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BlueWillow Biologics Names Leading Viral Infectious Disease Experts to Scientific Advisory Board

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  1. BlueWillow Biologics Names Leading Viral Infectious Disease Experts to Scientific Advisory Board

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    ANN ARBOR, Mich.–BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines, today announced the formation of the Company’s Scientific Advisory Board (SAB) with three leading viral infectious disease experts. The SAB will provide strategic and scientific counsel to BlueWillow’s clinical programs.

    The members of the BlueWillow Biologics SAB include:

    Robin Isaacs, M.D. – Dr. Isaacs was Chief Medical Officer of Entasis Therapeutics for 4 years. Prior, he held positions of increasing responsibility at Merck & Co., Inc., most recently serving as Vice President and Therapeutic Area Head, Vaccine Clinical Research. During his 18 years at Merck, Dr. Isaacs was involved with the worldwide development, regulatory submission and approval of several anti-infective, antiviral and vaccine products. He holds an M.B., B.H.B and M.D. from the University of Auckland.

    Akiko Iwasaki, Ph.D. – Dr. Iwasaki is a Waldemar Von Zedtwitz Professor at the Yale University Department of Immunobiology and Department of Molecular Cellular and Developmental Biology. She is currently an Investigator at the Howard Hughes Medical Institute. Dr. Iwasaki’s research focuses on the mechanisms of immune defense against viruses on mucosal surfaces, and her laboratory explores the relationship between viral infections and adaptive immunity. She holds a B.S. and Ph.D. from the University of Toronto. Dr. Iwasaki completed her Postdoctoral Fellowship at the National Institutes of Health Intramural Research Program.

    Steve Projan, Ph.D. – Dr. Projan is a Principal at Beat the Reaper, LLC. Previously, he served as a Senior Vice President of R&D in the Infectious Diseases & Vaccines Innovative Medicines unit (iMED) at MedImmune, where he led the strategy, prioritization and advancement of the company’s infectious disease and vaccine portfolio. Prior to MedImmune, Dr. Projan served as Vice President and Global Head of Infectious Diseases at the Novartis Institutes for Biomedical Research. He previously spent 15 years at Wyeth in roles of increasing responsibility, most recently as Vice President of Biological Technologies. He holds a B.S. from the Massachusetts Institute of Technology, as well as an M.A. and Ph.D. from Columbia University.

  2. 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

  3. BlueWillow Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

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    ANN ARBOR, Mich., (October 23, 2019) – BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for BW-1010, the company’s next-generation anthrax vaccine candidate. The Phase 1 clinical study is expected to begin enrollment this year and is being funded by the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH).

    Development of an intranasal anthrax vaccine is ongoing through BlueWillow’s partnership with Porton Biopharma Limited (PBL) under contract #HHSN272201600045C from NIAID for the development of a next-generation NanoVax® anthrax vaccine. The contract could be worth up to $24 million over its eight-year term if all options are exercised. The vaccine combines BlueWillow’s novel intranasal NanoVax system with recombinant protective antigen (rPA) for anthrax from PBL. The NanoVax platform employs a proprietary oil-in-water nanoemulsion adjuvant that elicits both systemic and mucosal immunity, uniquely enabling protection against challenging respiratory infections such as anthrax.

    Anthrax is listed as a Category A priority pathogen by NIAID, indicating the biological agent poses the highest possible risk to national security and public health. When introduced to the body through inhalation, ingestion or cuts in the skin, anthrax-causing bacteria can cause severe illness and death. The disease poses a massive threat in situations such as bioterrorism. To protect the nation against the potential risk of an anthrax attack, the U.S. Department of Health and Human Services (HHS) currently stores tens of millions of doses of injectable anthrax vaccine in the U.S. Strategic National Stockpile, the nation’s largest supply of potentially life-saving medical products for emergency use. The currently licensed injectable vaccine requires three immunizations in addition to antimicrobial therapy as a medical countermeasure following potential anthrax exposure. Evidence indicates the current vaccine may cause acute side effects, as well as the risk of potential fetal harm if administered to pregnant women.

