The collaboration aims to accelerate the development of an effective and affordable monoclonal antibody treatment for dengue caused by any of the four serotypes of dengue virus, in close cooperation with endemic countries, including Thailand, Malaysia, and Brazil. Despite the growing burden of dengue, there is still no specific treatment available.
GENEVA: Serum Institute of India (SII) Pvt. Ltd., part of Cyrus Poonawalla Group, the world’s largest vaccine manufacturer, and the not-for-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) signed a memorandum of understanding (MOU) to accelerate the clinical development of a monoclonal antibody treatment for dengue that will be affordable and accessible in low- and middle-income countries (LMICs).
Through this collaboration, both SII and DNDi will develop a work plan to implement R&D, additional Phase III clinical trials, and access activities, along with a joint strategy to raise necessary funds and resources. 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.
‘Dengue is a rapidly spreading, climate-sensitive disease for which medicines are urgently needed,’ said Dr André Siqueira, Head of Dengue at DNDi said “We are proud to partner with Serum Institute of India to advance the development of an affordable monoclonal antibody treatment. This partnership brings together complementary strengths to ensure that people most at risk have timely and equitable access to life-saving treatment.’
“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, DNDi. “What is deeply concerning is that dengue is no longer confined to historically endemic regions but is rapidly expanding into newer states. Addressing this growing threat demands a multi-pronged approach, including strengthened vector control, surveillance, community awareness, and, critically, the development of effective treatments and diagnostics. DNDi’s partnership with Serum Institute of India is a significant step forward in this direction.”
“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, Executive Director, Serum Institute of India. “We look forward to the positive impact this effort will have in reducing the burden of dengue and saving lives in vulnerable communities.”
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.
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.
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. The company will define and execute the regulatory strategy in India and will lead the commercialization of the product in the country.
Launched in 2022, the Dengue Alliance is a global partnership led by institutions from dengue-endemic countries and DNDi that aims to develop affordable and accessible treatments for dengue. The organization will also contribute to the regulatory and commercialization strategy in LMICs and will lead policy and advocacy activities to advance equitable access.
Dengue poses a significant threat, with 3.9 billion people at risk and cases more than doubling each year since 2021. It is also spreading to non-endemic areas due to climate change and urbanization. Despite its prevalence and severity, there is still no specific treatment available for dengue. Medicines that could prevent mild cases from becoming severe would therefore play an important role in reducing mortality and preventing hospitals from being overwhelmed during outbreaks.