, en particulier par l’inhibition des macrophages M2 pro-tumorigènes et par l’augmentation des macrophages M1 anti-tumorigènes. Par ailleurs, OSE-172 n’est pas lié à SIRP-γ, exprimé sur les cellules T humaines, et permet ainsi une forte prolifération de ces cellules T effectrices. Ce mécanisme d’action original induit une réduction de la croissance tumorale dans plusieurs modèles de tumeurs solides grâce à la transformation des cellules immunitaires dans le microenvironnement tumoral. Ainsi, l’association d’OSE-172 avec un anti-PD-L1 s’avère très efficace car elle permet aux macrophages effecteurs et aux cellules T d’agir ensemble au niveau de la tumeur. “ Avec le développement de notre antagoniste de SIRP-α, nous avons l’ambition de devenir un leader dans le domaine nouveau, très attractif et compétitif des cellules myéloïdes suppressives et des macrophages associés à la tumeur. En raison de leur rôle dans les limites de l’action induite par les check-points inhibiteurs des cellules T, le blocage de ces cellules suppressives suscite aujourd’hui un intérêt grandissant », commente Bernard Vanhove, Directeur général délégué d’OSE Immunotherapeutics, en charge de la R&D et des Collaborations scientifiques internationales. POUR PLUS D’INFORMATIONS SUR LA 24ÈME CONFÉRENCE « MOLECULAR MED TRI-CON 2017 », SESSION « CANCER IMMUNOTHERAPY » : http://www.triconference.com/Cancer-Immunotherapy/ 20-22 février 2017, Moscone North Convention Center, San Francisco, CA. Session : TARGETING MACROPHAGE CHECKPOINTS FOR NEW IMMUNOTHERAPIES AND COMBINATIONS Targeting SIRPα to Control Myeloid-Derived Suppressor Cells and Tumor-Associated Macrophages Bernard Vanhove, Ph.D., COO, OSE Immunotherapeutics A PROPOS D’OSE IMMUNOTHERAPEUTICS Notre ambition est de devenir l’un des leaders mondiaux en immunothérapie d’activation et de régulation OSE Immunotherapeutics est une société de biotechnologie spécialisée dans l’activation et la régulation immunitaire en immuno-oncologie, dans les maladies auto-immunes et en transplantation. La société dispose d’un portefeuille équilibré de premier plan, avec un profil de risque diversifié, allant de la phase clinique d’enregistrement à la R&D : En immuno-oncologie : Il existe plus de 80 maladies auto-immunes qui représentent un marché important intégrant des acteurs majeurs de l’industrie pharmaceutique, avec des chiffres d’affaires supérieurs à 10 milliards d’euros pour les principaux produits. Le besoin médical reste à ce jour largement insatisfait et nécessite la mise à disposition de nouveaux produits de régulation du système immunitaire innovants et adaptés. Plus d’informations sur http://ose-immuno.com Cliquez et suivez-nous sur Twitter et Linkedln Déclarations prospectives Ce communiqué contient de manière implicite ou expresse des informations et déclarations pouvant être considérées comme prospectives concernant OSE Immunotherapeutics. Elles ne constituent pas des faits historiquement avérés. Ces informations et déclarations comprennent des projections financières reposant sur des hypothèses ou suppositions formulées par les dirigeants d’OSE Immunotherapeutics à la lumière de leur expérience et de leur perception des tendances historiques, de la situation économique et sectorielle actuelle, de développements futurs et d’autres facteurs qu’ils jugent opportuns. Ces déclarations prospectives peuvent être souvent identifiées par l’usage du conditionnel et par les verbes « s’attendre à », « anticiper », « croire », « planifier » ou « estimer » et leurs déclinaisons et conjugaisons ainsi que par d’autres termes similaires. Bien que la direction d’OSE Immunotherapeutics estime que ces déclarations prospectives sont raisonnables, les actionnaires d’OSE Immunotherapeutics et les autres investisseurs sont alertés sur le fait que leur réalisation est sujette par nature à de nombreux risques connus ou non et incertitudes, difficilement prévisibles et en dehors du contrôle d’OSE Immunotherapeutics. Ces risques peuvent impliquer que les résultats réels et développements effectivement réalisés diffèrent significativement de ceux indiqués ou induits dans ces déclarations prospectives. Ces risques comprennent notamment ceux développés ou identifiés dans les documents publics déposés par OSE Immunotherapeutics auprès de l’AMF. De telles déclarations prospectives ne constituent en rien la garantie de performances à venir. Ce communiqué n’inclut que des éléments résumés et doit être lu avec le Document de Référence d’OSE Immunotherapeutics, déposé auprès de l’AMF le 8 juin 2016 sous le n° R.16-052, les états financiers consolidés et le rapport de gestion pour l’exercice 2015, ainsi que le Document E enregistré par l’AMF le 26 avril 2016 sous le numéro E.16-026, disponibles sur le site internet d’OSE Immunotherapeutics. OSE immunotherapeutics ne prend aucun engagement de mettre à jour les informations et déclarations prospectives à l’exception de ce qui serait requis par les lois et règlements applicables.