    “The BlueWillow/PBL anthrax vaccine has the potential to provide significant advantages over the current injectable vaccine,” said BlueWillow CEO Dave Peralta. “Animal studies have demonstrated BW-1010 is safe and elicits protection against anthrax after just one or two vaccinations. In addition, informal stability studies have shown that our vaccine has a shelf life of over five years, compared to three years for the current injectable vaccine. The improved stability of BW-1010 would allow for longer-term storage, potentially saving the U.S. government over $100 million annually.”

    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.

  4. BlueWillow Biologics Named to Crain’s ‘Cool Places to Work in Michigan’

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    Employees Rank Workplace Culture as Key Reason for High Satisfaction

    ANN ARBOR, Mich., (August 6, 2019) – BlueWillow Biologics® today announced the company has been recognized as one of the 2019 “Cool Places to Work in Michigan” by Crain’s Detroit. Select companies across the state were honored based on employee feedback.

    BlueWillow earned its spot on the list by being recognized as a company with a high level of employee engagement, satisfaction and a positive and empowering work culture. Finalists were selected based on confidential employee survey responses that analyzed perspectives on workplace culture, company leadership and other aspects of work.

    “BlueWillow has achieved many important accomplishments, and as we stand here today, the company is potentially entering the most exciting time in our history. Our achievements wouldn’t be possible without our talented and dedicated team of employees,” said BlueWillow CEO Dave Peralta. “We strive to create an environment that offers our employees a great place to work and provides them an opportunity to utilize and build upon their many unique talents. At BlueWillow, we genuinely care about our employees and I’m pleased that caring makes us ‘cool’. The recognition by Crain’s is truly an honor.”

    BlueWillow is an Ann Arbor-based biopharmaceutical company focused on developing intranasal vaccines with its patented nanotechnology. The company’s unique NanoVax technology elicits both systemic and mucosal immune responses, providing two layers of immunity for increased protection against respiratory and sexually transmitted diseases.

    Employee survey responses pointed to several areas that lead to high work satisfaction at BlueWillow, including supportive coworkers, effective leadership, commitment to work-life balance and the impact that the company’s technology can have on preventing disease. Competitive compensation, benefits and fun work events were also noted as items that differentiate BlueWillow from other workplaces.

    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.

  5. 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.

  6. BlueWillow Biologics Announces Issuance of Intranasal Anthrax Vaccine Patent

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    Initiation of Phase One Clinical Studies Expected This Year

    ANN ARBOR, Mich., (May 29, 2019) – BlueWillow Biologics® today announced the issuance of U.S. patent number 10,138,279 covering an intranasal NanoVax® anthrax vaccine. The patent, issued to the University of Michigan under exclusive license to BlueWillow, is based on research conducted by the University demonstrating the vaccine’s ability to elicit long-term protection against lethal anthrax challenge in animals.

    The National Institute of Allergy and Infectious Diseases (NIAID) lists Bacillus anthracis (anthrax) as a Category A pathogen, indicating the biological agent poses the highest possible risk to national security and public health. Anthrax exposure can cause severe illness and death when spores enter the body through inhalation, ingestion or cuts in the skin. The disease poses an immense threat in situations such as bioterrorism.

    BlueWillow’s intranasal NanoVax platform employs a novel oil-in-water emulsion adjuvant that elicits both systemic and mucosal immunity, thereby uniquely protecting against challenging respiratory infections. Advanced development of an intranasal NanoVax anthrax vaccine is ongoing through BlueWillow’s partnership with Porton Biopharma Limited (PBL) of the United Kingdom. Phase one clinical studies are expected to begin in the second half of 2019.

    PBL holds a contract (#HHSN272201600045C) from NIAID for the development of a next-generation NanoVax anthrax vaccine, which could be worth up to $24 million over its eight-year term, if all options are exercised. The vaccine combines BlueWillow’s novel intranasal adjuvant with PBL’s recombinant protective antigen (rPA) for anthrax. To date, the NanoVax anthrax vaccine has demonstrated safety, immunogenicity and protection in multiple animal studies. In contrast, animals exposed to anthrax without first receiving the NanoVax vaccine did not survive.

