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

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Tag Archive: NIH

  1. 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.

  2. 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.

  3. 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.

  4. 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.