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Royal Holloway University of London, UK
Principle Investigator: Professor Simon M. Cutting

RHUL is a major research university in the UK located close to London and is a non-profit organisation. With ~ 9000 students it is ranked in the top tier of UK research institutions. RHUL are acting as the co-ordinator of this collaborative project and will be the sponsor for the clinical trial.

Prof. Cutting is the leading authority on the use of Bacillus spores as vaccine vehicles. He has published numerous papers in internationally peer reviewed journals relating to the use of Bacillus spores as vaccine vehicles and is co-inventor on the two key RHUL patents that support the use of spores as vaccines. After obtaining his D.Phil. at Oxford University in 1983 he spent six years at Harvard University working with Prof. Richard Losick on the developmental genetics of Bacillus. Following four years at the University of Pennsylvania as an Assistant Professor, Prof. Cutting returned to the UK in 1996 and set up his own group at RHUL. He has received numerous research grants to support his work on Bacillus vaccines and leads a group of 10 researchers.

Prof. Cutting provides scientific leadership for this project and is developing the genetically engineered Bacillis strains that will be pivotal for the CDVAX vaccine.

L2D Services SARL (Leads To Development; L2D), France
Principle Investigator: Dr. Jonathan Kearsey

Leads To Development (L2D), is a biotechnology company with a proven track record in early stage therapeutic drug and vaccine development. L2D was founded in 2009 and is located in Paris, France. The company provides expertise in project design and management, as well as regulatory affairs.

Dr. Jonathan Kearsey has over fifteen years experience in the design and execution of drug development. He is highly experienced in all aspects of research and preclinical development, having advanced a number of therapeutic compounds and vaccines from the research stage to phase II clinical studies. Dr. Kearsey completed a post-doctoral fellowship at Oxford University and holds a PhD from the University of London. He has a track record of project valorisation and communication through national and international collaborations with both academic and industrial partners.

L2D will play a key role in the preclinical and clinical development of the CDVAX vaccine.

C.RIS Pharma SARL (C.RIS), France
Principle Investigator: Dr. Pierrick Auvray

C.RIS Pharma is Good Laboratory Practise (GLP) and ISO 9001:2008 certified independent biotechnology company located in Saint-Malo, France. C.RIS Pharma was founded in 2003, has 11 employees and is a subsidiary of Cellis Pharma’s Group, also founded and directed by Dr. Pierrick Auvray. C.RIS received GLP certification for toxicology experiments in 2008 and for bio-analytical experiments in 2011. All regulatory studies are performed according to OECD and FDA Guidelines.

Dr. Auvray obtained his PhD in Cell Biology and Cancerology in 1998. His work was to develop new anticancer drugs against hormone sensitive breast cancer. After a short post-doctoral period working on a new approach to transgenesis, he joined a pharmaceutical CRO specialising in oncology, where he became Chief of Department within four years. Dr Auvray then founded C.RIS Pharma in 2003.

C.RIS Pharma will undertake the analytical, bioanalytical and safety pharmacology studies that are required for the preclinical development of CDVAX.

Q-Biologicals NV (Q-BIO), Belgium
Principle Investigator: Dr. Annie van Broekhoven

Q-Biologicals is an ISO 9001:2008 certified independent biotechnology company, offering services to third parties to help them accelerate the development and manufacture of their biological products, including cGMP production. The company is located in Ghent, Belgium and is headed by Dr Annie van Broekhoven. The company originated from the former Biologicals department of Innogenetics–Fujirebio and is a spin-off from the Flemish Institute for Biotechnology (VIB). Currently  Q-Biologicals has 12 employees and will expand to 25 in 2013.

In the CDVAX project, the principle role of Q-biologicals is the production of spores from the genetically engineered Bacillus strain, including process and analytical method development, scale-up, formulation, stability and cGMP production.

FGK Clinical Research GMBH (FGK), Germany
Principle Investigator: Dr. Edgar Fenzl

FGK Clinical Research GmbH is a Europe-based full service Contract Research Organisation offering the complete range of clinical development and consulting services to biotechnology, medical device and pharmaceutical companies. With more than 80 highly-skilled and experienced employees, FGK operates from Munich on local and global projects, covering clinical studies (Phases I to IV).

Dr. Edgar Fenzl is the Managing Director of FGK and a physician with a doctorate in clinical pharmacology with more than 30 years of experience in pharmaceutical medicine. He has worked in a number of pharmaceutical companies and clinical research organisations. Dr. Fenzl has overseen a large number of in-house, national and international clinical studies ranging from phase I to IV in a broad range of medical indications.

FGK will carry out the first clinical trial of the CDVAX vaccine in healthy volunteers in order to assess the vaccine’s immunogenicity and safety.