Dr Matthew Lakelin is a co-founder of the company, who has led the deployment of TrakCel’s software to a wide range of advanced therapies, including CAR-T, TILs, personalised immunotherapies and neoantigen cancer vaccines. At Advanced Therapies 2023, we caught up with Lakelin to discuss the event, wider industry sentiments and how to ensure the public is educated and comfortable with cell and gene therapies, as they grow in popularity.
BPR: How has Advanced Therapies Europe 2023 been for you? Have you had any interesting conversations and identified any key trends from the event?
First of all, Advanced Therapies Europe is always a great event. It’s a real melting pot for the European cell and gene therapy community. A lot of the events we attend are very much US focused, so it’s nice to get a finger on the pulse of what’s going on in Europe at the moment with the Advanced Therapies community. As it’s a small community, it’s a great opportunity to catch up with old friends, people we’ve been speaking with for years. Also, to understand where the industry is going, in terms of those companies that have been trading for a few years – how well their clinical development is going and how their patients are responding. That’s always really exciting to find out, you’ve got these therapies that are starting to work and starting to show clinical promise. This is crucial for us as we get to understand how the industry as a whole is developing.
At the moment, the sector is really holding its breath, because there’s a whole raft of Advanced Therapy products currently going through assessment by the EMA and FDA. So I get this feeling that we’re pausing and anxiously awaiting their responses to those, as it could trigger a new wave of treatments that will encourage investment and further innovation. I’ve also noticed that the industry has started to think about different types of therapeutic products. So we might be seeing a shift from auto to allo or more targeted allo therapeutics, as well as some work around manipulated cells. This won’t come to fruition for about 10 years I think, but potentially moving away from viral vectors and using different ways to get genetic material into cells.
So, what we see here is an inflection point in the industry, where we’re waiting and I suspect what we’ll see is a lot of positivity coming towards the end of this year and significant investment on the back of this.
BPR: Are you seeing a change in the European market? Perhaps less of a reliance on the American market?
The smart companies are looking at both markets. A lot of these products are for relatively small patient populations, so therefore the smart companies are developing their products for both. But there was an interesting point made yesterday by Adaptimmune saying that, although you have the European Union, you may have country-specific regulations and approval mechanisms that need to be undertaken. So it’s easier and may be a little faster in the US. But it’s not to say that these companies aren’t focused on Europe, they absolutely are as there are so many patients here.
What I always find from TrakCel’s perspective is that it is easier to raise money in the US and the valuations tend to be higher for companies. So unfortunately, a lot of cell and gene companies are attracted to the US because of the ability to raise capital and large sums. What we’ve done at TrakCel to help those companies with smaller resources is we’ve introduced some entry-level orchestration systems. So for early first-in-human studies and smaller follow-up studies, they can use our platform, simply and cost-effectively, rather than purchasing full enterprise system. It’s a way of starting to use the type of technologies that they would need to get their products commercial as early as possible. They can get a feel for the technology and how they might manage their supply chains as they move forward.
BPR: Another key talking point at the event has been sustainability, in terms of flying cells and treatments across different countries and the carbon impact. Is this on TrakCel’s radar and how big of an issue do you think it is?
That’s a really interesting point. I think the industry is maturing and it's starting to recognise the impact it has on not just patients, but actually the environment as whole. Whereas if we think about five years ago, there was still a focus on the curative nature of these treatment and other considerations were very much secondary. To a certain extent that's sort of human nature because we're trying to save lives. But what I find really interesting is that companies are starting to think about their carbon footprint, how they can reduce it or potentially offset it. These products are very difficult to make and there are certain manufacturing challenges. At the moment, centralised manufacturing seems the smart thing to do – as it’s easier to control in one location.
So, companies should be thinking about carbon offsetting, because at the moment you still have to move cells around. The companies we’re speaking to are in a process of offsetting carbon, they are trying to reduce, but there are certain things that are unavoidable.
BPR: Are people not also focused on decentralised?
There is a movement in the industry to try and get decentralised manufacturing to work. But for early phase companies, there's a significant cost challenge associated and a risk with process drift. If you’re manufacturing a cell-based product in several locations, there is a risk that processes will change, over time tolerances will change, so you may get a different cell product. So offsetting against centralised manufacturing is far better. Certainly for that early phase work, I wholeheartedly recommend centralised manufacturing. Long term, it would be great if decentralised manufacturing could work, and potentially not a manufacturing facility but a hospital or manufacturing facility in every country. I believe you're still going to have to move those drug products, but it will decrease the carbon footprint there. However, there are significant challenges associated with that. Each facility will need to be regulatory-approved, inspected, and you'll have to have fully qualified staff members that can manufacture a range of products and that's where the challenges lie. Until we can really standardise certain aspects of manufacturing, decentralised manufacturing, is going to be challenging.
BPR: How do you see the public perception of cell and gene therapies changing over the next five years? Will they become more commonplace outside of the industry?
Taking one example, Adaptimmune has an approval underway at the moment. Once that comes through and hopefully it will be a positive approval, we’ll start to see these advanced therapies treating solid tumors. That’s going to really drive the industry forward because at the moment we’ve had a great deal of success in blood-based tumors, hematological malignancies. If we can start treating solid tumors, those patient populations become wider and more and more people will start to understand the profound effects that these advanced therapies can have.
There is also an education piece that needs to be done here. I think about some of the very extreme reactions to the COVID-19 vaccine, for example. We need to be sure as an industry that we present the way in which these therapies work and the way in which they're manufactured, in such a way that it's easy to understand, and hopefully easy to accept. Because we are, certainly for most of these treatments, we are genetically modifying some of the cells. It's an important part of the proliferation of these advanced therapies, to ensure that the general public understands that genetic modification is essential for the patient and is of no real risk to them. With all medicine, there's a risk benefit analysis and the risk of that genetic modification is far lower than the benefit that the treatment has. Therefore, there definitely needs to be a movement to help educate individuals. I have actually seen some really interesting aspects of this already being undertaken. I believe in the UK, in the GCSE syllabus, they have CAR-T treatments. So there is an approach now to start proliferating and get people thinking about these types of treatments.
But you're absolutely right, for acceptance, we do need to help with that education piece, because what we don't want to have is these wonderful, curative treatments available and certain portions of the population not wanting to take them because of concerns associated how they’ve been produced.
BPR: Can you share any upcoming developments at TrakCel?
We’ve got some customers that are about to launch their products commercially. So we’ll be supporting a few more commercial products by the end of this year, and that’s always exciting for us. As some of those customers have been with us since the very beginning, from their first into human studies. We love seeing our customers succeed. We love to see them treating patients. It’s brilliant to see them as they go through their clinical to commercial journey. Something we’ve also done at TrakCel, as well as helping with the transition from clinical to commercial, we’ve built some additional connections with different types of systems. We've got a connection with a pair of approval systems. So we're trying to simplify the supply chain for everyone, not just clinical suppliers but commercial suppliers too.
BPR: Following these companies along their clinical journey, it must be a rewarding part of your job?
It's a fabulous part of my job. Something we do at TrakCel is to help our employees understand the importance of the cell and gene therapy industry. We invite our customers to present to our groups and we really get them to focus on their patients and get them to focus on how their drug product is treating people and giving them hope. That is probably the best thing about working in the cell and gene therapy industry. We get to see those profound clinical responses for people who, a few years ago, wouldn't have had any hope of surviving.
