Thursday, May 3, 2012

Executive Spotlight: Kleanthis Xanthopoulos, Ph.D., CEO of Regulus Therapeutics Inc.

Kleanthis Xanthopoulos
Xanthopoulos understands the biotech business from the inside out. Xanthopoulos is president and CEO of Regulus Therapeutics Inc., which was formed in late 2007 by Alnylam Pharmaceuticals of Cambridge, Mass. and Carlsbad, Calif.-based Isis Pharmaceuticals. It is testing drugs that use microRNA technology, a gene “silencing” technique used for treating various diseases. Regulus has created leading strategic alliances with GlaxoSmithKline and Sanofi-Aventis to develop microRNA therapeutics. Regulus moved to La Jolla in mid-2010 in the proximity of leading academic institutions including The Scripps Research Institute, Salk Institute, Sanford-Burnham Medical Research Institute and UC San Diego.

Before joining Regulus, Xanthopoulos spent time as managing director of Enterprise Partners Venture Capital, where he analyzed the best deals in the biomedical space. Prior to that, he co-founded and served as president and CEO of Anadys Pharmaceuticals, Inc., and served as a member of the board until its acquisition by Roche in late 2011. And before Aurora Biosciences became Vertex Pharmaceuticals, he was vice president from 1997 to 2000. Xanthopoulos participated in The Human Genome Project as a section head of the National Human Genome Research Institute from 1995 to 1997. Previously, he was an associate professor at the Karolinska Institute in Stockholm, Sweden after completing a postdoctoral research fellowship at The Rockefeller University, New York.

An Onassis Foundation scholar, Xanthopoulos received his bachelor’s degree in biology with honors from Aristotle University of Thessaloniki, Greece, and received both his master’s and doctorate degrees in microbiology from the University of Stockholm, Sweden.

Q: You went from being head of a biotech to the investor world, and, now, as head of this company spun out of Alnylam and Isis. What has the transition back been like?

A: Entering biotech life again was a perfectly natural transition, like coming home. I fell in love with the groundbreaking biology and was enamored with the opportunity to translate this big idea into innovative medicines. I like to say that my time spent at the VC firm was as a biotech sabbatical — taking time off from my true passion of building companies.

Q: What led Regulus to locate on the Torrey Pines Mesa as opposed to, say, Carlsbad where Isis is located?

A: It made terrific sense to be incubated within Isis. There is a lot of educational knowledge that we extracted from Isis, and the best way to do this is by osmosis. So, being there was very important for the first years of Regulus’ life. But, ultimately, we wanted our own culture and identity, and we felt that, based on some local collaborations and activities that we have, it would be much better served if we were in the Torrey Mesa as opposed to North County.

Q: Regulus has made some major industry collaborations, big names such as GlaxoSmithKline. What can we expect from the Regulus partnerships in the years to come?

A: Regulus has a dominant locked-in position in the world of microRNAs, which are remarkable and elaborate. They manage control of transcription and post-transcription mechanisms by dictating the half-life of messenger RNA. More than 700 microRNAs have so far been identified in humans, so that means 700 targets. And that, for a small company like us, means collaboration. We have 40 active academic institutions that work with Regulus and many of them are in very close proximity, including one with UCSD. It is part of the strategy and one that we pursued and have benefitted from exceptionally well.

Within six months of formally announcing Regulus, we had the partnership with Glaxo. It is encompassed around four microRNAs. Only one had been identified before the collaboration. So what you should expect is steady stream of news over the period of the collaboration.

Q: Talk about the environment for startups in California. What would be your advice to start-ups looking to grow within the state, such as Regulus has?

A: The good news is that any good, solid idea that is addressing significant needs in the pharmaceutical drug development stage is going to get funded. The bad news is the other ideas, or maybe product ideas alone, have a much more difficult time. Re-licensed or repurposed drug stories, I think, are going to have a harder time moving forward. In the early part of this year, we have seen a resurgence of platform technology stories emerge successful on the biotech scene. These platform stories are getting attention from not only VC firms, but institutional investors looking to take additional risks in their portfolio. This is a departure from the past several years in which companies with later-stage assets were the only investment opportunities for institutional investors. The tide seems to have turned and the early platform companies are now vying for the same Wall Street monies as the later-stage companies. A truly innovative breakthrough idea, such as the one Regulus is pursuing, will get funded.

Q: When Regulus first began, the CEO of Alnylam told investors that he expected Regulus to "dominate the microRNA space.” How do you think Regulus has stood up to that test?

A: Unfortunately, we did better than expected. And by unfortunately, I mean, we have scared away a lot of competition. Many people think that is good. I, personally, think that a little bit of competition is very healthy. So, unfortunately, we don’t have that, so the case of microRNA almost exclusively relies on how good Regulus is going to do.

Q: That has also brought you some healthy collaborations and financial backing. Talk about your growth as a company and where you see yourselves going in the next five to 10 years.

A: The biggest risk for Regulus five years ago was, “Can you target microRNAs and have a sort of peak effect without having a lot of side effects?” That was the big biological risk. Today, we have been able to show in 25 different models of human studies and animal studies that you can do that with a good therapeutic model. So, now you can say that the proof of concept has been established.

So, how do we look five years from now? We are very likely going to be a public company. We are still going to be less than 100 people. We are religiously defending our turf when we can, maintaining that the best brain trust one can possibly have in-house, but also utilizing a lot of extra hands outside. We going to have at least three programs in the clinic and maintain four to six preclinical programs at any given time.

Q: What are some of your proudest accomplishments since Regulus was formed in September 2007?

A: For me, it is all about people, strategy and finance. I think we have been, so far, good on all three fronts, and that’s something I am proud about. We have brilliant people, who are all tremendously seasoned drug hunters or hugely experienced people in finance and operations. We are now at about 55 employees. We are one of the few companies that has been growing at significant rates over the past four years. We have raised over $110 million. The vast majority of this is from the alliances, so it is non-dilutive financing. And I think we have a very good strategy of how to methodically move the pipeline from a big idea to a meaningful set of preclinical and clinical progress.

CHI-Advancing California biomedical research and innovation

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1 comment:

bb said...

Regulus is a fine company, and you're a friend of Atlas and me. But to say you've scares away the competition? Come on, thats crazy.
MiRagen is a great company that we started at the same time and has done very well. Santaris is in the microRNA field and is the only one of the group with a clinical stage - sorry, Post-PoC clinical stage program. They may have other issues, but its unfair to say they aren't players. Mirna, Groove are newer companies in the field, and I wish them well. So there are lots of us who aren't afraid of Regulus. In fact, I hope Regulus' programs do well and further validate the important value of microRNA based drugs. But let's stop the posturing that you dominate the field. You don't. It's an exciting, active field today with high hopes for the future.