Todd Kays: [00:00:00] Hi, I’m Todd Kays, Vice President of Dermatology at Vial Health Technologies. I’m speaking today with Stephen Doyle, Chief Business Officer at ASLAN Pharmaceuticals. Welcome, Stephen.
Stephen Doyle: Hi. Thanks, Todd. It’s great to be here.
Todd Kays: Can you give us a little bit of an intro before we get into our specific questions, here?
Stephen Doyle: I’m based in Singapore, working for ASLAN Pharmaceuticals. I’m the Chief Business Officer, so responsibilities for licensing both inward and outward. I also support our CEO on investor relations. I’ve been with ASLAN for five years. We are a small biotech. About forty folks, both here in Singapore and in California in the US. Before joining ASLAN, I spent about twenty years in the pharmaceutical industry, big pharma, with names such as Novartis. I spent eleven years with Sanofi, and Boehringer Ingelheim.
I’m a pharmacist by background. I spent a fair bit of time, post-graduation, in oncology that led me into the pharmaceutical industry. I did a number of years in specialty care, so oncology transplantation hematology was my background. I’ve been working here in Asia for a number of years. I spent ten years in China, building sales and marketing teams and launching products to better the lives of patients.
Todd Kays: Coming from companies like Novartis, Sanofi, and Boehringer Ingelheim, what motivated you to join ASLAN? What is the most compelling thing about the company’s mission and vision that really enticed you to join?
Stephen Doyle: It’s been an interesting journey with ASLAN. We’re now an immunology-dermatology-focused company. But, winding back five years, that wasn’t the reason I joined. I actually joined because they had an oncology portfolio at the time. And as I said, my background was largely in oncology and hematology.
I got to know the guys that ran Aslan. It’s a small community here in Singapore. We’re quite well networked. I got to know the company and the management team well over a number of years. And then they asked me to join and at the time they were developing innovative cancer medicines.
Primarily targeting Asian prevalent tumor types, so gastric cancer, hepatobiliary carcinoma. That’s one of the reasons why I joined them. I was also keen to roll up my sleeves and try a bit of biotech. When you’re working in a big pharma, you tend to get a little bit boxed into one area. I was keen to try some different areas. That’s the beauty about working in biotech. You get pulled from commercial to investor relations to discussions on CMC to discussions on regulatory. It’s quite a wide span and great opportunity to learn different areas in the industry.
That was the real reason to come and join ASLAN. And, they had great products in oncology. We ran a number of trials in different areas. Unfortunately, that portfolio did either get licensed back by some companies, or the drug didn’t meet the primary endpoints. So we had to shelf a number of those products and move on with the portfolio. That’s where we’ve reinvented ourselves. We’re now very much an immunology play today.
Todd Kays: How do you think that ASLAN leverages this focus on immunology to really transform patients’ lives? What’s the company’s strategy for expanding into new markets and reaching more patients globally?
Stephen Doyle: We focus on immunology and dermatology, in particular, atopic dermatitis with our lead asset, Eblasakimab. Dupilumab has done a phenomenal job in changing the lives of patients. A great product, multiple indications and really has been a game changer for not just physicians but ultimately patients.
But there’s always opportunity to improve on what’s on the market and that’s the way we look at it. Although the efficacy is great, is there an opportunity to improve on what Dupilumab does? We certainly shoot for that. Dupilumab does come with some safety issues such as conjunctivitis. So, can we bring better products that address some of those safety issues, and ultimately convenience as well.
We’ve spent a lot of time thinking about what patients want. Would a monthly injection, for instance, right from the start, be more convenient than a bi-weekly injection? That’s something we’ve spent a bit of time trying to figure out as well. I still think there are opportunities to improve the lives and convenience of patients. Certainly, that’s one of the areas that we focus on today.
Todd Kays: The biologics have come on strong in atopic dermatology and psoriasis and other patients benefited from them. But like you said, all of those need some fine tuning because of unexpected side effects from it. I looked at your technology. You got a real possibility to increase the efficacy and reduce the side effects that we see with some of the others.
