Dr. Werner Cautreels, Selecta: From Big Pharma to Nanotechnology

Selecta Biosciences, based near Boston in Watertown, MA, is a clinical-stage biopharmaceutical company seeking to unlock the potential of biologic therapies by avoiding unwanted immune responses. Its tolerogenic Synthetic Vaccine Particles (SVP) technology platform is designed to enable a range of novel biologics for rare and serious diseases that require new treatment options. The company was founded in 2008 by three academic pioneers in the fields of nanotechnology and immunology: Professor Robert Langer (Massachusetts Institute of Technology), Omid Farokhzad (Brigham and Women’s) and Ulrich von Andrian (Harvard Medical School).

Dr. Werner Cautreels became Selecta’s first CEO in 2010. Formerly CEO of Solvay Pharmaceuticals (Brussels, Belgium) and first head of Sanofi R&D in the US, he talks to Pharm Exec about Selecta’s innovative technology and how his entrepreneurial experiences in big pharma prepared him for the challenge of a new startup.

PharmExec: What is unique about Selecta’s technology?

Werner Cautreels: As we all know, the innovation in medicine has shifted from small molecules into biologics. This comes with a paradox, which is that the patient’s immune system may consider these to be foreign proteins. As a result, the immune system will react to them and try to reject them. This can occur in rare diseases - think about enzyme replacement therapy, hemophilia, etc. - and if this is a unique treatment for the patient, it can come with very serious consequences. At Selecta, we have developed a technology that is designed to signal to the immune system that the biologic is a good guy.

The technology that we utilize is inspired by the fact that viruses are nanoparticles. We set ourselves the challenge of making synthetic viruses, i.e. biodegradable nanoparticles, in which we could load very specific signals to talk to the immune system. This took a number of years to achieve. We showed in preclinical models that we could do this in animals, and we are now starting to translate this into actual patients in Phase 1 and Phase 2 clinical settings.

You came on board from big pharma. What attracted you to Selecta?

I am from Belgium and started my career working for a small Belgian company. Back in 1979, I was recruited by Sanofi and I worked for the company in France for about ten years. I was then sent by Sanofi to the US in the late 1980s. At that time, Sanofi had zero presence there; I became Sanofi’s first head of R&D in the US. I moved to New York with my family and two suitcases, and from there we built a group of 20-30 people. It was a very entrepreneurial enterprise, not so different from what I have been doing at Selecta. After ten years building Sanofi’s presence in the US, I joined Solvay Parmaceuticals as head of global R&D and then was named Global Chief Executive Officer. When we sold Solvay’s pharmaceutical division to Abbott in 2010, I was not looking to follow the big pharma path but was much more interested in returning to an entrepreneurial role, as I consider myself more an entrepreneurial person than a big pharma person. That’s when I discovered Selecta and its unique technology, so I moved to Boston to take up my current role.

How different was it helping to set up a biopharma company 30 years after you first came to the US?

When I joined Sanofi in 1979, major innovation came from big pharma. It came from medicinal chemistry, testing small molecules in a more routine way into animal models. At that time, startups didn’t have the resources and the logistics to do this. But by the early 2000s, insights into the biologic mechanisms of a disease were much more developed in the academic world. Boston, for example, had led the way in the development of a unique ecosystem between academics who understood the mechanisms of disease and venture capitalists who were willing to invest risk capital in new technology. They understood that if you invest in 10 ideas, it takes only one of those to pay for the nine potential failures. This ecosystem also attracted scientists like myself, who thought, I can stay with big pharma and make an incremental contribution or I can leave this comfort zone and start a biotech and potentially do something that is  making a real difference for patients.

Can you outline how your Russian activities feature in your wider plan?

We still refer Russia and to the other BRIC countries as emerging markets, but this is a misnomer; in fact, it is a major error. These countries are not emerging markets but strategic markets. But, initially, Russia provided us with an opportunity. When I joined Selecta, the company was talking to a potential Russian partner, the Skolkovo Foundation, which was linked to the Massachusetts Institute of Technology (MIT) and aimed at creating a sort of a clone of MIT in Russia, marrying high-level technology with entrepreneurship. We also tapped into another Russian fund, RUSNANO, which was established as a $15-20 billion fund for all kinds of nanotechnology, which included nano-biotechnology. As we were a nano-biotech company with MIT cofounders, RUSNANO made a significant investment in us. Following that, we committed to conducting part of our portfolio research in Russia. We created a research lab close to Moscow and hired about a dozen high-level scientists there; scientists who have done their post-docs outside Russia, but who are motivated to return to their home country to live and work and further their careers.

What is the outlook now for Selecta?

When drugs come under attack from the patient’s own immune system, it results in the formation of “anti-drug antibodies” (ADAs), and this phenomenon takes its toll not only on patients; it also adversely affects the treating physicians and the drug industry at large. Drug developers may be forced to abandon promising candidates or face limited market uptake of an approved drug because of ADAs. The full impact of ADAs on the business of drug development is underappreciated. In time, as biologics continue to be among the fastest growing segments of new drugs and other modalities including antibody drug conjugates and gene therapies continue to emerge, we believe the impact of ADAs will become even more evident.  The potential benefits of overcoming immunogenicity could, therefore, be enormous not just for patients but also for the industry and for healthcare systems around the world.

We have shown pre-clinically in animals that the technology we have developed has worked with more than a dozen biologics, and we have data that shows it works with a biologic in humans. The translation into humans is, of course, the real objective, so what is important for Selecta now is to show that this translation was not a fluke… that the technology is much more broadly applicable across multiple biologics in the clinic. If we do that, we believe we can expand the field exponentially.

Dr. Werner Cautreels