    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.

  7. BlueWillow Biologics Awarded Grant for Chlamydia Vaccine Development

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    Studies Show NanoVax Technology Limits Chlamydia Infection and Prevents Pelvic Inflammatory Disease

    ANN ARBOR, Mich., (September 26, 2018) – BlueWillow Biologics® today announced the company has been awarded an NIH Small Business Innovation Research (SBIR) grant for the development of an intranasal NanoVax® vaccine for the prevention of chlamydia. There are more than 131 million new chlamydia infections worldwide each year1 and no approved vaccine currently exists to prevent the infection.

    Many cases of chlamydia are not treated or reported because patients are asymptomatic and do not get tested. Untreated infections in women can lead to pelvic inflammatory disease (PID), which can cause permanent damage to the uterus, fallopian tubes and surrounding tissue. Consequences of PID include chronic pelvic pain, tubal factor infertility and potentially fatal ectopic pregnancy.

    The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIH), awarded BlueWillow—formerly NanoBio Corporation—a one-year Phase I SBIR grant (R43AI134168) to fund in vivo studies combining the company’s patented NanoVax technology with a proven chlamydia antigen developed by Dr. James Mahony at McMaster University in Hamilton, Ontario.

    “When chlamydia goes undiagnosed, patients don’t get the antibiotics they need to treat the infection. An intranasal NanoVax vaccine incorporating the novel BD584 antigen could prevent chlamydia infections from occurring in the first place, reducing cases of PID,” said Mahony, an investigator under the grant. “Less PID means fewer women will suffer from pain and infertility, and healthcare costs incurred by the disease will be reduced. This vaccine could have an immeasurable global impact on quality of life, reproductive health and efficient healthcare utilization.”

    BlueWillow’s NanoVax platform employs a unique oil-in-water nanoemulsion adjuvant that elicits both systemic and mucosal immune responses, which could play an important role in the prevention of chlamydia and other sexually transmitted infections (STIs).

    “Initial data shows intranasal vaccination and mucosal immunity induction with NanoVax can reduce chlamydia infections and PID in mice. With this SBIR grant, we will continue our research with the goal of advancing this preventive solution toward clinical trials,” said Dr. Ali Fattom, Senior Vice President of Vaccine Research and Development, BlueWillow. “Too many STIs including chlamydia go undiagnosed and untreated. BlueWillow remains dedicated to developing solutions that address this critical global health issue.”

    1 World Health Organization. Sexually transmitted infections (STIs). 3 August 2016. http://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)

    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 infectious diseases, including RSV, pertussis, HSV2 and chlamydia, as well as intranasal vaccines for food and aeroallergens. Visit BlueWillow.com for details on the company’s vaccine pipeline and studies completed to date.

  8. 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.

  9. NanoBio Announces Corporate Name Change to BlueWillow Biologics and Closes $10M Series A Financing

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    Move Reflects Focus on Advancing Several Intranasal Vaccines to Human Studies

    ANN ARBOR, Mich., (May 7, 2018) – NanoBio Corporation, a clinical-stage biopharmaceutical company, today announced that it has changed its corporate name to BlueWillow Biologics® in conjunction with the closing of a $10 million Series A financing. The company’s new name reflects its evolution to a vaccines-focused company, and commitment to advancing its novel intranasal technology to develop new vaccines for several respiratory and sexually transmitted diseases. The Series A financing round was led by North Coast Technology Investors, Line Moon Ventures and the University of Michigan through its MINTS initiative.

    The company was originally founded as NanoBio Corporation to develop topical nanoscale therapies for various dermatology applications. BlueWillow will continue to develop skin and wound treatments through partnerships and external collaborations under the NanoBio® trademark.