Stephen Doyle: Also, the fact that the atopic dermatitis, in total, it’s estimated about twenty-three billion dollars. There’s one product on the market at the moment. The JAK inhibitors, which have some of the safety concerns. Still, the efficacy is very good, but I still think there’s definitely some safety issues that some doctors are concerned about. But, only one play in the biologic space that may change with a couple more products currently in development or going through the regulatory path. If you compare that to [00:05:00] psoriasis where you have fifteen biologics in this space that have been developed over a number of years, we’re very much at the start of biologic entry into atopic dermatitis.
There’s a long way to go. So, we certainly feel that the ticket entry for this is, you’ve gotta be as. Good as Dupilumab or better. And, we can certainly come in as good if not better than Dupilumab, but with some added advantages such as speed of onset controlling itch quickly, for instance.
Todd Kays: Yeah. I’ve worked in this field for a while, and on a biologic for a topic. The challenge is getting into that pediatric population where it’s a real problem. Biologics are just not there yet. If you can come up with something that’s, got a better safety profile. The acceptability would be a lot higher. That’s great.
Stephen Doyle: We certainly have plans to enroll, hopefully, in our next program, adolescents and then ultimately, pediatric patients as well, because as you said, the need there is very high. We certainly have plans to do that in the future.
Todd Kays: A huge unmet need. What do you think ASLAN’s main challenges are in developing innovative treatments? How does the company address these challenges while trying to still balance the need for scientific rigor and innovation with the financial pressures of today’s pharmaceutical industry?
Stephen Doyle: It’s a challenge. Costs are certainly going up, year on year. I was reading a report from Deloitte suggesting that costs of developing innovative medicines have gone up fifteen percent this year compared to last year. So the costs continue to rise and as we know, the estimates are anywhere between $300 million, perhaps with a small biotech up to about $2.3 billion for big pharma to bring a drug to market.
That’s a challenge. We have to find ways of reducing costs and bringing drugs to market, quicker and smarter. A challenge for us is to balance cost. But, you can’t do that at the expense of scientific rigor or safety. We’ve partnered with some great CROs in the past. We’ll continue to do so that can bring value to our clinical development program. We’ve developed programs that are rigorous, our current study, which reads out shortly. Our phase 2B, which we’ll read out in early July, is a placebo-controlled five arm study where we’re testing two different doses of drug and two different ways of administering the drug, either Q2 weekly or Q4 weekly.
You have to be innovative in terms of your approach. I think the challenges, though, are patients. It has been the challenge over covid to get those potential patients back into hospital. Doctors, staffing issues at certain sites has not helped with recruitment. Also, with CROs themselves, they’ve had a fairly high turnover, especially the big ones in the past few years. Resource and staffing turnover has been a challenge to get those patients onto studies, but we certainly try to address those challenges, and we’ve always tried to address with rigorous scientific studies.
Todd Kays: You’re absolutely right. Picking the right partner can provide you a creative strategy. Your five arm study gets more bang for your buck out of a single trial, and particularly as we move forward the new innovation that’s coming, more and more, on clinical trials, which is a focus for bio of course.
That leads me into my next question. How do you see the role of technology, and AI shaping the pharmaceutical industry in the future, particularly in immunology?
Stephen Doyle: It is an interesting new concept. Again, reading some articles, some people quote this in the last five years, especially VCs that are looking to fund some of these companies, it has gone from zero to one hundred-five years, where we had nothing. And this wasn’t really talked about in terms of our industry to, now, frontline head news.
It’s going to become, I hope anyway, a standard of care at the beginning of the process where you’re trying to screen drugs and do that more quickly and efficiently. Perhaps before you get into the clinic and jumping some of those steps where a lot of products do fall over in the early stages. That’s probably where this innovation will come, first. Ultimately, big pharma, especially, are looking at ways of reducing costs and making things more efficient. And, as we talked about, with the cost estimates as high as $2.8 billion in the top twenty pharma companies to bring a drug to market, which is phenomenal when you think about what you then have to do post-launch to recoup those costs, plus the drugs that have failed is you can’t have that many drugs fail. In order to be more efficient, AI will make a dent in that sort of early discovery stage in the drug development process.
