AsianScientist (Dec. 20, 2016) – Last month, you read about Sanofi Pasteur’s dengue vaccine, Dengvaxia. This month, we bring to you an update from Japanese pharmaceutical company Takeda, which also has a dengue vaccine in the works. Called TAK-003, the vaccine has been launched in a global Phase III clinical trial.
On top of that, Takeda has announced that it has been granted US$19.8 million initial funding by the US Biomedical Advanced Research and Development Authority (BARDA) to develop a vaccine for Zika. BARDA is a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services. The funding will go towards a Phase I clinical trial, according to Takeda.
This latest news builds on Takeda’s strong foundation of vaccine development for dengue and other infectious diseases. Below, the global dengue program medical director of Takeda, Dr. Derek Wallace, tells Asian Scientist Magazine about Takeda’s Vaccine Business Unit, the challenges surrounding the development of a tetravalent dengue vaccine, and future plans to develop a Zika vaccine.
- As global dengue program medical director, you are currently based in Zurich. Could you share with us where the dengue vaccine R&D team is based, and could you provide us a bird’s eye view into how this team operates in general?
As an organization, Takeda has a history of vaccine sales in Japan, but in order to be a vaccine company with a global footprint, we’ve built a team with significant experience in vaccine development and manufacturing.
Takeda’s Vaccine Business, created in January 2012, is a global organization focused on discovery, research and development, manufacturing and sales. The Vaccine Business is consolidating its footprint into global sites (Boston and Zurich for the vaccine business outside of Japan), regional hubs (Singapore and Brazil), and manufacturing hubs (Hikari, Durham and Singen) in order to improve effectiveness and efficiency of operations.
- Could you share with us what are the total dengue vaccine assets at Takeda, and what the vaccine candidate pipeline looks like right now?
Takeda has built a strong pipeline that is relevant to developed and developing countries. We are applying innovation to develop vaccine candidates for some of the world’s most challenging infectious diseases that affect millions of people all over the world. This includes dengue, norovirus, hand foot and mouth disease (enterovirus-71), polio, chikungunya and pandemic/seasonal influenza. Collectively, these diseases result in hundreds of thousands of deaths each year, majorly impacting global public health.
- Could you elaborate on how the Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial is going, particularly in Asia?
In September 2016, we initiated a Phase III clinical trial, TIDES, in nine countries across Latin America and Southeast Asia, including Brazil, Colombia, Dominican Republic, Nicaragua, Panama, the Philippines, Thailand, Sri Lanka and Vietnam. TIDES is a double-blind, randomized and placebo-controlled trial to investigate the efficacy, safety and immunogenicity of two doses of Takeda’s tetravalent dengue vaccine candidate (TAK-003) administered 90 days apart in healthy children aged four to 16 years living in dengue endemic areas.
Our goal is to develop and test a vaccine that is safe for and protects populations and individuals at risk for symptomatic dengue, including children, regardless of whether they have previously been exposed to the virus. TAK-003 is based on a dengue serotype 2 virus which provides the genetic ‘backbone’ for all four vaccine viruses. Phase III clinical trials have been designed to assess vaccine efficacy against both moderate and severe dengue caused by each of the four dengue serotypes.
The trial is on track and we expect to finish enrollment in the trial in the first half of 2017.
- How does TAK-003 match up against the vaccines being developed by other pharmaceutical companies, such as Sinovac Biotech for example?
We are proceeding with our plans for global clinical trials to confirm the safety and efficacy of our vaccine candidate in order to make it available as soon as possible to those who need it. There are populations that are in need of a vaccine that protects against all four dengue serotypes in people of all ages, regardless of previous exposure, which our Phase III trial will examine.
- Could you share with us what are the biggest challenges in making a pan-serotype vaccine that your team has encountered so far?
Dengue is the fastest spreading mosquito-borne viral disease. According to the World Health Organization, it is estimated that 390 million dengue infections occur globally on an annual basis, and there are more than 20,000 deaths each year around the world. It can infect people of all ages and is a leading cause of serious illness among children in some countries in Latin America and Asia.
Additionally, four dengue serotypes circulate globally. Infection with one dengue serotype confers life-long protection against re-infection with the same serotype, but only short-term protection against the other three serotypes. Sequential infections with different serotypes can potentially increase the risk of developing severe and lethal disease. There is also limited understanding of how the virus interacts with the immune system and how certain types of pre-existing immunity can exacerbate disease.
Taking this into account, it is clear that unmet needs in dengue prevention exist and we are working diligently to develop a vaccine that will protect all populations regardless of previous infection to the disease.
- Do you have any insights into the Zika vaccine project at Takeda?
Takeda announced on September 1, 2016 that BARDA selected Takeda’s Vaccine Business Unit to develop a Zika vaccine to support the response in the US and affected regions around the world. We are aiming for Phase I clinical trials to start in 2017. We cannot project timing milestones beyond this, but vaccine development takes several years after initiation of the first clinical studies. We are working closely with health authorities to conform to the latest guidelines on development of a Zika vaccine.
Copyright: Asian Scientist Magazine; Photo: Shutterstock.
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