2012-Annual Report. Annual Report Institut Pasteur

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1 2012-Annual Report Name of the Department: Name of the Structure: Direction Médicale Pôle Intégré de Recherche Clinique (PIRC) Secondary Affiliation: - Head of the laboratory: Dr Cécile Delval, Personnel: Personnel Cécile Artaud Olivia Chény Isaure de la Croix Margaux Dewitte Annick Dubois Nathalie Jolly Emmanuelle Laffly Hélène Lafolly Camille Pitrou Position Preclinical Clinical study coordinator Secretary Trainee Trainee Preclinical Research Coordinator Five Main publications (in years ): NON APPLICABLE Website address of your laboratory: Key-words of the annual report: Preclinical research Vaccine candidates Gene Therapy Clinical research Regulatory authorities Sponsor Ethic

2 2012-Annual Report I. Presentation The Pôle Intégré de Recherche Clinique (PIRC), created in January 2008: - represents the Institut Pasteur when sponsor, - ensures the coordination of the internal Institut Pasteur Clinical Research Committee (CoRC), - supports scientists for the preparation of clinical research projects before and after submission to the CORC, - is responsible for submission to competent regulatory authorities prior to the beginning of the research, - coordinates the conduct of the research in accordance with the Good Clinical Practices, - ensures all clinical research development steps including budget plan and follow up, - ensures the coordination of the development of the Institut Pasteur vaccine candidates/drugs/gene therapy (preclinical and clinical phases I/II), - ensures a quality assurance system and safety monitoring, - ensures a training course at Institut Pasteur (Recherche sur la Personne et Ethique Appliquée, Research on Human Beings and Applied Ethics, RPEA). II. Activities II. A. Preclinical Research In 2012, the PIRC was involved in two major vaccine development programs (MagTn3, Anthrax), two European FP7 Consortia (STOPENTERICS, ANTIFLU) and one Advanced Therapy project concerning gene therapy for Sanfilippo type B disease. MagTn3: development of a therapeutic anti-cancer vaccine targeting adeno-carcinomaassociated Tn carbohydrate antigen capable of inducing tumor-specific antibodies. Preclinical batches were produced. Toxicology studies and manufacturing of the clinical batches have started and are still on going. Collaboration with C. Leclerc, R. Lo-Man (Unité de Régulation immunitaire et vaccinologie) and S. Bay (Unité de Chimie des biomolécules). Mucopolysaccharidosis (MPS) type III: development of a gene therapy consisting of the intracranial injection of an Adeno-Associated Virus vector coding for the a-n-glucosaminidase, the deficient enzyme in the Sanfilippo type B patient. The PIRC was involved in the coordination of preclinical activities including manufacturing of clinical batches, management of the regulatory toxicology/biodistribution studies, and preparation of all required documentation for clinical trial authorization submission. Collaboration with J.-M. Heard (Département de Neuroscience). Anthrax: development of a therapeutic vaccine for the army force in case of high-risk exposure. The manufacturing of the FIS and rpa development batches and the analytical method development by the subcontractor in charge of the vaccine candidate manufacturing have started and are still on going. Collaboration with P. Goossens (Laboratoire Pathogénie des toxi-infections bactériennes). STOPENTERICS FP7 Consortium: development of a novel prophylactic vaccine against Shigella. As the PIRC is involved as sponsor representative of the phase I clinical trial, the PIRC has participated in the annual consortium meeting. The PIRC was also involved in the coordination of preclinical activities including manufacturing of the starting material for the preclinical and clinical batches of the vaccine candidate. Collaboration with P. Sansonetti, FP7 coordinator, and A. Phalipon (Unité de Pathogénie microbienne moléculaire) and L. Mulard (Unité de Chimie des biomolécules). ANTIFLU FP7 Consortium: development of new and alternative drugs against influenza by exploiting the crucial function of host cell determinants as targets of small molecules and RNAi inhibitors, so-called indirect antiviral targets, in order to prevent viral infection and growth. The PIRC has participated in the annual consortium meeting and will be involved in the coordination of the preclinical activities. Collaboration with M. Lecuit (Groupe à 5 ans Microorganismes et barrières de l'hôte) and T. Meyer (the Max Planck Institute for Infection Biology, FP7 Coordinator).

