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Chikungunya vaccine successful in clinical trial

VIENNA, Austria I November 23, 2014 I The Austrian biotech company Themis Bioscience GmbH in collaboration with  the Institut Pasteur (Paris, France) have developed a prophylactic vaccine against chikungunya.The vaccine appears to be safe, and produced an immune response that researchers suspect would protect people against infection.

The Vienna-based biotech company Themis Bioscience GmbH (‘Themis’) has received final results of a phase 1 clinical study of its prophylactic Chikungunya fever vaccine.

The study was carried out on 42 subjects at the Department of Clinical Pharmacology of the Vienna General Hospital (Allgemeines Krankenhaus der Stadt Wien) and confirms the previous interim results: The candidate not only proved to be well tolerated and safe, but also exhibited the required immune response in the form of neutralizing antibodies in all vaccinated subjects. Remarkably, the immune response was clearly dose-dependent with even the lowest dose being effective.

Details on the clinical trial were recently presented at two international conferences, namely the 26–28 October “8th Vaccine & ISV Congress” in Philadelphia, USA and the 2–6 November “ASTMH 63rd Annual Meeting” in New Orleans, USA.

Commenting on the success of this Chikungunya phase I study, Themis' founder and CEO, Dr. Erich Tauber, states: “We could confirm that our Chikungunya vaccine candidate is well tolerated, safe and elicits the expected immune response. Considering the ongoing spread of Chikungunya epidemic, we now focus on making the vaccine available as soon as possible. We will also strengthen our already successful alliance with the Institut Pasteur.”

The now confirmed success of the trial rests on the measles vector platform, whose core technology has been developed at the Institut Pasteur in Paris using a standard commercialised measles vaccine as a vector. Genes coding for selected antigens from the Chikungunya virus have been inserted into the genome of the well-established measles vaccine delivering those new antigens into the cells, thereby triggering a specific immune response against the Chikungunya virus.

Such phase 1 achievement with the Chikungunya vaccine candidate further validates this core technology, clinically and regulatory-wise, gearing it as well towards large scale, low cost production – a significant advantage for the development of vaccines against epidemic infectious diseases.

Themis and the Institut Pasteur will extend their collaboration towards a common goal of developing vaccines against numerous infectious diseases based on that promising vector. The long standing excellence of the world renowned Institut Pasteur in research, diagnosis and prevention of infectious diseases stands out as a welcome contribution to this process.

The pipeline already includes a dengue fever vaccine candidate, and the two partners will now collaborate on using Themaxyn® for additional targets. Frédéric Tangy, Institut Pasteur, states: “The phase I results of the Chikungunya vaccine candidate prove that the measles vector vaccine platform can be used successfully to develop a new generation of prophylactic vaccines, and the Institut Pasteur, which developed its core technology, is keen to strengthen its alliance with Themis to develop those innovative vaccine candidates.”

The Chikungunya epidemic, currently rampant in the Caribbean, shows that such a platform could soon be needed on a larger geographic scale. Having started in the Dominican Republic, it has already reached Haiti and fears are now growing that the disease could spread further to the USA, where isolated cases of Chikungunya have been observed in recent years. No effective vaccine for this serious disease had been available and the US Centers for Disease Control and Prevention (CDC) are said to have warned hospitals throughout the country. Accordingly, representatives of the CDC are quoted in The Wall Street Journal as saying: “We are preparing for the potential introduction into the United States”.

About Chikungunya virus:

Chikungunya is a mosquito-borne viral disease causing symptoms such as fever, joint pain, muscle pain, headache and nose and gum bleeding. Chikungunya is present in parts of Africa, Southeast Asia, the Americas and on the Indian subcontinent. The first transmission within continental Europe was reported from north-eastern Italy in August 2007. Every year, imported cases among tourists are identified in several European countries. Since late 2013, the first large outbreak of Chikungunya has been identified in the Americas, with more than 780,000 reported cases to date for this single epidemic.

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