Drug research is a long process that is loaded with a huge inherent risk. With opposition to animal testing rising and the data it generates being less than perfect, a via-media mode of testing done using live human skin models is slowly and steadily gaining acceptance among pharma and biotech companies.
Benzinga spoke with Genoskin's founder and CEO Pascal Descargues about a business idea with the potential to transform the way drug research is done in the coming years.
Benzinga: Could you please walk us through the beginnings of Genoskin — the vision behind the venture, and the business?
Descargues: We are a French-American company launched in France in 2011. After many years of doing research using animals — mice — to better understand skin disease, I thought something was missing: a tool for researchers to study humans to validate what we discover in terms of data and chemistry in humans.
So, I decided to launch the company with a new tool, namely ex-vivo human skin.
Genoskin provides phased, accurate, sustainable and accessible testing for biotech and pharmaceutical companies. Basically, we are just recycling human skin samples left over from plastic surgeries into standardized ready-to-use kits by keeping skin alive in order to enable testing of efficacy and toxicity.
BZ: Why would companies prefer ex vivo skin models for testing over animals?
Descargues: There are many reasons for explaining the shift away from animal testing. One reason is ethics. There is increasing pressure from the public to do away with the practice of using animals for testing.
The EPA has said within the next several years the agency will cut its funding for experiments on mammals in half by 2025 and that it plans to stop using mammal studies for the approval of new chemicals by 2035.
The other reason is scientific. Pharmaceutical companies, biotechs and research institutes are beginning to realize animal testing is an insufficient predictor of drug safety or efficacy. About 90% of drugs entering clinical trials fail despite preclinical animal testing. Most of these drugs fail because of toxicity, which is not detected in animals.
We are providing a solution here to help customers access human data even before starting a clinical trial in humans. This would help them save time, speed up the drug development process and essentially secure the development and clinical trials.
BZ: Can animal testing be completely replaced by ex vivo skin testing?
Descargues: Animal testing began to be used mainly after the World War II, and it has been used for decades to test drugs. New tools like skin models are developing right now and are becoming more and more important.
So, I would not say as of today we can replace animal testing completely. The idea is to make a bridge between the data you can get with animals and the clinical situation so that when you want to test patients in clinical trials, you want to avoid any failure.
Today we already helping people in this way. But if you think in the future, in 50 years, in 100 years — yes, probably yes. We may not use animals because there are more options of growing flexible skin like we do, by using skin from patients, or tissues from patients, bioprinting; all these technologies are developing and are used for drug development.
Genoskin's technology is not a substitute for a clinical trial, but the tests do provide more data that help exponentially in determining efficacy, thus speeding the drug development process.
BZ: How reliable is the safety and efficacy analysis done with the ex vivo skin models?
Descargues: By using the technology, our customers can better understand local toxicity induced by their products. With the technology, we do not necessary investigate data concerning the organ of the body but we do have everything to understand the local toxicity.
For example, a big concern now is the local reaction induced by a drug, be it a small molecule or biological drug, after an injection.
And thanks to the fact that our system is injectable, immune competent and human, you can get data that you can get only from patients.
There are many differences between the human skin and animal skin. There are many organ differences that you cannot see, especially in immune responses or metabolism, and this is very important and can induce false positive or negative data in animals.
BZ: Is there a difference between human skin when it comes to testing?
Descargues: Yes, there are many differences such as genetics and all those. Thanks to our technology, we can replicate these human diversities in a small study. And the customers or our partners can get different data from different donors for securing drug development process.
It is not about high throughput screening; it is really the last laboratory test you can make before starting a clinical trial. So you want require the validated data to be close to what you get during the clinical trials.
BZ: Is the local effect adequate to arrive at a conclusion regarding efficacy and safety?
Descargues: Obviously, it depends on the drug you are testing and the path of efficacy you want to address. We have customers developing anti-inflammatory drugs. With our system, we have developed a ex vivo model called inflammaskin that is dedicated to validate the efficacy of anti-inflammatory drugs. You can just observe the efficiency to block TH1 TH17 inflammation.
Another application could be with testing of vaccines. During the vaccination process, you inject through the skin, and right now the only way to validate the efficacy is to wait to analyze the humoral response and wait for many more days or months to see if it lasts.
With our technology, we offer a new way to validate vaccines by analyzing the primary effect of the vaccine on the skin resident immune cells. Using our system, we can get primary data that helps us to understand whether the vaccine will be effective or not.
