unimportant decoration Nano-scale droplet illustration

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

unimportant decoration

Tag Archive: intranasal vaccine

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

    Comments Off on BlueWillow Receives FDA Clearance to Begin Phase 1 Study of its Intranasal Anthrax Vaccine

    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.

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

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

    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.

  3. BlueWillow Biologics Announces Issuance of Intranasal Anthrax Vaccine Patent

    Comments Off on BlueWillow Biologics Announces Issuance of Intranasal Anthrax Vaccine Patent

    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.

  4. BlueWillow Biologics Awarded Grant for Chlamydia Vaccine Development

    Comments Off on BlueWillow Biologics Awarded Grant for Chlamydia Vaccine Development

    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.

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

    Comments Off on NanoBio Announces Corporate Name Change to BlueWillow Biologics and Closes $10M Series A Financing

    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.

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

    Comments Off on NanoBio to Present Intranasal Pertussis Vaccine Data at the Mucosal Immunology Course & Symposium Meeting

    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.