News

6 November 2017

Themis to Present Phase 2 Interim Results for Chikungunya Vaccine Candidate at ASTMH 2017 Annual Meeting

Vienna (Austria), 6 November 2017 – Themis today announced positive interim results from an ongoing phase 2 clinical study designed to demonstrate safety and immunogenicity of MV-CHIK, the Company`s live attenuated prophylactic vaccine candidate for chikungunya fever.

The data will be presented today for the first time at the Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH) in Baltimore, MA, USA.

Final results of the trial in 320 healthy subjects currently ongoing in Austria and Germany are expected in 2018.

“The data we have generated so far in our clinical development program for chikungunya are very encouraging. All currently active phase 2 trials including a study in a previously epidemic area are progressing well and we expect final results in 2018 and 2019, respectively to further increase the value proposition of our product candidate. Overall, Themis continues to lead in the development of a vaccine against chikungunya,“ commented Dr. Erich Tauber, CEO and founder of Themis. “Above and beyond chikungunya, the trial results further validate our technology platform, which has the potential to become the leading source for innovative vaccines against several emerging and established infectious diseases.”

Themis’ unique technology platform is based on a measles vaccine vector that can be easily modified genetically in a “plug-and play” fashion to express a variety of selected antigen proteins that are present in infectious pathogens. The Company’s product portfolio based on this platform includes clinical product candidates in chikungunya and Zika with additional preclinical candidates in Respiratory Syncytial Virus (RSV), norovirus and Cytomegalovirus (CMV).

About Themis:

Themis is developing urgently needed vaccines to prevent death and disability around the world. We lead in the development of a vaccine against chikungunya, a serious debilitating disease with global outbreak potential. Our innovation in vaccine technology has created a powerful platform and a growing pipeline addressing a broad range of infectious diseases. Together with industrial and academic leaders we work to prevent illness across the globe. For more information, visit http://www.themisbio.com.

About Chikungunya

Chikungunya fever is a viral infection transmitted by specific mosquitoes. It originates in Africa but the increase in global traveling and rising temperatures cause these mosquitoes and the viruses they carry to spread into more temperate zones. Within the last four years, well over 1.7 million cases have been reported from 45 countries in the Americas and the Caribbean alone. The majority of infected persons develop severe joint pain, which can become chronic.

For more information please contact:

Themis

Dr. Erich Tauber

CEO

Phone: +43 / 1 / 236 7151

[YjY0dGFnOmVyaWNoLnRhdWJlckB0aGVtaXNiaW8uY29t]

Media requests:

MacDougall Biomedical Communications

Mario Brkulj or Dr. Jacob Verghese

Phone: +49 89 2420 9345 or +49 89 2420 9346

[YjY0dGFnOm1icmt1bGpAbWFjYmlvY29tLmNvbQ==]

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5 September 2017

Chikungunya Vaccine Development Towards Phase III Trials Boosted by Innovate UK

Vienna (Austria), 5 September 2017

The further development of a promising Chikungunya vaccine candidate by Themis Bioscience is now supported with 3 Mio. GBP by the United Kingdom's innovation agency, Innovate UK. Themis, the Vienna-based specialist for vaccine development, will use these funds to identify and validate a correlate of protection for its prophylactic Chikungunya vaccination candidate. Currently the candidate is tested in three parallel phase II clinical trials, including one that is performed in an endemic area for Chikungunya. Already last year Innovate UK supported the development of Themis' Zika vaccine candidate currently investigated in a phase I clinical trail.

Today, Themis Bioscience GmbH (Vienna, Austria), a company specialized in vaccine development, announced a 3 Mio. GBP funding received by the innovation agency of the United Kingdom, Innovate UK. The funds are earmarked for the further development of the company's prophylactic Chikungunya vaccine candidate, that currently is tested in three phase II clinical trials. Together with the National Institute for Biological Standards and Control (NIBSC, UK) the company will now gear the vaccine's development towards a phase III clinical trial. The vaccine candidate is based on Themis' proprietary Themaxyn® platform that uses a well-established measles vaccine vector.

Dr. Erich Tauber, CEO and founder of Themis comments: "Analyzing efficacy of a Chikungunya vaccine in a large scale phase III clinical trial as well as a subsequent licence application in fact requires a valid correlate of protection. Thanks to the support by Innovate UK we now have additional means to quickly identify and validate such correlates together with NIBSC."

In this joint project the NIBSC will develop a non-humane primate (NHP) challenge model that will be used for testing human sera. Following this, a small scale phase I clinical trial with Themis' prophylactic vaccine candidate will be conducted in the UK. The aim of this is to identify and validate a correlate of protection and to identify a protective antibody threshold against the Chikungunya virus.

One of the major advantages of the Chikungunya vaccine candidate of Themis is a validated as well as cost-efficient production process. The measles vector technology developed by Themis forms the basis of all current vaccine candidates advanced by the company. It allows a rapid upscaling of the very cost effective vaccine production process once the vaccine candidate has been determined. This ability is critical for a vaccine that is supposed to combat diseases such as Chikungunya from spreading in highly populated areas. Additionally, the backbone measles vaccine has already proven its high efficacy and safety in well over a billion individuals over the last 30‑40 years, and the technology offers an excellent safety profile. Under the terms of a broad license agreement with the Institut Pasteur, Themis owns the rights to use the measles vector for a wide range of indications including Chikungunya and Zika.