We do not necessarily validate efficacy of the drug that targets the brain, or whatever. But we can analyze the efficacy of absorption of a drug. After an injection, you want to understand if your product is absorbed into the tissue or not. This becomes very important. You get data that is reflecting what you will get from the patients.
BZ: How difficult is it for you to source the skin models you process for end-market use?
Descargues: This is very important as it is an on-time process. Working with donors, clinicians and hospitals, we collect skin leftovers from plastic surgeries, after getting express consent from donors to donate excess tissues.
We have in place logistics to bring back all these tissues to our facilities both in France and here in the U.S. We source tissues from the U.S. and Europe.
Then we have a process to test the safety of the skin before it is integrated into our testing kits.
BZ: Is the supply adequate to meet the demand?
Descargues: Yes, it is, as we are constantly working on recruiting new hospitals and clinicians.
We are not only focusing on the expected analogies of the skin models, but also on recruiting surgeons everywhere in the world. Right now, we have in place arrangements to source 40 skin samples a week from 40 different donors with our facilities in France and the U.S. We want to double this in the next 12 months.
BZ: How long does the preserved skin remain viable for testing? Could you speak to the preservation techniques and technology Genoskin uses?
Descargues: Natural human skin can be kept alive for seven days. After projection, we can deliver it as a ready-to-use kit to our customers the world over, or we can test in our facility using the drugs provided by customers.
The patented technology is the use of a liquid matrix. We just put the skin in the matrix and the biopsies are floating in the liquid matrix. We induce acidification of the matrix. This particular matrix is just like the skin of our body, maintaining adhesion and nourishing the tissue in the culture.
BZ: How big of a market opportunity is there for ex-vivo skin models?
Descargues: The market opportunity is huge because all drugs approved by FDA needs to be tested in skin for toxicity. Without our platform, it isn't possible to test the administration of an investigational drug through the skin, toxicity in the skin or how the skin metabolizes the drug. So, it is $1-billion market.
And we are not necessarily targeting only pharmaceutical or biotech companies developing dermatological drugs. Our customers also develop drugs targeting cancer, neurological and metabolic inflammatory diseases.
BZ: You mentioned Genoskin's market opportunity is roughly around $2 billion to $10 billion and today's revenue run-rate is around $2.5 million. Why the huge gap, and how do you think it can be bridged?
Descargues: Even though the market potential is big, it is still new. As I said previously, people used to work on animals for many decades. Now, we have to help them migrate from animal testing to avoid all these clinical testing failures and to get human data. It involves a lot of work.
Our customers are mostly in the U.S. and Europe and to some extent in Asia too.
The challenge here is the internationalization, and we have invested money to reach our objectives here. We had 100% revenue growth last year and we're keeping this goal for this year and the coming year. So, the company is growing very rapidly now.
BZ: Could you please shed some light on the biopharma and biotech companies you are working with?
Descargues: We have published data with companies, including GlaxoSmithKline plc GSK, AstraZeneca plc AZN, Sanofi SA SNY and Leo Pharma.
These are the big pharma companies. We also have published data with biotech companies and a few biggies outside of the sector, such as Unilever NV UN.
I am also thinking of tapping into academic labs.
About 70% of our revenue comes from biopharma and biotech. So, this sector is very important for us; I think the main reason is because we provide them with human data.
We provide them with clinical data. Even with clinical trial, you probably cannot dissect and analyze the skin and tissues like we do because nobody would want to have 20 biopsies 1 inch in size to produce solid data.
BZ: It looks like there is no real competition for you?
Descargues: I think it's very hard to say there is no competition. But our technology is unique and it is patent-protected.
We have two types of competitors. First are technology-based bioprinting companies that do reconstruction of artificial tissues. The main limitation with them is that even if people claim they produce human tissue, it's not a tissue. A tissue or a human organ is much more complex.
The other competition are companies like bio banks that provide human tissues. They source tissues from hospitals and provide frozen tissues. The limitation here is that it is no longer very useful because it is dead. The tissue is dead and is in formalin. So, you cannot really test toxicity or efficacy with such tissue.
BZ: Where do you think the company is headed five years from now?
Descargues: We want to become the world leader in human skin and human skin data by providing all these technologies, by offering to the industry unique access to not only human data but also human diversity.
An ex-vivo clinical trial a unique way to perform a clinical trial that will help you with the development of drug. So, it is what we really seek now, and we want to expand globally.
BZ: Any public listing plans?
Descargues: In the future, it is something doable. We do not have any listing plans in the next 18 months. For now, we really want to focus on the development of the company with some of our partners.
Photo courtesy of Genoskin.
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