The purpose of Global BioShield is to provide widespread protection against the coronavirus SARS-CoV-2 (COVID-19), enabling the world to re-open and stop the damage to the global economy. It will create a platform for tackling future pandemics.
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. Meaningful interventions are urgently required to enable society and commerce to resume and approximate to the pre-pandemic norm.
Heroic efforts have led to the development of multiple active vaccines, but full roll out will be protracted and many groups will remain unprotected or sub-optimally so. Passive immunity is an important tool for the prevention and control of infectious pandemics and can help to fill the gap.
The Breakthrough Solution
Polyclonal anti-SARS-Cov-2 IgY
The Bridge Institute, working with a global team of medics, scientists and entrepreneurs, has progressed a passive immunity solution called Polyclonal anti-SARS-CoV-2 IgY. It is a humanitarian enterprise, designed to provide widespread and accessible protection via simple technology that can be transferred to every country for local production.
To create the product, chickens are immunized with an inactive form of SARS-CoV-2 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 self-administered intranasally, one or twice daily, and offers immediate short-term protection. The polyclonal IgY binds to and neutralizes SARS-CoV-2 virus in the nasal passage, preventing disease progression and rendering the infected person ‘virus-free’. This then stops virus spread, decreasing the transmission factor to very low levels. The product can be used ongoing for prevention in vulnerable individuals.
The product will be controlled as a biologic by regulatory bodies and will require physician prescription.
It can be cost-effectively scaled globally during 2021. It will be zero-waste, as all non-IgY components of the egg will be utilised. There are many situations where the product will be utilised and it should enable society to restart more securely alongside the current vaccine efforts.
A global passive immunity with Polyclonal anti-SARS-CoV-2 IgY
High impact, low burden
Vaccination of chickens and processing of eggs is already carried out on an industrial scale.
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
The proof of concept includes immunization, egg collection, IgY titer determination and neutralization studies – all of which have completed successfully. Regulatory interactions include submission of a pre-IND (Investigational New Drug) request to the US Food and Drug Administration (FDA) to align on the proposed development program. We will also ensure that other national agencies receive regulatory applications to allow the usage of the product worldwide.
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 globally, enabling rapid production at volume. This film demonstrates the pace at which egg procession already occurs: https://youtu.be/OVZCU4aOMAc.
Global BioShield Leaders
Global BioShield is being led and guided by an international group of professors of medicine, pharmaceutical scientists, immunologists, infection disease experts, and regulatory experts.
Declan has over 30 years of industry experience in both major pharma and biotech.
He was the Head of Worldwide Development at Pfizer, where many multi-billion-dollar programs were delivered (e.g., Viagra, Lipitor and Zoloft). He has held a number of executive positions in Pfizer in the US, the UK and Japan. Since leaving Pfizer in 2007 he has been engaged in executive roles in small pharma. Declan was CMO and acting CEO of Amarin (AMRN: Nasdaq), transforming it from a failing neuroscience company to a vibrant cardiovascular company. He went on to co-found Biohaven (BHVN: NYSE) specialising in neurology and psychiatry. Declan is also an investor in emerging biotechnology and technology companies. He holds a number of board appointments, principally in pharma companies, and has also Visiting Professor at Glasgow University Medical School.
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.
Eric J. Mathur
Eric Mathur serves as Chief Science Officer of Diomics Corporation. His career spans 40 years in basic & applied biotechnology with a focus on translational science. His expertise encompasses molecular biology, genome sciences, environmental microbiology, molecular diagnostics & high throughput drug discovery.
Eric is an accomplished biotechnologist with more than 50 publications and over 100 issued patents. His passion lies in leveraging genomics, biologics & polymer technologies to develop science-driven nutraceuticals, plant-based-medicines and modern therapeutics.
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.
Leonie Foster is an experienced retail leader. She has particular expertise in proposition development, digital transformation, communications and multi-channel operations.
She has held leadership roles at Tesco and OC&C Strategy Consultants and most recently at Dunelm, as Chief Customer & Digital Officer. She is a member of HMRC’s Customer Experience Committee. She is passionate about creating brands that make life better for people – both customers and colleagues.
Jane Sassienie is one of the co-founders of the Bridge Institute and the Programme Architect. She specialises in designing and facilitating tri-sector programmes that bring leaders together to come up with new ways of solving seemingly impossible societal problems.
With an organisational psychology and psychotherapy background, she researches new approaches for creating societal leaders and is currently researching how women leaders succeed to tackle the persistent inequality that plagues the world’s organisations.