Potential Impact of Takeda’s Dengue Vaccine Candidate Reinforced by Long-Term Safety and Efficacy Results

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− Takeda’s dengue vaccine candidate (TAK-003) prevented 83.6% of hospitalizations and 62.0% of dengue sickness total, with no recognized vital security dangers by three years following vaccination in ongoing pivotal Section 3 TIDES trial

− Regulatory filings for TAK-003 progressing in European Union and in lots of dengue-endemic international locations; submitting in United States deliberate for later this yr

− Dengue is the fastest-spreading mosquito-borne viral illness with an estimated 390 million circumstances and 500,000 hospitalizations per yr globally, with restricted choices for prevention

OSAKA, Japan & CAMBRIDGE, Mass. — Takeda Pharmaceutical Company Limited( TSE:4502/NYSE:TAK) (“Takeda”) right this moment introduced that its dengue vaccine candidate (TAK-003) demonstrated continued safety towards dengue sickness and hospitalization, no matter a person’s earlier dengue publicity, with no vital security dangers recognized by three years after vaccination within the ongoing pivotal Section 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial. TIDES enrolled greater than 20,000 wholesome youngsters and adolescents ages 4 to 16 years in dengue-endemic international locations in Latin America and Asia.

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“Dengue epidemics happen all of the sudden, and hospitals can grow to be overwhelmed with extreme illness circumstances and other people searching for testing,” mentioned LakKumar Fernandoⁱ, M.D., Heart for Medical Administration of Dengue and Dengue Haemorrhagic Fever, Negombo Common Hospital, Sri Lanka and a main investigator of the TIDES trial. “Outcomes from the long-term evaluation of Takeda’s dengue vaccine candidate recommend that it may assist with outbreak prevention, cut back charges of hospitalization and defend individuals from dengue no matter their earlier publicity. Importantly, no vital security dangers had been recognized.”

Security and efficacy outcomes from the 36-month follow-up exploratory evaluation of TIDES had been offered on Could 22, 2021, on the seventeenth Convention of the Worldwide Society of Journey Drugs (CISTM). By three years (36 months after the second dose), TAK-003 demonstrated total vaccine efficacy (VE) of 62.0% (95% CI: 56.6% to 66.7%) towards virologically-confirmed dengue (VCD), with 65.0% VE (95% CI: 58.9% to 70.1%) in seropositive people and 54.3% VE (95% CI: 41.9% to 64.1%) in seronegative people. TAK-003 additionally demonstrated 83.6% VE (95% CI: 76.8% to 88.4%) towards hospitalized dengue, with 86.0% VE (95% CI: 78.4% to 91.0%) in seropositive people and 77.1% VE (95% CI: 58.6% to 87.3%) in seronegative people. Observations of assorted VE by serotype remained in line with beforehand reported outcomes. No proof of illness enhancement was noticed. TAK-003 was typically nicely tolerated, and there have been no vital security dangers noticed. The outcomes reinforce the potential of TAK-003 to assist defend those that live in or touring to dengue-endemic international locations.

“Our dengue vaccine candidate continued to supply safety towards dengue all through three years, and was particularly strong in stopping hospitalization,” mentioned Derek Wallace, VP, Dengue World Program Chief at Takeda. “These outcomes reinforce my confidence that TAK-003 may also help deal with the numerous international burden of dengue.”

As beforehand reported, the TIDES trial met its primary endpoint of total VE towards VCD at 12-months follow-up (VE: 80.2%; 95% CI: 73.3% to 85.3%; p<0.001) and all secondary endpoints for which there have been a ample variety of dengue circumstances (measured at 18-months follow-up). The TIDES trial has been amended to incorporate the analysis of a booster dose to deal with the waning of total VE noticed over time (from 12 by 36 months after the second dose), largely pushed by outpatient dengue. Takeda intends to publish outcomes of the 36-month exploratory evaluation in a peer-reviewed journal this yr.

