Zydus Group and Infectious Disease Research Institute (IDRI), a Seattle-based non-profit research and product development organization, have decided to collaborate on the production and clinical development of IDRI's visceral leishmaniasis (VL) vaccine candidate, designed to prevent the deadly parasitic disease.  

Zydus & IDRI will collaborate to conduct clinical development activities in India with the goal of developing, registering and marketing this vaccine candidate for the prevention of VL, which will achieve the objective of global access - that is, ensuring the vaccine is affordable to and accessible by all people in need. Conducting trials in India, where there are real-life situations of disease exposure, is critical to determining the effectiveness of IDRI's VL vaccine candidate and ensuring it is approved and available within endemic countries.

Pankaj R Patel, chairman and managing director, Zydus group, said, “Zydus has always been committed to working with partners and collaborating to bridge unmet healthcare needs. By partnering with IDRI on this very important mission, we will be taking an all important step to eradicate visceral leishmaniasis which is a huge healthcare burden.”

VL, known as kala-azar in India, is transmitted by the bite of an infected sand fly. There are over 5 lakh new VL cases and 50,000 associated deaths each year. VL is the most severe form of leishmaniasis, affecting vital organs, and, if left untreated, the disease can be fatal. A vaccine is considered essential to control and eliminate the disease. Currently, leishmaniasis occurs in four continents and is considered to be endemic in 88 countries; 72 of those are developing countries, with the disease being most common in India, Nepal, Bangladesh, Sudan and Brazil. While there are drugs to treat the disease, they are expensive and often toxic. To date, a safe and efficacious vaccine to prevent this disease does not exist.

IDRI's VL vaccine candidate, LEISH-F3+GLA-SE, is the product of more that 20 years of research and development supported by the US National Institutes of Health (NIH) and the Bill & Melinda Gates Foundation. The defined, purified, recombinant vaccine comprises two fused leishmania parasitie proteins and an adjuvant to stimulate a protective immune response against the parasite. After completion of a Phase 1 clinical trial of 36 US adult volunteers to test safety and immunogenicity, the vaccine was shown to be safe and to induce potent immune responses in healthy volunteers.

Dr Steven G Reed, IDRI founder and president, said, “Expertise and breadth of development and commercialization experience of Zydus will be instrumental in getting IDRI's VL vaccine to the people who need it most. We are appreciative of Zydus' commitment to this programme. This is an excellent example of cooperating to help combat a devastating disease without consideration for a profit motive. IDRI could not ask for a better partner in this endeavor.”