Currently Themis' live attenuated prophylactic Chikungunya vaccine candidate is tested in two parallel phase II studies in both, the USA and Austria/Germany. An additional trial in Puerto Rico in collaboration with the Walter Reed Army Institute of Research (WRAIR), an institution of the US Department of Defense just commenced. This trial is intended to evaluate the influence of previous chikungunya infections on the safety and immunogenicity of the vaccine candidate. Erich Tauber on these trials: "All three trials combined well over 700 volunteers will receive our vaccine candidate. This will be a very substantial data set."

In the wake of the development of the Chikungunya vaccine and supported with another 1 Mio. GBP grant by Innovate UK last year the company also succeeded in advancing the development of a live attenuated recombinant Zika vaccine. Currently, this is tested in a phase I clinical trial at the Medical University of Vienna, Austria.

About Themis (September 2017):

Themis Bioscience GmbH develops prophylactic vaccines from the preclinical to the early clinical phase, focusing on emerging tropical infectious diseases, with initial vaccine candidates currently being developed against Chikungunya and Zika. The company's highly innovative and fully patent-protected measles virus vaccine vector technology platform forms the basis for all current vaccine candidates of the Vienna-based company.

www.themisbio.com

About the vaccine technology:

The core technology relies on the use of the standard measles vaccine as a vaccination vector. Genes coding for selected antigens from the Chikungunya virus have been inserted into the genome of this well-established vaccine. The measles-Chikungunya vaccine triggers the expression of the selected antigens which then are presented in macrophages and dendritic cells – the most potent and effective antigen-presenting cells, thereby triggering a specific immune response to Chikungunya virus. This results in a powerful, antigen-focused immune response, which is most likely to confer long-term immunity as does the measles vaccine.

About Innovate UK:

Innovate UK is the UK's innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. For further information visit www.innovateuk.gov.uk

Contact Themis Bioscience GmbH:

Dr. Erich Tauber

CEO

Muthgasse 11/2

1190 Vienna, Austria

T +43 / 1 / 236 7151

E [YjY0dGFnOmVyaWNoLnRhdWJlckB0aGVtaXNiaW8uY29t]

W http://www.themisbio.com

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27 July 2017

Chikungunya-Fever: Themis Bioscience Starts Phase II Clinical Study in Endemic Area

Vienna (Austria), 27 July 2017

A promising prophylactic vaccine candidate against chikungunya fever will be tested from August on in a phase II clinical study in Puerto Rico, a chikungunya fever endemic area. Developed by the Austrian biotech company Themis Bioscience GmbH the live attenuated vaccine is considered as one of the most advanced candidates globally. It is based on a standard measles vaccination vector that offers an excellent immunogenicity and safety profile. The vaccine candidate already showed high seroconversion rates in the preceding phase I clinical trial: Up to 100 percent of all vaccinated subjects produced neutralizing antibodies against the chikungunya virus. Currently the vaccine candidate is tested in two parallel phase II studies in both, the USA and Austria/Germany. The additional trial in Puerto Rico is intended to evaluate the influence of previous chikungunya infections on the safety and immunogenicity of the vaccine candidate.

The biotech company Themis Bioscience GmbH (Vienna, Austria) today announced the start of a further Phase II clinical trial of a prophylactic vaccine for Chikungunya fever. Based on excellent data from a previous Phase I study this promising vaccine candidate already is tested in two ongoing Phase II clinical trials in the USA and Austria/Germany. The now commencing trial will focus on the influence of previous Chikungunya infections on the safety and immunogenicity and hence will be performed in Puerto Rico, a chikungunya fever endemic area.

Commenting on the trial, Dr. Erich Tauber, CEO and co-founder of Themis says: "Chikungunya virus remains a growing risk in many tropical areas. A prophylactic vaccine against Chikungunya is highly desirable and we are happy to offer this live attenuated vaccine candidate that many consider as the most advanced Chikungunya vaccine candidates worldwide. It is based on a standard measles virus vaccine as a vector that offers an excellent safety profile and clear advantages in terms of a validated, low-cost production process."

The new trial will be carried out in collaboration with the Walter Reed Army Institute of Research (WRAIR), an institution of the US Department of Defense. 100 volunteers will be vaccinated and over the period of a year will be tested for their immune responses and safety parameters. One half of the volunteers will have experienced an previous infection with the Chikungunya virus whilst the other half will show no sign of previous infections. All volunteers will receive two jabs with one at study begin and a further one four weeks later.

Erich Tauber adds: "This current study will complement our two ongoing Phase II studies with additional data that are of specific importance for the safety of the vaccine in areas where Chikungunya fever is or has been endemic. Taking together in all three trials well over 700 volunteers will receive our vaccine candidate. This will be a very substantial set of data."

The prophylactic Chikungunya vaccine under development at Themis is based on a standard measles virus vaccine as a vector. This constitutes the basis of the company's pipeline that also includes a prophylactic Zika vaccine currently tested in a Phase I clinical trial in Austria. For the development of the live attenuated Chikungunya vaccine genes coding for selected antigens from the Chikungunya virus have been inserted into the genome of the well-established measles vaccine. Those new antigens are thus produced within the cells, thereby triggering a specific immune response against the Chikungunya virus. As measles vaccines have been successfully used in hundreds of millions of people globally it offers an excellent safety profile and clear advantages in terms of a validated, low-cost production process.