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TIDES security and efficacy knowledge by 36-months follow-up was included in regulatory submissions to the European Union and dengue-endemic international locations and will probably be a part of extra filings deliberate for 2021, together with in the USA. Takeda will search a sign for TAK-003 for the prevention of dengue illness in people 4 to 60 years of age, no matter earlier virus publicity, based mostly on knowledge in each adults and youngsters. There stays a necessity for dengue vaccines that can be utilized in each dengue-naïve and dengue-exposed adults and youngsters.

About TAK-003

Takeda’s tetravalent dengue vaccine candidate (TAK-003) is predicated on a live-attenuated dengue serotype 2 virus, which gives the genetic “spine” for all 4 vaccine viruses.¹ Medical Phase 2 knowledge in youngsters and adolescents confirmed that TAK-003 induced immune responses towards all 4 dengue serotypes, in each seropositive and seronegative contributors, which endured by 48 months after vaccination, and the vaccine was discovered to be typically secure and nicely tolerated.² Thepivotal Section 3 Tetravalent Immunization towards Dengue Efficacy Research (TIDES) trialmet its primary endpoint of overall vaccine efficacy (VE) towards virologically-confirmed dengue (VCD) at 12-months follow-up and all secondary endpoints at 18-months follow-up for which there have been a ample variety of dengue circumstances, together with VE towards hospitalized dengue and VE in baseline seropositive and baseline seronegative people.^3,4 Efficacy diverse by serotype. The outcomes demonstrated TAK-003 was typically nicely tolerated, and there have been no vital security dangers noticed so far.

In regards to the Section 3 TIDES (DEN-301) Trial

The double-blind, randomized, placebo-controlled Section 3 Tetravalent Immunization towards Dengue Efficacy Research (TIDES) trial is evaluating the protection and efficacy of two doses of TAK-003 within the prevention of laboratory-confirmed symptomatic dengue fever of any severity and as a result of any of the 4 dengue virus serotypes in youngsters and adolescents.⁴ The TIDES trial is Takeda’s largest interventional scientific trial so far and enrolled over 20,000 wholesome youngsters and adolescents ages 4 to 16 years dwelling in dengue-endemic areas. Research contributors had been randomly assigned to obtain both TAK-003 0.5 mL or placebo by subcutaneous injection on Day 1 and Day 90.⁴ The examine is comprised of 5 components. Half 1 and the first endpoint evaluation evaluated vaccine efficacy (VE) and security by 12 months after the second dose.⁴ Half 2 continued for an extra six months to finish the evaluation of the secondary endpoints of VE by serotype, baseline serostatus and illness severity, together with VE towards hospitalized dengue.⁴ Half 3 is evaluating VE and long-term security by following contributors for an extra two and a half to a few years.^{5 Half 4 will consider efficacy and security for 13 months following booster vaccination and Half 5 will consider long-term efficacy and security for one yr after completion of Half 4.5}

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The trial is going down at websites in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, the Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka) the place there are unmet wants in dengue prevention and the place extreme dengue is a number one trigger of significant sickness and loss of life amongst youngsters.⁴ Baseline blood samples had been collected from all people collaborating within the trial to permit for analysis of security and efficacy based mostly on serostatus. Takeda and an unbiased Knowledge Monitoring Committee of consultants are actively monitoring security on an ongoing foundation.

About Dengue

Dengue is the quickest spreading mosquito-borne viral illness and was one of many WHO’s prime 10 threats to international well being in 2019.^6,7 Dengue is principally unfold by Aedes aegypti mosquitoes and, to a lesser extent, Aedes albopictus mosquitoes. It’s brought on by any of 4 dengue virus serotypes, every of which may trigger dengue fever or extreme dengue. The prevalence of particular person serotypes varies throughout completely different geographies, international locations, areas, seasons and over time.⁸ Restoration from an infection by one serotype gives lifelong immunity towards solely that serotype, and later publicity to any of the remaining serotypes is related to an elevated threat of extreme illness.

