Ganesan S, Acosta H, Brigolin C, Orange K, Trabbic K, et al. (2022) Intranasal nanoemulsion adjuvanted S-2P vaccine demonstrates protection in hamsters and induces systemic, cell-mediated and mucosal immunity in mice. PLOS ONE. 2022 Nov 2;17(11): e0272594.
ANN ARBOR, Mich.–(BUSINESS WIRE)–BlueWillow Biologics, Inc. today announced that the company will present positive interim data from its phase 1 clinical trial of a novel intranasal anthrax vaccine at a Lightning Talks Session of BARDA’s Industry Day, November 3 and 4, 2021.
BlueWillow’s rPA/NE01 anthrax vaccine, BW-1010, developed in collaboration with Porton Biopharma Limited (UK) and funded by the National Institute of Allergy and Infectious Diseases, is an intranasal recombinant protein vaccine candidate against anthrax with proven safety and immunogenicity data in humans that can potentially protect from infection, disease and carriage. BlueWillow has received funding support as a subaward under NIAID contract HHSN272201600045C to PBL. The phase 1 trial was completed in September 2021, setting the stage for advancement to late-stage clinical development as early as 2023.
ANN ARBOR, Mich.–BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines, today announced the formation of the Company’s Scientific Advisory Board (SAB) with three leading viral infectious disease experts. The SAB will provide strategic and scientific counsel to BlueWillow’s clinical programs.
The members of the BlueWillow Biologics SAB include:
Robin Isaacs, M.D. – Dr. Isaacs was Chief Medical Officer of Entasis Therapeutics for 4 years. Prior, he held positions of increasing responsibility at Merck & Co., Inc., most recently serving as Vice President and Therapeutic Area Head, Vaccine Clinical Research. During his 18 years at Merck, Dr. Isaacs was involved with the worldwide development, regulatory submission and approval of several anti-infective, antiviral and vaccine products. He holds an M.B., B.H.B and M.D. from the University of Auckland.
Akiko Iwasaki, Ph.D. – Dr. Iwasaki is a Waldemar Von Zedtwitz Professor at the Yale University Department of Immunobiology and Department of Molecular Cellular and Developmental Biology. She is currently an Investigator at the Howard Hughes Medical Institute. Dr. Iwasaki’s research focuses on the mechanisms of immune defense against viruses on mucosal surfaces, and her laboratory explores the relationship between viral infections and adaptive immunity. She holds a B.S. and Ph.D. from the University of Toronto. Dr. Iwasaki completed her Postdoctoral Fellowship at the National Institutes of Health Intramural Research Program.
Steve Projan, Ph.D. – Dr. Projan is a Principal at Beat the Reaper, LLC. Previously, he served as a Senior Vice President of R&D in the Infectious Diseases & Vaccines Innovative Medicines unit (iMED) at MedImmune, where he led the strategy, prioritization and advancement of the company’s infectious disease and vaccine portfolio. Prior to MedImmune, Dr. Projan served as Vice President and Global Head of Infectious Diseases at the Novartis Institutes for Biomedical Research. He previously spent 15 years at Wyeth in roles of increasing responsibility, most recently as Vice President of Biological Technologies. He holds a B.S. from the Massachusetts Institute of Technology, as well as an M.A. and Ph.D. from Columbia University.
BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines, today announced positive interim results from the Phase 1 clinical trial of BW-1010, its next-generation intranasal anthrax vaccine candidate.
BW-1010 combines BlueWillow’s patented technology, a novel oil-in-water emulsion platform that efficiently presents antigens to the immune system via the nasal mucosa, with Porton Biopharma Limited’s (PBL) recombinant protective antigen (rPA) for anthrax. The interim data showed that vaccine administered intranasally as two doses 4 weeks apart was safe and well tolerated. In addition, BW-1010 induced systemic and mucosal immunity as evidenced by levels of neutralizing systemic antibodies, nasal IgA/IgG and Th17 response in peripheral blood cells. The trial was funded under contract HHSN272201600045C from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Anthrax is included in the list of NIAID Category A priority pathogens that pose the highest risk to national security and public health. Pathogens in this category can be easily disseminated, may result in high mortality rates, and have the potential for major public health impact.