Chikungunya fever is a viral infection transmitted by specific mosquitoes. It originates in Asia and parts of Africa but the increase in global traveling and rising temperatures cause these mosquitoes and the viruses they carry to spread into more temperate zones. Within the last four years well over 1.7 million cases have been reported from 45 countries in the Americas and the Caribbean alone. The majority of infected persons develop severe polyarthralgias which can become chronic. Development of an effective vaccine is urgently needed and will significantly impact health costs for treatment of chronic diseases and disabilities.

About Themis (June 2017):

Themis Bioscience GmbH develops prophylactic vaccines from the preclinical to the early clinical phase, focusing on emerging tropical infectious diseases, with initial vaccine candidates currently being developed against Chikungunya and Zika. The company's highly innovative and fully patent-protected measles virus vaccine vector technology platform, licensed from the internationally respected Institut Pasteur in Paris, forms the basis for all current vaccine candidates of the Vienna-based company.

www.themisbio.com

About the vaccine technology:

The core technology of the measles vector platform has been developed at the Institut Pasteur in Paris and is licensed to Themis. It relies on the use of the standard measles vaccine as a vaccination vector. Genes coding for selected antigens from the Chikungunya virus have been inserted into the genome of this well-established vaccine. The measles-Chikungunya vaccine triggers the expression of the selected antigens which then are presented in macrophages and dendritic cells – the most potent and effective antigen-presenting cells, thereby triggering a specific immune response to Chikungunya virus. This results in a powerful, antigen-focused immune response, which is most likely to confer long-term immunity as does the measles vaccine.

Contact Themis Bioscience GmbH:

Dr. Erich Tauber

CEO

Muthgasse 11/2

1190 Vienna, Austria

T +43 / 1 / 236 7151

E [YjY0dGFnOmVyaWNoLnRhdWJlckB0aGVtaXNiaW8uY29t]

W http://www.themisbio.com

more

6 June 2017

NIH and Themis Bioscience Announce the Initiation of a Clinical Trial of a Chikungunya Vaccine

Vienna (Austria), 6 June 2017

A prophylactic vaccine candidate against Chikungunya fever developed with proprietary technology of Themis Bioscience GmbH will be tested in a clinical trial sponsored by the U.S. National Institutes of Health (NIH). The vaccine, developed by Themis, is based on a standard measles vaccine as a vaccination vector and hence offers an excellent safety profile. It already showed high seroconversion rates in the preceding Phase I clinical trial: 100 percent of all vaccinated candidates produced antibodies against the virus. This trial has started in May 2017 in the U.S. and is intended to provide data to support approval by the Food and Drug Administration (FDA). In Europe the vaccine is already tested in a clinical trial phase II since August 2016. The urgent need for a prophylactic vaccine is emphasized by recent Chikungunya outbreaks raging through the Caribbean and the Americas.

The biotech company Themis Bioscience GmbH (Vienna, Austria) today announced the start of a NIH-sponsored clinical trial of a prophylactic vaccine candidate against Chikungunya fever. The NIH's decision to sponsor the development of this urgently needed vaccine candidate was largely based on promising results of a previous Phase I clinical trial (published in The Lancet Infectious Diseases, DOI: http://dx.doi.org/10.1016/S1473-3099(15)70043-5). Data from this trial proved the safety and tolerability of the vaccine candidate and showed an high seroconversion rate for all patients after a second vaccination regardless of dosage. In order to support U.S. approval of the vaccine by the FDA, the forthcoming double-blinded randomized trial will be conducted exclusively in the U.S. and will focus on the induction of neutralizing antibodies as well as the T-cell response. For European approval by the European Medicines Agency, a Phase II clinical trial commenced in August 2016 and results are expected in the second half of 2017.

Commenting on the joint trial, Dr. Erich Tauber, CEO and founder of Themis says: "We are proud of the support of the NIH, which will sponsor the trial. In turn, Themis will provide all necessary doses of the vaccine in order to enroll up to 180 persons for this clinical trial and the clinical data will be used for regulatory purposes." The trial centers, which are funded by Vaccine and Treatment Evaluation Units (VTEU) contracts from the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH, will be at the University of Iowa in Iowa City, the Baylor College of Medicine in Houston as well as at the Emory University in Atlanta. There 180 persons will either receive the vaccine candidate (150 persons) or a placebo (30 persons) and three different treatment protocols using two different dosages will be applied. "The generous sponsoring of the trial by the NIH allows Themis also to gear further investments towards other vaccine candidates currently under development in our preclinical development pipeline", adds Dr. Tauber. The company recently announced the successful closing of a Series B financing round of EUR 10 Mio.

Themis' prophylactic Chikungunya vaccine is based on a measles vector platform, where selected antigens from the Chikungunya virus have been inserted into the well-established measles vaccine delivering those new antigens into the cells, thereby triggering a specific immune response against the Chikungunya virus. As the measles vaccine has already proven its high efficacy and safety on well over a billion individuals over the last 30–40 years, it offers an excellent safety profile and a validated, cost-efficient production process.

Chikungunya fever is a viral infection transmitted by mosquitoes. It originates in Asia and parts of Africa but the increase in global traveling and rising temperatures may cause it to spread into more temperate zones. Within the last three years well over 1,5 million case have been reported in the Americas and the Caribbean alone, highlighting the urgent need for an affordable prophylactic vaccine.

