In an interview with PharmaShots, Elke Walter, Senior Director, Global Zika Program Lead & Derek Wallace, Vice President, Global Dengue Program Lead at Takeda share their views on TAK-003 & highlighted 10 presentations from dengue and zika programs at ASTMH

Shots:

• The company reported a cumulative safety assessment included long-term safety data from the five trials of TAK-003 which showed that the therapy was well-tolerated in patients aged 4 to 60yrs.
• In the P-III (TIDES) trial, the therapy showed overall protection against symptomatic & hospitalized dengue, regardless of prior dengue exposure & no safety risks were observed through 3yrs. follow-up. The MAA is currently under EMA’s review for TAK-003 in the EU
• The results from the Zika program showed that Zika virus-specific Abs can be distinguished from Abs to other flaviviruses that improved differential diagnosis, support development & implementation of Zika vaccines in flavivirus-endemic countries

Tuba: Tell us about the posters that you presented at the ASTMH 2021 annual meeting.

Derek Wallace: We presented data from our dengue and Zika vaccine programs at the American Society of Tropical Medicine and Hygiene (ASTMH) 2021 Annual Meeting in November. As we continue to progress our dengue program, we were excited to share a cumulative safety assessment that included long-term safety data (36 months after the second dose) across five trials of Takeda’s dengue vaccine candidate, TAK-003. Results showed that TAK-003 was well-tolerated in individuals aged four to 60 years old regardless of prior dengue exposure. Notably, this included data from our Phase 3 The Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial.

Elke Walter: We also presented data from our Zika program that shows Zika virus-specific antibodies can be distinguished from antibodies to other flaviviruses, which may improve differential diagnosis and support development and implementation of Zika vaccines in flavivirus-endemic countries.

Tuba: Put a glance at the epidemiology of dengue. (Derek Wallace)

Derek Wallace: Dengue is the fastest spreading mosquito-borne viral disease, affecting people of all ages and was recognized by the World Health Organization (WHO) in 2019 as one of the top ten threats to global health. An estimated 3.9 billion people around the globe – half of the world’s population – are currently at risk of dengue. It is now endemic in more than 100 countries and causes an estimated 390 million infections and 500,000 hospitalizations each year.

Dengue is a complex disease, and there are four disease serotypes that circulate globally. Many cases of dengue are mild, and recovery from infection with one serotype is thought to provide lifelong immunity against that serotype but temporary, partial protection against the others. Because of this and the cyclical nature of the disease, it is possible to be infected with dengue more than once. It is important to note that infections can vary, and a secondary infection with a different serotype can potentially increase the risk of developing severe dengue disease.

Tuba: Can we discuss the data from the pivotal P-III trial for Takeda’s dengue vaccine candidate, TAK-003? (Derek Wallace)

Derek Wallace: At ASTMH, we presented a cumulative safety assessment of TAK-003, which included data from the TIDES trial and further reinforced the potential of our dengue vaccine candidate. Overall, TIDES data through three years after vaccination has continued to demonstrate overall protection against symptomatic and hospitalized dengue, regardless of an individual’s previous dengue exposure. Efficacy has varied by serotype, and no important safety risks have been identified in the TIDES trial through three years follow-up.

As we have previously reported, the TIDES trial met its primary endpoint of overall vaccine efficacy (VE) against virologically-confirmed dengue (VCD) with 80.2% efficacy at 12-months follow-up. The trial also met all secondary endpoints for which there were a sufficient number of dengue cases at 18-months follow-up.

We are encouraged by our data and believe it supports the potential of TAK-003 to fill a critical gap in dengue prevention.

Tuba: Do you have any plan to commercialize TAK-003? (Derek Wallace)

Derek Wallace: We are currently progressing regulatory filings for TAK-003 worldwide with the goal of making it available to those who may need it. The European Medicines Agency (EMA) is currently reviewing our Marketing Authorization Application (MAA) for review of TAK-003 in the EU, and an application for the EU-M4all (previously Article 58) procedure for countries outside of the EU. Additionally, we have begun and will continue to progress regulatory filings in some dengue-endemic countries, including Argentina, Brazil, Colombia, Indonesia, Malaysia, Mexico, Singapore, Sri Lanka and Thailand, and intend to file in the United States.

If approved, we will continue working with authorities to evaluate paths to access for TAK-003 for people who can potentially benefit from it and supporting access in private and public markets.

Tuba: Please share the data from Takeda’s Zika program (Elke Walter)

Elke Walter: The data presented at ASTMH helps describe the development of a Zika virus-specific assay design by allowing for detection of Zika-virus antibody levels in the presence or absence of antibodies to other flaviviruses. The data suggests that the assay can differentiate Zika virus-specific antibodies from antibodies to other flaviviruses caused by infection or vaccination, which will improve differential diagnosis and support development and implementation of Zika vaccines in flavivirus regions.

We continue to advance our Zika program and have completed the Phase 1 trial of our Zika vaccine candidate, TAK-426, called ZIK-101, which met the primary objective of the study. Initial results from the Phase 1 trial were published in The Lancet Infectious Diseases. The Phase 2 clinical protocol is finalized with a planned mid-2022 study start.

According to the WHO, as of July 2019, a total of 87 countries and territories recorded Zika transmission, and there are currently no marketed vaccines for the prevention of Zika.

Tuba: What more is in your pipeline for non-communicable diseases (treatment or vaccine)? (Derek Wallace)

Derek Wallace: In addition to our dengue vaccine candidate, we are developing a Zika vaccine candidate, as well as partnered programs for COVID-19 and norovirus vaccines. You can find more about our pipeline here.

Tuba: Are you working/planning to initiate any awareness program for dengue? (Derek Wallace)

Derek Wallace: Takeda is committed to providing transparent information on the risks of dengue and making that information broadly available and understandable. One example from last year is DengueAcademy.com – a website we launched dedicated to providing dengue disease awareness and medical education resources for an international audience of health care professionals.

Tuba: Is Takeda planning to market this vaccine in 3rd world nations with more cases of dengue on their own or via any partnership? If with partners can we know more? (Derek Wallace)

Derek Wallace: We are committed to bringing our dengue vaccine candidate to people living in and traveling to dengue-endemic regions, including in lower- and middle-income countries in Latin America and Asia where the burden of dengue is often present. We have begun and will continue working with regulatory authorities in many of those countries to bring TAK-003 to all who can potentially benefit from it. We currently do not have any partnerships to disclose.

Source: Medical News Today

About Authors:

Elke Walter

Elke Walter is the Senior Director and Global Zika Program Lead at Takeda where she leads the global program team in the development of Takeda’s Zika vaccine candidate, TAK-426. Walter has 18 years of experience in the biotechnology and pharmaceutical industries. She received PhD from the University of Marburg, Germany.

Derek Wallace

Derek Wallace is the Vice President and Global Dengue Program Lead at Takeda where he leads the global program team in the development of Takeda’s dengue vaccine candidate, TAK-003. Wallace has over 16 years of experience in clinical development, infectious diseases and medical affairs. He holds a Diploma of Vaccinology from the Institute Pasteur and a Diploma in Pharmaceutical Medicine from the University of Wales, Cardiff. He received his Bachelor of Medicine, Bachelor of Surgery from the University of Queensland.