How competitive is this field? What are the clinical advantages/disadvantages of your technology compared to other solutions on the market?
As things stand, the gold standard regenerative treatment for traumatic cartilage damage is called ‘microfracture’, which consists of perforating the subchondral bone (the layer of bone just underneath the cartilage) to induce bleeding, allowing stem cells from the bone marrow to leak out. In time, this leads to the formation of fibrocartilage – a sort of scar tissue – but this is naturally of lower quality and durability than the original cartilage. So, this treatment only offers short-term relief. After three to five years, according to our research, patients generally experience advanced degeneration and have to resort to a complete knee replacement. This is an invasive procedure with a long and complex recovery, and it still doesn’t solve the problem in the long term, as it must be replaced every 15 to 20 years, which is obviously not ideal for patients under 60.
When it comes to more innovative approaches in the field of regenerative knee repair, there is significant competition, but in my eyes, many of the options are fundamentally flawed. This is because most other competitors only use the autologous approach (where cells come from the patient), which has significant drawbacks, as patients must undergo two surgeries – one to extract their cells and one to re-implant them. And above all, it’s wildly expensive. As such, this autologous cell therapy is only available to a limited number of patients in the United States.
This is where Vanarix can come in: with our allogenic product (where cells come from donors), we can manufacture bio-implants from a cell bank, meaning patients undergo just one surgery within a much shorter timeframe. The product could feasibly be ready to implant in less than two weeks. The allogenic approach is particularly exciting, as it should allow us to keep production costs down and treat a wide range of people – cells from one donor could serve millions of patients.
What’s more, according to feedback from the 20 patients that we’ve treated thus far, the recovery trajectory is very positive. The patient can walk out of the treatment centre on the day of their procedure and then, between five and six weeks after transplantation, they can return to doing intensive physical activity.
When developing the Cartibeads technology, did you try out different approaches? What are the challenges you’ve encountered so far?
I did what everyone else has been doing for the past 30 years, which is to cultivate cartilage cells in the laboratory with growth factors. However, not only are cartilage cells not amplifiable ad infinitum, they also quickly lose their original properties. That’s why my patented technique is crucial: I’ve found a way to mass amplify the cells but then make them re-differentiate – ‘recover their memory’ so to speak – to become cartilage cells again.
Today, the main challenge we’re facing is the same one that affects the whole cell therapy industry: cost of production. At the moment, we’re working with a manual production process, which is inherently costly and difficult to scale up. Furthermore, there are stringent regulatory requirements to consider when working in this field, which can also raise costs, as we have to work in a specialised lab with state-of-the-art equipment.
We now need to forge the right partnerships to build a sophisticated master cell bank and automate our process, so that we can make an affordable, accessible solution. It doesn’t make sense to produce a treatment that’s only available to a tiny proportion of wealthy patients.