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BlueWillow Awarded NIH Contract to Advance Development of its Therapeutic Peanut Allergy Vaccine

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  1. BlueWillow Awarded NIH Contract to Advance Development of its Therapeutic Peanut Allergy Vaccine

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    Research Will Progress Treatment for Millions Suffering from Peanut Allergies

    ANN ARBOR, Mich., (October 1, 2019) – BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced it has been awarded a Fast-Track Small Business Research Innovation (SBIR) contract from the National Institute of Allergy and Infectious Diseases (NIAID) for the development of an intranasal therapeutic peanut allergy vaccine using the company’s NanoVax® platform. Pending approval of all phases, the contract will provide funding of up to $3.2 million which will enable BlueWillow to complete preclinical research and prepare to file an Investigational New Drug (IND) application for its candidate vaccine.

    Peanut allergy is one of the most common food allergies, affecting over 7 million people worldwide and forcing families, schools and caregivers to manage the daily challenge and stress of keeping loved ones safe. Unfortunately, there are no approved treatments for peanut allergy. The current standard of care remains peanut avoidance which leaves many at risk of accidental exposure and potentially life-threatening allergic reactions. Oral and topical allergen-specific immunotherapies attempt to temporarily desensitize patients by regularly administering a progressively increasing amount of peanut allergen. However, these treatments can induce serious allergic reactions and their benefits are rapidly lost if therapy is ceased.

    “Food allergy is a very significant healthcare concern today, and even more alarming is the fact that incidence is increasing,” said BlueWillow CEO Dave Peralta. “The immunotherapy regimens being studied provide some hope for families with loved ones suffering from food allergies, but these therapies come with risks and limitations. BlueWillow’s peanut allergy vaccine is a unique approach which combines miniscule amounts of purified peanut protein with our novel intranasal NanoVax system and is designed to reprogram the immune system to induce long-term suppression of allergic reactions. Our peanut allergy vaccine has demonstrated this profile in numerous animal studies, and we are thrilled to win this Fast-Track contract which will allow us to advance the program towards Phase I clinical studies.”

    In animal studies conducted by researchers at the University of Michigan and published last year in The Journal of Allergy and Clinical Immunology, the NanoVax peanut vaccine was effective in treating established allergic disease by shifting the immune system towards a Th1/Th17 response and thereby suppressing inflammatory allergic responses. The first phase of the project will be completed in collaboration with Dr. Jessica J. O’Konek and other peanut allergy experts at the Mary H. Weiser Food Allergy Center at the University of Michigan. The associated work is being funded in whole with $300,000 of federal funds from NIAID, an institute within the National Institutes of Health (NIH) which is part of the Department of Health and Human Services, under Contract No. 75N93019C00035.

    About BlueWillow

    BlueWillow Biologics® is a clinical-stage, privately-held biopharmaceutical company focused on developing and commercializing prophylactic and therapeutic vaccines using its patented NanoVax® platform. The NanoVax platform employs a novel oil-in-water nanoemulsion adjuvant that is effective when administered intranasally, intramuscularly and topically, and can elicit both mucosal and systemic immunity.

    BlueWillow is currently developing intranasal vaccines for several respiratory and sexually transmitted infections, including RSV, HSV2, pandemic influenza and anthrax, as well as vaccines for peanut allergy and other 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.

  3. NanoBio to Present Data Demonstrating Benefit of Its Intramuscular Nanoemulsion Pandemic Influenza Vaccine

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    Recent Studies Indicate the Company’s Novel Adjuvant Technology Elicits Immunity Via Intranasal or Intramuscular Administration

    ANN ARBOR, Mich., (June 1, 2016) – NanoBio Corporation today announced that the company will present key data at the GTCbio 14th Vaccines Research & Development Conference in San Diego on June 3, 2016, demonstrating the advantages of its nanoemulsion (NE) adjuvant for use in the development of intramuscular vaccines for pandemic influenza and other diseases.

    The primary research being presented at the conference was conducted under a five-year contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Pursuant to the contract, NanoBio is developing both an intranasal and an intramuscular NE adjuvant for use with pandemic influenza vaccines. The studies were conducted using a plant-based recombinant H5 pandemic influenza antigen.

    “The combined effort of researchers at NanoBio and the Michigan Nanotechnology Institute for Medicine and Biological Sciences at the University of Michigan have led to the very significant discovery of a new NE adjuvant formulation that appears optimal for intramuscular administration,” said David Peralta, Chief Executive Officer, NanoBio. “Given most vaccines today are injected, this NE formulation has the potential to enhance the effectiveness of many intramuscular vaccines currently available and in development stages.”

    “Our recent studies in mice demonstrate that intramuscular NE vaccination elicits robust antibody responses as well as the type of balanced cellular immunity we strive to achieve to protect against certain diseases,” said Dr. Ali Fattom, Senior Vice President of Vaccine Research and Development, NanoBio. “We’ve observed this profile of immune response in the pandemic influenza studies being presented at the conference, as well as other studies testing the NE with several additional antigens.”

    Fattom continued, “We have also confirmed that the NE is compatible with other intramuscular vaccine adjuvants. In studies testing such combination-adjuvant vaccines, we observe significant synergy particularly with respect to cell-mediated immunity. This may play an important role in the development of intramuscular vaccines that elicit the desired immune response required for durable efficacy against selected infectious diseases, cancers and allergies.”

