Delenex May Be First Therapeutic Company With Tissue Penetrant Antibodies

Delenex Therapeutics, a Swiss biotech in the Greater Zurich Area is developing antibodies to treat serious medical conditions with high unmet need. Below, CEO, Dr. Eric de La Fortelle discusses opportunities within the space in the Swiss market. PENTRA, the company’s registered trademark has the ability to penetrate tissues in contrast with all antibodies on the market today. “This means they can be administered locally as a topical cream,” de La Fortelle noted. “…Or when they are administered in the blood systemically, they can penetrate tissues extremely rapidly and be very fast acting.”

 

Click below to hear the full audio interview and see transcript that follows.

Matthew Margolis:    Greetings from OneMedRadio, I’m Matt Margolis. Today, I’m with Dr. Eric de La Fortelle, CEO of Delenex Therapeutics, a Swiss biotech developing antibodies to treat serious medical conditions with high unmet need. The company’s proprietary PENTRA antibodies are clinically validated and applicable to both topical and systemic administration. The company is in clinical proof of concept studies for dermatological applications, gastrointestinal disease, and acute inflammation. Thank you for joining us, Eric.

Eric de La Fortelle:     Thanks for having me.

MM:      Sure. So today, we’re discussing some opportunities in the Swiss market and commercialization for biotech companies in the area, but first I think we should learn a little bit more about our guest. So Eric, what makes Delenex unique?

Eric de La Fortelle:     So, Matt, thanks for the opportunity to talk here about Delenex. I think we’re unique on two points. The first one is that among the many companies dedicated to cutting-edge antibody therapeutics, we believe we are the only one with a complete focus on tissue penetrant antibodies to the point where we are contemplating a topical, a skin topical application of our antibody and we believe this has never happened before, to have a cream of an antibody that people at their home can keep a tube in the fridge and can apply on their inflammatory lesions on the skin for instance. The second point that makes us maybe not completely unique, but very original is our unusual focus on the patients. For an early stage biotech company where you expect people to be in the lab, in the test tube, we are bucking that trend and with three clinical trials ongoing, we are thinking patients in the morning, at midday, and in the evening.

MM:   Great. Can you go into some detail about the PENTRA technology?

Eric de La Fortelle:     So PENTRA, which is our registered trademark, is used to describe a class of antibodies that have highly unusual properties. On the one hand, they’re as good as classical antibodies as regard to their potency and their selectivity, which is what antibodies are good at. They are easy to manufacture. They are manufactured in bacterial systems, and they’re very robust and stable. That’s for the usual expected characteristics.

On the other hand, where they are different is their surprising ability to penetrate tissues in contrast with all antibodies on the market today. This means they can be administered locally as a topical cream as I was saying, as an ointment, or when they are administered in the blood systemically, they can penetrate tissues extremely rapidly and be very fast acting. So on both counts, topical administration and fast acting, we think we are extending the reach of antibodies beyond what can be done today.

MM:     And in our introduction, we talked a little bit about the indications that you’re targeting so can you go into some detail about your pipeline and business model?

Eric de La Fortelle:     Sure. So we are looking at three main indication areas. The first one is dermatology. From what I’ve said already  if we can apply an antibody as a cream, we can take a target that has been validated via the systemic route and the most validated is TNF. You’ve got antibodies on the market and the brand names are Humira for instance, which target TNF, which are used for millions of psoriasis patients today. But with these antibodies, you really flood the body of the patient with a high dose of antibody, a very, very, very small fraction of which is going to reach the points of the disease, the psoriatic plaque.

So we take these validated targets, we raise a new antibody against it and we apply it topically. We have full IP protection for this new drug, but the likelihood is that it’s going to be very concentrated at the points of the inflammatory lesion, the psoriatic plaque and it’s going to be a very little concentration in the blood. So we are going to be higher efficacy and higher safety at the same time through this mode of administration.