3 II.B. The clinical research activities The role of the PIRC is to ensure the representation of Institut Pasteur when sponsor. Its duty is to bridge laboratory-based research with patient-oriented clinical research. Scope of activities of the PIRC: Clinical research = any research involving human beings: biological samples and/or personal data and/or physiopathology and/or epidemiology, and/or clinical trials In 2012: 186 projects were piloted by the PIRC since new clinical research projects were reviewed by the Clinical Research Committee (CoRC) according to regulatory, legal and ethical compliance. The Institut Pasteur was sponsor/legal responsible for 29/46 projects (63%) of these projects. 11/46 projects (24%) were conducted in collaboration with Institut Pasteur International Network. Repartition of Institut Pasteur sponsorship of research projects (n=178) Major studies piloted by the PIRC, completed in 2011 (IP sponsor): BCG & bladder cancer: Objective: to analyze predictive factors for success of BCG therapy in bladder cancer. Collaboration with M. Albert (Centre d Immunologie Humaine). RMV HIV: Objective: to test a HIV vaccine based on a recombinant Measles vaccine vector. This Phase I clinical trial is an open-label, single-centre dose-escalation study on healthy subjects. Results were analyzed and study report was completed. Publication is in progress and publically registered on Belgian Competent Authorities data base. Collaboration with F. Tangy (Unité de Génomique virale et vaccination).

4 Major studies piloted by the PIRC (IP sponsor), still in progress: Chronovac: Objective: to evaluate immune response of the administration of 2 vaccines against yellow fever and measles in young children. Start of volunteers recruitment in February 2011; current status (Dec. 2012) : 97 included/124 planned. Collaboration with C. Goujon (Centre Médical de l Institut Pasteur, clinical investigator) and M.-L. Gougeon (Unité de Recherche et d Expertise Immunité anti-virale). METHS: Objective: to identify causes of Verneuil disease. Collaboration with A. Nassif (Centre Médical de l Institut Pasteur, clinical investigator) and O. Joint-Lambert (Laboratoire de Microbiologie, Hôpital Necker, Paris). Start of volunteers recruitment in November 2011 ; current status (Dec. 2012) : 35 included/75 planned. LabEx Milieu Intérieur Genetic & Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine : Objective: constitution of a large healthy volunteers cohort to define the determinants of human immune variance. Start of volunteers recruitment in September 2012; current status (Dec. 2012): 261 included/1000 planned. Collaboration with M. Albert (Centre d'immunologie Humaine) and L. Quintana-Murci (Unité Génétique évolutive humaine). INECOC: Objective: to detect and characterize the presence of infectious agent transcripts in oncology. Start of volunteers recruitment in February 2012; current status (Dec. 2012): 15 included/100 planned). Collaboration with A. Gessain (Unité d'epidémiologie et physiopathologie des virus oncogènes). EVOIMMUNOPOP: Objective: to characterize the genetic architecture of populations with different ethnic backgrounds. Start of volunteers recruitment in December 2012 ; current status (Dec. 2012) : 31 included/400 planned. Collaboration with L. Quintana-Murci (Unité Génétique évolutive humaine). II.C. European Ethical Process In 2012, the PIRC was fully involved in the preparation of Applications for EU Grant in order to support scientists in the implementation of the Regulatory & Ethical considerations. II.D. PIRC as a regulatory-ethical referent The PIRC was solicited to contribute to the implementation of the non-opposition procedures for collections of human biological samples stored by the CNRs. In order to support scientists in their publication, the PIRC has deeply reviewed the guidelines of the International Committee of Medical Journal Editors (ICMJE) and implemented specific recommendations for scientists. II.E. Teaching / communication Bimonthly workshops Ateliers du PIRC Objective: to clarify scientific, regulatory and ethic aspects of the clinical research environment. Started in 2010, this initiative was largely successful and was renewed in Training Course «Recherche sur la Personne et Ethique Appliquée / Research on Human Beings and Applied Ethics» (RPEA) Objective: to clarify the rules of the research on human beings with a particular focus on ethics. For the fourth consecutive year, this course has trained students with previous experience in clinical research to the regulatory aspects of research on the person.

5 Training Course «Clinical Research in the Institut Pasteur International Network ( CREPIN ) In 2012, PIRC has been requested by the International Division to build up a new course on Clinical Research dedicated to the International Network. The first session will teach students from Asia; it will take place in Cambodia in April PIRC web site In 2012, the PIRC set up a new web site

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