About Themis (March 2017):

Themis Bioscience GmbH develops prophylactic vaccines from the preclinical to the early clinical phase, focusing on emerging tropical infectious diseases, with initial vaccine candidates currently being developed against Chikungunya and Zika. The company's highly innovative and fully patent-protected measles virus vaccine vector technology platform, licensed from the internationally respected Institut Pasteur in Paris, forms the basis for all current vaccine candidates of the Vienna-based company.

www.themisbio.com

About the vaccine technology (March 2017):

The scientific basis for Themis' measles vector Themaxyn® platform has been developed at the Institut Pasteur in Paris and is licensed to Themis. It relies on the use of the standard measles vaccine as a vaccination vector. Genes coding for selected antigens from the chikungunya virus have been inserted into the genome of this well-established vaccine. The measles-chikungunya vaccine delivers the chikungunya antigens directly to macrophages and dendritic cells – the most potent and effective antigen-presenting cells, thereby triggering a specific immune response to chikungunya virus. This results in a powerful, antigen-focused immune response, which is most likely to confer long-term immunity as does the measles vaccine.

Contact Themis Bioscience GmbH:

Dr. Erich Tauber

CEO

Muthgasse 11/2

1190 Vienna, Austria

T +43 / 1 / 236 7151

E [YjY0dGFnOmVyaWNoLnRhdWJlckB0aGVtaXNiaW8uY29t]

W http://www.themisbio.com

more

11 April 2017

Zika Virus: Themis Bioscience Initiates Worldwide First Study With Live Attenuated Recombinant Vaccine

Vienna (Austria), 11 April 2017 A promising vaccine for the Zika virus is now being tested by Themis Bioscience GmbH, a specialized biotech company developing prophylactic vaccines against emerging tropical infectious diseases. After recent progress with the development of a Chikungunya vaccine the company succeeded in swiftly adapting their proprietary vaccine technology for their Zika vaccine program. This program is based on a live attenuated recombinant vaccine that promises a fast and effective immune response.

Themis Bioscience, a Vienna based biotech company, announced today the first clinical study worldwide of a live attenuated recombinant Zika vaccine tested in human volunteers. The vaccine is based on a well-established vaccine vector technology that uses a measles virus vaccine backbone. Previously the company succeeded in exploiting this technology for the development of a prophylactic Chikungunya vaccine. Following this success Themis quickly adapted the proprietary technology for the development of the Zika vaccine that now will be tested in a Phase I trial (MV-ZIKA-101).

Dr. Erich Tauber, CEO and founder of Themis explains: "We not only manage to initiated one of the first studies of Zika vaccines at all, but globally the first study to test a live attenuated recombinant Zika vaccine. Live attenuated vaccines are regarded as superior as they induce a faster and more complete activation of the immune system leading to durable immunity. We are happy to be at the forefront of developing such a powerful vaccine against Zika."

The clinical study will focus on identifying the most suitable doses of the vaccine candidate in regard to immunogenicity, safety, and tolerability. Therefore up to 48 healthy volunteers will participate in the study and three different treatment regimens will be compared with a placebo treatment. One treatment group will receive one injection of high dose vaccine, the other two groups will receive two shots of either high dose or low dose vaccine. Safety will be measured according to the occurrence of adverse events and side effects of the study medication. Efficacy will be detected by evaluating the elucidation of a Zika-specific immune response. Results of all groups are expected within the next six months. The study will be conducted at the "Department of Clinical Pharmacology" and the "Institute of Specific Prophylaxis and Tropical Medicine" at the Medical University of Vienna, Austria. These site will be opened for enrolment during April and first volunteers are expected from 10. April.

The prophylactic Zika vaccine is based on a measles vector platform, where selected antigens from the Zika virus have been inserted into the well-established measles vaccine delivering those new antigens into the cells, thereby triggering a specific immune response against the Zika virus. As the measles vaccine has already proven its high efficacy and safety on well over a billion individuals over the last 30 – 40 years, it offers an excellent safety profile and a validated, cost-efficient production process. Based on this technology Themis already tested a number of candidate Zika vaccines in animal models, initiated a toxicity study and established GMP manufacturing. The promising results from the animal models advanced the now tested candidate rapidly to the clinical stage.

Zika is a viral infection transmitted by mosquitoes. It originates in Asia and parts of Africa but the increase in global traveling and rising temperatures may cause it to spread into more temperate zones. Recently, the virus spread across the Pacific Ocean to the Americas, leading to the 2015 – 16 Zika virus epidemic.

About Themis (April 2017):

Themis Bioscience GmbH develops prophylactic vaccines from the preclinical to the early clinical phase, focusing on emerging tropical infectious diseases, with initial vaccine candidates currently being developed against Chikungunya and Zika. The company's highly innovative and fully patent-protected measles virus vaccine vector technology platform, licensed from the internationally respected Institut Pasteur in Paris, forms the basis for all current vaccine candidates of the Vienna-based company.

www.themisbio.com

About the vaccine technology:

The core technology of the measles vector platform has been developed at the Institut Pasteur in Paris and is licensed to Themis. It relies on the use of the standard measles vaccine as a vaccination vector. Genes coding for selected antigens from the Zika virus have been inserted into the genome of this well-established vaccine. The measles-Zika vaccine delivers the Zika antigens directly to macrophages and dendritic cells – the most potent and effective antigen-presenting cells, thereby triggering a specific immune response to Zika virus. This results in a powerful, antigen-focused immune response, which is most likely to confer long-term immunity as does the measles vaccine.

