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Recipharm AB Announces Successful Pre-Clinical Tuberculosis Vaccine Results using its Oral Vaccine Delivery Platform (ORT-VAC(TM))


1/13/2011 6:58:57 AM

January 13, 2011 - Keele, UK: RecipharmCobra Biologics, the international manufacturer of biopharmaceuticals, today announces that it has published the results of a study to develop an oral vaccine against tuberculosis in the journal Vaccine. This is in collaboration with the Royal Holloway, University of London and the Università Cattolica del Sacro Cuore, Rome, Italy.

The study showed that the orally delivered ORT-VAC™ DNA vaccine produced higher immune responses in mice than the injected DNA vaccine. This resulted in a reduction in the lungs of the TB bacterium Mycobacterium tuberculosis in immunised mice. Previous studies using ORT-VAC™ to deliver protein vaccines have protected against bubonic plague and anthrax in mice.

RecipharmCobra’s vaccine delivery technology ORT-VAC™ employs live Salmonella bacteria to deliver a TB vaccine orally. The Salmonella bacteria have been modified so that they do not cause disease. The vaccine is a DNA vaccine, a relatively new vaccine approach where a gene from a disease-causing microorganism is used to stimulate an immune response.

ORT-VAC™ stabilises plasmids without the need for antibiotics, so no antibiotic resistance genes are present on the plasmid. This also reduces the potential transfer risk to pathogens, which could result in the generation of antibiotic-resistant ‘superbugs’.

Simon Saxby, VP of Biologics at RecipharmCobra Biologics, said: “Using an attenuated bacterium to deliver vaccines orally is a very exciting new area, and the delivery of DNA vaccines has been particularly challenging. The study illustrates the versatility of RecipharmCobra’s ORT-VAC™ technology to provide a delivery route for needle-free administration of a DNA vaccine. A vaccine based on ORT-VAC™ could be inexpensive to produce, simple to distribute and easy to administer, which is essential for tackling the disease in developing countries.

About plasmids

Plasmids are autonomously replicating, circular DNA molecules that are naturally found in microorganisms. Plasmids from E. coli are used widely in molecular biology, and enable several hundred plasmids to be produced per cell. Genes of interest are inserted into plasmids to produce proteins, and plasmids are also designed for therapeutic applications. E. coli plasmids also replicate in Salmonella, but are often lost following cell division.

About ORT-VAC™ Technology

The ORT-VAC™ technology allows easy oral administration and cost effective manufacture of vaccines. It utilises the ORT® (Operator-Repressor Titration) technology that RecipharmCobra uses to manufacture protein and DNA therapeutics for its biotech and pharmaceutical customers in E. coli. With ORT®, an essential chromosomal gene in the bacterial cell is switched off by the binding of a repressor protein to an ‘operator’ sequence. The plasmid also contains the same operator sequence, so when it is inserted into the bacterial cell, it produces multiple copies of itself, which bind the repressor so the essential gene is switched on and the cell can grow.

Any suitable bacterial strain can be converted to an antibiotic–free strain for DNA and recombinant protein vaccine delivery in humans. Recombinant vaccines are becoming increasingly important as a prophylaxis and as a therapy. ORT-VAC™ vaccines will have applications in cancer and numerous infectious diseases such as TB and influenza, as well as diseases such as bubonic plague and anthrax posed by the threat of bioterrorism. The ultimate goal of the ORT-VAC™ programme is to avoid the cold storage, complicated logistics and needle-based administration of conventional vaccines by the development of a stable, oral ‘vaccine pill’.

About RecipharmCobra Biologics

RecipharmCobra Biologics has a proven track record in the development and manufacture of monoclonal antibodies, recombinant therapeutic proteins, viruses and DNA as well as cell based vaccines and therapies for clinical trials and regulatory approvals. RecipharmCobra Biologics has two GMP approved production facilities, from which a comprehensive service is provided; including cell line development, process and analytical development, GMP manufacture, coordination of formulation and fill/finish activities, and release to clinic.

RecipharmCobra is the specialist biologics division of Recipharm AB. www.recipharmcobrabio.com

About Recipharm

Recipharm AB is a leading contract development and manufacturing organisation based in Sweden with 2,000 employees. The company operates 12 development and manufacturing facilities in Sweden, France, the UK, Spain and Germany and is headquartered near Stockholm. We supply the global pharmaceuticals market with hundreds of different products in most dosage forms, including solid dose, granulates, powders, sterile liquids and lyophilisates, semisolids, beta-lactams, hormones, and inhalers.

www.recipharm.com

Contact Simon Saxby Vice President of Biologics, RecipharmCobra Biologics +44 1782 714 181 Tristan Jervis or Alex Heeley De Facto Communications t.jervis@defacto.com or a.heeley@defacto.com +44 207 861 3019/3043



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