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Maroun Khoury and Max Kunze, Co-Founders of EVast Bio, introduce the cutting-edge biotech company. Focused on the development of extracellular vesicles (EVs), particularly small extracellular vesicles (sEVs), the duo discusses the therapeutic role of these cell-derived particles and their potential to revolutionize the cell and gene therapy industry.
To start with, please could you introduce yourselves and tell us a little about EVast Bio?
Maroun: I’m Maroun Khoury, I’m the Chief Scientific Officer and Co-Founder of EVast Bio.
Max: I’m Max Kunze, I’m the Business Co-Founder of EVast Bio, a newly created biotech company here in the United States, but with track record based on very interesting data generated in Chile.
EVast Bio is a newly born startup. It’s focused mainly on the development of extracellular vesicles (EVs), also called exosomes.
Maroun: They are like cell dust released by different types of cells, including stem cells, they have therapeutic effect and can also be used as advanced drug delivery.
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Max: We are aiming to apply our knowledge, our experience, but our resources as well, our strategy, to becoming one of the greatest companies in this space that can deliver extracellular vesicles into the clinic, for a variety of indications including autoimmune diseases, inflammatory-related conditions, etc.
What is the therapeutic role of extracellular vesicles?
Maroun: Extracellular vesicles in their native form, which means unmanipulated cells that secrete these vesicles, can be used to deliver their cargo. It could be microRNA, but also protein, in the different spectra of applications.
In our case, at EVast, we have validated the proof of concept in the osteoarthritis model, both preclinically, but also in the clinical stages of showing the systemic intra-articular delivery of these molecules (nanotherapeutics, we like to call them), and to show the effect on inflammation and mitigating the disease and the quality of life for our patients.
Max: Extracellular vesicles are kind of ‘the new kid on the block’. They have very unique capabilities in terms of what you can cargo inside and what tissues they can target. I believe they will be the initiators of a new era within cell and gene therapy in that cells will be slowly but surely replaced by more effective treatments such as extracellular vesicles that have the unique properties and therapeutic characteristics of the parental cells, but that have inherent characteristics, such as safety and a better dosing profile.
What impact could small extracellular vesicles (sEVs) contribute to the cell and gene therapy industry?
Maroun: Let’s talk about expectation and realistic expectation and as well mistakes and things to improve in the field of CGT.
As you all know, mesenchymal stem cells, the parental cells of this, of EVs, had a lot of challenges and very few pipelines were able to reach the market. The pressure that EVs have on their shoulders is not to commit the same mistakes the parental cells did.
Why do we think EVs have the chance to show a better therapeutic effect and drug delivery? Because they answer the challenges and hurdles we’re facing with MSCs, including manufacturing, scaling, safety, targeting, but also potency testing. They are easier to manipulate, being a compound rather than living cells that can fluctuate with their plasticity according to the milieu.
Preclinical – and we’re starting to see clinical – data supports all these claims.
Max: They can catapult many of the drugs that have poor pharmacokinetics or dangerous levels of serious adverse events into new realms of safety and efficacy.
We can partner with many of the manufacturers out there, the big pharmas, the mid-pharmas, that have an interesting drug under development, but that maybe had poor results in the clinical phases. We can partner with those companies and help them achieve the promise they anticipated these drugs could have, but now delivered through an effective mechanism or a safety vehicle – extracellular vesicles – and that’s why EVast has been launched, and we believe will serve the community very well.
What challenges are currently facing early biotechnology companies in this space?
Maroun: The challenge of any biotech company is to understand the type of investors we have to fundraise from, the regulatory framework, but also how to bring forward a competitive advantage of your technology. These three have been tackled from different angle, and have been the main challenges, as well.
Max: If we think of therapies for different indications, we have to compare ourselves with the current standard of care.
Today, many of the treatments have certain price ranges, and to be competitive and to access the market and the patients and to be offered as an alternative by physicians, we have to understand that we have to come into the market with a certain price range limitation.