“Given the numerous advantages of intranasal over intramuscular vaccination and the growing recognition of the critical importance of mucosal immunity, we’re confident that BlueWillow’s platform is game-changing vaccine technology,” said Chad Costley, MD, CEO of BlueWillow. “We’re thankful for the commitment of our colleagues at PBL and NIAID’s support for the Phase 1 trial. We look forward to reporting complete results when the trial concludes this fall and advancing the anthrax vaccine through further clinical trials. The human proof of concept demonstrated through this program will prove invaluable to our robust pipeline of vaccine candidates.”
More information on the Phase 1 clinical trial for BW-1010 can be found at https://clinicaltrials.gov/ct2/show/NCT04148118.
About PBL
PBL is a biopharmaceutical development and manufacturing company with approximately 400 staff. It was formed in April 2015 as a spin-out company of Public Health England, and has a sole shareholder in the Department of Health and Social Care. PBL is based at Porton Down, Wiltshire, which has a long history of pharmaceutical development and manufacturing.
Tapei, Taiwan & ANN ARBOR, Michigan, November 10, 2020 – Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, and BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines through its patented NanoVax™ adjuvant, today announced a partnership to develop S-2P-NE-01, a nasal vaccine for SARS-CoV-2, the virus that causes COVID-19.
While the majority of COVID-19 vaccines in development today are delivered via intramuscular injection, research has demonstrated that nasal delivery – often the initial site of the infection – can prevent the virus from taking hold in the body. Preclinical research demonstrated that BlueWillow’s nasal vaccine adjuvant combined with Medigen’s S-2P spike protein resulted in an extremely high neutralizing antibody response, as well as a superior immunoglobulin A (IgA) response in both serum and lung secretions (BAL) samples in mice compared to intramuscular injection of S-2P adjuvanted with alum. Mucosal immune response is critical in reducing viral nasal colonization and preventing the spread of SARS-CoV-2.
“Our partnership with MVC is a tremendous milestone in our plan to develop a nasal vaccine for SARS-CoV-2 and we are buoyed by the preclinical results showing that intranasal vaccination with S-2P-NE-01 holds great promise for both mucosal and serologic immunity to SARS-CoV-2,” said Chad Costley, MD, CEO of BlueWillow Biologics. “Our plan is to rapidly advance S-2P-NE-01 into human clinical trials as we move forward to battle this global pandemic.”
“As the COVID-19 pandemic continues to spread around the world, there is an urgent need to develop a vaccine to fight this global crisis and we are proud to partner with BlueWillow to create an intranasal vaccination that has the potential to save human lives,” said Charles Chen, CEO of MVC. “While there has been a lot of movement in the development of vaccines, research continues to show the vast benefits of an intranasal vaccination and we look forward to the ongoing clinical development of our product candidate.”
BlueWillow’s vaccine technology utilizes a novel oil-in-water nanoemulsion (NE) adjuvant to enable intranasal vaccines for challenging diseases and intranasal immunotherapy (INIT) for food allergies. The adjuvant includes soybean oil, water and a cationic surfactant cetylpirdinium chloride (CPC) and is currently in use in the company’s clinical-stage anthrax and pandemic flu programs and National Institutes of Health (NIH)-funded preclinical stage RSV, HSV and peanut immunotherapy programs. When used with intranasal vaccination, the NE adjuvant elicits both mucosal and systemic immunity.
MVC’s subunit vaccine is based on the stable prefusion form of the SARS-CoV-2 recombinant spike protein with global technology license from the U.S. Vaccine Research Center at the National Institutes of Health (NIH).
MVC is a biopharmaceutical company using cell-based technologies for the development of vaccines and biosimilars. With a goal of national self-sufficiency, MVC also aims to provide vaccines and biopharmaceuticals to meet regional needs and with a desire to help globally against the threats of infectious diseases. MVC’s pipeline includes enterovirus EV71 vaccine, dengue vaccine, and influenza quadrivalent vaccine, which have all entered late clinical stage. MVC’s large-scale production facility is state of the art and adherent to international PIC/s and GMP requirements. For more information, visit www.medigenvac.com.
BlueWillow Biologics® is a clinical-stage, privately held biopharmaceutical company focused on developing and commercializing topical antiseptic and anti-infective products and intranasal vaccines using its patented nanotechnology platform. The platform employs novel oil-in-water nano-droplets for products administered to the skin and nose. In addition to NanoBio® Protect, BlueWillow is currently developing intranasal vaccines that elicit both systemic and mucosal immunity for several respiratory and sexually transmitted infections, including SARS-CoV-2 (COVID-19), RSV, HSV2, pandemic influenza and anthrax, as well as intranasal immunotherapy for peanut allergy and other allergic conditions. Visit www.BlueWillow.com for details on the company’s pipeline and studies completed to date.
