OraPro oral vaccine technology

A new paradigm in distribution, administration and immunization

Vaccinations have changed the world and saved tens of millions of lives. But the methods for distributing and administering them have historically restricted their use worldwide. Injections must be given by healthcare professionals and most vaccines are still dependent on the ‘cold chain’ – constant refrigeration throughout the transit process from lab to patient. Any break in this chain will render the vaccine inactive.

Our proprietary thermally stable oral vaccine platform technology, OraPro, enables the provision of vaccines in a tablet, capsule or nasal spray. This ground-breaking technology successfully delivers non-replicating viral vector vaccines through the mucous membranes, creating effective immunity against infectious diseases. The OraPro approach can be applied to most respiratory, intestinal or systemic viruses.

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Our oral vaccine pipeline

OraPro technology provides the delivery system for several different vaccines developed alongside our partners, one of which – OraPro-Covid-19 – is currently undergoing clinical trials.

Vaccines

Biotherapeutic

SegmentCandidateDiscoveryPreclinicalIND/CTA ReadyClinical
Covid-19
Influenza & Covid-19
Zika
Rhinovirus
Norovirus
GI Therapeutics
Oncology
Vaccines
Biotherapeutics
Vaccines
Biotherapeutics
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Advantages of our oral vaccine technology:

FASTER

No need to schedule appointments or wait for availability at healthcare clinics – all oral vaccine doses could simply be posted directly to the patient’s door for immediate self-administration.

SAFER

No need for the patient to come into contact with healthcare staff or other patients in order to get vaccinated, reducing the spread of the virus. The elderly and disabled are spared the potential challenges of travelling to a clinic.

CHEAPER

With no need for clinics and healthcare professionals to administer the vaccines, and no cold chain requirements resulting in simpler modes of storage and distribution the cost savings are significant.

TARGETED IMMUNITY

OraPro is delivered to the body via the same route as an infection, ensuring that the vaccine cargo goes directly to the target cells where it generates both a mucosal and systemic immune response.

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OraPro ‐ how it works

OraPro is a ‘plug and play’ platform that produces a thermally stable viral vector, engineered with a DNA sequence to produce a target protein.

When administered orally, it uses the body’s own cells in mucosal surfaces under the tongue or in the gastrointestinal tract to produce proteins that provide novel therapies or induce immunity.

The thermostability technology within the OraPro oral vaccine platform enables the viral vector to pass through the stomach to the GI tract without being damaged or rendered ineffective by the body’s 37C temperatures.

The OraPro platform can be used to administer vaccines for many different diseases – only the DNA insert coding for the infectious disease antigen is changed, and a new vaccine can then be created using the same viral vector.

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OraPro Covid-19

The world’s first thermally stable oral Covid-19 vaccine.

As the coronavirus pandemic rages on around the world, scientists are working day and night to create safe and effective vaccines that will allow life to return to normal. Although great leaps forward have been made, we are already seeing the supply chain and logistical problems of injectable vaccines that require cold or ultra cold chain storage. And as further mutations of the virus continue to emerge, the ability to tweak and readminister vaccines becomes ever more crucial.

OraPro-Covid-19 deploys our ground-breaking oral vaccine delivery platform with the aim of creating a Covid-19 vaccine that can be sent by post and swallowed at home.

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Immunity advantages

OraPro Covid-19 vaccine vs other existing vaccines

Quad immunity

Respiratory infections are caught when viruses enter the mucosal cells in the nose, throat, lungs or intestines. Vaccines offer the best protection against respiratory infections like coronaviruses when they engage both mucosal and systemic immune responses, combined with a lasting T cell response. The primary effect of intramuscular vaccines delivered by needle is to induce systemic immunity, with the hope that this then develops into a mucosal immune response. Oral vaccines are delivered directly to mucosal immune cells, with the aim of targeting the virus where it lives.

Superior T cell response

Targeting the N-protein delivers a stronger T cell response than those vaccines that only target the S-protein. Certain T cells kill the virus and infected cells, while memory T cells provide long-lasting immunity.

Enhanced protection against mutations

All the approved Covid-19 vaccines, and most candidates, only target the spike or ‘S-protein’. This is a potential vulnerability because these vaccines may become less effective as the virus mutates. OraPro-Covid-19 targets two antigens: the S-protein and the N-protein. It is highly unlikely that the virus would simultaneously mutate in both proteins, making the ImmunityBio vaccine highly escape-resistant.

No anti-vector immunity

Some of the approved Covid-19 vaccines can only be used once, as the patient develops immunity to the viral vector itself. Thermally stable oral vaccine delivery directly to the GI tract, which is inherently tolerant to foreign substances, prevents anti-vector immunity developing. This means OraPro can be used to deliver multiple vaccines to the same patient. It is likely that the same will be true of sublingual administration.

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Our data

In recent studies, OraPro-Covid-19 has elicited antibody and T cell immunity in non-human primates, and we are now embarking on clinical trials.

NHP study - Operation Warp Speed

On behalf of ImmunityBio, Operation Warp Speed performed an independent trial of their Covid-19 vaccine in non-human primates (NHP). The trial comprised a subcutaneous injection of the Covid-19 vaccine, the Prime, then 14 days later a Covid-19 vaccine capsule using OraPro oral vaccine technology, the Boost. After 28 days, the NHPs were challenged by a full dose of Covid-19. The results show complete elimination of Covid-19 5 days after the challenge.

Antibodies

Anti-Spike lgG levels rise sharly after oral dosing

T cells

Introduction of memory T cell (CD4⁺) response to both antigens

Protection

Rapid clearance of SARS-CoV-2 from nasal and airway tissue

Ref: Gabitzsch E, et al., (2020) Complete Protection of Nasal and Lung Airways Against SARS-CoV-2 Challenge by Antibody Plus Th1 Dominant N- and S-Specific T-Cell Responses to Subcutaneous Prime and Thermally-Stable Oral Boost Bivalent hAd5 Vaccination in an NHP Study. bioRxiv 2020.12.08.416297; doi: https://doi.org/10.1101/2020.12.08.416297

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Democratizing vaccines:

a significant humanitarian and commercial opportunity

The limiting factors of current vaccine technology hinder immunization coverage in many developing countries – the World Health Organization estimates that 3 million people die each year from diseases that could have been prevented by vaccines. In the developed world, we are already seeing the difficulties of distributing and storing the injectable COVID-19 vaccines.

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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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