Prokarium and Probiomed Scale Up Manufacture of Oral Vaccines

Biotech firms Prokarium and Probiomed have announced a collaboration to scale-up the manufacture of orally administered vaccines in a formulation that would enable stability at 40°C for several weeks.

The first vaccine to be manufactured will be developed to prevent so-called ‘Montezuma’s revenge’ or diarrhoea, which affects the local population as well travellers in Mexico and many countries.

The leading bacterial causes of diarrhoea are Shigella, enterotoxigenic E. coli (ETEC) and Non-Typhoidal Salmonellosis which together account for 1 billion cases worldwide every year. When children in developing countries contract diarrhoea and it is not treated, it can cause severe dehydration and death. A vaccine could prevent bacterial diarrhoea but none is currently available.

This two-year project builds on preclinical work already conducted on a diarrhoea vaccine using UK-based Prokarium’s novel oral vaccine delivery platform and combines this with Mexican Probiomed’s pharmaceutical manufacturing capability to construct, test and manufacture to clinical scale a novel oral, thermostable vaccine against diarrhoea.

Self-administered oral vaccines will significantly reduce the cost and increase the scope of vaccination, especially if they are thermostable over several weeks during the final stages of distribution. Syringe reuse causes 1.3 million deaths p.a. and results in over $535 million p.a. in additional healthcare costs. Injections must be carried out by healthcare professionals and in combination with the need for a refrigerated supply chain, this means many people never get vaccinated.

A capsule or liquid is swallowed and passes through the stomach to the intestine where it releases safe bacteria. These have been engineered to produce vaccine from inside the body’s own immune cells – right where it is needed and where it minimises chances of side effects.

Prokarium’s CEO Ted Fjallman commented: “Prokarium’s technology avoids the need for injections with a needle and more importantly means it can be delivered to people living in remote resource-poor areas, as the vaccine is stable at high temperatures and can be manufactured for approx. one third of the price of conventional injectable vaccines. Together with Probiomed we now aim to prove we can scale-up and make enough of these vaccines to really make a difference to people worldwide.”

Probiomed’s CEO Jaime Uribe Wiechers added: “One of Probiomed’s strategic goals focuses on the company’s capitalisation of its advanced manufacturing technologies; a very important step is taken by this collaboration. I’m positive that the technological background of this product, along with Prokarium’s expertise in biotechonolgy and our own, will lead to a high added value vaccine that will enhance people’s health on both continents.”

The collaboration is supported by the UK government’s Newton Fund, administered by Innovate UK, and by the Mexican government’s innovation agency CONACYT. The project is important both for Mexico’s own people and for its tourism industry. The results will be widely applicable to many different vaccines for difficult-to-target diseases worldwide.