Serum Institute of India (SII), the world’s largest vaccine manufacturer, on Friday said it has signed a memorandum of understanding (MoU) with the Drugs for Neglected Diseases initiative (DNDi) to co-develop a monoclonal antibody treatment for dengue, aiming to make it affordable and accessible across low- and middle-income countries.
The collaboration will focus on advancing the potential drug candidate—formerly known as VIS513—through Phase III clinical trials in India, Brazil and other dengue-endemic countries. The treatment is designed to be effective against all four serotypes of the dengue virus, a critical need as the disease continues to spread rapidly due to climate change and urbanisation.
“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,” said Prasad Kulkarni, executive director at SII. “Our focus is on making treatment affordable and accessible.”
SII has already completed pre-clinical and Phase I/II trials in India, demonstrating safety and efficacy. The company is currently leading a pivotal Phase III trial in India and will provide manufacturing and regulatory support for DNDi-led trials in Brazil and Southeast Asia.
DNDi, a not-for-profit medical research organisation that develops affordable treatments for neglected people, will act as the lead sponsor for international trials and will coordinate with the Dengue Alliance, a global partnership launched in 2022 to accelerate dengue treatment access.
“Dengue is a rapidly spreading, climate-sensitive disease for which medicines are urgently needed,” said André Siqueira, head of dengue at DNDi. “This partnership brings together complementary strengths to ensure that people most at risk have timely and equitable access to lifesaving treatment.”
Dengue affects an estimated 3.9 billion people globally, with cases more than doubling since 2021. India alone reports tens of thousands of cases annually, with outbreaks occurring every two to three years and expanding into new regions.
“Dengue is no longer confined to historically endemic regions,” said Kavita Singh, director, South Asia, at DNDi. “This partnership is a significant step forward in addressing the growing threat.”
The dengue initiative adds to SII’s growing portfolio of affordable biologics and vaccines. The company, part of the Cyrus Poonawalla Group, has delivered over 2 billion COVID-19 vaccine doses globally and manufactures key vaccines like Pneumosiil, Cervavac and R21/Matrix-M.
With subsidiaries in the UK and US, SII is expanding its global presence while maintaining its core mission: affordable, lifesaving immuno-biologics for the world’s most vulnerable populations.
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