Contact Themis Bioscience GmbH:

Dr. Erich Tauber

CEO

Muthgasse 11/2

1190 Vienna, Austria

T +43 / 1 / 236 7151

E [YjY0dGFnOmVyaWNoLnRhdWJlckB0aGVtaXNiaW8uY29t]

W http://www.themisbio.com

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13 December 2016

Zika Virus: Top EU-Groups Join Forces in Quest for Vaccine. Themis Measles Vector Technology Central to Action Plan

Vienna (Austria), 13 December 2016

Leading European research groups pool their expertise for the fast development of an effective and affordable vaccine against the Zika virus. Supported with very substantial funding by the EU, the ZIKAVAX consortium consists of Themis,the European Vaccine Initiative, Institut Pasteur and the Commissariat à l'énergie atomique et aux énergies alternatives. Pivotal to the joint development initiative is Themis' propietary technology platform based on a well-established measles vaccine vector.

A safe, effective and affordable vaccine for the prevention of Zika virus infections is the aim of the newly established ZIKAVAX consortium. To this end, the consortium received 5 M EUR funding from the EU's Horizon 2020 program which supports combating this emerging infectious disease that rapidly spreads to previously unaffected regions of the world. Partners in the consortium are the nonprofit product development partnership European Vaccine Initiative (ZIKAVAX coordinator), the world renowned Institut Pasteur in Paris, the successful vaccine developer Themis from Vienna, Austria and the Commissariat à l'énergie atomique et aux énergies alternatives (CEA), a french public government-funded research organization.

At the heart of the joint effort will be the Themaxyn® platform of Themis, a vector technology with a preclinical and clinical track record of adaptability and effectiveness for the development of vaccines. This successful technology uses a standard measles virus vaccine as a vector, developed at Institut Pasteur in Paris. It has proven its excellent safety profile and clear advantages in terms of a validated, low-cost production process in hundreds of millions of people globally who have received measle vaccinations. Dr. Erich Tauber, CEO and co-founder of Themis comments: "The recently phase 1 clinical trial results of our lead product, a Chikungunya vaccine, which is now tested in a phase 2 trial, have proven the suitability of the vector for other indications and we will now pursue the adaption of the technology for developing a Zika vaccine. The exceptional expertise combined in ZIKAVAX will guarantee quick progress and we are happy to be part of this consortium."

"Developing an effective Zika vaccine has become a global health priority for preventing the further spread of the virus. We are convinced that the use of the measles vaccine delivery platform, one of the safest and most efficacious vaccines available to date, will allow for a rapid and cost-effective development of a Zika vaccine", says Dr. Odile Leroy, Executive Director of the European Vaccine Initiative and coordinator of the ZIKAVAX project.

The work of the ZIKAVAX consortium will compliment Themis' internal Zika R&D project, with the common goal of developing a Zika vaccine rapidly. Themis has tested a number of candidate vaccines in animal models, initiated a toxicity study and established GMP manufacturing with the goal to start phase 1 trials early next year. This expertise and progress is very welcome by the consortium and has additionally been acknowledged by the United Kingdom's innovation agency, Innovate UK, with a 1 M GBP grant to Themis for the development of a Zika vaccine.

Quick Facts about ZIKAVAX:

Start Date: 1 October 2016

End Date: 30 September 2020

Coordinator: Odile LEROY, European Vaccine Initiative

Project Funding: EU H2020

Contact:

Dr. Odile Leroy

European Vaccine Initiative (EVI)

Email: [YjY0dGFnOmNvbnRhY3QudXNAZXV2YWNjaW5lLmV1]

Phone: +49 / 6221 / 565974

 

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28 November 2016

Themis Bioscience Successfully Closes 10 M EUR Financing Round

Vienna (Austria), 28 November 2016

The vaccine development specialist Themis Bioscience successfully closed a Series B financing round of 10 Mio Euro. The fresh capital will be used to complete a phase 2 clinical trial of its lead product, a vaccine candidate against Chikungunya fever. Further products that will benefit include the company's Zika virus vaccine whose development just recently received significant financial support by Innovate UK.

Dr. Erich Tauber, CEO and co-founder of Themis, on the successful completion of the company's second financing round: "We are delighted about the continuous trust of our existing investors and of Austria's leading Venture Fund aws Gruenderfonds. This trust and our recent excellent product development and technology progress have also attracted new investors and we are very grateful for their support." The now successfully closed investment round included the existing investors Ventech, Omnes Capital and Wellington Partners with the latter leading the round. New investors were undisclosed business angels with a focus on vaccine development and the aws Gruenderfonds.

Dr. Regina Hodits, General Partner at the lead investor Wellington Partners, comments on their investment decision: "Themis' focus on prophylactic vaccines for emerging tropical infectious diseases, its patented platform technology and the recent very encouraging results from a phase 1 clinical trial of its lead candidate make the company a very attractive investment opportunity. We want the company's vaccine portfolio to develop at a fast pace and are willing and determined to support Themis on its growth path."

At the heart of Themis' success lies the company's proprietary Themaxyn® platform. It uses a standard measles virus vaccine as a vector, developed at Institut Pasteur in Paris, and constitutes the basis of the company's pipeline. As measles vaccines have been successfully used in hundreds of millions of people globally, the Themaxyn® platform offers an excellent safety profile and clear advantages in terms of a validated, low-cost production process. Recent phase 1 clinical trial results of the company's lead product, a Chikungunya vaccine, proved the suitability of the vector for other indications and the observed immune responses encouraged the management to move this vaccine candidate rapidly to a phase 2 trial, which has been initiated earlier this year.

