V591


V591

formerly known as COVAX, 
is a measles vector vaccine candidate.

Under development by Themis Bioscience GmbH, Vienna, in cooperation with Institut Pasteur, Paris, with manufacturing anticipated to occur in Germany

Themis Bioscience GmbH has been acquired by Merck on May 26, 2020

The EU Malaria Fund has announced on June 3, 2020 that it has approved to finance parts of the development of V591.

Merck ended its V591 vaccine program on January 25, 2021, citing inferior immune responses.

V591

Themis Bioscience GmbH, an Austrian biotechnology subsidiary of Merck Inc, is applying its expertise and experience toward the rapid development of a novel coronavirus vaccine candidate that can be potent and capable of eliciting a safe, robust and specific immune response to SARS-CoV-2, the virus that causes COVID-19. As announced on March 19th, 2020, Themis is collaborating with the Institut Pasteur in Paris, France, the Centre for Vaccine Research at the University of Pittsburgh in Pennsylvania and the Coalition of Epidemic Preparedness Initiative (CEPI) to achieve this. Themis is also preparing its facilities and manufacturing systems to produce the vaccine for broad use, as well as engaging in discussions with other manufacturing organizations to enable production globally. 
 
Themis has developed a sophisticated platform to rapidly advance immune modulation therapies for a range of infectious diseases and cancer. At the heart of this platform lies the proprietary measles vector that has been used for decades to immunize billions of people around the world and which has been licensed exclusively to Themis by the Institut Pasteur. Themis has developed this vector into a broadly applicable platform technology and built a highly advanced, commercial-scale, manufacturing process for the production of its vaccine and immunotherapy candidates. What makes Themis’ platform unique is its versatility and the ability to insert multiple large recombinant protein antigens into the vector, overcoming limitations found in other approaches. As the most advanced vaccine candidate, the company’s Phase 3-ready vaccine against Chikungunya has shown an excellent safety and immunogenicity profile in hundreds of subjects to date. 

"a versatile platform for directed, effective immune modulation"

COVAX - our insight of the week
Erich Tauber, MD is the Founder and CEO of Themis Bioscience. He started the company 10 years ago with the aim of developing vaccines to protect against infectious diseases worldwide. Dr. Tauber’s company is now sharing the spotlight with other organizations taking the initiative to develop a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. 

“Vaccines are among the most cost-efficient and effective tools to prevent disease. Since the start of my career, when I was a pediatrician, the power of vaccines has fascinated me. After practicing medicine for several years, I then moved into the biotechnology industry and based on my subsequent experience in developing vaccines and being responsible for the clinical development and licensing of the Japanese Encephalitis vaccine, Ixiaro, I decided to start Themis in 2009. Our original vision was to develop a broad pipeline of vaccines against those infectious diseases that have high outbreak potential and no vaccine approved for use.” 
Erich Tauber, MD, Founder and CEO of Themis

In ten years, Themis has grown into a biotech company with a track record for developing vaccine candidates for diseases including Zika, Chikungunya, Lassa fever and MERS. Today, Themis employees are working towards safeguarding people from COVID-19 by doing what they do best: developing a vaccine. 

Themis aims to battle COVID-19 through the application of its measles virus vaccine vector technology, which you likely have come into contact with if you’ve been vaccinated against measles. The company holds an exclusive worldwide license for the measles vaccine vector developed at the renowned Institut Pasteur in Paris and has adapted it to create innovative product candidates that are designed to be safe and effective in protecting against infectious diseases. Themis has also built a robust commercial-scale manufacturing process around this technology. Equipped with this knowledge and a highly motivated team of experts and collaborators, Themis is rapidly developing its own COVID-19 vaccine candidate. 

Explained simply: Themis starts by incorporating multiple large recombinant protein antigens into the measles vaccine vector backbone. This vector acts as a delivery vehicle to transport the antigen payload directly to macrophages and dendritic cells. In case you haven’t heard of them before, these immune cells are the body’s first line of defense against a foreign pathogen and the most potent and effective antigen-presenting cells. The vaccine thus triggers a specific immune response to the selected antigens, in this case SARS-CoV-2. The vector actively replicates and continuously expresses the antigens, even after immunization, meaning that the vaccine is expected to provide long-term immunity against the virus.

Themis calls this “a versatile platform for directed, effective immune modulation,” that enables the technology to be applied across many infectious diseases as well as cancer.

Today, the entire world is in a race against time to try to bring a vaccine to market as swiftly as possible without compromising on safety or efficacy. However, developing a vaccine requires careful planning and each phase in the process is designed to minimize health risks, therefore it takes time. It is critical to obtain the right support and work closely with regulatory agencies to determine the fastest path toward making the vaccine available once it is proven to be safe and effective. Themis is moving quickly with its COVID-19 vaccine, which will enter clinical trials in healthy humans before the end of 2020. Themis is already conferring with other manufacturers on the objective of producing its vaccine on a global scale.

For its COVID-19 program, Themis is backed by a consortium that includes France's Institut Pasteur, the University of Pittsburgh’s Center for Vaccine Research and CEPI, the Coalition for Epidemic Preparedness Innovations. 

Themis and other companies rely not only on support from founders, coalitions and investors, but also from governments. While outbreaks occur frequently, they rarely result in a global pandemic. COVID-19 has shed light on the importance of proactively developing vaccines for a plethora of infectious diseases and governments worldwide are taking note of the importance of funding such programs to prevent and prepare for future outbreaks. 

Another unusual challenge the Themis team is adapting to in their effort to develop a vaccine: continue practicing the social distancing measures essential to curtailing the spread of the virus. The company is working toward its goals despite such difficulties and continues to dedicate long hours under these safe conditions. This is a constant reminder and perhaps motivator in the crucial search for a vaccine to protect against COVID-19. 

May 1, 2020 by Acumen
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