    Peralta noted, “Our future development efforts at NanoBio will continue to incorporate intranasal administration of NE vaccines, given our NE adjuvant’s unique ability to elicit both a systemic and mucosal immune response following this route of application. However, with this new discovery, we will increasingly also explore use of intramuscular NE vaccination as we seek to advance several vaccine candidates to human clinical studies in the years ahead.”

    Following are details of NanoBio’s upcoming oral presentation at the GTCbio 14th Vaccines Research & Development Conference

    Title:          Novel Nanoemulsion-based Intramuscular Vaccine Adjuvant for H5N1 Pandemic Influenza

    Date/Time:          June 3, 2016 / 9:40 a.m. PT

    Location:         Catamaran Resort, San Diego, California

    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.

  4. NanoBio to Present Data Demonstrating the Potential for its Intranasal Vaccine to Protect Against Genital Herpes Infection

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    One Out of Every Six Americans Aged 14 to 49 Years Have Genital Herpes

    ANN ARBOR, Mich., (October 8, 2014) – NanoBio Corporation today announced that the company will present data at The Keystone Symposia Conference, The Modes of Action of Vaccine Adjuvants, in Seattle on October 12, 2014. The Company’s presentation will highlight the advantages of its nanoemulsion (NE) adjuvant in the development of a prophylactic genital herpes vaccine that induces protection by eliciting both systemic and mucosal immune responses.

    Genital herpes is a sexually transmitted disease most commonly caused by the herpes simplex virus-2 (HSV-2). Infections are lifelong and often asymptomatic facilitating the spread of the disease amongst sexual partners and from mother to child during birth. Genital herpes is also associated with an increased risk of HIV acquisition. The disease is widespread in both developed and underdeveloped countries, and is a global health priority. Currently, there are no approved vaccines for HSV-2.

    Utilizing preclinical services provided by the National Institute of Allergy and Infectious Diseases’ Division of Microbiology and Infectious Diseases, NanoBio is studying the potential of an intranasal NE-adjuvanted glycoprotein vaccine in a guinea pig challenge model. During the Symposia, data will be presented demonstrating the potential advantages of NanoBio’s prophylactic NE HSV-2 vaccine candidate, including:

    The prevention of infection and viral latency, as measured by the absence of viral infection of the dorsal root ganglia in 92% of animals vaccinated with the NE vaccine.

    The ability to induce enhanced protection against chronic recurrence of herpes lesions as compared to the intramuscular MPL/Alum gD2 vaccine (p=0.01). 83% of animals vaccinated with the intranasal NE vaccine were completely lesion-free during the seven week chronic phase, as compared to 58% of animals immunized with an intramuscular MPL/Alum gD2 vaccine.

    The achievement of enhanced protection despite eliciting lower systemic antibodies than the intramuscular MPL/Alum gD2 vaccine, demonstrating the benefit of the mucosal and cellular immune responses elicited by the intranasal NE vaccine.

    Genital herpes is a serious disease that causes painful sores, increased potential of contracting HIV, psychological damage and can be passed from a mother during childbirth with potentially fatal implications. The disease is transmitted primarily through sexual contact, therefore developing a vaccine that induces both mucosal and systemic immunity is critical to minimizing spread of the disease. Recent clinical studies of intramuscular vaccine candidates have failed to demonstrate adequate protection against HSV-2 infection, likely due to the inability to protect mucosal pathways from HSV pathogens.

    “Genital herpes is a serious health issue globally. Once infected, the virus establishes latency in the nervous system causing chronic recurrences and the potential for transmission through sexual contact,” said Dr. Lawrence Stanberry, Reuben S. Carpentier Professor and Chairman of the Department of Pediatrics at the College of Physicians and Surgeons at Columbia University, and Pediatrician-in-Chief of the Morgan Stanley Children’s Hospital of New York Presbyterian. “Historically, vaccines have focused on preventing infection and/or recurrence by boosting systemic immunity. To date, this approach has not proved to be effective. HSV-2 enters the body through the genital mucosa. Therefore, a vaccine that induces both systemic and mucosal immune responses has significant potential to impact the spread of this disease.”

    NanoBio’s NanoStat® technology platform employs a novel oil-in-water nanoemulsion 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 mucosal immunity as well as systemic immunity.

    Following are details of NanoBio’s upcoming oral presentation at the Keystone Symposia:

    Intranasal Nanoemulsion-Adjuvanted Genital Herpes Vaccine: A New Approach Utilizing Mucosal Immunity to Induce Protection Against HSV-2 Infection

    Presenter :    Tarek Hamouda, MD, PhD, Sr. Director of Vaccine Research, NanoBi

    Date/Time:     October 12, 2014 / 2:00 p.m. PM

    Location:     Sheraton Seattle Hotel, Seattle, Washington

    About NanoBio

    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 platform utilizes a novel oil-in-water emulsion adjuvant to enable vaccines that elicit broad protection against disease. The company’s headquarters and laboratory facilities are located in Ann Arbor, Michigan. For more information on NanoBio or its products, please visit www.bluewillow.com