Todd Kays: That’s where I’ve seen the biggest impact so far. We used to do it years ago on a much lower scale. But now it lets you screen through a lot of potential candidates if you’ve got your target identified, and reduce what you’re doing on the discovery side of things and narrow the funnel down a little bit when you get into the preclinical work.
Stephen Doyle: We certainly see that if you just look at the space VCs would ultimately focus very much on clinical stage companies, and they were putting money in there, but there’s certainly a lot of money going into this AI med tech space. You look at the changes that pharma is making, they’re bringing a lot of data scientists on board now, as well, to work with them and understand this. It [00:10:00] hasn’t been a “bread and butter” understanding in pharmaceuticals AI. We have to draw on the expertise from the outside world. You see that in terms of recruitment that these guys are certainly being employed by big pharma. There’s a change afoot, which, ultimately, is going to be great for efficiency. And, be great for patients being able to bring products to market quicker.
Todd Kays: Your description of recruiting from outside your field perfectly describes Vial. We have a large number of very smart people in development. We’re engineering in other industries. They’re bringing their expertise to us and really helping us move things forward. So that’s exciting.
You mentioned before that when you first attracted ASLAN, you were working in the oncology field, and now you’ve switched over to more dermatology. How does ASLAN approach the development of treatments, selecting a new therapeutic area from the inception of what you want to go after through your clinical trials, and then through your regulatory approval?
Stephen Doyle: The short answer to that, as we’ve had to rebuild the team. We’ve had to rebuild and bring in some of the best, smartest, brightest folks in the dermatology field. We’ve been able to attract really top talent, especially in the medical field. Our folks have backgrounds from Leo (Pharmaca) which, of course, is a big dermatology play especially in Europe. Folks from Lilly, Dermira, acquired by Lilly. Sanofi.
We did feel when we started to move quickly into this dermatology-focused area, that we were lacking some medical expertise and folks that had good relationships with some of the top key opinion leaders around the world. That was a big focus, for us, as this asset came up from behind from the oncology assets and became our number one focus.
We had to rebuild the team. We also had to build out the team in the US. The market, initially, focused for us was oncology, and was Asian prevalent tumor types, so it made sense to be in Singapore. Now though we have an office in San Mateo, California. Seventy percent of DPI sales and AD today are generated from the us.
This is very much, to an extent, for want of a better word, consumer sort of type market, a lot of TV advertising. Our focus and footprint had to be in the US, as well. That was certainly a shift for us away from Asia to focus on building the team in the US to address the US market.
We’ve been successful in doing that. Partnering with the right CRO was critical for us as well. We were able to complete our TREK-AD study. Three hundred patients in twelve months, which is phenomenal when you consider the competition in that space at the moment. There’re a lot of companies going after modern atopic dermatitis patients. We were able to do that with the talent we had with the networks we were able to create, going beyond the US. Fifty percent of our patients from TREK-AD came from the US, but we had to look at other markets. In Europe, we recruited from India, Canada, Australia, and also here in Asia. It’s been great for us. A real success that’s been driven by the folks that we were able to bring on board, and the CRO we’ve partnered with.
Todd Kays: It sounds like you brought on the right people. Actually, it drowns out the question I had for you afterwards, but, when you’re looking to bring people on, what kind of qualities are essential for success in the industry? Once you bring those in, how do you cultivate that into people that are already on your own team?
Stephen Doyle: As a small biotech company in Singapore and in the US, running two phase two programs with forty folks is certainly a challenge. There is not a lot of handholding in small biotech. [laughter] We had to get folks with great experience both from the biotech field, but also from big pharma who had run these type of studies or larger studies, phase three programs, for instance, but in the dermatology space. It was great to be able to build that team. We’ve got a great team that would rival any biotech team now anywhere in the dermatology space.
And people, as I said, it’s difficult. There’s not a lot of hand holding that you can do if people really hit the ground running at ASLAN. We’ve been able to do that and people really have to be agile, quick decision makers, we give people a lot of autonomy to make decisions themselves. We put a lot of trust from the management team in those folks that we brought on board. People have clear, defined goals and objectives. We try to achieve them and check in with folks to make sure they’re on track in delivering those goals.
