Ann Arbor-based NanoBio Corp. last week announced a licensing agreement with the National Institutes of Health that represents a significant step forward in developing the first vaccine to protect against respiratory syncytial virus (RSV) infections.

The agreement provides NanoBio with rights to a novel RSV antigen, developed by the NIH using proprietary viral-selection and reverse-genetics technology.

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 to 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.

“Our plan is to formulate the NIH antigen in combination with our NanoStat adjuvant technology for use as an intranasal vaccine,” said Ali I. Fattom, NanoBio senior vice president of vaccine research and development. “Based on our earlier mouse studies, we expect that a NanoStat adjuvanted RSV vaccine will induce robust protective immunity, without eliciting the enhanced respiratory disease that has caused other RSV vaccine candidates to fail.”

In collaboration with the University of Michigan, NanoBio previously showed that the NanoStat adjuvant combined with killed RSV was able to elicit strong immune responses and protect challenged mice without causing increased mucus production or other signs of enhanced respiratory disease.

“RSV remains a major cause of serious lung infections in children and the elderly,” said James R. Baker Jr., M.D., NanoBio founder and CEO. “Despite the large unmet need, a safe and effective vaccine is not available today. The novel properties of our NanoStat technology — including its ability to elicit both mucosal and Th1 cellular immunity — are critical elements for overcoming the challenges seen thus far in RSV vaccine development. In November of last year, NanoBio announced a substantial grant for RSV vaccine development from the Bill & Melinda Gates Foundation. Today’s announcement with the NIH coupled with the ongoing support and commitment of the Gates Foundation, means the pieces are now fully in place for NanoBio to develop and commercialize an intranasal RSV vaccine.”

NanoBio vaccines are based on a nanoemulsion of tiny particles that have elicited robust immune responses in animals vaccinated against seasonal and pandemic influenza, hepatitis B, RSV, HIV, pneumococcus, anthrax, smallpox and other diseases. The company’s NanoStat adjuvant platform technology has demonstrated numerous potential advantages over traditional vaccines, including the ability to generate robust mucosal, systemic and cellular immunity; antigen-sparing qualities; cross-protection against strains not contained in the vaccine; ability to adjuvant multiple antigen types without inducing inflammation; thermally stabilizing the vaccine; and removing the need for needles.

NanoBio’s lead vaccine candidate, NB-1008, is a seasonal influenza vaccine administered intranasally. In a recently completed Phase 1 clinical study, NB-1008 was well-tolerated and elicited both mucosal and systemic immune responses following a single intranasal vaccination in a study of 199 healthy adults.

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