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BlueWillow Biologics Awarded Patent for Intranasal Genital Herpes Vaccine

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Tag Archive: STD

  1. 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.

  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’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.