Takeda is one stride closer to reaching the sizable market waiting for dengue vaccines as it reports positive top-line results from a massive Phase III trial.
The analysis, which constitutes the first of a three-part study, concludes that the company’s tetravalent dengue vaccine TAK-003 was efficacious at 15 months in preventing dengue fever caused by any of the four serotypes of the virus, thereby meeting the primary endpoint. And while they are saving the details for a peer-reviewed journal, Takeda $TAK researchers say the vaccine was “well tolerated with no significant safety concerns to date.”
The safety element is particularly important given the fresh memories of a public health controversy that Sanofi was mired in involving the use of its pioneering dengue vaccine in a major vaccination campaign in the Philippines. Given to anyone who had not already been infected, Dengvaxia left people vulnerable to severe, life-threatening dengue in the event they were subsequently infected by wild type dengue. As a result, Sanofi limited its use to protect people who have had a prior infection — but stopped short of issuing refunds.
Dengvaxia was the first approved vaccine for the mosquito-borne viral disease, and a blockbuster-to-be that cost $1.5 billion over 20 long years to develop. Initial sales were a disappointment even at its peak in 2016, and in the first 6 months of the year 2018 Sanofi reported €1 million in sales revenue, down 94.4% from the year before.
Though careful not to draw direct comparisons, Derek Wallace, vice president and global dengue program head from Takeda, told Endpoints News that its study was designed differently than other dengue vaccine trials so far.
We specifically designed our Phase 3 vaccine efficacy trial to assess the safety and efficacy against all four serotypes and for both dengue naïve and exposed individuals. Baseline blood samples were collected from all individuals participating in the trial to allow for evaluation of safety and efficacy based on serostatus. The structure of our vaccine candidate, the unique immunogenicity profile elicited by it and the rapid development of a four-serotype antibody response following immunization in most naïve and previously-exposed individuals are reasons that we believe TAK-003 has a different safety and efficacy profile relative to the currently-licensed dengue vaccine.
While prepping a more extensive review of this data on TAK-003, Rajeev Venkayya, president of Takeda’s global vaccine business unit, said in a statement that they will also be “advancing the clinical development, commercial manufacturing, and stakeholder consultations to support a potential future global launch of the vaccine.”
Parts 2 and 3 of the TIDES trial — the largest vaccine trial at 20,000 patients, according to Takeda — will assess secondary endpoints in six months and longterm safety with three years, respectively. Trial sites are located in dengue-endemic areas in Latin America (Brazil, Colombia, Panama, Dominican Republic and Nicaragua) and Asia (Philippines, Thailand and Sri Lanka).
“We expect key secondary endpoint data from the TIDES trial in later this year, including safety, efficacy against hospitalization, and analyses of efficacy by baseline serostatus, serotype, and severity,” Wallace wrote in an email.
Vaccines was one of four key areas (alongside cancer, GI and CNS diseases) that CEO Christophe Weber prescribed for Takeda in an effort to transform the Japanese drugmaker into a global player — before vaulting to the top 10 list via the acquisition of rare disease giant Shire. It remains one of three “global business units,” Wallace said, along with oncology and plasma-derived therapies.
“Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Neuroscience and Rare Diseases, while we also make targeted R&D investments in Plasma-Derived Therapies and Vaccines,” he wrote.
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