    BlueWillow’s innovative intranasal vaccine platform is built upon the company’s patented NanoVax® technology that employs a unique oil-in-water nanoemulsion adjuvant to elicit both systemic and mucosal immunity. Most infectious pathogens enter the body across mucosal surfaces, yet most vaccines today are injected and fail to elicit mucosal immunity. BlueWillow’s technology has the potential to improve upon many existing vaccines as well as enable the creation of new vaccines for diseases that currently cannot be prevented through vaccination.

    “Over the past several years, our research has increasingly demonstrated that our intranasal platform can play a pivotal role in the vaccines of tomorrow,” said Dave Peralta, Chief Executive Officer of BlueWillow. “Much of our data points to increased protection against some of the world’s most severe respiratory and sexually transmitted infections. With the commitment of our Series A investors and the tremendous support we continue to receive from the National Institutes of Health (NIH), BlueWillow is now rapidly approaching Phase 1 human clinical studies in several programs.”

    The name BlueWillow Biologics is a nod to the company’s roots as well as a commitment to the company’s future as a developer of the next generation of vaccines. “Blue” is a subtle reference to the University of Michigan, where the company’s nanotechnology was discovered. While “Willow” refers to willow trees, which are known to have deep, strong roots and large, protective branches.

    “The NIH, Bill & Melinda Gates Foundation, State of Michigan, Michigan Nanotechnology Institute for Medicine and Biological Sciences and the University of Michigan Technology Transfer Office have been instrumental in the advancement of BlueWillow’s intranasal vaccine platform,” Peralta said. “We are very grateful to each of these partners, as well as our core investors, for their support, guidance and investment in BlueWillow’s promising future.”

    About BlueWillow

    BlueWillow Biologics is a privately-held biopharmaceutical company headquartered in Ann Arbor, Michigan, focused on developing and commercializing intranasal 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.

  10. University of Michigan Researchers Show Intranasal NanoVax Vaccination Suppresses Peanut Allergies in Mice

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    Ann Arbor, Mich., (April 11, 2018)— BlueWillow’s intranasal NanoVax vaccination protected mice from allergic reactions when exposed to peanut, according to U-M researchers. The researchers aim to “change the immune system response by developing a therapeutic vaccine for food allergies.”

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  11. NanoBio and Porton Biopharma Receive Approval to Advance Next Generation Anthrax Vaccine

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    ANN ARBOR, Mich., (June 19, 2017) – NanoBio Corporation today announced the progression of a novel intranasal anthrax vaccine into a pre-clinical IND-enabling toxicology study funded by the U.S. National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID). The vaccine combines NanoBio’s novel intranasal nanoemulsion (NE) adjuvant with recombinant protective antigen (rPA) for anthrax from Porton Biopharma Ltd (PBL). Following the pre-clinical toxicology study, the vaccine will progress to a Phase 1 clinical trial.

    The advanced development of the vaccine candidate is the result of a modification to PBL’s existing NIAID contract (#HHSN272201600045C), which totals more than $24 million throughout it’s eight-year term if all options are exercised. The modification, valued at $5.6 million, supports further research of the vaccine components and technologies that accelerate the immune responses for use in post-event settings following the intentional release of the Category A priority pathogen Bacillus anthracis, the bacterium that causes the disease anthrax. Under the contract, NanoBio, PBL and Public Health England are partnering to produce a more effective vaccine than the currently licensed injectable product, by enabling immunity to be achieved in fewer doses and via intranasal delivery.

    “Based on studies completed in the primary animal challenge model for anthrax, our vaccine offers the potential to enhance immunity with fewer doses and easier administration,” said David Peralta, chief executive officer of NanoBio. “Our partnership with PBL and Public Health England—clear leaders in the field of anthrax vaccine research and development—is critical to efficiently progressing our intranasal NE-rPA vaccine candidate to human clinical trials.”

