NanoBio Corporation, a privately-held biopharmaceutical company, was recently issued U.S. Patent No. 9,492,525, titled Human respiratory syncytial virus vaccine. The ‘525 patent broadly covers the composition of NanoBio’s intramuscular and intranasal RSV vaccine candidates, which combine the company’s innovative nanoemulsion (NE) adjuvant with strain L19 of RSV. Additional patent applications covering the combination of the NE adjuvant with other strains of RSV and with RSV F protein are currently being pursued.
Respiratory syncytial virus, commonly referred to simply as RSV, is a highly contagious viral disease and is one of the most common causes of bronchiolitis and pneumonia. Up to 2.5 million infections occur in the U.S. each year. It is also the leading cause of childhood hospitalization globally. Nearly all children are infected with the virus at least once by the age of two to three years, and many develop pulmonary disease and/or asthma that persists throughout adult life, making them susceptible to re-infection. RSV particularly dangerous for premature babies, children with preexisting health conditions and the elderly, and is responsible for 16,000 deaths each year in adults over 65.
RSC not only presents a problem for children and senior citizens, but is also quite problematic for transplant patients and those suffering from chronic obstructive pulmonary disease (COPD). The ‘525 patent explains “development of a safe and immunogenic vaccine to address the infant and elderly population presents a unique opportunity.” Currently, there are no approved vaccines for RSV.
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The Summary of the Invention for the ‘525 patent explains:
The present invention provides a novel approach for inducing a protective immune response against HRSV infection by the isolation of a HRSV viral strain which is a hyperproducer of the pivotal immunogenic viral structural proteins, F and G proteins. Having a vaccine candidate that produces higher levels of F protein in its native state within the confines of the normal viral replication cycle is seminal for its usage as an immunogen, as ample amount and proper conformational epitopes will be presented for the generation of neutralizing antibodies and further induction of the protective cellular arm of the immune response.
The inventors have succeeded in cultivating HRSV-L19 and demonstrating that the viral strain is a hyperproducer of F and G viral proteins when compared to the commonly used RSV viral strain A2. The more than 2-fold greater levels of the immunogenic F and G protein found within HRSV-L19 is a novel observation which allows for the use of either attenuated or inactivated virus as a vaccine.
The invention encompasses a vaccine composition comprising a purified respiratory syncytial virus (RSV) strain L19 (RSV-L19). In another embodiment, the RSV-L19 virus is a hyperproducer of Fusion (F) and Glycoprotein (G) structural proteins associated with viral particles. In yet another embodiment, the RSV-L19 virus is attenuated human respiratory syncytial virus (HRSV) strain L19. In one embodiment, the vaccine composition comprises a human respiratory syncytial virus deposited with the American Type Culture Collection (ATCC) as HRSV-L19.
“This critical patent strengthens NanoBio’s position as we prepare to advance our NE RSV vaccine into clinical studies,” said Dr. Ali Fattom, Senior Vice President of Vaccine Research and Development, NanoBio. “Based on our research to date, the use of whole inactivated RSV L19 in combination with our NE adjuvant elicits robust protection across multiple strains of RSV in both cotton rats and non-human primates, without evidence of safety concerns or the enhancement of disease observed with prior formalin-inactivated vaccines.”
NanoBio focuses on developing and commercializing vaccines and anti-infective treatments derived from its patented NanoStat® technology platform. The company’s NanoStat® vaccine technology employs a novel oil-in-water nanoemulsion (NE) that can incorporate, deliver and adjuvant multiple antigen types. The NE adjuvant is effective when administered via intranasal or intramuscular vaccination. When applied intranasally, NE vaccines elicit both mucosal and systemic immunity. In addition to working on an RSV vaccine, NanoBio is currently developing NE vaccines for several respiratory and sexually transmitted diseases, including pertussis, pandemic influenza, anthrax, and prophylactic and therapeutic HSV2.