Dengue is pandemic inclined, and outbreaks are noticed in tropical and sub-tropical areas and have just lately precipitated outbreaks in components of the continental United States and Europe.^9,10 Roughly half of the world now lives below the specter of dengue, which is estimated to trigger 390 million infections and round 20,000 deaths globally every year.^10,11 The dengue virus can infect individuals of all ages and is a number one trigger of significant sickness amongst youngsters in some international locations in Latin America and Asia.¹⁰

Takeda’s Dedication to Vaccines

Vaccines stop 2 to three million deaths every year and have reworked international public well being.¹² For the previous 70 years, Takeda has provided vaccines to guard the well being of individuals in Japan. At this time, Takeda’s international vaccine enterprise is making use of innovation to deal with a number of the world’s most difficult infectious illnesses, similar to dengue, COVID-19, Zika and norovirus. Takeda’s workforce brings an excellent monitor document and a wealth of data in vaccine improvement, manufacturing and international entry to advance a pipeline of vaccines to deal with a number of the world’s most urgent public well being wants. For extra info, go to www.TakedaVaccines.com.

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About Takeda Pharmaceutical Firm Restricted

Takeda Pharmaceutical Firm Restricted ( TSE: 4502/NYSE: TAK) is a worldwide, values-based, R&D-driven biopharmaceutical chief headquartered in Japan, dedicated to find and ship life-transforming therapies, guided by our dedication to sufferers, our individuals and the planet. Takeda focuses its R&D efforts on 4 therapeutic areas: Oncology, Uncommon Genetic and Hematology, Neuroscience, and Gastroenterology (GI). We additionally make focused R&D investments in Plasma-Derived Therapies and Vaccines. We’re specializing in growing extremely progressive medicines that contribute to creating a distinction in individuals’s lives by advancing the frontier of latest remedy choices and leveraging our enhanced collaborative R&D engine and capabilities to create a strong, modality-diverse pipeline. Our staff are dedicated to bettering high quality of life for sufferers and to working with our companions in well being care in roughly 80 international locations. For extra info, go to https://www.takeda.com.

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This press launch comprises details about merchandise that will not be out there in all international locations, or could also be out there below completely different logos, for various indications, in several dosages, or in several strengths. Nothing contained herein must be thought-about a solicitation, promotion or commercial for any prescribed drugs together with those below improvement.

ⁱ Dr. LakKumar Fernando didn’t obtain compensation for his assertion.
¹ Huang CY-H, et al. Genetic and phenotypic characterization of producing seeds for tetravalent dengue vaccine (DENVax). PLoS Negl Trop Dis. 2013;7:e2243.
²Tricou, V, Sáez-Llorens X, et al. Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2-17 years: a randomised, placebo-controlled, phase 2 trial. Lancet. 2020. doi:10.1016/S0140-6736(20)30556-0.
³ Biswal S, et al. Efficacy of a tetravalent dengue vaccine in wholesome youngsters and adolescents. N Engl J Med. 2019; 2019;381:2009-2019.
⁴ Biswal S, et al. Efficacy of a tetravalent dengue vaccine in wholesome youngsters aged 4-16 years: a randomized, placebo managed, part 3 trial. Lancet. 2020. 2020;395:1423-1433.
⁵ ClinicalTrials.Gov . Efficacy, Safety and Immunogenicity of Takeda’s Tetravalent Dengue Vaccine (TDV) in Healthy Children (TIDES). Retrieved March 2021.
⁶ World Well being Group. Factsheet. Dengue and Severe Dengue. April 2019. Retrieved February 2021.
⁷ World Well being Group. Ten threats to global health in 2019. 2019. Retrieved February 2021.
⁸ Guzman MG, et al. Dengue: a continuing global threat. Nature Evaluations Microbiology. 2010;8:S7-S16.
⁹ Knowlton Ok, et al. Mosquito-Borne Dengue Fever Threat Spreading in the Americas. The Pure Assets Protection Council (NRDC). 2009. Retrieved February 2021.
¹⁰ Chan E, et al. Utilizing net search question knowledge to observe dengue epidemics: a brand new mannequin for uncared for tropical illness surveillance. PLoS Negl Trop Dis. 2011;5:e1206.
¹¹ Facilities for Illness Management and Prevention. About Dengue: What You Need to Know. Could 2019. Retrieved February 2021.
¹² UNICEF. Vaccination and Immunization Statistics. 2019. Retrieved February 2021.

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