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BlueWillow Biologics Awarded Patent for Intranasal Genital Herpes Vaccine

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  1. BlueWillow Biologics Awarded Patent for Intranasal Genital Herpes Vaccine

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    Vaccine Expected to Deliver Therapeutic and Preventive Protection

    ANN ARBOR, Mich., (July 23, 2019) – BlueWillow Biologics® today announced the issuance of U.S. patent number 10,206,996 to BlueWillow for the development of an intranasal NanoVax® herpes simplex virus (HSV) vaccine. The patent protects the use of BlueWillow’s unique NanoVax adjuvant platform in the development of a vaccine that provides protection against HSV-1 and HSV-2, the two viruses that can cause genital herpes.

    More than one in six people aged 14–49 are infected with genital herpes and an estimated 776,000 new infections occur annually, according to the Centers for Disease Control and Prevention (CDC). Genital herpes increases a person’s risk of contracting HIV and can lead to miscarriage and premature birth in infected pregnant women. Herpes can also be passed from the mother to child during birth, potentially resulting in neonatal herpes, a fatal infection. Most genital herpes vaccine candidates have failed or been abandoned in recent years, leaving no reliable therapeutic or preventive vaccine for the disease.

    BlueWillow’s intranasal NanoVax platform elicits both mucosal and systemic immunity through its novel oil-in-water nanoemulsion (NE) adjuvant, offering a unique advantage to combat sexually transmitted infections (STIs) including genital herpes. The mucosal immunity elicited by intranasal NE vaccines provides critical protection against infections at the port of entry by which a pathogen enters the body.

    The intranasal NanoVax HSV vaccine has demonstrated safety and efficacy in both prophylactic and therapeutic animal models for genital herpes. In a prophylactic guinea pig study, the intranasal vaccine prevented genital herpes infection in 92 percent of animals vaccinated. Therapeutic study animals previously infected with genital herpes who received the BlueWillow vaccine reduced recurrent lesions and viral shedding by more than 50 percent compared to animals who received no treatment.

    “Genital herpes is easily and often unknowingly transmitted between partners. The lifelong infection frequently causes psychological distress and negatively impacts quality of life,” said Dr. Ali Fattom, Senior Vice President of Vaccine Research and Development, BlueWillow. “After years of research in animals, we are moving closer to studies in humans where we expect results to validate the potential of this much-needed vaccine.”

    About BlueWillow

    BlueWillow Biologics® is a privately-held biopharmaceutical company headquartered in Ann Arbor, Michigan, focused on developing and commercializing vaccines using its patented NanoVax® technology platform. The technology employs a novel oil-in-water nanoemulsion adjuvant that is effective when administered via intranasal or intramuscular vaccination and can elicit both mucosal and systemic immunity when applied intranasally.

    BlueWillow is currently developing intranasal vaccines for several respiratory and sexually transmitted infections, including RSV, influenza, anthrax, prophylactic and therapeutic HSV-2 and chlamydia, as well as vaccines for selected allergic conditions. Visit BlueWillow.com for details on the company’s vaccine pipeline and studies completed to date.

  2. BlueWillow Biologics Announces Issuance of Therapeutic Cancer Vaccine Patent

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    NanoVax Technology Could Generate Immune Response to Treat Mucosal and Other Cancers

    ANN ARBOR, Mich., (May 30, 2018) – BlueWillow Biologics® today announced the issuance of U.S. patent number 9,974,844, entitled “Cancer Vaccine Compositions And Methods Of Using The Same,” to the University of Michigan under exclusive license to BlueWillow. The patent allows for the use of BlueWillow’s NanoVax® platform with tumor antigens, including neoantigens, to create novel therapeutic vaccines that have the potential to generate balanced and durable immune responses to treat existing cancers.

    “The awarding of this patent demonstrates that our NanoVax technology has potential in areas beyond infectious disease. We have a clear opportunity to leverage our innovative platform in the immuno-oncology space and are now actively exploring collaborations with experts in this field,” said Dave Peralta, Chief Executive Officer of BlueWillow. “Cancer has a devasting impact on so many lives. On behalf of the employees at BlueWillow, we are thrilled to have an opportunity to play a role in fighting this terrible disease.”

    BlueWillow’s innovative vaccine platform is built on the company’s patented NanoVax technology that employs a unique oil-in-water nanoemulsion adjuvant. When administered intranasally, BlueWillow vaccines elicit both systemic and mucosal immune responses, which could play an important role in treating mucosal cancers including tumors of the mouth, nose, throat and lung. Animal studies conducted at the University of Michigan have shown that intranasal vaccination with NanoVax technology reduces metastasis of colon cancer to the lung. Future studies are expected to incorporate both intranasal and intramuscular administration of vaccines built on the NanoVax platform.

    About BlueWillow

    BlueWillow Biologics® is a privately-held biopharmaceutical company headquartered in Ann Arbor, Michigan, focused on developing and commercializing vaccines using its patented NanoVax® technology platform. The technology employs a novel oil-in-water nanoemulsion adjuvant that is effective when administered via intranasal or intramuscular vaccination, and can elicit both mucosal and systemic immunity when applied intranasally. BlueWillow is currently developing intranasal vaccines for several respiratory and sexually transmitted infections, including RSV, pertussis, influenza, anthrax, prophylactic and therapeutic HSV-2 and chlamydia. Visit BlueWillow.com for details on the company’s vaccine pipeline and studies completed to date.

  3. NanoBio Awarded U.S. Patent for RSV Vaccine

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    Broad Intellectual Property Protection Secured Through 2034

    ANN ARBOR, Mich., (December 19, 2016) – NanoBio Corporation today announced the issuance of U.S. Patent No. 9,492,525 Human Respiratory Syncytial Virus (RSV) Vaccine. The 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.

    “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.”

    Formulation of RSV L19 virus with NanoBio’s NE adjuvant splits and fully inactivates the virus as a result of the adjuvant’s inherent antimicrobial properties, yet the immunogenicity of L19’s native viral proteins is preserved. The resulting NE RSV vaccine incorporates all of the viral epitopes-including F, G and other proteins-enabling a potentially much broader immune response than what is elicited by subunit vaccine candidates.

    About RSV

    Respiratory syncytial virus, commonly referred to 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 the number one 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. The disease is particularly dangerous for premature babies, children with preexisting health conditions and the elderly. RSV is responsible for 16,000 deaths each year in adults older than 65. Currently, there are no approved vaccines for RSV.

    About NanoBio

    Headquartered in Ann Arbor, Michigan, NanoBio® Corporation is a privately-held biopharmaceutical company focused 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.

    NanoBio is currently developing NE vaccines for several respiratory and sexually transmitted diseases, including RSV, pertussis, pandemic influenza, anthrax, and prophylactic and therapeutic HSV2.