The purpose of BioShield is to provide widespread protection against the novel coronavirus SARS-CoV-2 (COVID-19), enabling the world to re-open and stop the damage to the global economy.
The coronavirus SARS-CoV-2 (COVID-19) is now a worldwide pandemic, overwhelming health care systems globally and creating profound economic and human distress and damage. In addition, risks of food insecurity in developing economies are growing rapidly. Meaningful interventions are urgently required to enable society and commerce to begin to re-open and approximate to the pre-pandemic norm.
Vaccines are key to the long-term solution, but may take one to two years to be developed and may not work for all groups, such as the elderly. In the interim, an important tool for the prevention and control of infectious pandemics is passive immunity.
The Breakthrough Solution
Polyclonal anti-SARS-Cov-2 IgY
The Bridge Institute, working with leading scientists, has progressed a passive immunity solution called Polyclonal anti-SARS-CoV-2 IgY. Specific pathogen-free chickens are immunized with inactivated SARS-CoV-2 coronavirus and their eggs are harvested. Polyclonal yolk immunoglobulin (IgY) is extracted from the yolks using a water dilution method, followed by further purification. Clinical studies have demonstrated that polyclonal IgY antibodies with high purity can neutralise viruses with efficacy and safety.
After refinement, the product can be administered orally and/or intranasally, twice daily. The polyclonal IgY binds to and neutralizes SARS-CoV-2 virus in the nasopharynx and gastrointestinal tracts, offering immediate protection. This product will rapidly clear the virus from the nasal passages and gastrointestinal tract, thus rendering the infected persons “virus free’. This then stops virus spread, decreasing the transmission factor to very low levels.
It can be cost-effectively scaled globally by October 2020. It is a bridging solution, which offers immediate short term protection for individuals, until a global vaccine is developed.
A global passive immunity with Polyclonal anti-SARS-CoV-2 IgY
It is rapidly scalable
Vaccination of chickens and automated collection and processing of eggs is already carried out on an industrial scale – 30m doses a day could be made in one farm.
It is inexpensive
Estimated cost of each dose is between (US) 3 cents and 12 cents.
It is safe
IgY has been proven to be safe for humans and does not create an inflammatory response. It is natural and does not involve humans being exposed to the virus.
It is suitable for all
Including compromised patients with comorbidities and the elderly.
The protection is immediate
Consumption twice a day will provide the required protection.
It will not burden the health system
A self-administered treatment, either intranasal or oral.
The Stages of Development
The program comprises of two key stages: (1) Proof of Concept and Regulatory Interactions and (2) Human Studies, Scale up and Manufacturing.
Proof of Concept and Regulatory Interactions
Human Studies, Scale-up and Manufacturing
This stage includes the clinical development program as agreed with regulators (e.g. the FDA), and the national / international planning and preparation for scale-up. Manufacturing feasibility has been established for inoculant preparation, flock immunization, egg collection, breaking, separating and drying. Large scale IgY extraction and lyophilization facilities are commercially available, enabling rapid production at volume.
BioShield is being led and guided by an international group of professors of medicine, pharmaceutical scientists, immunologists, infection disease experts, and regulatory experts.
Declan Doogan MD, FRCP (Glasg), FFPM, Dsc has had a 40 year career in Pharmaceuticals. He is CMO at Juvenescence.
His experience includes Head of Worldwide Development, Pfizer; Chairman at Biohaven, Celleron and Causeway; Member of Kleo, Apterna, Intensity; visiting Progessorships in Drug Development Science at Glasgow Medical School, Kitasato University Tokyo. He is a Trustee of Bridge Institute.
Marguerita Cattell DVM MS ABVP is a specialist in Food Animal and Preventative Medicine and has conducted over a dozen clinical trials for FDA and USDA approval.
As Research Director for PanTheryx, Inc. she developed IP and conducted in vitro and in vivo studies for successful infectious disease programmes for Clostidium difficile, norovirus and rotavirus, providing patented passive immune prophylaxis and therapy for infectious diarrhoea globally.
Donnie McGrath M.D. MPH is Chief of Corporate Strategy and Business Development at Biohaven Pharmaceuticals a commercial stage public (NYSE) pharmaceutical company based in New Haven, CT. He is acting CEO of Biohaven‘s Asia-Pacific subsidiary, Bioshin, based in Shanghai, China.
He has over 25 years of clinical research and pharmaceutical business development experience. Prior to joining Biohaven he was Vice President, Business Development, and Head of Search & Evaluation at Bristol-Myers Squibb. From 1998-2005 he was a member of the Division of Geographic Medicine and Infectious Disease at Tufts-New England Medical Center.
Ronnie Miller has a strong quality background and extensive knowledge of all aspects of bio-manufacture production, characterisation testing and release of mammalian, microbial and viral bank products to cGMP compliance.
After 18 years in academia, Ronnie formed three start-up companies before he moved into the commercial world full time. He spent time at Invitrogen and Sigma Aldrich, before spending 11 years as head of Cell Biology department in Merck BioReliance, developing manufacturing and genetic stability testing strategies for stem cell, CAR-T and CRISPR constructs.
Nancy A Higley
Nancy Higley Ph.D is a food and beverage expert with forward-thinking vision enabling proactive approach to compliance and regulatory challenges, saving millions of dollars, and enabling rapid, efficient product advancements.
She has extensive experience with major authoritative bodies including Codex, China, EFSA, GCC, India, USA (FDA, TTB, USDA) and others in winning acceptance and approvals for new, market-leading ingredients.
Anthony Zolezzi is committed to making the world a better place by celebrating the incredible and extraordinary people that inhabit it. Over the last 30 years, he has worked to improve our food supply through organic agriculture, supporting small family farms, and cleaning up the planet through recycling remediation businesses and initiatives.
Zolezzi believes that people that understand how incredible and awesome they are will do what’s right for people and the planet. So we need to make sure people understand how incredible and extraordinary each individual, animal, cell or plant is on this planet.
Simon McKenzie (Mac)
Mac McKenzie is a Director of and one of the co-founders of the Bridge Institute. He specialises in facilitating strategic breakthrough for governments, corporates and civil society.
The strategic breakthrough programmes bring the highest levels of government, business and civil society together to solve pressing societal challenges and have a tested and proven approach to making breakthroughs in thinking and action to progressing the Sustainable Development Goals. Recent societal challenges have included economic growth policy, education reform, peacebuilding, safety, reconciliation, water and youth development.