Clinical Trials

* On March 2, 2015, Themis Bioscience, a biotechnology company developing innovative prophylactic vaccines for emerging tropical infections, and the Institut Pasteur announced the publication of the phase I study results for a recombinant measles-virus-based chikungunya vaccine (MV-CHIK) in The Lancet Infectious Diseases. The study was performed in collaboration with the Department of Clinical Pharmacology at the Medical University of Vienna and the Viral Diseases Branch of the Walter Reed Army Institute of Research (WRAIR) in the USA. The peer-reviewed article is entitled “Immunogenicity, safety, and tolerability of a recombinant measles-virus-based chikungunya vaccine: a randomised, double-blind, placebo-controlled, active-comparator, first-in-man trial”. Themis’ recombinant measles-chikungunya vaccine phase I study was conducted between November 2013 and June 2014 with a total of 42 healthy male and female individuals from age 18-45 being randomised into 4 cohorts for this dose escalation study. Subjects were administered one injection with either a low, medium or high dose of the chikungunya vaccine or the active comparator Priorix (standard measles vaccine). The study investigated the immunogenicity, safety and tolerability of the vaccine. In addition, randomized participants received a booster injection on either day 28 or day 90 after the first vaccination.

The candidate vaccine raised concentrations of neutralising antibodies to chikungunya in all dose cohorts after one immunisation, with seroconversion* rates of participants producing anti-chikungunya antibodies of 44% in the low, 92% in the medium, and 90% in the high-dose group. The immunogenicity of the candidate vaccine was not affected by pre-existing anti-measles immunity. The second vaccination resulted in a 100% seroconversion for all participants in the candidate vaccine groups. The candidate vaccine had an overall good safety profile, and while the rate of adverse events increased with vaccine dose and volume, no vaccination-related serious adverse events were recorded. The company now aims to move rapidly into phase II studies.

* On November 20, 2014, Themis Bioscience announced that the induction of neutralizing antibodies by a prophylactic Chikungunya vaccine candidate has now been confirmed by the final results of a phase 1 clinical trial, as well as its tolerability and safety. 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. 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." Themis and the Institut Pasteur will extend their collaboration towards a common goal of developing vaccines against numerous infectious diseases based on that vector. 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."

* On June 12, 2014, the Vienna-based biotech company Themis Bioscience received the interim results of a phase 1 clinical study of its Chikungunya fever prophylactic vaccine that uses a standard anti-measles vaccine as a vector. The study was carried out on 42 subjects in the Department of Clinical Pharmacology at the Vienna General Hospital (Allgemeines Krankenhaus der Stadt Wien, ‘AKH’) and confirms the expectations pinned on the vaccine: it not only proved to be well tolerated and safe, but also exhibited the required immune response in the form of neutralizing antibodies. Even the lowest doses used showed to be effective, and increasing doses led to respective stronger immune responses in the study subjects. In light of such developments, the advantages of Themis' patent-protected Themaxyn® platform are several fold, including a proven production process ensuring at a later stage the rapid supply on a large scale. Themis intends to adapt the vector of the Themaxyn® platform to new indications. In this context, the company has already secured the rights for Dengue fevers. Themis aims to provide third parties with the rights to license, manufacture and market its development programs once the clinical proof of concept has been established.

* On November 7, 2013, Themis Bioscience has announced that its vaccine against Chikungunya fever is now undergoing clinical testing for the first time. The vaccine is based on a standard anti-measles vaccine. Themis expects to see results from this recently initiated study on the Chikungunya vaccine during 2014 - the company then plans to begin clinical testing of the Dengue vaccine. However, the Viennese biotech boutique has even more in the pipeline. The company has also secured options to develop vaccines against yellow fever, Japanese encephalitis, West Nile fever and other unnamed indications, based on the Themaxyn platform. The Chikungunya vaccine is currently being tested in a phase I clinical study at Vienna General Hospital (AKH).

* On March 27, 2013, Themis Bioscience has reported rapid progress in the development of two highly efficient vaccines against dengue and chikungunya fever. In the just concluded preclinical studies, the two vaccine candidates, based on a technology by the Parisian Pasteur Institute, displayed exceedingly good efficacy. With a single vaccination against Chikungunya it was possible to develop full vaccination protection. The Dengue fever vaccine candidate proved effective against all of the four known serotypes of this infection. On the basis of these excellent results, Themis will start the clinical phase I study for both vaccines before the end of this year. 
In addition to this, the Themis team is already developing vaccine candidates of the second generation against Dengue fever - and securing options for itself for the development of vaccines against yellow fever, Japanese encephalitis, West Nile Fever and further undisclosed targets on the basis of the Themaxyn platform.