Press Releases 09.09.2015
Visterra, Inc. and Serum Institute of India Ltd. Announce Collaboration to Advance VIS513, a Monoclonal Antibody in Development for the Treatment of Dengue, in the Indian Subcontinent
CAMBRIDGE, Mass. & PUNE, India--(BUSINESS WIRE)--Visterra, Inc., a clinical-stage biotechnology company that uses its proprietary technology platform to identify unique disease targets and design novel therapeutics for infectious diseases, and Serum Institute of India Ltd. (Serum Institute), a global leader in vaccine development and manufacturing, today announced that the companies have entered into a license agreement for the development, manufacture and commercialization of VIS513 in the Indian subcontinent countries.
VIS513 is Visterra’s humanized monoclonal antibody that was designed to bind and potently neutralize all four serotypes of dengue virus and was engineered using Visterra’s innovative and proprietary HierotopeTM 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.
“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,” said Adar Poonawalla, Chief Executive Officer of Serum Institute. “This collaboration further strengthens our pipeline of innovative biologics and we look forward to working closely with Visterra and its talented team.”
“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,” said Brian J. G. Pereira, M.D., President and Chief Executive Officer of Visterra. “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.”
Developed using Visterra’s innovative and proprietary technology platform, VIS513 is an engineered humanized antibody that targets a conserved region on dengue virus domain III of the E protein that is present across all dengue virus serotypes. In preclinical studies, VIS513 has demonstrated that it potently neutralized all four serotypes of dengue virus and protected animals challenged with a lethal dose of dengue virus. Visterra is currently developing VIS513 as a single administration for the treatment of dengue virus infection in collaboration with strategic partners.
Dengue is a mosquito-borne viral infection found in tropical and sub-tropical regions around the world. There are four distinct, but related, serotypes of the virus, each of which can cause dengue. The virus infects cells of the human immune system and other cell types, leading to symptoms that include high fever, severe headache, severe pain behind the eyes, joint pain, muscle and bone pain, rash, and mild bleeding. In severe cases, plasma leaks out of the circulatory system and can be fatal. There is currently no specific treatment for dengue and prevention depends solely on effective vector control measures. The global incidence of dengue has grown dramatically in recent decades. About half of the world's population is at risk for dengue and a recent study estimates that approximately 390 million people are infected each year. The World Health Organization estimates that 500,000 people with severe dengue require hospitalization each year, a large proportion of whom are children, and more than 20,000 of those affected die each year.
Visterra is a biotechnology company that uses its proprietary Hierotope™ Platform to identify unique disease targets and design and engineer effective therapeutics. The company’s technology is powered by computational tools and techniques, the core of which is Atomic Interaction Network (AIN) analysis, which uniquely identify an area, or epitope, on the target site that is fundamental to its structure and function. This ideal epitope, or hierotope, becomes the target against which the company designs a novel therapeutic to effectively and durably combat the disease. The company is currently focused on therapeutics for infectious diseases, and its lead product candidate, VIS410, is a broad spectrum human monoclonal antibody for the prevention and treatment of both seasonal and pandemic influenza. The company’s second product candidate, VIS513, is a human monoclonal antibody for the treatment of dengue that has been shown to broadly neutralize all four dengue virus serotypes. Visterra was founded based on scientific work developed in the laboratory of Dr. Ram Sasisekharan and licensed from MIT. For more information, please visit www.visterrainc.com.
About Serum Institute of India (SIIL)
Serum Institute of India is based in Pune, India and is the world’s largest vaccine manufacturer in number of doses manufactured and supplied. It supplies its vaccine to more than 140 countries. For more information, visit www.seruminstitute.com.