In order to fulfill the promise of advanced therapies, we have to understand that regarding cost structure, we have to adequate ourselves into certain cost regimes so that we can ultimately have a drug that has a better safety, a better efficacy profile, but that is still competitive regarding other modalities but can be still offered by a physician.
That’s why we believe that in order to fulfill our promise we have to be competitive, even with drugs that may not be as good as the ones we’ve been developing.
What strategies can be employed to circumvent these challenges?
Maroun: Yeah, I like this question very much, because when we look at different fields, let’s forget for a minute biotech and CGT and look at transportation, they had a disruptive idea when ‘Uber’ and other companies came and disrupted the whole model, accommodation had their ‘Airbnb’ moments, and my question is, when will this disruptive model occur in the biotech sector? Do we need it? Or are we fine having a 12-year pipeline?
The pandemic showed us that there are ways to improve things in terms of funding but also acceleration. Should we keep spending that much money on a long pipeline? Is it reasonable to spend 3–6 million on GLP studies? Can we find a way to deliver the same safety without much spending?
These are the models that we, as a company, have built a story behind it. We’re a new company, but then with our data, the pipeline has been developed for more than a decade. Our back office is based in Chile, and this is bringing a different model in terms of cost, but also timeline. We can do clinical trials at a faster pace, also at a lower cost, and this can support the pipeline that we are developing here in the US.
What do see for the future of he industry, and what will EVast Bio’s role be in realizing this future?
Max: I believe this century will be the century of biotech, the century of AI, and in that regard, I believe that within the 5–10 years, many of the therapies that will be blockbusters will come to the market. I hopefully expect that EVast will help many of the companies that are developing drugs, to get into the market with better efficacy and ultimately serve the patients in a better way.
EVast is also developing its own portfolio of technologies, its own portfolio of clinical programs, and my goal for the next 5 years is that we take these programs into a more advanced clinical stage for the sake of the lives of our patients.
Maroun: What I see today is we have reached immaturity. We brought expectation to something more real. We know that success in recent approvals from the FDA will keep going and will expand to more approvals, and I think within 5 years, we’re going to see more treatments reaching the patients.
I’m not only talking about regulatory approvals, but also accessibility and pricing in 5 years. Today, we do have approved CGTs. In 5 years, we might have more accessible CGTs and that would be the main difference. Not only in number of approved products, but their access as well.
If we’re thinking about the pipeline of development and can reduce in time and cost without cutting corner on safety, then you can deliver more accessible therapies and therefore create better access. As scientists, we are very enthusiastic and proud when we see one of our ideas reaching the clinic and then reaching the patient, but when we know that it’s only reaching a particular group and not everyone, that is where I think there’s much more to do than just create nice ideas and deliver them in the pipeline.
Why cell and gene therapy? What gets you out of bed in the morning?
Max: Ultimately, it’s about providing hope to those who are desperate and for me, that’s the reason why I get out off bed with a smile and with the drive to ace another day, and ultimately, it’s very fulfilling to be involved in this industry because you’re developing something that will change families and potentially even communities at a large scale for many years.
Developing technology that is very disruptive, that has a component of engineering, biology, chemistry, all blended together, I think that’s very interesting from a personal perspective, but also the outcomes for patients that these technologies may have.
Maroun: I think we all share the same goal. We want to improve live quality for our patients and their families. That’s a long-term goal, and you need to have small, achievable mid-term goals or daily ‘baby steps’ that keep the motivation going.
The motivation, it’s not linear. It goes up and down, and that line, that thread, has to be linked to why we’re doing this. Many of us feel that this is our vocation. We’re inspired by developing things beyond the intellectual curiosity, so what motivates us on daily basis are the small things: having our student achieve some interesting data, our technician having an experiment not working, working, and those small daily successes are part of the whole mission and goal of any biotech company including EVast Bio.
This interview was produced in partnership with EVast Bio.