Medigen Contact:
Paul Torkehagen
Director, Overseas Business Development
paul@medigenvac.com
BlueWillow Contact:
Lauren Arnold
Vice President
LArnold@macbiocom.com
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.”
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.
ANN ARBOR, Mich., (August 6, 2019) – BlueWillow Biologics® today announced the company has been recognized as one of the 2019 “Cool Places to Work in Michigan” by Crain’s Detroit. Select companies across the state were honored based on employee feedback.
BlueWillow earned its spot on the list by being recognized as a company with a high level of employee engagement, satisfaction and a positive and empowering work culture. Finalists were selected based on confidential employee survey responses that analyzed perspectives on workplace culture, company leadership and other aspects of work.
“BlueWillow has achieved many important accomplishments, and as we stand here today, the company is potentially entering the most exciting time in our history. Our achievements wouldn’t be possible without our talented and dedicated team of employees,” said BlueWillow CEO Dave Peralta. “We strive to create an environment that offers our employees a great place to work and provides them an opportunity to utilize and build upon their many unique talents. At BlueWillow, we genuinely care about our employees and I’m pleased that caring makes us ‘cool’. The recognition by Crain’s is truly an honor.”
BlueWillow is an Ann Arbor-based biopharmaceutical company focused on developing intranasal vaccines with its patented nanotechnology. The company’s unique NanoVax technology elicits both systemic and mucosal immune responses, providing two layers of immunity for increased protection against respiratory and sexually transmitted diseases.
Employee survey responses pointed to several areas that lead to high work satisfaction at BlueWillow, including supportive coworkers, effective leadership, commitment to work-life balance and the impact that the company’s technology can have on preventing disease. Competitive compensation, benefits and fun work events were also noted as items that differentiate BlueWillow from other workplaces.
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.
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.”
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.
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.
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.
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.
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.
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.
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.”
ANN ARBOR, Mich., (June 19, 2017) – NanoBio Corporation today announced the progression of a novel intranasal anthrax vaccine into a pre-clinical IND-enabling toxicology study funded by the U.S. National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID). The vaccine combines NanoBio’s novel intranasal nanoemulsion (NE) adjuvant with recombinant protective antigen (rPA) for anthrax from Porton Biopharma Ltd (PBL). Following the pre-clinical toxicology study, the vaccine will progress to a Phase 1 clinical trial.
The advanced development of the vaccine candidate is the result of a modification to PBL’s existing NIAID contract (#HHSN272201600045C), which totals more than $24 million throughout it’s eight-year term if all options are exercised. The modification, valued at $5.6 million, supports further research of the vaccine components and technologies that accelerate the immune responses for use in post-event settings following the intentional release of the Category A priority pathogen Bacillus anthracis, the bacterium that causes the disease anthrax. Under the contract, NanoBio, PBL and Public Health England are partnering to produce a more effective vaccine than the currently licensed injectable product, by enabling immunity to be achieved in fewer doses and via intranasal delivery.
“Based on studies completed in the primary animal challenge model for anthrax, our vaccine offers the potential to enhance immunity with fewer doses and easier administration,” said David Peralta, chief executive officer of NanoBio. “Our partnership with PBL and Public Health England—clear leaders in the field of anthrax vaccine research and development—is critical to efficiently progressing our intranasal NE-rPA vaccine candidate to human clinical trials.”
Anthrax is caused by the spore-forming bacterium Bacillus anthracis, and most commonly infects wild and domestic animals. Anthrax occurs in humans when they are either exposed to infected animals or to the organism directly, which could occur following a bioterrorist attack. In humans, the mortality of untreated cutaneous anthrax ranges up to 25 percent, but increases to nearly 100 percent in inhalational and intestinal cases. The currently available vaccination schedule for anthrax consists of three primary injections at zero, one, and six months, two booster doses at months twelve and eighteen, and then followed by annual boosters for prolonged protection. Epidemiological evidence indicates the current vaccine may cause acute side effects and may only provide partial protection from certain strains.
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, prophylactic and therapeutic HSV-2, and chlamydia.