Thomas Lonngren joins S2N

S2N is delighted to welcome Dr Thomas Lonngren onto the team.

Thomas has enjoyed an illustrious career, including serving as Executive Director of the European Medical Agency for almost a decade, and as chair and director of several new and exciting publicly-listed biotech companies.

Click here for more details about Thomas’ career and the background of the entire S2N leadership team.

To mark this special occasion, S2N Co-Founder and Chief Scientist Professor Michael Valenzuela had the pleasure of conducting this one-on-one interview.

[MV] Imagine we were facing the COVID delta variant without a vaccine? I think people in and outside biotech have been absolutely inspired by the whole vaccine story  –  from creation, development, approval, and even roll out despite hiccups along the way. Right now is there any more important sector to be in?!

[TL] Thank you, Michael. Yes, I agree with you, to get a vaccine against COVID so quickly to the market is a fantastic success story. But there was a long way to that. And the whole mRNA technology, when this comes to air, was started 10, 15 years ago. I think we were very lucky that this technology was mature enough in order to be used in these fantastic vaccines that we have now on the market.

It also shows how the world could come together. Big pharmaceutical company, the healthcare system, governments giving funding to this research, and the academics who were prepared to help with clinical trials and investigation into the efficacy of these vaccines. Also, not only the vaccines we have to think about, but also the new therapeutics that is now coming that could treat the disease in an early stage. So, it's a tremendous success story. And of course, this has given a big boost to the pharmaceutical industry and also to the tech sector. So, I agree with you, this is the right sector to be in just now. 

Perhaps because of this, biotech and regenerative medicine and advanced therapies in particular are going through a renaissance. Given your unique international perspective, what do you think is driving this?
Yes. I think that regenerative medicine advanced therapy started the renaissance before COVID. I have been following it since the launch of the advanced therapy legislation in Europe and that was during my time as executive director. We could see the number of products in the pipeline. At the EMA and also the FDA, these type of products have increased over the years. I think for the moment, if you look at the pipeline, there is a record number or products in pipeline, waiting to be looked at by both the EMA, FDA and other regulators in the world.

But the question is, why do we have this renaissance? Yes, I think we have tried with small molecules. We have tried with large molecules, biologicals to treat and prevent disease. But maybe it's time to use cells now as a modality in order to treat the disease, in order to get another way, in order to tackle underlying disease.

I think that is one of the drivers why we have an increased interest in this. But also of course there have been some success stories. I'm thinking about the CAR-T cells that have come out for the treatment of cancer that have been very successful. There are several driving forces for this, and it will be very exciting to follow what will come to the market, and will be approved by the agencies in the world. Exciting time.

Are there any trends or emerging issues that concern you?
Yes there are, especially environmental change that we have with floods, storms, and fires all over the world that are affecting us -- this is a serious issue that concerns me a lot. So, if that is the macro level, the climate change and change in the world, we also have changes in the micro environment, as we could see for the pandemic that came, and we also see other kinds of viruses and bacteria that are starting to spread all over the world from geographical areas where they were before to other new geographical areas. So I don't know if it's connected, but it is a concern, and I think that is something that the world politicians need to take more serious than they are doing today.

Small and large reg med companies alike face formidable challenges around manufacture, especially in the transition from early phase to pivotal trials. Do you think regulators are moving in the right direction in terms of clarity and guidance on this?
Yes, I agree. There is a challenge around manufacturing, especially the transition from early phase to clinical trials ongoing in first in human. This is extremely important of course, that the manufacturing is done according to the best GMP that could be achieved in an early stage. For small molecules it's easier to do, large molecules like biologics and that are more difficult, but a lot of experience has accumulated there. And I think when it's come to advanced therapy, when it's come to cell therapy, a tissue engineering therapy, they has been anevolving knowledge among the regulators, what kind of requirement that we have to put on the CMC aspects of these medicines. And certainly for these type of medicines, the CMC is so strongly related to the frequency and the safety of the end product, that you have to pay more attention to the CMC.

It's living material we are dealing with, so it's not so easy as a small molecule, but if you're looking at the guidelines produced both by the EMA and FDA, there are several guidelines now that have been published in order to help manufacturers and developers in this area. But of course, each product is very unique in itself, so that could be the situation that there are no guideline that are really fitted into this kind of product. And in this case, the regulators are quite open in order to come in for advice for the company, scientific advice, and I think that is the way to move if the guidelines doesn't really give you a clear indication where to go.

So seek scientific advice from the FDA and EMA, and I think that both regulators are moving on it. We have to understand that if it is new for the developers, it's also new for the regulators, and the dialogue between developers and regulators, that is extremely important here in order to find the right direction for the CMC aspect and the quality aspect, before you are going into clinical trials.

You’ve had an stellar career and clearly still incredibly passionate about biotech and developing new medicines. What’s your grand plan…what do want to achieve in the next few years?
What is my grand plan? Yes, that is a very good question.

I will continue my engagement in the companies that I'm involved in today, and also the new company Skin2Neuron, where I will join the Advisory Board.

I'm involved as a board member in two biotech companies, one in Stockholm. We are developing a product for rare disease in children. So in the orphan space, the company's name is Egetis Therapeutics, and I'm the chairman of that company. The other company where I'm a board member is Compass Pathways and it's London-based, listed on New York Stock Exchange. We are developing psilocybin for treatment resistant depression.

Both these companies are in phase two and they will reel out their phase two studies this year and the beginning of next year.

And hopefully during the five years, they will be able to get the product authorized and approved on the world markets, so that could be a big achievement to be involved in.

Also, I'm looking forward to be involved in Skin2Neuron, and hopefully we also could get the product into serious clinical trials during these five years, and approaching regulatory approval maybe in the end of the period.

So that's the main plan, and of course I will also at the same time have some fun because I just love to be involved in drug development and in the biotech sector. 

S2N is very excited to have you join the team. What intrigued you about what we’re doing and drew you on board?
Thank you, Michael, for inviting me to the team. First of all, I think for me, it's important to be involved in companies that are developing drugs in a high unmet medical need area. Certainly, Alzheimer's is one of the highest unmet medical need area that we have for the moment. If we are looking back on the development of drugs for Alzheimer's disease, we have more or less a failure rate of 99%. So there have not been any new breakthrough in this area for many, many years. Recently, we had an approval by the FDA for the aducanumab new product, even though that seems to be controversial. Maybe there is a little hope that could come up when we will know more about that drug.

The concept that Skin2Neuron has is a completely different one. I think it's time that we are testing a new way, a new modality to treat Alzheimer's disease and also be able to change the course of the disease. I was impressed by the preclinical data in rats and dogs that you, Michael, have worked on for several years and the whole concept of using the hair cells to develop the cells and then using them to inject them to the brain in order to regenerate the neurons in the brain. It's very exciting. I think that is something that is worthwhile to explore further.

So that was one of my reason why I wanted to join the Skin2Neuron. The other reason is, of course, you Michael, with your background and also the other staff of the company. That's the second reason why I'm joining. The third reason is my close connection with Australia since my wife is Australian. We have a second home in Sydney and I'm looking forward to be in the country finally after the COVID has locked me into Sweden for nearly 18 months now, to also to help Australian biotech companies to come up on the world scene with a new treatment, especially for such an important disease as Alzheimer's. I'm looking forward to work together with the company.