Stabilitech’s OraPro™ technology enables the oral administration of ‘plug and play’ viral-vectored biopharmaceuticals and vaccines
OraPro: a ‘plug and play’ oral vaccine/biopharmaceutical platform
- Oral administration of non-replicating vector
- Thermally stable oral capsule, cold-chain free distribution & storage and able to withstand the temperature and acidity of the stomach
- Provides both systemic and mucosal immunity from viruses
- Repeat administration is possible with the same vector carrying the same or new payload
- Transient biopharmaceutical production is induced within the patient’s gut
- Suitable for vaccines, therapeutic proteins and enzyme replacement
By re-using the vector for new developments, large parts of the regulatory dossier can be reused, accelerating research, testing and manufacturing
Currently, biopharmaceutical proteins are synthesised using recombinant technologies within various expression platforms, such as mammalian, plant and bacterial cells. The result is that biopharmaceutical drugs are expensive and time-consuming to manufacture and many have therapeutic complications.
One of the key advantages of oral administration of a non-replicating viral vector is that it offers the potential for repeat administration of the same vector. This is due to a lack of anti-vector immunity in the gastrointestinal (GI) tract. This allows the same vector to be repeatedly administered and re-used for multiple developments.
However, effective oral administration is difficult because of challenges within the human gut: it takes time to reach the small intestine and the thermal and acidic conditions in the GI tract are hostile to viruses. Without protection, considerable numbers of viruses can be lost, significantly affecting the viability and efficacy of the vector. This remains the major barrier to the development of oral vaccines and companies using viral vectors are forced to revert to using injections.
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 the GI tract to produce proteins to provide novel therapies or induce immunity. The novel technology within the OraPro platform protects and delivers non-replicating viruses to the GI tract, ensuring a high delivery of viable viruses. Because OraPro is a ‘plug and play’ platform, only the DNA insert coding for the infectious disease antigen is changed. A new vaccine is therefore created using the same viral vector. By delivering the viral vector directly to the gut, OraPro bypasses existing or subsequent immunity due to the immune tolerance of the GI tract.
Stabilitech has successfully used OraPro to develop an oral Zika vaccine, OraPro-Zika™, which is ready for Phase I clinical trials and an oral COVID-19 vaccine, OraPro-COVID-19, which is currently in the development phase.