This progress not only pleased existing investors but also raised the interest of new ones such as the aws Gruenderfonds. Ralf Kunzmann, CEO of aws Gruenderfonds, comments: "We re happy to support Erich Tauber and his team in the further development of the promising prophylactic vaccines for emerging tropical infectious diseases and to be part of the strong investor syndicate. We are looking forward to take the next steps together with Themis."

Dr. Gerd Zettlmeissl, Chairman of the supervisory board of Themis, comments on the future company plans: "We are grateful for the trust of our existing and new investors and I am pleased to welcome Ralf Kunzmann of the aws Gruenderfonds as a new member of our supervisory board. The new capital will primarily be dedicated to finalize the phase 2 clinical trial of our Chikungunya vaccine and to prepare for respective phase 3 trials." Furthermore, Themis will use the additional investment to continue the exploitation of the know-how it acquired with the Chikungunya vaccine's development for further prophylactic vaccines. These include a vaccine against the Zika virus whose advance into the clinical trial phase by Themis was recently supported by the United Kingdom's innovation agency, Innovate UK, with 1 Mio. GBP.

About Themis (November 2016):

Themis Bioscience GmbH develops prophylactic vaccines from the preclinical to the early clinical phase, focusing on emerging tropical infectious diseases, with initial vaccine candidates currently being developed against Chikungunya and Zika. The company's highly innovative and fully patent-protected measles virus vaccine vector technology platform, licensed from the internationally respected Institut Pasteur in Paris, forms the basis for all current vaccine candidates of the Vienna-based company.

www.themisbio.com

About the vaccine technology (November 2016):

The scientific basis for Themis' measles vector Themaxyn® platform has been developed at the Institut Pasteur in Paris and is licensed to Themis. It relies on the use of the standard measles vaccine as a vaccination vector. Genes coding for selected antigens from the chikungunya virus have been inserted into the genome of this well-established vaccine. The measles-chikungunya vaccine delivers the chikungunya antigens directly to macrophages and dendritic cells – the most potent and effective antigen-presenting cells, thereby triggering a specific immune response to chikungunya virus. This results in a powerful, antigen-focused immune response, which is most likely to confer long-term immunity as does the measles vaccine.

About aws Gruenderfonds (November 2016):

aws Gruenderfonds is Austrian's leading venture capital fund with around EUR 70 M EUR under management. The parent company is the Austrian Wirtschaftsservice Gesellschaft mbH (aws). The fund invests in Austrian startups with high growth potential in their early growth or expansion stage. aws Gründerfonds is a long term partner who takes hands-on approach and actively assembles a syndicate of international co-investors out of their international network. Currently the fund has invested in 20 startups, further investments in the life science segment include e.g. Miracor Medical Systems and Panoptes.

Contact Themis Bioscience GmbH:

Dr. Erich Tauber

CEO

Muthgasse 11/2

1190 Vienna, Austria

T +43 / 1 / 236 7151

E [YjY0dGFnOmVyaWNoLnRhdWJlckB0aGVtaXNiaW8uY29t]

W http://www.themisbio.com

more

6 September 2016

Zika Vaccine Development Receives Big Boost by Innovate UK

Vienna (Austria), 6 September 2016

The further development of a promising Zika vaccine candidate by Themis Bioscience has received a strong support by the United Kingdom's innovation agency, Innovate UK. Themis, a Vienna-based specialist for vaccine development, will receive 1 Mio. GBP supporting the further development of this prophylactic vaccine and the conducting of a Phase 1 clinical trial. 

Today, Themis Bioscience GmbH (Vienna, Austria), a company specialized in vaccine development, announced that it will receive 1 Mio. GBP in funding by the innovation agency of the United Kingdom, Innovate UK. The funds will accelerate the further development of a vaccine candidate against the Zika virus infection and its first clinical trial. The vaccine candidate is based on Themis' proprietary Themaxyn® platform that uses a well-established measles vaccine vector whose core technology has been developed at the Institut Pasteur, France.

Dr. Erich Tauber, CEO and founder of Themis welcomes the support: "We recently succeeded in quickly advancing a Chikungunya vaccine candidate into Phase 2 clinical trials and Themis demonstrated its expertise in the fast and focused development of promising vaccines. Thanks to the support of Innovate UK, we can now apply our platform technology for the further development of our prophylactic Zika vaccine candidate, which will address the worldwide emerging Zika threat."

In the past twelve months, Themis identified several suitable validated Zika antigens for the development of the vaccine. The company's team had tested a number of candidate vaccines in animal models, and has already initiated a toxicity study and GMP manufacturing. The main part of the program supported by Innovate UK is the Phase 1 clinical trial, as well as the development of a thermostable formulation for the vaccine.

One of the major advantages of the Zika vaccine candidate of Themis is a validated as well as cost-efficient production process. The measles vector technology developed by Themis forms the basis of all current vaccine candidates advanced by the company. It allows a rapid upscaling of the very cost effective vaccine production process once the vaccine candidate has been determined. This ability is critical for a vaccine that is supposed to combat diseases such as Zika from spreading in highly populated areas. Additionally, the measles vaccine has already proven its high efficacy and safety on well over a billion individuals over the last 30–40 years, and the technology offers an excellent safety profile. Under the terms of a broad license agreement with the Institut Pasteur, Themis owns the rights to use the measles vector for a wide range of indications including Chikungunya and Zika.