We have other kinds of antibodies as well. We are also applying this strategy to gastrointestinal inflammation, Crohn’s disease with the same principle, getting the antibody to the intestinal mucosa, not in the blood will give you much higher concentration at the point where the disease happens and much less in the blood.

The third area of indications that we are exploring is acute inflammation. Here, in contrast with the other two, we give the drug in the blood. It goes to the system very quickly. It goes into the tissues very quickly, but then the second property of our antibody is that it disappears from the blood. It is cleared in a matter of days as compared to a matter of months with typical antibodies. Because of that, we can dose very high and we have safety data saying that we can dose very high without any harm to the patient. We can have an immediate massive therapeutic effect for people who need the cure or a relief very quickly and it’s not dangerous because it’s gone a few days later from the patient’s blood.

So to sum up, three areas of concentration: One is dermatology, the second is gastrointestinal, the third one is acute inflammation. Now our technology is much broader than this. We could explore central nervous system, brain diseases applications. We could explore lung disease applications for exactly the same reasons. But as a small company, we had to focus, we focused on inflammation and within inflammation these three areas.

MM:    And so you mentioned that you had full IP protection and now I want to broaden our discussion a little bit to use Delenex as a case study in Switzerland. So perhaps we can talk about the state of patent protection in Switzerland and you can talk about your experiences.

Eric de La Fortelle:     My experiences are good in terms of the ability to have highly competent people in Switzerland both on the side of IP attorneys and on the side of the patent office. However, Switzerland is only one country among many, many that we need to protect our products into. Intellectual property is worldwide and should be considered worldwide. So for instance, we have currently 32 patents granted or allowed in 14 patent families. Meaning there’s at least one country that granted us the patent for 32 different patent applications. That’s a large patent portfolio. This patent portfolio is prosecuted worldwide because we don’t want to be in the position where we are protecting only a part of the world and some competitors gets a free ride manufacturing or producing in a different country. So we are protecting worldwide and there is no small country. Of course, we have to protect in the countries that are large markets, but then we have to also protect countries that are known R&D hubs.

So to give you an example, our lead compounds we have patents issued in the US so our lead compound is called DLX-105, the anti-TNF I’ve been speaking about. It’s issued in the US, but it’s also issued in Russia, in Australia, Mexico, New Zealand, Singapore, and South Africa. It is pending in Switzerland and in the European Union, however, we expect this to be granted in the coming months also in other countries. Just to tell you that Switzerland is a good place because there’s a lot of competence but in matters of IP, we are really thinking worldwide.

MM:     In May 2011, Delenex extended series A financing to over 30 million Swiss Franc. Can you put this series A financing into perspective?

Eric de La Fortelle:     Sure. We’ve been both prudent and aggressive in using this equity capital. We’ve been prudent in the current economic circumstances because we keep the fixed cost low. We have 16 fulltime employees, small discovery labs in Schlieren outside Zurich and minimal administrative overhead. At the same time, we’ve been very aggressive because we have two lab discovery programs and three proof of concept clinical trials ongoing at the same time, which is almost unheard of for a series A biotech company. Our goals are clear. We want to find a major strategic partner or acquirer in 2013, next year, and use this extra support to continue revolutionizing the treatment of autoimmune disease.

MM:   And can you describe your efforts in actually raising capital domestically? I’ve been told that the Swiss venture capitalist market as well as private financing is very healthy and robust.

Eric de La Fortelle:     Yes, there is a strong network of well-financed venture capital funds in Switzerland and we’ve tapped into this. Three of our venture capital backers are Swiss, the names are BiomedInvest, HBM Ventures, and VI Partners. Now the two co-leads of our current series A rounds are not Swiss. One is Danish, Novo Ventures and one is Anglo-American this is SV Life Sciences. So again, like I said in IP, we are rooted in Switzerland, Delenex is rooted in Switzerland, but it really looks worldwide. I wouldn’t mind if we do a next round of financing having a Californian or Asian venture capital funder enter into our capital as long as we share the vision for the company and as long as we’re aligned as to the goals.

