EU grant for Dr. Marien de Jonge (Laboratory of Pediatric Infectious Diseases)

Jonge de, Marien

AMBITIOUS PNEUMOVAC PROJECT AWARDED EMERGING MARKET SUBSIDY

The Dutch/Swedish/South‐African consortium consisting of Drug Discovery Factory BV (DDF), CoVaccine BV, Radboud University Nijmegen Medical Center (UMC St. Radboud), Xbrane Bioscience AB and The Biologicals and Vaccine Institute of Southern Africa (The Biovac Institute) will join forces to investigate the development of broad protecting and affordable vaccine candidates against pneumococcal diseases. This project of ~2 million Euro will be supported with 500.000 Euro from the Emerging Markets program by the Ministry of Economic Affairs in the Netherlands and 142.500 Euro from VINNOVA in Sweden within the EUREKA framework.

About pneumococcal infections and vaccines

Pneumococcal infection often affects individuals with either an immature or waning immune system, i.e. young infants and the elderly. Invasive pneumococcal diseases (e.g. pneumonia, bacteremia and meningitis) currently cause more deaths than all other vaccine‐preventable infectious diseases combined. Despite available vaccines, including conjugate vaccines, pneumococcal disease still poses an enormous threat to public health worldwide. All currently marketed vaccines are based on the capsular polysaccharide. In spite of the substantial success, these vaccines evoke protection against a limited number of serotypes and the regional distribution of predominant serotypes differs throughout the world. Furthermore, their high manufacturing complexity and costs limit their use in developing nations where morbidity and mortality from pneumococcal disease is highest. Therefore, there is an urgent need for the development of a novel more broadly protective and affordable vaccine for pneumococcal disease. Natural colonization or carriage ofS. pneumoniaeinduces both mucosal and systemic humoral and cellular immune responses. Enhancing those responses by mucosal vaccination is an attractive immunization approach against pneumococci as it mimics the natural route of infection.

About this project

Recent advances in vaccine technology by the consortium offers great potential. At the laboratory of pediatric infectious diseases, novel pneumococcal genes essential for in vivo survival in the host have been discovered using Genomic Array Footprinting (GAF). Some of these genes encode potential lead antigens for a novel, broadly protective, protein‐based vaccine candidate. These antigens will be expressed using a platform for display of antigens on the cell surface of bacteria developed by Xbrane Bioscience. CoVaccine will be responsible for the mucosal adjuvant formulations. Drug Discovery Factory BV (DDF) will monitor the development program. DDF, UMC St Radboud, CoVaccine and Xbrane Bioscience will combine the expertise to develop a protein‐based intranasal vaccine prototype. Subsequently, the technology will be transferred to The Biovac Institute where a limited feasibility study of production and upscaling will be conducted at their R&D facility in South Africa.

About the partners:

Drug Discovery Factory BV (DDF), Bussum, The Netherlands, will be the project leader. DDF is an R&D driven SME that selects the most attractive and leading research projects at University Medical Centers and other institutes, and transforms them into successful business propositions. DDF has a strong track record in monitoring of R&D projects in collaboration with academics and industry. The company will bring to the project their vast experience in the often long and difficult road of early stage development projects (DDF has successfully set up >15 life‐science companies). The vast experience of DDF in turning scientific ideas and technologies into successful medical products, will greatly contribute to the commercial success of the novel vaccine against pneumococcal disease. DDF will provide scientific expertise on the R&D program. The scientific team will offer its input to guide the scientific process in line with regulatory requirements, but also in data analysis, study performance, scientific decision making and development plans to ensure that the research steps will result in commercially viable projects as soon as possible. DDF will also be involved on IP‐strategies, licensing‐strategies and regulatory aspects with FDA and EMEA.

The Radboud University Nijmegen Medical Center (UMC St Radboud), Nijmegen, The Netherlands, is one of the leading Dutch academic institutions for biomedical research. The department of Pediatrics is a full‐facility center in which the Laboratory of Pediatric Infectious Diseases (headed by professor Peter Hermans) focuses on translational research by exploring host pathogen interaction mainly to the development of vaccines to prevent infections and development of biomarkers to diagnose and monitor infectious diseases. UMC St. Radboud will provide its expertise onS. pneumoniaeantigen selection technologies and experimental infection models, and as such, UMC St. Radboud will significantly contribute to the design of the prototype vaccine. The laboratory allows testing of relevant bacterial antigens, antigen purification, immunological assays and proof of principle in studies usingin vitroassays andin vivoexperimental animal models. RUNMC will perform all vaccine efficacy studies in standardized mouse models, and the toxicity and safety assessments of the best performing vaccine formulations in rabbit models. This project offers the RUNMC the opportunity to remain one of the leading specialist centres in the Netherlands and the world for research and development into new vaccination strategies.

CoVaccine BV, Ophemert, The Netherlands, is an R&D performing SME company focusing on vaccine adjuvants. CoVaccine was co‐founded by Dr. L. Hilgers as a spin‐off of Animal Sciences Group of Wageningen University Research. The company developed the highly effective adjuvant CoVaccine HT that allows effective immunization with many different vaccines. This adjuvant was sold to Protherics PLC (UK) in 2006 for further clinical development and marketing. Protherics licensed CoVaccine HT to Nobilon International BV (now part of Merck) for her pandemic influenza vaccine. CoVaccine will provide the adjuvant for the envisioned vaccine. With her specific know‐how and expertise on lead‐finding, development and manufacturing technology, CoVaccine will design and prepare a new and highly effective adjuvant prototype for mucosal immunization. CoVaccine will be involved in the vaccine formulation throughout the project and in the nonclinical efficacy and safety testing.

Xbrane Bioscience AB,Stockholm, Sweden, was founded in early 2008 as a spin‐off from the worldleading Center for Biomembrane Research at the Arrhenius Laboratories at Stockholm University. Xbrane Bioscience offers a unique proprietary product portfolio and world‐leading expertise within protein expression. Xbrane Bioscience markets two patented bacterial based protein expression systems, Xbrane Lemo System and Xbrane Rhamex System, which through its unique tunable features increase protein yields and enable expression of otherwise host‐toxic proteins. In collaboration with the

Department of Molecular Microbiology at VU University, Amsterdam (headed by Dr. Joen Luirink), Xbrane Bioscience develops a vaccine platform, Xbrane Expose System, enabling high‐density display of antigens on the surface of bacteria cell. A patent for the surface display of antigens and its use in combination with Outer Membrane Vesicle technology has been filed and this technology in combination with the Xbrane Lemo System will be used in this project.

The Biovac institute, Pinelands, South Africa, is a Public Private Partnership between the South African government and the Biovac Consortium. As the only human vaccine manufacturing facility in South Africa, The Biovac Institute's focus is on ensuring that the country has the required domestic capacity to respond to both local and regional vaccine needs. Recognizing the need for a domestic manufacturer of vaccines to enable the South African Health industry to respond to epidemic emergencies and secure the health of the country's children, the Department of Health (DoH) partnered with a strategic equity partner, the Biovac Consortium to create The Biovac Institute in 2003. The Biovac Institute's vision is to be a Centre of Excellence rooted in Africa for the development and manufacturing of affordable quality vaccines for Africa and the developing world's needs. By participating in this project, The Biovac Institute will broaden its skills base to manufacture recombinant vaccines. It is envisaged that should this initial project have a positive outcome, more funding will be sought to optimise and finalise the manufacturing processes whereafter clinical manufacture will follow with Biovac as the manufacturer of choice.

Further information

For further information please contact: Theodoor Rutgers

theo.rutgers@drugdiscoveryfactory.nl

 


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