About Themis (September 2016):

Themis Bioscience GmbH develops prophylactic vaccines from the preclinical to the early clinical phase, focusing on emerging tropical infectious diseases, with initial vaccine candidates currently being developed against Chikungunya and Dengue. The company's highly innovative and fully patent-protected measles virus vaccine vector technology platform, licensed from the internationally respected Institut Pasteur in Paris, forms the basis for all current vaccine candidates of the Vienna-based company.

www.themisbio.com

About the vaccine technology:

The core technology of the measles vector platform has been developed at the Institut Pasteur in Paris and is licensed to Themis. It relies on the use of the standard measles vaccine as a vaccination vector. Genes coding for selected antigens from the zika virus have been inserted into the genome of this well-established vaccine. The measles-zika vaccine delivers the zika antigens directly to macrophages and dendritic cells – the most potent and effective antigen-presenting cells, thereby triggering a specific immune response to zika virus. This results in a powerful, antigen-focused immune response, which is most likely to confer long-term immunity as does the measles vaccine.

About Innovate UK:

Innovate UK is the UK's innovation agency. It works with people, companies and partner organisations to find and drives the science and technology innovations that will grow the UK economy. For further information visit www.innovateuk.gov.uk

Contact Themis Bioscience GmbH:

Dr. Erich Tauber

CEO

Muthgasse 11/2

1190 Vienna, Austria

T +43 / 1 / 236 7151

E [YjY0dGFnOmVyaWNoLnRhdWJlckB0aGVtaXNiaW8uY29t]

W http://www.themisbio.com

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12 July 2016

New worldwide, exclusive license agreement provides broad access to Institut Pasteur's virus vector technology – Zika vaccine development progressing with high priority.

Vienna (Austria), 12 July 2016

Themis successfully extended its existing license agreement with Institut Pasteur, France, which grants the company a broad access to a well-established virus vaccine vector technology. The safety and tolerability profile of the vector was already proven in a Phase I trial when the two partners used the technology platform for the development of a first in class Chikungunya vaccine, which will enter into Phase II later this year. Now the platform will inter alia also be applied for the development of a Zika vaccine, a high priority project within Themis' pipeline.

Today the vaccine development specialist Themis Bioscience GmbH (Vienna, Austria) announced the significant extension of an existing license agreement with the world renowned Institut Pasteur in Paris. Under the terms of the new agreement Themis will have extensive rights to use the well-established vaccine vector technology initially developed by the Institut Pasteur in a variety of highly relevant vaccine indications including Zika. The technology uses a measles virus vaccine backbone, and measles vaccines have already been successfully used in well over a billion individuals over the last 30–40 years, which suggests an excellent safety and immunogenicity profile as well as an efficient production process.

Dr. Isabelle Buckle, Executive Vice President Technology Transfer & Industrial Partnerships at Institut Pasteur comments on the new agreement: "The potential of this vaccine vector is enormous. Themis' competence in the fast and focused development of promising vaccine candidates will now fully exploit this potential for the development of vaccines against multiple indications. As a first step we prioritize and accelerate the development of our prophylactic Zika vaccine candidate under a collaboration with Themis, which will address the worldwide growing concern about the emerging Zika threat."

"We are intending to begin clinical trials within the next twelve months", further explains Dr. Erich Tauber, CEO and founder of Themis, with regard to the current plan for this project, which will not only benefit from the well-proven safety and tolerability of the measles vector but also from the cost-efficient production process allowing for rapid upscaling of the vaccine production.

 

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SYMPOSIUM: 15 September 2016, Vienna (Austria)

New Horizons For Measles-Based Vaccines And Therapies

Social Event and
Pre-Symposium Dinner, 14 September
Starting at 16:00

AGENDA


TOPIC 1

Setting the stage:
Viral vectors and global challenges

9:00 - 9:20: Christian Mandl
"History of Viral Vectors - current opportunities and challenges"

9:20 - 9:50: Scott Weaver
"Emerging Viral Infections: West Nile, Chikungunya, Zika ... how can we prepare?"

9:50 - 10:20 Erich Tauber
"Rapid development of new vaccines against Chikungunya and Zika using measles vaccine vectors"


Coffee Break (20 min)


TOPIC 2

Molecular biology and host immune response:
challenges, opportunities and new insights

10:40 - 11:10: Frederic Tangy
"History of measles vector and discovery of its utility in human vaccination"

11:10 - 11:40: Diane Griffin
"Persistence of measles virus RNA and vaccine boosting of immune responses in nonhuman primates and humans"

11:40 - 12:10: Roberto Cattaneo
"Structural and functional determinants of measles virus tropism"


Lunch Break (1 hr)


TOPIC 3

Rapid Response and Emerging infections
The roles of Big Pharma, Biotech, Public and Private Funders

13:10 - 14:00: Podium Discussion


Coffee Break (30 min)


TOPIC 4

Measles vectors as a broad platform

14:30 - 15:00: Michael Muehlebach
"Exploring novel vaccine targets"

15:00 - 15:30: Steve Russell
"Preclinical and clinical experience with oncolytic measles approaches"


TOPIC 5

Translation of Basic Research into
Clinical Vaccine Candidates
The roles of Academia, Biotech, Big Pharma and Funders

15:30 - 16:30 Podium Discussion


MEETING CONCLUSION

16:30 - 16:45: Gerd Zettlmeissl
"Conclusions and Farewell"

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19 January 2016

Two renowned Vaccine Experts Joining Themis Bioscience GmbH

Vienna (Austria), 19 January 2016 – Themis Bioscience GmbH, a leading company developing prophylactic vaccines against emerging tropical infectious diseases, today announced the appointment of two new leadership members, Dr. Philippe Dro and Dr. Christian Mandl. The appointment follows in the wake of the successful completion of a phase I clinical trial of the company's Chikungunya vaccine, and so Themis is heading for hot times - and is growing steadily.

