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Paris et Boston, le 7 décembre 2016 - NEOVACS (Alternext Paris : ALNEV), leader de l'immunothérapie active pour le traitement des maladies auto-immunes, annonce aujourd'hui avoir obtenu le statut « Fast-Track » de la Food and Drug Administration (FDA), pour l'IFNalpha Kinoïde dans le traitement du Lupus, le vaccin thérapeutique le plus avancé, issu de la recherche de Néovacs. La désignation « Fast-Track » mise en place par la FDA est réservée aux thérapies en développement qui ciblent des maladies sévères, mettent en jeu le pronostic vital et ayant montré avec des données cliniques leur aptitude à répondre à un besoin médical insatisfait. Ce statut facilite les échanges avec la FDA, permet d'accélérer le développement du produit et de bénéficier d'un examen prioritaire du dossier d'enregistrement. Grâce à cette désignation « Fast-Track », Néovacs réunit désormais les conditions nécessaires pour permettre un accès plus rapide de l'IFNalpha Kinoïde pour les patients aux États-Unis. Pour rappel, Néovacs mène actuellement une étude clinique de phase IIb internationale (étude IFN-K-002) dans le lupus érythémateux systémique (LES), une maladie auto-immune, chronique et invalidante, pour laquelle les traitements standards n'offrent pas de bénéfices thérapeutiques satisfaisants aux patients. L'objectif de cette étude est d'évaluer l'efficacité biologique et clinique de l'IFNalpha Kinoïde chez des patients atteints de forme modérée à sévère du LES. L'essai, en cours de recrutement, inclura 178 patients dans 21 pays en Amérique latine, Asie, Europe et aux Etats-Unis. À propos de la technologie Kinoïde développée par Néovacs  Elle vise le traitement de pathologies associées à une surproduction d'une cytokine endogène. Cette technologie relève de l'immunothérapie active et est basée sur la génération d'une réponse immunitaire grâce à l'administration d'un complexe immunogène associant la cytokine ciblée (par exemple l'IFNalpha, fabriquée par 3P Biopharmaceuticals) à une protéine porteuse (par exemple la KLH, produite par notre partenaire Stellar Biotechnologies). L'injection intramusculaire de ce Kinoïde au patient va permettre d'induire la réponse immunitaire et de stimuler la production d'anticorps polyclonaux dirigés contre la cytokine cible. On parvient ainsi à bloquer la surproduction de la cytokine et ses effets biologiques. Plusieurs pathologies auto-immunes et inflammatoires (lupus érythémateux systémique, dermatomyosite et diabète de type 1.) se caractérisent par un dérèglement du fonctionnement de cytokines (IFNalpha) qui se retrouvent produites en excès. Cette surproduction va favoriser l'inflammation et la dérégulation de l'immunité. À propos de Néovacs Cotée sur Alternext Paris depuis 2010, Néovacs est devenu un acteur majeur dans les vaccins thérapeutiques ciblant le traitement des maladies auto-immunes et/ou inflammatoires. Grâce à sa technologie innovante induisant une réponse immunitaire polyclonale, protégée potentiellement jusqu'en 2032 par 5 familles de brevets, Néovacs concentre ses efforts de développement clinique sur l'IFNalpha-Kinoïde pour le traitement du lupus et de la dermatomyosite. Néovacs réalise également des travaux précliniques sur d'autres vaccins thérapeutiques pour le traitement des maladies auto-immunes, cancers, allergies et diabète de type 1. L'ambition de cette « approche Kinoïde » est de permettre aux patients de mieux supporter un traitement à vie qui serait plus efficace, bien toléré et très souple dans son administration. Néovacs est éligible au plan PEA-PME. Pour plus d'information sur Néovacs, visitez le site web : http://neovacs.fr/


