US-based biotech company Visterra and Serum Institute of India Ltd (Serum Institute), a global leader in vaccine development and manufacturing, have entered into a license agreement for the development, manufacture and commercialisation of VIS513 in the Indian subcontinent countries.

VIS513 is Visterra’s humanised monoclonal antibody that was designed to bind and potently neutralise all four serotypes of dengue virus and was engineered using Visterra’s innovative and proprietary Hierotope technology. Preclinical studies of VIS513 have demonstrated a rapid reduction in viral titers after a single systemic administration, which supports its continued development as a single administration for the treatment of dengue virus infection.

Under the terms of the agreement, Serum Institute receives an exclusive license to VIS513 for the Indian subcontinent, including India, Pakistan, Bangladesh, Nepal, Bhutan, Maldives, and Sri Lanka. Serum Institute will pay Visterra a US$ 5 million upfront payment, plus up to US$ 34 million based on the achievement of certain development and commercial milestones. Additionally, once VIS513 is commercialized, Visterra will be eligible to receive tiered, double-digit royalties based on net sales in the licensed territories.

Serum Institute will fund and be responsible for the clinical development of VIS513 in the licensed territories, including the filing of regulatory applications. The companies will establish a joint steering committee primarily to coordinate VIS513 development activities for the Indian subcontinent with the global development strategy. Following regulatory approval, Serum Institute will be responsible for commercializing VIS513 in the licensed territories.

Adar Poonawalla, CEO of Serum Institute says, “We believe that VIS513 is a promising novel monoclonal antibody being developed for the treatment of dengue, which is a major healthcare concern to India and surrounding countries. We are excited to take on this important role to advance the development of a potential treatment that could address a significant unmet medical need. This collaboration further strengthens our pipeline of innovative biologics and we look forward to working closely with Visterra and its talented team.”

Brian J G Pereira, MD, president and CEO of Visterra says, “An important goal for us is to provide a therapeutic option as quickly as possible for patients with dengue, as there is currently no specific treatment and disease prevention is solely dependent on limiting or eradicating mosquitoes that transmit the virus. We believe that we can best fulfill this goal in the Indian subcontinent by pursuing the development of VIS513 with Serum Institute. Serum Institute has a proven track record in developing novel biological products and expansive commercialization capabilities in the Indian subcontinent, which makes them the ideal partner.”