unimportant decoration Nano-scale droplet illustration

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

unimportant decoration

Tag Archive: NIAID

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

    Comments Off on NanoBio’s Genital Herpes Vaccine Demonstrates Efficacy in Guinea Pigs as Both a Prophylactic and a Therapeutic Vaccine

    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.