The Cytuvax vaccine for so-called non-responders to Hepatitis B vaccinations has helped more than one hundred physicians in clinical trials. “About 5 % of the people who are vaccinated in the standard way do not have a reaction to this vaccine. This group remains susceptible to Hepatitis B,” explains Paul van den Brekel, one of the shareholders of the Maastricht company. The last thing you want as a surgeon is to infect your own patients on the operating table. But police agents, firefighters and officers of the law also need to be protected.” For these professions: no reaction to the vaccine means no permission to work. “In order to protect these non-responders, they sometimes receive a double dose or a change in the shot schedule. (Normally you get three injections with a specific amount of time between them. By administering injections within a shorter period of time, it is possible that some people may react. ed) But none of these alternatives has been researched well enough,” van den Brekel states.
The second clinical study revealed that 92% of patients react to the vaccine based on Cytuvax’s technology. The technology works as an adjuvant. ” To put it simply, this is a product that enhances the effect of an existing product. In this case, it is a vaccine to prevent a viral disease. But at the moment we are also researching this technology for therapeutic use with a view to treating diseases.”
When will the vaccine be available?
We have demonstrated through two studies that we not only have an effective, but also a safe drug that non-responders could react to. Yet with a surprisingly high response rate of 72% in the control group, this is a bit too one-sided. This is not distinctive enough. The discrepancy is not large enough. That’s regrettable, although 92% is extraordinarily high and it does show that the technology works.”
Why didn’t you just get a salaried job?
One day I’m in contact with a German professor, the next I’m talking to a Portuguese investor. In Maastricht, we are working together with doctors from the Maastricht University Medical Centre (MUMC). The small core team I work with is also very diverse in terms of age, nationality and experience. This is a very stimulating environment. It is very different from a large, global company like AstraZeneca and Organon, where I have worked in the past. Now the lines of communication are much shorter and I feel that I can have more of an impact.”
Running a start-up is always unpredictable, especially in the pharmaceutical world. I find it very satisfying that I have been able to let go of the comfort zone that’s associated with working for a “Fortune 500” company. And that I am also able to work very well in an environment with more uncertainty. Furthermore, as an entrepreneur in a start-up, you learn so much more than you would do if you were an employee. And not just not scientifically, but also when it comes to business.
Can you give an example of the ways in which you can have more of an impact with a start-up?
During our second clinical study on the hepatitis B vaccine, we were informed that the key trial medication was temporarily unavailable. Clinical studies often fail due to a lack of funding or because patient recruitment is too slow. We had this all sorted out. That’s why it was extra difficult that things were in danger of going wrong because of something that was beyond our control.
I then phoned every supplier imaginable. I was able to arrange the necessary medication in the end thanks to my past contacts. Normally this would be done by various departments at a large company. Now I had direct contact and managed to sort out something that enabled our research to continue. Large companies are less dependent on one or two studies because their portfolios are so wide-ranging.”
How does your company differ from other medical start-ups?
We want to use our technology as a platform. This means that we are examining what other conditions we could use the technology for. We are currently carrying out a preclinical study so we can develop a drug for patients with pancreatic cancer. It works as follows: this therapy does not tackle the source of cancer, but gives the immune system a boost. We hope that the body will ultimately be able to purge the tumor itself. But we are still a long way from that. Pancreatic cancer is one of the most deadly forms of cancer. So if we succeed in prolonging the lives of patients, that’s already a huge step forward.
Aside from our good contacts with the MUMC, you can easily get to Germany or Belgium in no time from here. We work together with specialists in Antwerp, Hasselt, Bochum and Aachen. This cross-border cooperation is important. This makes us more flexible when it comes to setting up a study that we think has the greatest chance of actually being able to help patients”.
Is that the ultimate goal?
Absolutely, it makes me incredibly proud that in the various phases of the study for the non-responders vaccine, we got more than a hundred doctors back on the floor. They had limited access to their profession or were unable to do so because they were at risk of infection or could transmit hepatitis to their patients.
The first step on the therapeutic side of things is to make the drug so safe that we can test it out on patients. This won’t be possible until 2021 at the earliest. We will only be successful if we can help these vulnerable patients in this way. In the end, that’s what it’s all about for me.”