Q&A on Nipah Virus with Wayne Channon, Executive Chairman

1. What exactly is Nipah Virus and how does it affect patients?

Nipah virus is a zoonotic infectious disease, meaning that it has jumped from animals to humans, like coronavirus. Nipah lives in fruit bats and can spread to humans through food and drink contaminated by fruit bat droppings. The virus was first discovered in 1999 following an outbreak of disease in pigs and people in Malaysia and Singapore. It’s part of the henipavirus genus of paramyxoviruses, similar to measles and mumps and is incredibly serious. It can kill as many as three out of four infected people so there is an extremely urgent need to develop a safe, effective and easily administered vaccine to prevent a future pandemic.

2. Why has it been deemed a future pandemic threat?

While outbreaks so far have been small and localised to parts of the Indian sub-continent as well as Asia, the opportunity for the virus to spread from fruit bats to other animals and to humans is extremely high given they are in close contact. The virus can also spread from human-to-human and is thought to do so through saliva and respiratory secretions, similar to coronavirus. It also has an incubation period in humans of up to 45 days, increasingly the likelihood of human-to-human spread. There is very little awareness about the virus, which increases the chance of outbreaks.

3. What is the funding you’ve received to progress your Nipah virus vaccine candidate?

We’ve received £288,000 in funding from the Department of Health and Social Care’s UK Vaccine Network programme, delivered by Innovate UK. It is part of a larger programme by the UK government, funded by UK Aid, to develop new vaccines and technologies to tackle diseases that have the potential to become epidemics. It’s fantastic to see the UK government thinking ahead and supporting innovation in this important and previously underserved area. The funding will be used to help us develop an oral vaccine candidate against Nipah.

4. What will the funding enable you to do?

This funding will help us to develop a tailored adenovirus vector to deliver some of the genetic material of the Nipah virus into human cells, which will trigger an immune response and stimulate the body to produce antibodies and T cells to protect against future exposure. We will be utilising our OraPro™ thermal stabilization technology to create a vaccine that can be administered orally. It will allow us to undertake preclinical studies and get the vaccine to a point where we have a candidate that’s ready to progress towards clinical testing.

5. Could you tell us more about your OraPro™ thermal stabilization technology and how it was developed?

Our OraPro™ platform technology enables us to create vaccines that can be administered orally in capsule form. It makes the viral vector thermally stable, capable of withstanding temperatures of up to 50°C, and so can pass through the hostile conditions in the stomach without loss of efficacy.

It was developed out of original work being done by our Chief Innovation Officer, Dr. Jeff Drew, to alleviate the cold chain requirements for vaccines, which results in around half of vaccines being wasted due to storage at incorrect temperatures and limits global access to vaccines, particularly to low- and middle-income countries where temperature control is expensive. The ability of our oral vaccines to withstand high temperatures removes refrigeration requirements during manufacturing, shipping and storage, and increases access.

6. What will be the biggest challenges for this vaccination programme?

The lack of awareness of the virus within the communities where the risk of infection is high is a huge challenge. Given these communities are situated in rural, difficult to reach areas, once a vaccine is approved, there will be a big challenge in shipping and storing the vaccines. An oral vaccine would be extremely advantageous in that it does not require refrigeration and can be taken in capsule form without the need for a healthcare professional.

Q&A – Jeff Drew, Chief Innovation Officer

1. Tell us about your career before founding iosBio.

I was a relatively late starter into a scientific career. I have always been interested in science and microorganisms, but my interest wasn’t properly ignited until I undertook a technical qualification at a south Wales college. This led me to my undergraduate degree in Microbiology and Virology at Manchester University and subsequently on to a PhD in Molecular Virology from The Institute of Animal Health at Pirbright & Reading University. During my career I’ve covered a wide range of research areas including virology, cancer, gene therapy and genetic research at a number of institutions including University of Oxford, Marie Curie Research Institute, the Exotic Virus Research Laboratories at the Institute of Animal Health, and the Institute of Cancer Research.

2. How did you become interested in the field of virology?

There was always a boyhood fascination with microbiology, however my exposure to the undergraduate study of viruses re-focussed my interest and I became spellbound with how they work, are able to avoid the immune system and cause disease, and how vaccines can be used to eradicate those diseases. My first degree cemented that fascination, provided context and detail and instigated some of my early thinking of how to utilise the core features of viruses, i.e. essentially avoiding the immune system to deliver genetic information to cells, to immunise against infectious disease but also the potential to treat genetic diseases.

3. How did you come to develop iosBio’s proprietary OraPro™ technology?

Our original work at iosBio was aimed at alleviating the cold chain for vaccines, a system which often fails and leads to around 50% of all vaccines being wasted, largely due to storage at incorrect temperatures. The thermal stability our core technology provides to vaccines and viral vectors enables 25°C storage for years and 56°C for short periods of time – sufficient for cold chain free delivery to locations anywhere in the world. As we began developing our own viral vector-based pipeline we explored other routes of vaccine administration, which ultimately led to our OraPro™ technology.