    Anthrax is caused by the spore-forming bacterium Bacillus anthracis, and most commonly infects wild and domestic animals. Anthrax occurs in humans when they are either exposed to infected animals or to the organism directly, which could occur following a bioterrorist attack. In humans, the mortality of untreated cutaneous anthrax ranges up to 25 percent, but increases to nearly 100 percent in inhalational and intestinal cases. The currently available vaccination schedule for anthrax consists of three primary injections at zero, one, and six months, two booster doses at months twelve and eighteen, and then followed by annual boosters for prolonged protection. Epidemiological evidence indicates the current vaccine may cause acute side effects and may only provide partial protection from certain strains.

    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, prophylactic and therapeutic HSV-2, and chlamydia.

  12. NanoBio Receives SBIR Grant For Genital Herpes Vaccine

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    Pre-Clinical Studies Demonstrate Prevention of Infection, Recurrent Lesions and Viral Shedding

    ANN ARBOR, Mich., (March 6, 2017) – NanoBio Corporation today announced that it has been awarded a two-year Phase II Small Business Research Innovation (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for the development of an intranasal nanoemulsion (NE) adjuvanted vaccine for the prevention of genital herpes. The grant will fund up to $1.5 million of critical preclinical research and process development activities, including the completion of a pre-IND meeting with the U.S. Food and Drug Administration.

    Genital herpes is a sexually transmitted disease most commonly caused by the herpes simplex virus-2 (HSV-2). Infections are lifelong and are 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. According to estimates from the Centers for Disease Control and Prevention (CDC), over 24 million people in the United States are infected with HSV-2 and there are 776,000 new infections each year. Approximately one out of every six people aged 14 to 49 years has an HSV-2 infection. Currently, there are no approved vaccines to prevent or treat the disease.

    Under NIAID’s suite of preclinical services, researchers at the Cincinnati Children’s Hospital Medical Center previously tested NanoBio’s intranasal vaccine in several guinea pig challenge studies. “NanoBio’s intranasal vaccine is one of the only vaccine candidates we’ve studied that has shown efficacy in both the prophylactic and the therapeutic animal models,” said Dr. David I. Bernstein, Professor of Pediatrics at Cincinnati Children’s Hospital Medical Center. “Based on our data with this unique approach, we look forward to seeing the intranasal NE vaccine progress to human clinical studies.”

    In the prophylactic guinea pig study, the intranasal NE HSV-2 vaccine prevented infection and viral latency in 92 percent of animals vaccinated, versus 8 percent in a no treatment arm. In a separate therapeutic study, animals with recurrent HSV-2 infection were vaccinated with the intranasal NE vaccine. During the post-vaccination observation period, the NE HSV2 vaccine reduced recurrent lesions and viral shedding by more than 50 percent as compared to animals that received no treatment. No adverse events were observed in any of the animals that received the NE vaccine.

    “The Phase II SBIR grant is a testament to the potential of NanoBio’s intranasal NE vaccine for genital herpes. The funding enables the next step in the development research process,” said Dr. Ali Fattom, Senior Vice President of Vaccine Research and Development, NanoBio. “Throughout the past several years, we have consistently observed that our intranasal vaccine elicits both a serum and a mucosal immune response in animals. This differentiates our program from the many intramuscular HSV-2 vaccines in development. NanoBio’s intranasal NE vaccine provides protection both systemically and in mucosal tissues at the port of entry for the herpes virus. Based on pre-clinical data to date, we believe this first line of defense is essential to adequately protect against genital herpes.”

    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, prophylactic and therapeutic HSV-2, and chlamydia.

  13. 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.

  14. 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.

  15. 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.

  16. NanoBio’s Genital Herpes Vaccine Demonstrates Efficacy in Guinea Pigs as Both a Prophylactic and a Therapeutic Vaccine

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    Nanobio’s Genital Herpes Vaccine Demonstrates Efficacy in Guinea Pigs as Both a Prophylactic and a Therapeutic Vaccine

    ANN ARBOR, Mich., (September 22, 2015) – NanoBio Corporation today announced that its intranasal nanoemulsion (NE) adjuvanted genital herpes vaccine has demonstrated efficacy in studies conducted in both the prophylactic and the therapeutic guinea pig model. Guinea pigs represent the primary animal model used to study genital herpes vaccines. The data was recently presented at the 40th Annual International Herpesvirus Workshop in Boise, ID.

