Serum Institute of India (SII), the world's largest vaccine manufacturer, has entered into a strategic partnership with the Drugs for Neglected Diseases initiative (DNDi) to co-develop an affordable monoclonal antibody treatment for dengue. The collaboration aims to make this potentially life-saving therapy accessible across low- and middle-income countries where dengue poses the greatest threat.
Advancing a Promising Drug Candidate
The partnership will focus on advancing a monoclonal antibody 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, addressing a critical medical need as the disease continues to spread rapidly due to climate change and urbanization.
"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 Dr. Prasad Kulkarni, Executive Director at SII. "Our focus is on making treatment affordable and accessible."
SII has already completed pre-clinical studies and Phase I and II clinical trials that demonstrate the candidate is safe and effective. The company is currently leading a pivotal Phase III trial in India for licensure and will provide manufacturing and regulatory support for DNDi-led trials in Brazil and Southeast Asia.
Addressing a Growing Global Health Crisis
Dengue represents a significant and expanding global health threat, affecting an estimated 3.9 billion people worldwide. Cases have more than doubled since 2021, with the disease spreading to previously non-endemic areas. India alone reports tens of thousands of cases annually, with outbreaks occurring every two to three years and expanding into new regions.
"Dengue is a rapidly spreading, climate-sensitive disease for which medicines are urgently needed," said Dr. 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."
Despite the prevalence and severity of dengue, no specific treatment is currently available. Medicines that could prevent mild cases from becoming severe would play an important role in reducing mortality and preventing hospitals from being overwhelmed during outbreaks.
Strategic Division of Responsibilities
Under the collaboration agreement, DNDi will act as the lead partner for Phase III clinical trials, including trial leadership, sponsorship, and implementation in Brazil and potentially other endemic countries in Southeast Asia. The organization will coordinate with the Dengue Alliance, a global partnership launched in 2022 to accelerate dengue treatment access.
SII will be responsible for manufacturing, development, and provision of clinical supplies of the monoclonal antibody candidate. The company will also define and execute the regulatory strategy in India and lead commercialization of the product in the country.
"India reports tens of thousands of dengue cases every year, with outbreaks occurring every two to three years in different states," said Dr. Kavita Singh, Asia Continental Lead & Director South Asia at DNDi. "What is deeply concerning is that dengue is no longer confined to historically endemic regions but is rapidly expanding into newer states."
Building on Manufacturing Excellence
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 including Pneumosiil, Cervavac, and R21/Matrix-M.
With subsidiaries in the UK and US, SII continues to expand its global presence while maintaining its core mission of providing affordable, lifesaving immunobiologics for the world's most vulnerable populations. The company's multifunctional production facilities in Pune have an annual capacity of 4 billion doses and have contributed to saving over 30 million lives over the years.