MM:   Now is it your opinion that a Swiss company should be exploring international suitors to fund the company from development into market?

Eric de La Fortelle:     Yes. I think being in Switzerland is great because Switzerland is a wonderful place to do business. The rules are clear, they’re well enforced, and they don’t change easily. Geographically also, Switzerland is very central in Europe and that enables us from a secure base in Switzerland to explore worldwide, globally the best opportunities for collaboration, financing, and eventually a trade sale to anyone in the world who’s well aligned with our strategy.

MM:     And now it’s been said that Switzerland is a unique entity in the public sector fostering drug development, can you talk a bit about your experiences moving from preclinical phase to clinical?

Eric de La Fortelle:     Yeah. So we’re in the middle of an existential crisis in Europe and Switzerland provides I would say institutional serenity. People are nonplused by the whole crisis here in Switzerland. They deal with it and there is no excitement, business goes forward. It has the best concentration of life sciences talent thanks to two pharma giants Roche and Novartis and a thriving biotech sector.

So for example, I’ll give you an example here locally. Out of the dozen or so world-class biotech companies in the field of novel antibodies, five are in our street in Schlieren, the biotech center of Zurich and two have already been acquired by larger companies for several hundred million dollars. That’s really the power of the hub either locally here in Zurich or you can also consider Switzerland as a biotech and pharma hub, it’s a good place to be.

MM:    Uh-hum. And I’m curious if you can go into some detail about your relationship with big pharma like Roche and Novartis that you mentioned? You know, how greatly can companies of your size rely on them to license, partner, and actually provide capital?

Eric de La Fortelle:     So although I’ve made a big case for being global, geography still exists and it facilitates networking. So in my last job, I’ve spent six years at Roche and I know a lot of people there. They tend to change on a rolling basis but the networking with Roche is very easy. The networking with Novartis is equally easy because I know people there both professionally and socially in Basel. But at the end of the day, deal making especially costly acquisition is determined by the strategic needs of potential acquirers, not mostly by some good relationship. So I’m in face to face, email, telephone contact with decision-makers from about 40 companies, pharma and biotech companies, all that are potential strategic partners or acquirers. We don’t have a priori favorites, although sometimes networking is easier locally.

MM:     So wrap up, I want to ask you two questions. One, what’s the future hold in store for Delenex? You know, what can we expect to see in the second half of 2012 and beyond?

Eric de La Fortelle:     So thanks to our recent clinical results, we’ve received two results in the last two weeks, we are now able to intensify our business development discussions with interested partners. At the end of 2012, we have two more clinical proof of concept studies reading out and hopefully these will make Delenex an even more attractive acquisition target. On this basis, 2013 is the year where we count on a strategic partner or an acquirer to propel us into the next stage of our corporate development.

MM:   So now I’m going to ask you to put on your diplomat hat for a second and muse on why foreign investors should be intrigued by the Switzerland life sciences sector?

Eric de La Fortelle:     Well very simply, it’s the best concentration I would say in Europe certainly and anywhere in the world. You’ve got these companies, Roche and Novartis that are in the middle of restructuring left and right. They are donating extremely high talents to the job market either by pushing people out or by discouraging them into giving their very best. That wasn’t very diplomatic but that’s the reality.

I’ll give you one example. I’ve been able to hire in at the time a ten-person company the head of translational medicine of Novartis. This person was dealing with about a hundred clinical trials every year. He comes to us and he does three and the difference is he’s much freer to do the things that he thinks are going to create value. There’s no 20 committees to convince before anything can get done. This kind of talent exists in Switzerland, it’s going to continue nourishing the biotech sector, and we are benefiting immensely from it.

MM:     That was a company snapshot of Delenex Therapeutics, a case study of an intriguing company operating in Switzerland with CEO Dr. Eric de La Fortelle. With OneMed Radio, in New York, I’m Matthew Margolis signing off.