Dr. Philippe Dro, a renowned life science entrepreneur will join the Board of Directors. The Scientific Advisory Board of Themis Bioscience will in the future benefit from the outstanding experience of Dr. Christian Mandl as chair.

Welcoming his new colleagues, Dr. Erich Tauber, CEO and founder of Themis comments: "Themis is heading towards exciting times with our lead project, a Chikungunya vaccine candidate entering clinical trials phase II this year. The combined industry and vaccine development expertise of Dr. Dro and Dr. Mandl creates a fantastic asset for the company during its growth and continued partnering efforts."

In the last 20 years Dr. Dro initiated and executed several strategic transactions. Prior to its acquisition by GSK, he served at the vaccine developer GlycoVaxyn AG as CEO and member of the Supervisory Board. Before that, he was leading Endoart S.A., a medtech company, in the position of CEO and Chairman of the Board through a successful sale process of the company to Allergan. When Actelion acquired Axovan AG, he was acting CFO and Head of Business Development. Prior to that, he served at Novartis, SkyePharma and Antares Pharma in a number of responsible functions.

Dr. Mandl has served as head of Novartis Vaccines' US research and as global head for all viral vaccine research projects. He directed a team of 300 scientists working on over 15 viral and bacterial vaccine pipeline projects and platform technologies. Prior to this he acted as Deputy Head of the Department of Virology at the Medical University of Vienna. He is an internationally renowned expert in flaviviruses and co-inventor on several patents related to the marketed vaccine for tick-born encephalitis.

With the appointment of Drs. Dro and Mandl Themis Bioscience's recent series of exceptional positive developments continues. In late 2014, the phase I clinical trial of the Chikungunya vaccine was successfully completed and results were published in "The Lancet" in early 2015. A few months later the company succeeded in raising several millions of additional capital from existing and new investors. Commenting on this, Dr. Tauber states: "The clinical data proved the suitability of our Themaxyn® platform that uses a standard anti-measles vaccine as a vector and constitutes the basis of our pipeline. The anti-measles vaccine has already proven itself a million times over, and hence offers an excellent safety profile and clear advantages in terms of a validated, low-cost production process. Our Investors appreciate this highly.

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5 May 2015

Themis Bioscience’s Raises up to EUR 10 Million in Series B New Board to drive partnerships and commercialization of product pipeline

Vienna (Austria), 5 May 2015 – Themis Bioscience (‘Themis'), a biotechnology company developing innovative prophylactic vaccines for emerging tropical infections, announced today the first closing of EUR 7 Million in a Series B financing of up to EUR 10 Million, led by new investor Wellington Partners. Existing investors Ventech and Omnes Capital (formerly Crédit Agricole Private Equity) also participated in the round. Dr Regina Hodits, General Partner at Wellington Partners will join Themis' Board.

With their Chikungunya fever vaccine candidate demonstrating good immunogenicity, safety and tolerability in a Phase 1 clinical trial (Results published in The Lancet Infectious Diseases, March 2015), Themis plans to progress this lead product candidate into clinical phase II trials. In parallel the company will advance its other promising development pipeline in collaboration with the Institut Pasteur in Paris, originators of the measles vector platform licensed to Themis.

Themis also announced the new structure of its Board with Dr Gerd Zettlmeissl being named Chairman of the Board. Dr Zettlmeissl spent more than 20 years in executive positions in the international pharmaceutical and vaccine biotech industry. From 2005 until May 2011 he served as CEO of Intercell AG. Experienced biotech and vaccine industry expert Dr Jean-Paul Prieels will join as a new member the expanded board. He served as Senior Vice President of R&D at GlaxoSmithKline Biologicals until January 2011, led GSK's global vaccine R&D development activities and was Head of Research for GSK Vaccines.

Dr Erich Tauber, CEO of Themis stated: "With the new funds, we are planning to move our Chikungunya vaccine candidate quickly into a Phase 2 clinical trial and also achieve important milestones for the other vaccine candidates in our preclinical development pipeline. We are very pleased to have Wellington Partners leading this financing round and I would like to welcome Dr Regina Hodits and Dr Jean-Paul Prieels to the Board. I am sure that Themis will profit from their scientific and industrial expertise in supporting our goals to establish new partnerships within the pharmaceutical industry and to drive our product pipeline towards commercialisation."

Dr Regina Hodits, General Partner at Wellington Partners, commented: "With global warming and increased travel activities, tropical diseases like Chikungunya, Dengue fever, and other viral diseases are becoming a serious threat to global health. Based on a proven measles vaccine platform, Themis' portfolio of vaccine candidates represent an attractive investment opportunity for Wellington, and they have the potential to address urgent unmet medical needs."

In 2011, Themis raised EUR 5 Million in a series A financing following a seed financing round from Austria Wirtschaftsservice (AWS) in 2009, and other substantial financial contributions from Austrian national funding agencies like FFG and Inits.

 

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