Serum Institute signs MoU with DNDi to develop dengue treatment candidate

Serum Institute and DNDi sign MoU to develop and scale a dengue monoclonal antibody vaccine with Phase 3 trials in India, Brazil and other endemic countries

Serum Institute of India (SII) on Friday signed a memorandum of understanding (MoU) with medical research organisation Drugs for Neglected Diseases initiative (DNDi) to accelerate clinical development of a monoclonal antibody treatment for dengue that will be affordable and accessible in low- and middle-income countries (LMICs).

 

As part of the collaboration, both SII and DNDi will develop a work plan to implement research and development, Phase 3 clinical trials, and access activities, along with a joint strategy to raise the necessary funds and resources.

 

SII stated that it has already conducted pre-clinical studies and Phase 1 and 2 clinical trials that show the candidate (formerly VIS513) is safe and effective. It is currently leading the Phase 3 clinical trial in India for licensure.

 

 

SII and DNDi will now work together to conduct additional Phase 3 trials in other dengue-endemic countries as well, such as Brazil.

 

The Pune-based company added that a joint project team will be formed to advance clinical trials, with the goal of registering and deploying the dengue monoclonal antibody in India and other countries, provided the studies confirm its safety and efficacy. 

 

Commenting on the partnership, Prasad Kulkarni, executive director at SII, said that the 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.

 

DNDi will act as the lead partner for these clinical trials, including trial leadership, sponsorship, and implementation in Brazil and potentially other endemic countries in Southeast Asia.

 

“Both participants will also lead strategic engagement efforts with the Dengue Alliance, relevant industry stakeholders, and policymakers in LMICs,” they added.

 

Kavita Singh, Asia Continental Lead and Director – South Asia at DNDi, said that India reports tens of thousands of dengue cases every year, with outbreaks occurring every two to three years in different states.

 

“Addressing the growing threat demands a multi-pronged approach, including strengthened vector control, surveillance, community awareness and the development of effective treatments and diagnostics,” she added.

 

DNDi noted that the partnership brings together complementary strengths to ensure that people most at risk have timely and equitable access to life-saving treatment.