4. Can you tell us a bit about how OraPro™ works?

Viral vectors are used to deliver DNA to a cell so a particular protein, such as a SARS-CoV-2 antigen or a therapeutic protein, can be produced from that cell to provide a patient with immunity or therapy. Typically, viral vectors are engineered to be non-replicating, that is they cannot make more viral vector copies of themselves within a patient’s cells, so preservation of vector activity is pivotal for maintaining efficacy.

When delivered via injection, a patient’s immune system will develop immunity to the viral vector, meaning subsequent uses of that viral vector will be less effective or have no effect in causing cells to produce the protein. However, as the gastrointestinal tract is home to a huge microbiome (bacteria, yeasts, viruses) it has intrinsic tolerance mechanisms which mean repeated use of a viral vector would be possible. However, viruses and viral vectors are typically very sensitive to both temperature and acidic environments – oral delivery of a vaccine relies on transit through the stomach for several hours at 37°C and a low pH, which would cause rapid breakdown of a viral vector.

Our OraPro™ platform combines both thermal and acidic protection for a non-replicating viral vector through the stomach and a controlled release in the small intestine where the viral vector can cause gut cells to produce antigens for vaccines or proteins for therapeutics. The oral delivery allows us to reuse our viral vector repeatedly without generation of an anti-vector response. When viewed from a patient and healthcare perspective oral medicines are much preferred and far easier to distribute.

5. Tell us about your role as Chief Innovation Officer. What does a typical day look like for you?

Whilst every day is different, typically there’s a lot of technical dialogue and data interpretation and providing scientific direction. We’re fortunate to run a closely knit scientific team where everyone supports each other & our work dovetails across our development programmes so technical debriefs are intellectually rewarding and push our science forward rapidly. I also dedicate a reasonable proportion of my time to developing new IP.

6. What excites you about iosBio?

The progression from a preclinical company into clinical company has been an incredibly rewarding time for us; building up the strength in depth of our team of scientists, expanding our manufacturing expertise to transition our technology from pilot/small scale to manufacturing at commercial scale with ImmunityBio has also been rewarding. Taking our oral delivery technology to address other vaccines and using it to increase vaccine coverage and improve their effectiveness will be incredibly exciting for me and the whole iosBio team.

7. What do you see as the biggest challenges facing vaccination programmes around the world?

The emergence of COVID-19, the rapid development of vaccines has shone a light on the two aspects that our technology address – thermal stability and reliance on needles for administration.

8. Why are oral vaccines poised to transform the future of vaccination?

Protection at the surfaces where most infectious diseases gain entry to their target is provided by the mucosal immune system. Typically, by administration of an injected vaccine a systemic level of immunity is provided, but limited mucosal immunity is generated – thus a pathogen can often still gain entry, replicate and cause onward transmission to those who are not vaccinated or immune. Oral vaccines engage with mucosal associated lymphoid tissue and Peyer’s patch to induce antibody and T cell responses both systemically and at the mucosal surfaces, ultimately resulting in enhanced protection.

From an administration perspective, oral vaccines are self-administered by the individual which means no physical contact required between the healthcare professional and the patient – in pandemic/epidemic situations this will reduce risk of transmission during the vaccination process. There’s also the possibility of vaccines being delivered by mail or door to door which has been successfully demonstrated in typhoid vaccine studies in Nigeria, Zambia and Guinea.

9. With no need for cold chain storage, tell us about the impact that oral vaccines can have on developing countries.

The WHO produced a report on vaccine wastage that showed around 50% of all vaccines are wasted. A large proportion of these are due to lack of temperature control and the logistics required for an unbroken cold chain. Thermally stable vaccines will mean all nations should have the ability to access effective vaccines for prevalent or emergent infectious diseases.

It’s also worth pointing out that this isn’t just an issue for developing countries, controlled cold chain logistics are prone to errors or failures – an audit within the USA found that 76% of vaccine centres exposed their vaccines to inappropriate temperatures, whilst in Korea recently they had to dispose of 5 million flu vaccine doses after they were stored at an incorrect temperature.

10. What are you hoping to achieve at iosBio?

The ultimate goal is to transform vaccinology through thermally robust vaccines, delivered without the need for needles, which provide the broadest immunity possible.

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The team of doctors and scientists at iosBio believe that the next great leap forward in immunization will be oral delivery

Enabling the fastest and most cost-effective deployment of vaccines the world has ever seen. This is not just a huge leap forward from a humanitarian perspective, oral vaccine technology also represents a significant commercial opportunity.

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