An employee in personal protective equipment (PPE) prepares before operating a filling machine inside a lab at Serum Institute of India, Pune. REUTERS/Francis Mascarenhas
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FRANCIS MASCARENHAS
Vaccine-maker Serum Institute of India and not-for-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) have formalised a memorandum of understanding (MOU) for the clinical development of a monoclonal antibody treatment for dengue, that will be affordable and accessible in low- and middle-income countries (LMICs).
Phase III clinical trials
“Both organisations will develop a work plan to implement Phase III clinical trials, and access activities, along with a joint strategy to raise necessary funds and resources,” a joint note said. Additionally, a joint project team will be formed to advance clinical trials, to register and deploy the dengue monoclonal antibody in India and other dengue-endemic countries, provided the studies confirm its safety and efficacy, it added.
Dengue poses a significant threat, with 3.9 billion people at risk and cases more than doubling each year since 2021. It is a rapidly spreading, climate-sensitive disease for which medicines are urgently needed, said André Siqueira, Head of Dengue at DNDi.
India reports tens of thousands of dengue cases every year, with outbreaks occurring every two to three years in different states, said Kavita Singh, Asia Continental Lead and Director South Asia, DNDi.
“What is deeply concerning is that dengue is no longer confined to historically endemic regions but is rapidly expanding into newer states,” she added.
SII has already conducted pre-clinical studies and Phase I and II clinical trials that show the candidate (formerly VIS513) is safe and effective. Currently, SII is leading the pivotal Phase III clinical trial in India for licensure, the note said. SII and DNDi will now work together to conduct additional Phase III trials in other dengue-endemic countries, including Brazil. DNDi will act as the lead partner for these Phase III clinical trials, including trial leadership, sponsorship, and implementation in Brazil and potentially other endemic countries in Southeast Asia. DNDi and SII will lead strategic engagement efforts with the Dengue Alliance, relevant industry stakeholders, and policymakers in low- and middle-income countries, it added.
For the DNDi-led trial in Brazil and other countries, SII will provide development background and technical support. Furthermore, SII will be responsible for the manufacture, development, and provision of clinical supplies of the monoclonal antibody candidate, it said. The company will also define and execute the regulatory strategy in India and will lead the commercialization of the product in the country, it added.
“This collaboration with DNDi will be instrumental in advancing clinical development of a dengue monoclonal antibody in Brazil and potentially other endemic countries in Southeast Asia, with a focus on making treatment affordable and accessible,” said Dr Prasad Kulkarni, SII Executive Director.
Launched in 2022, the Dengue Alliance is a global partnership led by institutions from dengue-endemic countries and DNDi. The organization will also contribute to the regulatory and commercialization strategy in LMICs and will lead policy and advocacy activities to advance equitable access, the note said.
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Published on June 13, 2025