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Czech-based SOTIO from PPF Group plans to start clinical trials for its BOXR treatment this year. “The first patient will be from the US,” says Chief of Manufacturing Division, Luděk Sojka

Sotio

12/10/2021 | 7 minutes to read

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The biotech company SOTIO, owned by PPF Group which was founded by the recently deceased billionaire Petr Kellner, has made marked progress in the fight against cancer. It plans on starting clinical trials for BOXR, a product that the company hopes will allow the treatment of solid tumors. “We want to be on the map with the big names in pharmaceuticals, which are mainly based in Boston and London,” says Luděk Sojka, chief of manufacturing division of SOTIO.

Ever since its foundation, SOTIO has been regarded as the most ambitious, but also the riskiest project that PPF has embarked on. Can you explain this ambition?
Well, no doubt because we want to turn a biotech venture into an operational pharmaceutical company with a registered medication in the future. We want SOTIO to be on the map with the big names in pharmaceuticals, which are mostly located in Boston and London. We have made great strides in fulfilling this ambition over the last two years.

And why is it considered as PPF’s riskiest project?
Globally, most products tested in a preclinical stage don’t make it all the way. Either they fail to meet the safety requirements early on in the process, or they prove to have insufficient efficacy. So, this is not the type of investment where you could see a high probability that you will succeed and make a profit. In addition, we are talking about really large amounts, whether for the separate labs and the necessary equipment, then the preclinical experiments, or, most relevantly, the clinical trials themselves. That’s why we are speaking of a risky investment.

How long does it actually take to develop a treatment like the one that you are currently preparing for production in Holešovice?
Preclinical development usually takes seven to ten years before you get somewhere. This means specialized lab experiments and testing on animal models. The clinical stage – that is to say, testing on patients – only follows if you succeed. It usually takes another seven to ten years. Therefore, development takes 15 to 20 years from discovery, the time when a scientist finds something that could theoretically work. There are certain exceptions where things go faster – and you need a little luck. We bet on both with our BOXR project, in which we see a great potential for the treatment of solid tumors.

How likely is it that the development of such a treatment will not fail during these 15 to 20 years?
During clinical development, when patients are included in the studies, you have a roughly five per cent chance that everything will turn out well in the development of a new treatment for cancer, and that you will go through all the prescribed phases without any problems. Even in the last phase of clinical development, there is still a high risk that the product will not even make it to a broad group of patients. There is a more than 60 per cent chance that in the last phase, just before commercialization, you will have been working on something for 15 years but then you will have to stop.  And lose the tremendous amount of money invested up to that point.

If I’m not mistaken, there is no company comparable to SOTIO on the Czech market?
There are some biotech companies that manufacture various products; some even research and develop their own. However, no one else has gotten as far in clinical development as we have.

Is it possible to do what you do here in Holešovice without the enormous capital backing that you are getting from PPF?
It’s not. Even if you had no labs and outsource a lot of the stuff, which is what some companies do, you could not do it without really huge investments.

What is currently the biggest challenge for you? Is it the pandemic?
The pandemic is such a universal excuse when something is not going right these days. The biggest challenge for our manufacturing division is the BOXR project, which is based on modified T lymphocytes coming directly from the patient being treated, called CAR-T cells. We want to achieve what we set out to do and have our first patient in a clinical study at the end of this year. It will most likely be a patient from the US.

First, we will sample their blood in America and transfer it to Prague. Here, we will produce a tailor-made therapy, and if airlines still keep flying, we will transport the preparation back to the clinical center in America. That is currently the biggest challenge for me.

Why will the first patient be from the US?
To put it simply, regulatory requirements differ across the world. The process is fastest in America, which is also where our local team is developing BOXR. This is why we are launching our clinical trials there, and we plan on continuing in selected European countries. In this phase of clinical trials, we will first focus on patients suffering from liver carcinoma and lung carcinoma.

What will follow this first clinical phase?
The first part of the clinical trials involves some 20 patients. Then we want to get to the point where we have patients with other types of solid tumors as well. We are expecting some 80 to 100 patients.

What makes your product a breakthrough?
The treatment method that we are focusing on works very well today for blood cancers, such as various types of leukemia. We are talking primarily pediatric patients here, in whom the results achieved with this technology are truly phenomenal. These treatments actually save patients, prolong their lives, and cure some of them completely. Unfortunately, no one has succeeded yet in using this approach to treat what are known as solid tumors. We believe that the BOXR technology could breach the solid tumor barrier.

Can you say what the costs of such a project are?
We know the global statistics on how much the development of such a therapy costs. If we consider it from the time of the scientific discovery up to market launch, then, if everything goes well and all risks are overcome, a successful development project costs about $1 billion. But if you add dozens of failed attempts and dead ends, you will arrive at a cost of about $2.7 billion.

How about return on investment?
To put it simply again, everything depends on the achieved efficacy. That determines the subsequent possibilities for bringing the treatment to a broader group of patients and helping them. How prevalent the disease is matters too. For example, a medicine for lung cancer, which is one of the most common diseases, logically has big potential because many people suffer from lung cancer.

You will run the clinical trials in the US and  certain European countries, but you will prepare the actual treatments in your Prague labs. How demanding is this for you in terms of logistics?
Logistics is a big issue with a highly individualized therapy, since you need to transport each patient’s blood across the globe within a precise time limit. We already have extensive experience with this from the development of DCVAC. When we conducted clinical trials for that product, we had to transport the patients’ blood cells from the US to Prague within 30 hours. And we can do that.

Are you considering building labs in the US in the future?
This would be necessary for the commercial production of the preparation, because we will need a much higher capacity to treat patients in America. That being said, we are talking about the future now – a matter of five to six years. It is not necessary for clinical development and for testing the product’s efficacy, however. So, this question is not on the agenda at this time.

In addition to Prague, you also have labs in Beijing. Why there exactly?
We have built cell therapy labs in Beijing because there is a high potential for such a treatment there. For example, the most lung cancer patients are in China, whether this is due to air pollution in big cities, and a large proportion of the population are heavy smokers

Regulation in China is so specific that it is virtually impossible to develop and manufacture treatments for the local market anywhere else. So, founding a branch office and investing in labs there, as we did in Prague, made sense for us.

Are you considering the acquisition of another manufacturing business?
This is not in our interest now. Our own capacity for clinical trials is sufficient. On the contrary, we are actually talking about how we would like to reduce our investments in operations by starting to manufacture someone else’s products at our facilities. That’s the way we want to go.

Luděk Sojka (42)

  • Graduated from the Faculty of Science, Charles University. Worked at the Institute of Molecular Genetics and the Institute of Microbiology of the Czech Academy of Sciences, specializing in transcriptional regulation and protein synthesis.
  • He later joined the Department of Immunology of the Second Faculty of Medicine, Charles University, where he studied cancer immunology and treatment.
  • He has been with SOTIO for ten years. He is currently in charge of its manufacturing division.

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