News Article | February 21, 2017
Site: www.businesswire.com

SEATTLE--(BUSINESS WIRE)--Nativis Inc., a clinical stage life science bio-electronic company developing non-invasive, safe and highly effective treatments for cancers and other serious diseases, today announced that Dr. Una Ryan has been appointed to its board of directors effective immediately. Ryan is a biologist and seasoned healthcare executive with extensive experience serving on the boards of public, private and non-profit companies. She is currently a limited partner at Breakout Ventures, Managing Director of Golden Seeds, an investment firm empowering women entrepreneurs, and a partner in Astia Angel, investing in women-led ventures. Ryan currently serves on the boards of AMRI, a global contract research and manufacturing company and RenovoRx, a medical device company. She was previously the President and CEO at Diagnostics for All, Inc., a developer of inexpensive diagnostic tools for global health and agriculture; Waltham Technologies, a cleantech start-up; and AVANT Immunotherapeutics Inc. (now Celldex), a company developing vaccines for cancer and global health. Throughout her career, Ryan has successfully translated science into successful businesses, driving growth and overseeing multiple M&A’s in order to create robust and diverse organizations. Ryan spent more than 20 years as a Professor of Medicine at the University of Miami, Washington University, St. Louis and Boston University where she conducted research on vascular biology. She holds a Ph.D. in Cellular and Molecular Biology from Cambridge University and BS degrees in Zoology, Microbiology and Chemistry from Bristol University. She received an Honorary Doctor of Science degree from Bristol University in 2009. “We are thrilled to be able to continue to diversify our board of directors and welcome Una, a distinguished entrepreneur, biologist and healthcare executive,” said Nativis CEO Chris Rivera. “Una brings a broad range of experience in the life science and investment arenas to the board, and her insight will be of great value to Nativis as we continue to develop and seek long term partners for of our novel ulRFE technology. Una’s background in global health and developing medical technologies adds significantly to the diversity of our other Directors’ extensive industry experience, which includes, for example; cyber-security, disruptive technologies, financial management, venture capital and bio-pharmaceutical development.” Ryan added, “I am excited to join the Nativis team, and look forward to helping guide the company through the development of its unique technology platform. Nativis’ ulRFE technology represents an unprecedented opportunity to advance a new wave of treatment for recurrent glioblastoma multiforme and other health care indications, and I believe that with the right resources and strategies, the company can position itself for future success.” Founded in 2002 and headquartered in Seattle, WA, Nativis is a clinical-stage bio-electronics company. Nativis has invented and patented a groundbreaking technology that utilizes precisely targeted, ultra-low radio frequency energy (ulRFE™) to specifically regulate metabolic pathways on the molecular and genetic levels – without chemicals, radiation or drugs – delivered via a simple-to-use non-invasive device called Nativis Voyager®. The company’s goal is to transform disease treatment on a global scale with ulRFE that can potentially be applied to a wide range of conditions and other health-related needs (including agriculture, bio-fuels and veterinary medicine, to name a few). Nativis’ initial focus is on the treatment of patients with brain cancer (initially, recurrent glioblastoma), who are not well served by conventional standard of care therapies, which often result in poor outcomes and devastating side effects. Additional pre-clinical work is being completed for melanoma, lung cancer, liver cancer, inflammatory disease and chronic pain.


