VIS513 for Dengue
Our second product candidate, VIS513, is a monoclonal antibody, or mAb, for the treatment of Dengue. Dengue is a viral illness spread by Aedes mosquitos that affects individuals of all ages. The clinical features can range from fever, headache and muscle aches to a severe, life-threatening infection characterized by uncontrolled bleeding and organ failure, commonly known as Dengue hemorrhagic fever. Dengue is caused by infection by any one of four genetically related but serologically distinct Dengue viruses. In preclinical studies, VIS513 was effective against all four serotypes of the Dengue virus, or DENV. We have also studied VIS513 in several mouse models of Dengue virus infection, where we examined the ability of VIS513 to reduce the circulating levels of the virus, prevent enhanced disease and reduce thrombocytopenia, or platelet loss. We have observed in vivo activity by VIS513 against all four Dengue serotypes, and VIS513 has demonstrated consistent results in reducing the virus level across all of these mouse models. Furthermore, we studied VIS513 in a non-human primate (NHP) model of Dengue virus infection, where one serotype of the Dengue virus was administered to NHPs and 24 hours after detection of virus in circulation, a single 50 mg/kg dose of VIS513 or control antibody was administered. For NHPs that received VIS513 the blood levels of virus were undetectable after administration as compared to the NHPs that received the control antibody and demonstrated circulating virus for approximately six days, with peak levels of approximately 200 to 300 plaque forming units, or infectious particles, per milliliter of blood.
In August 2015, we entered into an agreement with the Serum Institute of India Private Limited, or SIIPL, pursuant to which SIIPL will be responsible for developing, manufacturing, obtaining regulatory approval for and commercializing VIS513 in India, Pakistan, Bangladesh, Nepal, Bhutan, Maldives and Sri Lanka, territories which we refer to collectively as the Indian subcontinent. We received an upfront payment from SIIPL and could receive development and, if approved, commercial milestone payments and royalties of net sales of VIS513 in the Indian subcontinent. We retain the rights to commercialize VIS513 outside the Indian subcontinent. We expect that Phase 1 clinical trials of VIS513 will be initiated by SIIPL in the first half of 2018. Based on the clinical data generated in our collaboration with SIIPL, we will evaluate whether additional clinical trials are warranted and/or needed to support regulatory approval of VIS513 outside the Indian subcontinent. If the results of the ongoing and planned clinical trials of VIS513 are successful, we expect the submission of applications for marketing approval for VIS513 for the treatment of Dengue initially in the Indian subcontinent, and later in other countries where Dengue is prevalent, based on the need to conduct additional clinical trials and the regulatory approval requirements. We intend to fund our VIS513 development with third party financing and will continue to explore additional partnering opportunities to advance the development of VIS513 for the treatment of Dengue on a global basis, outside of the Indian subcontinent.
Dengue is a viral illness spread by Aedes mosquitos that affects individuals of all ages. The clinical features can range from fever, headache and muscle aches to a severe, life-threatening infection characterized by uncontrolled bleeding and organ failure, commonly known as Dengue hemorrhagic fever. It is a growing global health problem and is the most common mosquito-borne disease in the world. Dengue is caused by infection by any one of the four genetically related but serologically distinct Dengue viruses, referred to as DENV-1, DENV-2, DENV-3 and DENV-4. According to an article published in 2013 in a peer-reviewed scientific journal, over 390 million DENV infections occur worldwide each year and approximately 96 million people manifest clinical disease, resulting in approximately 22,000 deaths. The increasing incidence and geographical spread of the disease has been linked to human population growth and urbanization, expanded travel, increasing globalization of the world economy and lack of effective mosquito control.
Dengue is an acute disease with a wide spectrum of clinical manifestations, ranging from mild febrile illness to life-threatening hemorrhagic fever and shock syndrome. DENV infects cells of the human immune system, leading to symptoms that include high fever, severe headache, eye pain, joint pain, muscle and bone pain, rash and mild bleeding. In severe cases, plasma leaks out of the circulatory system and collects in body cavities, a condition that can be fatal. There is no specific treatment for Dengue and prevention depends solely on effective mosquito control measures. The global economic burden from Dengue is estimated at approximately $40 billion annually.
As of 01/15/17