Agreement addresses future production needs of IFNα, key component of IFN Kinoid1 PARIS and BOSTON, Nov. 23, 2016 (GLOBE NEWSWIRE) -- Neovacs (Alternext Paris:ALNEV), a leader in active immunotherapies for the treatment of autoimmune diseases, today announced a partnership with 3P Biopharmaceuticals, a leader in the production of biological drugs, for the manufacture of interferon alpha (IFNα). Today’s collaboration follows the recent acquisition of the technology for the manufacture of IFNα by Neovacs from AMEGABIOTECH. This license agreement will allow Neovacs to directly transfer AMEGABIOTECH's technology to the production site of 3P Biopharmaceuticals, which will ensure the manufacture of the IFNα cytokine. As the only Spanish manufacturer of biological products in the healthcare field, 3P Biopharmaceuticals has a successful track record working with top pharma and biotech companies throughout Europe and the United States. Miguel Sieler, CEO of Neovacs, said, “This partnership is in line with the recent license agreement signed with AMEGABIOTECH. The completion of these two steps allows us to secure the complete production chain for the manufacture of IFNα, one of the primary raw materials of our most advanced product, IFNα Kinoid. In addition, the agreement complements the partnership signed earlier this year with Stellar Biotechnologies, the supplier of the other main component of our vaccine IFNα Kinoid, Keyhole Limpet Hemocyanin (KLH). Within the framework of this partnership, Stellar Biotechnologies holds 30% of Neostell, the production subsidiary of Neovacs.” Elena Erroba, Business Development Director of 3P Biopharmaceuticals, affirmed: “3P Biopharmaceuticals is very happy with this collaboration. It will allow 3P Biopharmaceuticals to contribute to a very innovative therapeutic approach, with our strong competence in the field of manufacturing high quality protein.” _____________________________ 1 IFNα Kinoid: Therapeutic vaccine from Neovacs technology, which is composed of the targeted cytokine IFNα, conjugated with a carrier protein, Keyhole Limpet Hemocyanin. About 3P Biopharmaceuticals 3P Biopharmaceuticals is a leading European CDMO specialized in the process development and GMP manufacturing of biologics and cell therapy products in mammalian, microbial and yeast expression systems. With a highly qualified team of experts, 3P supports its clients offering manufacturing related drug development solutions from initial research, through preclinical and clinical trials to commercialization. 3P was created and promoted by a group of shareholders and institutions with large expertise in the biotechnology and pharmaceutical sector. Thanks to their financial effort and full confidence, 3P has been able to consolidate its activity into the international market and has become a reference for the biotech sector. http://www.3pbio.com/ About Neovacs Technology Neovacs targets pathologies associated with an overproduction of endogenous cytokines. This technology is based on active immunotherapy to generate an immune response through the administration of an immunogenic complex involving the target cytokine to a carrier protein. The intramuscular injection of this Kinoid induces an immune response and stimulates the production of polyclonal antibodies against the target cytokines. It is thus possible to block cytokine overproduction and its biological effects. Several autoimmune and inflammatory diseases (Type 1 diabetes, systemic lupus erythematosus, psoriasis, etc.) are characterized by a disorder of cytokines that are found produced in excess (ex: IFNα). This overproduction will promote inflammation and dysregulation of the immune system. About Neovacs Listed on Alternext Paris since 2010, Neovacs is today a leading biotechnology company focused on an active immunotherapy technology platform (Kinoids) with applications in autoimmune and/or inflammatory diseases. On the basis of the company’s proprietary technology for inducing a polyclonal immune response (covered by five patent families that potentially run until 2032) Neovacs is focusing its clinical development efforts on IFNα Kinoid, an immunotherapy being developed for the indication of lupus, dermatomyositis and also in preclinical trial for Type 1 diabetes. Neovacs is also conducting preclinical development works on other therapeutic vaccines in the fields of auto-immune diseases, oncology and allergies. The goal of the Kinoid approach is to enable patients to have access to safe treatments with efficacy that is sustained in these life‑long diseases. www.neovacs.fr


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.1.4-4 | Award Amount: 7.73M | Year: 2012

Age-related Macular Degeneration (AMD), a neurodegenerative disease of the retina, is a major cause of blindness in elderly people. Due to the aging population, AMD has been referred to as a time bomb in society. In the exudative form of AMD, high levels of vascular endothelial cell growth factor (VEGF) and low levels of pigment-epithelial derived factor (PEDF), an inhibitor of vascularization and a neuroprotective factor produced by retinal pigment epithelial (RPE) cells result in subretinal neovascularization and retinal pigment cell degeneration. The current treatment by monthly injections of anti-VEGF antibodies is only effective for ~30% of patients. To avoid the severe side effects, high costs and the overall continuing burden on health care associated with monthly antibody injections, inducing a higher level of PEDF expression to inhibit neovascularization would be a viable therapeutic alternative. TargetAMD will subretinally transplant genetically modified, patient-derived, iris- or RPE cells that overexpress PEDF to provide a long-lasting cure of AMD. Stable PEDF gene delivery will be based on the non-viral Sleeping Beauty transposon system, which combines the efficacy of viral delivery with the safety of naked DNA plasmids. Academic scientists and SME partners will produce innovative gene delivery technologies, reagents and devices to be translated into a simple and safe gene therapeutic treatment for exudative AMD. Experienced clinicians will perform two clinical trials, comprising isolation and PEDF-transfection of a patients pigment epithelial cells and implantation of transfected cells into the patient during a single, 60-minute surgical session. This project will bring a significant enhancement on quality of life to AMD patients, highlight the synergistic power of academic, clinical and industrial cooperation to the scientific arena, and open new markets for novel products for clinical applications of transposon-based gene therapy to industry.


Amezqueta S.,University of Navarra | Schorr-Galindo S.,Montpellier University | Murillo-Arbizu M.,University of Navarra | Murillo-Arbizu M.,3P Biopharmaceuticals | And 3 more authors.
Food Control | Year: 2012

Ochratoxin A (OTA) is a secondary metabolite produced by filamentous fungi of the genera Aspergillus and Penicillium present in a wide variety of foodstuffs. The most relevant OTA-producing species are Penicillium verrucosum (P. verrucosum), Aspergillus ochraceus (A. ochraceus), Aspergillus niger and Aspergillus carbonarius due to their prevalence in foodstuffs (cereals, grapes, coffee, etc.) and the number of strains able to produce OTA. To target pre- and post-harvest control programs, studies concerning the toxigenic fungi in each foodstuff are essential. This paper summarizes the state-of-the-art and the requirements in OTA control. © 2012 Elsevier Ltd.