NANTES, France, Feb. 21, 2017 (GLOBE NEWSWIRE) -- OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) announced today that the company has been invited to present its SIRP-α antagonist OSE-172 (Effi-DEM), and its main preclinical results at the 24th Molecular Med TRI-CON 2017 Meeting, session “Cancer Immunotherapy” in San Francisco (CA) on February 20-22, 2017. OSE-172 (Effi-DEM) is a humanized monoclonal antibody targeting SIRP-α expressed on suppressive cells involved in the tumor micro-environment (Myeloid cells, named Myeloid Derived Suppressive Cells and Tumor Associated Macrophages). OSE-172 is an antagonist of SIRP-α which transforms these suppressive cells into effector cells, in particular it inhibits macrophages M2 pro-tumorigenic cells and increases M1 anti-tumorigenic cells. In addition, OSE-172 does not bind human T-cells (does not bind SIRP-g expressed on T-cells), allowing strong effector T-cell proliferation. This original mechanism of action provides reduction of tumor growth in various solid tumor models through such an immune-cell transformation in the tumor micro-environment. As an example, the combination of OSE-172 with anti-PD-L1 is very effective allowing effector macrophages and T-cells to work together at tumor level. “Our vision is to become a leader with our SIRP-α antagonist in the very attractive and competitive new field of myeloid suppressive cells and tumor associated macrophages. The interest of the blockade on such cells is today increasing as these cells are involved in the limits of action related to T-cell checkpoint inhibitors”, said Bernard Vanhove, COO of OSE Immunotherapeutics, in charge of R&D and International scientific collaborations. FOR MORE INFORMATION ON THE 24TH MOLECULAR MED TRI-CON 2017 MEETING, SESSION “CANCER IMMUNOTHERAPY”: http://www.triconference.com/Cancer-Immunotherapy/ February 20-22, 2017 - Moscone North Convention Center, San Francisco Session: TARGETING MACROPHAGE CHECKPOINTS FOR NEW IMMUNOTHERAPIES AND COMBINATIONS Targeting SIRPα to Control Myeloid-Derived Suppressor Cells and Tumor-Associated Macrophages Bernard Vanhove, Ph.D., COO, OSE Immunotherapeutics ABOUT OSE IMMUNOTHERAPEUTICS Our ambition is to become a world leader in activation and regulation immunotherapies OSE Immunotherapeutics is a biotechnology company focused on the development of innovative immunotherapies for immune activation and regulation in the fields of immuno-oncology, auto-immune diseases and transplantation. The company has a balanced portfolio of first-in-class products with a diversified risk profile ranging from clinical phase 3 registration trials to R&D: The portfolio’s blockbuster potential gives OSE Immunotherapeutics the ability to enter global agreements at different stages of development with major pharmaceutical players. Immunotherapy is a highly promising and growing market. By 2023 Immunotherapy of cancer could represent nearly 60% of treatments against less than 3% at present * and the projected market is estimated at $67 billion in 2018 **. There are more than 80 autoimmune diseases that represent a significant market including major players in the pharmaceutical industry with sales towards $10 billion for the main products. The medical need is largely unmet and requires the provision of new innovative products involved in the regulation of the immune system. Click and follow us on Twitter and Linkedln This press release contains express or implied information and statements that might be deemed forward-looking information and statements in respect of OSE Immunotherapeutics. They do not constitute historical facts. These information and statements include financial projections that are based upon certain assumptions and assessments made by OSE Immunotherapeutics’ management in light of its experience and its perception of historical trends, current economic and industry conditions, expected future developments and other factors they believe to be appropriate. These forward-looking statements include statements typically using conditional and containing verbs such as “expect”, “anticipate”, “believe”, “target”, “plan”, or “estimate”, their declensions and conjugations and words of similar import. Although the OSE Immunotherapeutics management believes that the forward-looking statements and information are reasonable, the OSE Immunotherapeutics’ shareholders and other investors are cautioned that the completion of such expectations is by nature subject to various risks, known or not, and uncertainties which are difficult to predict and generally beyond the control of OSE Immunotherapeutics. These risks could cause actual results and developments to differ materially from those expressed in or implied or projected by the forward-looking statements. These risks include those discussed or identified in the public filings made by OSE Immunotherapeutics with the AMF. Such forward-looking statements are not guarantees of future performance. This press release includes only summary information and should be read with the OSE Immunotherapeutics Reference Document filed with the AMF on 8 June 2016 under the number R.16-052, the consolidated financial statements and the management report for the fiscal year 2015, as well as the Merger Document registered with the AMF on 26 April 2016 under number E.16-026, all available on the OSE Immunotherapeutics’ website. Other than as required by applicable law, OSE Immunotherapeutics issues this press release at the date hereof and does not undertake any obligation to update or revise the forward-looking information or statements.


