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RSV Vaccine

Respiratory syncytial virus (RSV) is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. It is the number one cause of childhood hospitalization both in the United States and around the world. Nearly all children are infected with the virus at least once by the age of 2-3 years. The disease is particularly dangerous for premature babies, children with other health conditions and the elderly. Many children develop pulmonary disease and/or asthma from RSV that persists throughout adult life making them susceptible to re-infection. Currently, there are no approved vaccines for RSV.

In November 2010, NanoBio received a $6M grant from the Bill & Melinda Gates Foundation to support the development of a safe and effective nanoemulsion (NE) adjuvanted vaccine for RSV. This grant supported NanoBio’s initial preclinical development program, including studies in mice, cotton rats and non-human primates. These studies demonstrated that both intranasal and intramuscular NE-RSV vaccines induce robust protective immunity, without eliciting the enhanced respiratory disease that has caused other RSV vaccine candidates to fail.

Data from NanoBio’s cotton rat and non-human primate studies are pending publication. However, the initial studies in mice conducted by the University of Michigan and NanoBio have been published1. As shown in the charts below, these studies demonstrate robust Th1, Th17 and antibody responses from the intranasal NE-RSV vaccine, as well as protection following challenge.

Immunogenicity in mice:

Mouse lung cytokine data:

Protection upon challenge, as measured by viral clearance in the lungs of mice:

Lung histology in mice following RSV challenge:

In December 2011, NanoBio Corporation entered into a preclinical collaboration with Merck, focused on the development of an intranasal vaccine for RSV. This research was directed towards evaluating the combination of Merck’s proprietary RSV antigen with NanoBio’s NE adjuvant technology. As part of the agreement, Merck has the option to negotiate a non-exclusive license to the NE adjuvant for development of a commercial RSV vaccine.

In July 2013, NanoBio entered into an agreement with the Division of Microbiology and Infectious Diseases (DMID), a division of NIAID. Under the agreement, DMID has agreed to fund certain activities and studies in support of developing an intramuscular NE vaccine for RSV. Such activities and studies are currently ongoing.

In March 2014, NanoBio entered into a licensing agreement with Merck for the use of its NE technology. Under the agreement, Merck received exclusive rights to the NE adjuvant for use in an intranasal RSV vaccine and non-exclusive rights for use in an intranasal seasonal influenza vaccine. NanoBio received an upfront payment and is eligible to receive future development and commercial milestone payments, as well as royalties on future sales.

1 Lindell 2011 PLoS ONE 6:e21823; " A Novel Inactivated Intranasal Respiratory Syncytial Virus Vaccine Promotes Viral Clearance without Th2 Associated Vaccine-Enhanced Disease"


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