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

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Tag Archive: vaccine

  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 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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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  7. 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.

  8. 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.