Tag Archive for: intranasal

BlueWillow Awarded NIH Contract to Advance Development of its Therapeutic Peanut Allergy Vaccine

Research Will Progress Treatment for Millions Suffering from Peanut Allergies

ANN ARBOR, Mich., (October 1, 2019) – BlueWillow Biologics®, a clinical-stage biopharmaceutical company, today announced it has been awarded a Fast-Track Small Business Research Innovation (SBIR) contract from the National Institute of Allergy and Infectious Diseases (NIAID) for the development of an intranasal therapeutic peanut allergy vaccine using the company’s NanoVax® platform. Pending approval of all phases, the contract will provide funding of up to $3.2 million which will enable BlueWillow to complete preclinical research and prepare to file an Investigational New Drug (IND) application for its candidate vaccine.

Peanut allergy is one of the most common food allergies, affecting over 7 million people worldwide and forcing families, schools and caregivers to manage the daily challenge and stress of keeping loved ones safe. Unfortunately, there are no approved treatments for peanut allergy. The current standard of care remains peanut avoidance which leaves many at risk of accidental exposure and potentially life-threatening allergic reactions. Oral and topical allergen-specific immunotherapies attempt to temporarily desensitize patients by regularly administering a progressively increasing amount of peanut allergen. However, these treatments can induce serious allergic reactions and their benefits are rapidly lost if therapy is ceased.

“Food allergy is a very significant healthcare concern today, and even more alarming is the fact that incidence is increasing,” said BlueWillow CEO Dave Peralta. “The immunotherapy regimens being studied provide some hope for families with loved ones suffering from food allergies, but these therapies come with risks and limitations. BlueWillow’s peanut allergy vaccine is a unique approach which combines miniscule amounts of purified peanut protein with our novel intranasal NanoVax system and is designed to reprogram the immune system to induce long-term suppression of allergic reactions. Our peanut allergy vaccine has demonstrated this profile in numerous animal studies, and we are thrilled to win this Fast-Track contract which will allow us to advance the program towards Phase I clinical studies.”

In animal studies conducted by researchers at the University of Michigan and published last year in The Journal of Allergy and Clinical Immunology, the NanoVax peanut vaccine was effective in treating established allergic disease by shifting the immune system towards a Th1/Th17 response and thereby suppressing inflammatory allergic responses. The first phase of the project will be completed in collaboration with Dr. Jessica J. O’Konek and other peanut allergy experts at the Mary H. Weiser Food Allergy Center at the University of Michigan. The associated work is being funded in whole with $300,000 of federal funds from NIAID, an institute within the National Institutes of Health (NIH) which is part of the Department of Health and Human Services, under Contract No. 75N93019C00035.

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.

BlueWillow Biologics Awarded Patent for Intranasal Genital Herpes Vaccine

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.

BlueWillow Biologics Announces Issuance of Intranasal Anthrax Vaccine Patent

Initiation of Phase One Clinical Studies Expected This Year

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.

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.

BlueWillow Biologics Announces Issuance of Therapeutic Cancer Vaccine Patent

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.

NanoBio Announces Corporate Name Change to BlueWillow Biologics and Closes $10M Series A Financing

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.

University of Michigan Researchers Show Intranasal NanoVax Vaccination Suppresses Peanut Allergies in Mice

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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NanoBio Awarded U.S. Patent for RSV Vaccine

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.