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BlueWillow Biologics Announces Positive Interim Results from Phase 1 Trial of Intranasal Anthrax Vaccine

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  1. BlueWillow Biologics Announces Positive Interim Results from Phase 1 Trial of Intranasal Anthrax Vaccine

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    BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines, today announced positive interim results from the Phase 1 clinical trial of BW-1010, its next-generation intranasal anthrax vaccine candidate.

    BW-1010 combines BlueWillow’s patented technology, a novel oil-in-water emulsion platform that efficiently presents antigens to the immune system via the nasal mucosa, with Porton Biopharma Limited’s (PBL) recombinant protective antigen (rPA) for anthrax. The interim data showed that vaccine administered intranasally as two doses 4 weeks apart was safe and well tolerated. In addition, BW-1010 induced systemic and mucosal immunity as evidenced by levels of neutralizing systemic antibodies, nasal IgA/IgG and Th17 response in peripheral blood cells. The trial was funded under contract HHSN272201600045C from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

    Anthrax is included in the list of NIAID Category A priority pathogens that pose the highest risk to national security and public health. Pathogens in this category can be easily disseminated, may result in high mortality rates, and have the potential for major public health impact.

    “Given the numerous advantages of intranasal over intramuscular vaccination and the growing recognition of the critical importance of mucosal immunity, we’re confident that BlueWillow’s platform is game-changing vaccine technology,” said Chad Costley, MD, CEO of BlueWillow. “We’re thankful for the commitment of our colleagues at PBL and NIAID’s support for the Phase 1 trial. We look forward to reporting complete results when the trial concludes this fall and advancing the anthrax vaccine through further clinical trials. The human proof of concept demonstrated through this program will prove invaluable to our robust pipeline of vaccine candidates.”

    More information on the Phase 1 clinical trial for BW-1010 can be found at https://clinicaltrials.gov/ct2/show/NCT04148118.

    About PBL
    PBL is a biopharmaceutical development and manufacturing company with approximately 400 staff. It was formed in April 2015 as a spin-out company of Public Health England, and has a sole shareholder in the Department of Health and Social Care. PBL is based at Porton Down, Wiltshire, which has a long history of pharmaceutical development and manufacturing.

  2. NanoBio Protect nasal antiseptic withdrawn from market

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    BlueWillow Biologics announced today that NanoBio Protect, the over-the-counter nasal antiseptic launched in 2020, is no longer for sale in the U.S.  “The decision to withdraw the product from the market was made in April 2021.  At that time, it was delisted from Amazon and distributors/retailers were notified that marketing support for the product was ending.  While a limited number of retailers continued to offer the product for sale as they already held inventory, that has now ended,” said Chad Costley, MD, CEO of BlueWillow.  “We are a vaccine company developing novel intranasal vaccines to prevent respiratory and sexually transmitted infections as well as food allergies.  We will maintain that steadfast focus going forward.”

  3. Medigen and BlueWillow Biologics Partner to Develop Intranasal Vaccine for SARS-CoV-2

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    Research indicates that intranasal administration is effective at stimulating the mucosal immunity response. Preclinical study shows positive serum and mucosal immune response.

    Tapei, Taiwan & ANN ARBOR, Michigan, November 10, 2020 – Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, and BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines through its patented NanoVax™ adjuvant, today announced a partnership to develop S-2P-NE-01, a nasal vaccine for SARS-CoV-2, the virus that causes COVID-19.

    While the majority of COVID-19 vaccines in development today are delivered via intramuscular injection, research has demonstrated that nasal delivery – often the initial site of the infection – can prevent the virus from taking hold in the body. Preclinical research demonstrated that BlueWillow’s nasal vaccine adjuvant combined with Medigen’s S-2P spike protein resulted in an extremely high neutralizing antibody response, as well as a superior immunoglobulin A (IgA) response in both serum and lung secretions (BAL) samples in mice compared to intramuscular injection of S-2P adjuvanted with alum. Mucosal immune response is critical in reducing viral nasal colonization and preventing the spread of SARS-CoV-2.

    “Our partnership with MVC is a tremendous milestone in our plan to develop a nasal vaccine for SARS-CoV-2 and we are buoyed by the preclinical results showing that intranasal vaccination with S-2P-NE-01 holds great promise for both mucosal and serologic immunity to SARS-CoV-2,” said Chad Costley, MD, CEO of BlueWillow Biologics. “Our plan is to rapidly advance S-2P-NE-01 into human clinical trials as we move forward to battle this global pandemic.”

    “As the COVID-19 pandemic continues to spread around the world, there is an urgent need to develop a vaccine to fight this global crisis and we are proud to partner with BlueWillow to create an intranasal vaccination that has the potential to save human lives,” said Charles Chen, CEO of MVC. “While there has been a lot of movement in the development of vaccines, research continues to show the vast benefits of an intranasal vaccination and we look forward to the ongoing clinical development of our product candidate.”

    BlueWillow NanoVax Adjuvant Technology

    BlueWillow’s vaccine technology utilizes a novel oil-in-water nanoemulsion (NE) adjuvant to enable intranasal vaccines for challenging diseases and intranasal immunotherapy (INIT) for food allergies. The adjuvant includes soybean oil, water and a cationic surfactant cetylpirdinium chloride (CPC) and is currently in use in the company’s clinical-stage anthrax and pandemic flu programs and National Institutes of Health (NIH)-funded preclinical stage RSV, HSV and peanut immunotherapy programs. When used with intranasal vaccination, the NE adjuvant elicits both mucosal and systemic immunity.

    MVC S-2P Spike Protein

    MVC’s subunit vaccine is based on the stable prefusion form of the SARS-CoV-2 recombinant spike protein with global technology license from the U.S. Vaccine Research Center at the National Institutes of Health (NIH).

    About Medigen Vaccine Biologics (MVC) Corporation

    MVC is a biopharmaceutical company using cell-based technologies for the development of vaccines and biosimilars. With a goal of national self-sufficiency, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs and with a desire to help globally against the threats of infectious diseases. MVC’s pipeline includes enterovirus EV71 vaccine, dengue vaccine, and influenza quadrivalent vaccine, which have all entered late clinical stage. MVC’s large-scale production facility is state of the art and adherent to international PIC/s and GMP requirements. For more information, visit www.medigenvac.com.

    About BlueWillow Biologics

    BlueWillow Biologics® is a clinical-stage, privately held biopharmaceutical company focused on developing and commercializing topical antiseptic and anti-infective products and intranasal vaccines using its patented nanotechnology platform. The platform employs novel oil-in-water nano-droplets for products administered to the skin and nose. In addition to NanoBio® Protect, BlueWillow is currently developing intranasal vaccines that elicit both systemic and mucosal immunity for several respiratory and sexually transmitted infections, including SARS-CoV-2 (COVID-19), RSV, HSV2, pandemic influenza and anthrax, as well as intranasal immunotherapy for peanut allergy and other allergic conditions. Visit www.BlueWillow.com for details on the company’s pipeline and studies completed to date.

    Contacts

    Medigen Contact:
    Paul Torkehagen
    Director, Overseas Business Development
    paul@medigenvac.com

    BlueWillow Contact:
    Lauren Arnold
    Vice President
    LArnold@macbiocom.com