News Article | February 24, 2017
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Prima BioMed Ltd would like to update shareholders on recent developments with the company regarding active clinical trials, current partnership developments, and cash reach in conjunction with the release of the Half Year report for the period ended 31 December 2016. Prima is pleased to announce the following updates on our clinical applications of IMP321: AIPAC (Active Immunotherapy PAClitaxel), completed the safety-run in phase in December 2016. The randomized phase started in January 2017 with 30 mg of IMP321 as the recommended phase 2 dose. First patients have been recruited and we plan to open further clinical sites in the near term to ramp up the patient recruitment. In total, the trial aims to recruit up to 226 patients in a randomized, placebo-controlled, double blind setting. TACTI-mel (Two ACTive Immunotherapeutics in melanoma), our Australian melanoma trial is progressing well with the first patient cohort of this Phase 1 dose escalation study completed in December 2016. The second cohort, receiving 6 mg of IMP321, is underway and already 4 out of 6 patients have been successfully treated; no dose limiting toxicity has yet been reached. The open label, Phase 1 study is designed to recruit 18 patients and anticipated to be fully recruited in the third quarter of 2017. Patients with unresectable or metastatic melanoma that have had a suboptimal response to KEYTRUDA® are being dosed with IMP321 in combination with KEYTRUDA and there should be multiple data readouts throughout 2017. A data update -- including efficacy of all 15 patients from the safety-run in phase of AIPAC (open label) is expected to be published in mid-2017. As a result of careful financial management, Prima remains in a solid financial position with approximately $15.5M cash as of mid-February 2017. Based on our forecast, the current operational cash reach has been extended to end of first quarter calendar year 2018. Prima BioMed is listed on the Australian Stock Exchange, and on the NASDAQ in the US. For further information please visit www.primabiomed.com.au


THERADIAG (Paris:ALTER) (ISIN: FR0004197747, Ticker: ALTER), a company specialized in in vitro diagnostics and theranostics, has today announced the appointment of Dominique Costantini, MD and Dominique Takizawa to its Board of Directors subject to ratification by shareholders at the forthcoming Annual General Meeting. “We are delighted to welcome Dominique Costantini and Dominique Takizawa to Theradiag as independent board members. Their complementary expertise in immunology, the biotech sector and finance will be tremendous assets, supporting our development strategy. As we continue to pursue international expansion through partnerships with major pharma and diagnostics groups, their insight and counsel will be invaluable”, commented Gérard Tobelem, Chairman of Theradiag’s Board of Directors. They are taking over from Truffle Capital, a company represented by Philippe Pouletty and Antoine Pau. These appointments are subject to ratification by shareholders at the forthcoming Annual General Meeting on April 27, 2017. Following these appointments, Theradiag’s Board of Directors has the following members: With over 20 years’ experience in the pharmaceutical industry, Dominique Costantini has supported numerous therapeutic innovations in the international oncology sector. During her career, she has held various management positions at HMR (now Sanofi), where she ran the medico-marketing launch activities (immunology, endocrinology, infectiology and oncology). In 1997, Dominique Costantini co-founded BioAlliance Pharma, a biotechnology company specialized in oncology and supportive care, and was its Chief Executive Officer until 2011. During her tenure, she oversaw the Company’s IPO on Euronext (2005) and was the architect behind various international industry partnerships (Europe, United States, China, Japan, South Korea). She also oversaw the marketing approval process for new products in Europe and the United States. To date, BioAlliance Pharma (renamed Onxeo in 2014) is the only French biotechnology company to have obtained marketing approval from the FDA for three drugs (Beleodaq®, Livatag® and Validive®). In 2012, Dominique Costantini co-founded and became Chief Executive Officer of OSE Pharma, a biotechnology company developing immunotherapy products to treat invasive stage cancers. In May 2016, she led the merger between OSE Pharma and Effimune to jointly found OSE Immunotherapeutics, a biotech company specialized in the activation and regulation of the immune response in immuno-oncology, in autoimmune conditions and in transplantation, and is its Chief Executive Officer and Director. Dominique Costantini is a doctor (Paris V) specialized in immunology. Dominique Takizawa has been Secretary General of the Institut Mérieux since 2006. After joining the Mérieux group in 2001, she contributed to its strategic development, through her involvement in mergers & acquisitions, and in the management of relations with shareholders and investors. Dominique Takizawa managed market transactions and supported bioMérieux’s IPO. Previously, she was Chief Financial Officer for various companies, including Pasteur-Mérieux Connaught (now Sanofi Pasteur) and Rhône Mérieux/Mérial, during a period of major strategic change. Dominique Takizawa is also a Director and Chairman of the Audit Committee of listed companies April and Adocia. Dominique Takizawa is a graduate of the HEC business school (Ecole des Hautes Etudes Commerciales) and holds a DECF diploma in finance and accounting. About Theradiag Capitalizing on its expertise in the distribution, development and manufacturing of in vitro diagnostic tests, Theradiag innovates and develops theranostics tests (combining treatment and diagnosis) that measure the efficiency of biotherapies in the treatment of autoimmune diseases, cancer and AIDS. Theradiag notably markets the Lisa Tracker® range (CE marked), which is a comprehensive multiparameter theranostic solution for patients with autoimmune diseases treated with biotherapies. With its subsidiary Prestizia, Theradiag is developing new biomarkers based on microRNAs for the diagnosis and monitoring of rectal cancer, auto-immune and inflammatory diseases and HIV/AIDS. Theradiag is thus participating in the development of customized treatment, which favors the individualization of treatments, the evaluation of their efficacy and the prevention of drug resistance. The Company is based in Marne-la-Vallée, near Paris, and in Montpellier, and has over 75 employees. For more information about Theradiag, please visit our website: www.theradiag.com

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