Ordonez Y.N.,U.S. National Institute of Standards and Technology | Ordonez Y.N.,3P Biopharmaceuticals | Anton R.F.,Medical University of South Carolina | Davis W.C.,U.S. National Institute of Standards and Technology
Analytical Methods | Year: 2014

Carbohydrate deficient transferrin (CDT) is a biochemical marker for congenital disorders of glycosylation (CDG), chronic alcohol consumption, and forensic medicine diagnosis. However it is necessary to take into account that CDT is not a single molecular entity but refers to a group of transferrin (Tf) sialoforms (asialo-, monosialo-, disialo- and occasionally trisialo-Tf). A number of methods have been developed for CDT measurement based on different analytical techniques and principles without harmonization or calibration to a reference method or a certified reference material, hampering understanding of the diagnostic value of CDT and its routine use. Thus, it is unquestionable that there is a need for a reference material which permits the accurate and precise determination of each individual Tf sialoform which could serve as a universal calibrator for routine immunologic methods used in clinical laboratories. In this work, we describe highly sensitive ICP-MS isotope dilution analysis (IDA) methods for the separation and quantification of the different Tf sialoforms in human serum. The methodology was applied to measure the concentration of each sialoform of Tf and the total concentration of Tf in the NIST Standard Reference Material (SRM) 909c human serum. Additionally, two clinical laboratory control serums utilized for routine analysis of CDT were also analyzed. The separation of the sialoforms was achieved by anion exchange chromatography. The two IDA techniques applied for the quantification of the Tf sialoforms were: (a) post-column IDA and (b) species-specific IDA with the total concentration of Tf calculated by these two being the sum of the individual sialoforms. A third IDA technique, exact matching IDA was applied to determine the total concentration of Tf in SRM 909c. All the Tf measurements were validated with the ERM-DA470-IFF human serum (IRMM, Geel, Belgium) certified for total Tf. Finally, the identification of each Tf sialoform previously separated in the serum (SRM 909c) was carried out by LC/MS/MS. © 2014 the Partner Organisations.


Trademark
3P Biopharmaceuticals | Date: 2014-10-14

Pharmaceutical and veterinary products; sanitary products for medical use; dietetic food and substances for medical or veterinary use, food for babies; nutritional supplements for humans and animals; plasters, materials for dressings; teeth filling and dental impression materials; disinfectants; products for destroying vermin; fungicides, herbicides. Research and development of pharmaceutical products and in connection with biotechnology.


Patent
3P Biopharmaceuticals | Date: 2014-05-20

The present invention relates to polynucleotides and alphaviral vectors for the expression of genes of interest in mammalian cells. Additionally, the invention relates to cells which comprise said polynucleotides and alphaviral vectors and are capable of stably expressing one or more genes of interest. The invention also relates to methods for obtaining said cells, to methods for expressing a gene of interest in said cells, and to methods for replacing the gene of interest stably expressed by said cells with another gene of interest.


Patent
3P Biopharmaceuticals | Date: 2016-03-30

The present invention relates to polynucleotides and alphaviral vectors for the expression of genes of interest in mammalian cells. Additionally, the invention relates to cells which comprise said polynucleotides and alphaviral vectors and are capable of stably expressing one or more genes of interest. The invention also relates to methods for obtaining said cells, to methods for expressing a gene of interest in said cells, and to methods for replacing the gene of interest stably expressed by said cells with another gene of interest.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.2.3.0-1 | Award Amount: 5.06M | Year: 2013

FLUTCORE will develop a novel universal influenza A virus (IAV) vaccine based on the tandem core vaccine platform. Recent influenza pandemics have emphasized the urgent need for better vaccines that are reactive with multiple IAV subtypes and that are no longer dependent on intimate knowledge of the prevalent virus. We propose to replace the existing seasonal IAV vaccine with a virus like particle (VLP) carrying several invariant universal influenza antigens. Previous attempts to use these targets have failed due to the poor antigen expression and immunogenicity. The highly immunogenic tandem core system overcomes this limitation. Specifically, we propose to develop a VLP carrying two or more invariant influenza antigens, express these in yeast and then examine immunogenicity in mice. The vaccine will be further tested in the rigorous ferret system before being scaled up for manufacture. An optimal clone will then be transferred to an accredited contract manufacturer for production. A phase I clinical trial will be carried out once pre-clinical toxicology has been successfully completed. Our consortium will examine the immune responses in both animals and humans thoroughly to ensure that the vaccine candidate chosen can produce a protective IAV immune response in all individuals. To achieve these objectives, our proposal builds upon the complementary expertise of seven high-performing partners representing four European countries, with world leadership in HBV core biology, immunological analysis, commercial manufacture and influenza clinical trials, making our consortium ideally positioned to develop the vaccine and to take it from bench to bedside. The leading role of SMEs in the consortium will ensure that the technology developed by FLUTCORE will generate highly marketable products, offering both improved patient protection and long-term cost savings for health care in Europe once annual influenza vaccines are replaced.


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