Prokarium and Probiomed Scale Up Manufacture of Oral Vaccines

Prokarium, a UK-based biotech company focused on oral vaccines, and Probiomed, a privately owned Mexican biopharmaceutical company, have begun 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 companies announced on January 4, 2016. The first vaccine to be manufactured will be developed to prevent diarrhea, which affects the local population as well travelers in Mexico and many countries.

The leading bacterial causes of diarrhea are Shigella, enterotoxigenic E. coli (ETEC) and Non-Typhoidal Salmonellosis, which together account for one billion cases worldwide every year, according to a press release from the companies. When children in developing countries contract diarrhea and it is not treated, it can cause severe dehydration and death. A vaccine could prevent bacterial diarrhea, but none are currently available. The two-year project builds on preclinical work already conducted on a diarrhea vaccine using Prokarium’s novel oral vaccine delivery platform and Probiomed’s pharmaceutical manufacturing capability to construct, test, and manufacture to clinical scale a novel oral, thermostable vaccine against diarrhea.

The use of self-administered oral vaccines will significantly reduce the cost and increase the scope of vaccination, especially if the doses are thermostable over several weeks during the final stages of distribution. Syringe reuse causes 1.3 million deaths and results in over $535 million in additional healthcare costs each year, according to the press release. 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 vaccine, however, is swallowed and passes through the stomach to the intestine where it releases safe bacteria that have been engineered to produce vaccine from inside the body’s own immune cells.

“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 approximately one-third of the price of conventional injectable vaccines,” said Prokarium’s CEO Ted Fjallman in the release. “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.”

“One of Probiomed’s strategic goals focuses on the company’s capitalization of its advanced manufacturing technologies; a very important step is taken by this collaboration,” said Probiomed’s CEO Jaime Uribe Wiechers in the release. “I’m positive that the technological background of this product, along with Prokarium’s expertise in biotechnology 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.

Source: Prokarium and Probiomed