    Under the National Institute of Allergy and Infectious Diseases’ (NIAID) preclinical services program, researchers at the Cincinnati Children’s Hospital Medical Center investigated the potential of NanoBio’s intranasal NE glycoprotein vaccine in guinea pig challenge models. Using the prophylactic model, guinea pigs were administered an intranasal NE vaccine then subsequently challenged with the herpes simplex virus-2 (HSV2). In this study, the NE HSV2 vaccine prevented infection and viral latency in 92 percent of animals vaccinated, versus 8 percent in the no treatment arm. No adverse events were observed in any of the animals that received the NE vaccine.

    In a separate therapeutic guinea pig study, animals were first infected with HSV2 then vaccinated with the intranasal NE vaccine. During the post-vaccination observation period, the NE HSV2 vaccine reduced recurrent lesions by 64 percent and viral shedding by more than 50 percent, as compared to animals that received no treatment. Of the animals receiving the NE vaccine, 53 percent did not shed any detectable virus. Again, no adverse events were observed in any of the animals that received the NE vaccine.

    “The results of these studies demonstrate the potential impact and benefits of intranasal NE vaccines to prevent and treat sexually transmitted diseases. Based on the consistently positive data observed in four guinea pig studies conducted to date, we are planning to raise additional capital in 2016 to advance our NE-HSV2 vaccine candidate into Phase 1 clinical studies,” said David Peralta, Chief Executive Officer of NanoBio. “The use of intranasal NE vaccination elicits a mucosal immune response in addition to the systemic immunity generated by intramuscular vaccines, offering unique and significant advantages. A mucosal response is potentially critical to adequately protect against certain respiratory and sexually transmitted pathogens that enter the body across mucosal surfaces.”

    About Genital Herpes

    Genital herpes is a sexually transmitted disease most commonly caused by the herpes simplex virus-2 (HSV2). 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 to prevent or treat genital herpes.

    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 intranasal 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 in RSV and seasonal influenza vaccines.

    For more information on NanoBio or its products, please visit www.bluewillow.com.

  17. 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

  18. NanoBio’s Intranasal Vaccine Demonstrates Robust Protection Against Herpes Simplex-2 Infection

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    ANN ARBOR, Mich., (April 28, 2014) – NanoBio Corporation today announced that the company will present new data at the National Foundation for Infectious Diseases’ 17th Annual Conference on Vaccine Research (NFID ACVR ), demonstrating the benefits of its nanoemulsion (NE) adjuvant in the development of an intranasal herpes simplex virus-2 (HSV-2) vaccine. (more…)

  19. NanoBio Awarded Up to $10 Million in NIH Funding to Develop a Pandemic Influenza Vaccine

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    Additional funding allocated to research nanoemulsion-adjuvanted HIV vaccine

    ANN ARBOR, Mich., (October 29, 2013) – NanoBio Corporation today announced that the company has been awarded an initial contract worth $5.5 million from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop a nanoemulsion (NE) adjuvant for use with a pandemic influenza vaccine. (more…)

  20. NanoBio to Present Data at ICAAC Supporting the Development of Safe and Effective RSV and Herpes Simplex Virus-2 Vaccines

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    Pre-clinical data demonstrates the ability of nanoemulsion-adjuvanted vaccines to provide immunogenicity and protection against illness and disease

    ANN ARBOR, Mich., (September 11, 2013) – NanoBio Corporation today announced that the company will present new data at the 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting showing the safety and efficacy of a nanoemulsion (NE) adjuvanted intramuscular vaccine for the prevention of respiratory syncytial virus (RSV). RSV plagues nearly all children by the age of three and can be life-threatening for premature babies, children with other health conditions, and the elderly. Currently, a vaccine for the prevention of RSV is not commercially available. (more…)