The non-invasive delivery of biological drugs remains a major challenge for those working in the pharmaceuticals industry. However, there have been breakthroughs in recent times. Swiss biotech company BioLingus has been named European CEO’s Most Innovative Biotech Company 2016 for its part in driving developments in this area. Such technology represents a game-changing innovation for the treatment of diabetes and inflammatory diseases, but also a social innovation for third-world countries in that it facilitates the development of low-cost oral vaccines.
Yves Decadt, CEO of BioLingus, spoke to European CEO about the marketplace in which his company is operating, and put the significance of the company’s achievements in a historical context.
What is the process of sublingual delivery and what new kinds of treatments is it making available?
Sublingual delivery means delivering medicine under the tongue. In itself, the technique is not new. However, we have developed sublingual and mucosal delivery specifically for biological molecules, and that is new. It opens the door to non-invasive delivery of many biological molecules that have so far only been taken by injections. For instance, in diseases such as diabetes and inflammatory disease, many patients have to take daily injections, as it is the only way to get their medicines administered. For some of those patients, our technology may significantly improve the quality of their daily lives.
What is BioLingus’ Seed technology and how was it inspired?
Nature is a slow but excellent designer. It has, for instance, designed the human body during evolution so that it is very effective in digesting meat. Proteins and peptides are constituents of meat, but also of a novel generation of medicines that we call biological molecules. As mentioned before, most biological molecules could previously only be taken intravenously; at BioLingus, however, we decided to look to nature to find a solution to this problem.
Stabilising the proteins and peptides was the first hurdle in order to secure oral availability for use in pharmaceuticals. While other companies have been relying more on advanced chemical excipients, BioLingus has relied on a more natural solution.
The seeds of plants contain a high concentration of proteins, which have to survive and remain intact for years, sometimes in extreme conditions of temperature, moisture or drought. The most extreme example is the sacred lotus plant, in which seeds are preserved intact over 1,000 years, meaning the proteins inside remain stable and bioactive for an extremely long time.
BioLingus’ Seed technology mimics these mechanisms, and through advanced bioengineering we have been able to come up with a way to preserve and stabilise proteins for a very long time at room temperature.
What are the benefits of sublingual delivery as compared to injections?
The main benefit of sublingual delivery is ease of administration; the sublingual area is not a very common place to deliver drugs, but it is very effective. It has a thin layer of epithelial cells and a strong bloodflow, so it’s very good if you want the drugs to be taken up quickly into the body. It is also a very good place to deliver immuno-active drugs, because of the presence of mucosal immune receptor cells.
And of course, as mentioned before, sublingual drugs can be stored at room temperature, while injection solutions must usually be refrigerated. In itself, this opens up the possibility for social innovation as well as biological innovation.
Due to the strong stability of Biolingus’ technology, sublingual drugs are very well suited for use in third-world countries. Biological drugs usually have to be cooled all the way from manufacturing right up to when they reach the patient, and then injected. In many countries, however, effective logistical cold chains are non-existent or not very good. With Biolingus’ sublingual technology, however, the cold chain may be minimised or not needed at all.
And, because the drugs can be given orally instead of by injection, complications due to infected needles (such as HIV, HBV and HCV), are also prevented. What’s more, although the technology is hi-tech, from a manufacturing perspective it is relatively low-cost. So, the combination of these factors make it an excellent technology for use in third-world countries – very much a social innovation.
What’s next in the pipeline for BioLingus?
BioLingus has a unique and proprietary technology in the strong and growing biological market. Our breakthrough technology platform allows for different types of innovation to happen in parallel, from incremental innovation through to social innovation and disruptive innovation.
In terms of incremental innovation, we are developing oral versions of the diabetes drug exenatide. We also plan to develop a sublingual cannabis extract; although this is not a biological molecule, our technology is well suited for such hydrophobic small molecules.
In terms of social innovation, we have an ongoing project to develop an oral vaccine for the treatment of leishmaniasis, which is a neglected tropical disease transmitted by sandflies.
In terms of disruptive innovation, we are conducting a project on the treatment of early-onset type 1 diabetes, with very low dose oral interleukin-2. We are also working on developing an oral influenza vaccine.
Of course, we are open to working with other innovative partners to develop additional treatments that can benefit from our technology. Combining all these different kinds of innovation could be an innovation in itself – an innovative business model.