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BlueWillow Biologics Awarded Patent for Intranasal Genital Herpes Vaccine

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Tag Archive: Dr. Ali Fattom

  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. NanoBio to Present Intranasal Pertussis Vaccine Data at the Mucosal Immunology Course & Symposium Meeting

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    Data Demonstrates Potential for the Company’s Intranasal Vaccine to Combat Reemergence of Whooping Cough Infections

    ANN ARBOR, Mich., (July 27, 2016) – NanoBio Corporation today announced that the company will present key data at the Mucosal Immunology Course & Symposium Meeting (MICS) in Toronto on July 29, 2016, demonstrating the advantages of its intranasal nanoemulsion (NE) adjuvant for use in the development of vaccines for pertussis, commonly known as whooping cough. NanoBio will also present data further supporting the advantages of intranasal NE vaccines for pandemic influenza.

    “The resurgence of pertussis infections in the United States and worldwide has become quite concerning, as infections in the U.S. have recently reached a 50-year peak. Given vaccination rates have remained high, the concerning increase in infections points to potential limitations with the existing intramuscular pertussis vaccines,” said Dr. Ali Fattom, Senior Vice President of Vaccine Research and Development, NanoBio. “We recently tested an intranasal NE pertussis vaccine in animals and the data indicates important benefit in comparison to current intramuscular vaccines. NanoBio’s vaccine elicited robust systemic immunity and triggered a mucosal immune response believed to be critical in reducing the time pertussis is carried in the respiratory tract of individuals exposed to the bacteria. A reduction of carriage would lead directly to lower rates of transmission.”

    At the MICS conference, NanoBio will present data from a study in rats comparing its intranasal NE pertussis vaccine to the standard intramuscular Alum vaccine. The research indicated that both vaccines elicited similarly high levels of serum bactericidal activity against pertussis. However, the intranasal NE vaccine uniquely elicited high levels of cytokines that are associated with mucosal immunity. Given the promising results, efficacy of the intranasal NE pertussis vaccine is currently being studied in a baboon challenge model with support from the National Institutes of Health (NIH).

    NanoBio will also present data at the MICS meeting highlighting results from a mice study testing an intranasal NE vaccine for pandemic influenza. The research being presented was conducted under a five-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

    “Our recent studies in mice have demonstrated that intranasal NE vaccination elicits robust neutralizing antibody and cellular immune responses against H5 pandemic influenza,” said Dr. Fattom. “In addition, the intranasal NE-rH5 vaccine uniquely elicited a mucosal immune response, which we expect will play an important role in protecting against H5 infection. With these results in hand, we are currently initiating a ferret challenge study to test the efficacy of the NE vaccine in the primary animal model.”

    Following are details of NanoBio’s upcoming oral presentations at the MICS Meeting at the Westin Harbour Castle Hotel, Toronto, Canada:

    • Nanoemulsion: A Novel Mucosal Adjuvant for Pandemic H5N1 Influenza
      Friday, July 29, 2016 / 3:30 p.m. ET
    • Intranasal Nanoemulsion-Based Vaccines for the Elicitation of Mucosal and Systemic Immunity to Combat Reemergence of B. Pertussis Infections
      Friday, July 29, 2016 / 3:45 p.m. ET

    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 pertussis, pandemic influenza, anthrax, prophylactic and therapeutic HSV2, chlamydia and HIV. In addition, the company has licensed its NE adjuvant to Merck for use with intranasal vaccines for RSV and seasonal influenza.