Our philosophy moving forward is to give those folks, stretch goals, stretch challenges, and people live up to the challenge at ASLAN. They’re the type of folks we want and the success of the program today are those people.
Todd Kays: It sounds like you put together a great team. You need those people that are willing to roll up their sleeves and dig in or wear a different hat on a different day, depending on what the demands are.
Stephen Doyle: When I joined ASLAN, the last thing I was thinking was going out with our CEO and our chief Scientific officer at the time, and IPOing the company in the US. You don’t get that opportunity in big pharma to, as you said, roll up your sleeves and let’s do an IPO Road show in the US. Within the first month or two I was asked to go along and talk about, my background was very [00:15:00] much commercial at the time, so commercial implications of the oncology portfolio that we had at the time. Big opportunities. A little scary at times when you’re given those opportunities. But as I said, the folks we bring on, and I hope myself, live up to those challenges and I’ve loved the last five years and certainly hope to be loving it for the next five-plus years. And, Moving on as well.
Todd Kays: It certainly sounds great. I think as you mentioned before, enrolling a study and doing that pivot and moving and quickly getting into the new field and having success in it so far, at least with the products that you have out there and what you’re seeing in the data from your clinical trials.
Looking ahead, what are some of ASLAN’s more exciting initiatives and projects, and how do you see the company growing and evolving in the coming years moving on from the products you’ve got, getting those products approved and moving on from that?
Stephen Doyle: We’re in a very exciting time for ASLAN. We’ve finished enrolling patients in our phase 2b biologic naive program that’s called TREK-AD, the three hundred patient study we talked about earlier that had recruited over twelve months, the five arm study, top line data from that program we’ll read out in July of this year. We’re looking forward to the data from that program, which will certainly guide us as to what’s next for Eblasakimab in that patient population.
We also have another program in Dupilumab-experienced patients. There are a lot of patients, as great a drug as Dupilumab is, who, for a number of reasons, do fall off treatment. It could be health insurance reasons, perhaps safety. Some patients just don’t achieve the optimal response they were hoping for. Physicians and patients are always looking for alternatives. We feel there is a population out there and we call it the Dupilumab Experience Group who need alternative therapies.
We have a study enrolling now, which is due to readout quarter one in 2024. We have another asset, as well, Farudodstat which is a DHODH inhibitor, which we’ve moved into the clinic in alopecia areata. We enrolled the first patient on that study just last week. That study in that program is now up and running as a phase 2a study.
You get data very quickly on those patients is very quite subjective. The hair grows back or it doesn’t. We’ll probably get to hear of some anecdotal cases as those patients enroll onto that program. The interim top line data is due to read out again in quarter one, 2024.
We’ve got a lot of milestones, a lot of exciting data coming up. Middle of this year, as I said, in July and early next year. We’ve continued to pump out a lot of papers. We get a lot of great data from our studies. We’re doing a lot of work looking at translational programs, biologic markers trying to figure out do you treat all AD patients or is there perhaps a subset of AD patients that you might want to go after? We’ve got a great translational scientist on board, Ferda (Cevikbas) she’s leading that program. We just had four papers, four posters at ISID the Japanese conference, earlier this month.
There’s a lot of exciting things for ASLAN over the coming six-to-twelve months. We’re looking forward to that. It keeps us on our toes and keeps us busy.
Todd Kays: Yes. I looked at the press releases and the papers. The volume of things coming out and we discussed this at AD, too, particularly for alopecia that every other paper was definitely a hot topic and you’re in the AD realm, which is an unmet need. You’ve got a lot of bright things on the horizon for ASLAN. I appreciate you taking your time to speak with us today. Any last things you’d like to leave as parting comments?
Stephen Doyle: It’s been great to talk today, Todd. Personally, five years ago, had you had asked me did I think I’d be working in dermatology, I would’ve probably said, “Hell no.” Oncology and hematology was my field. But, lo and behold, what I didn’t know was immunology and dermatology were going through this real change. I didn’t know about the biologics of the JAK inhibitors that were making an impact on patient’s lives. I’m very excited to be working in this field. The science is great and been able to change that paradigm for physicians and ultimately patients. It’s exciting to be working here and to be spending the time in this field moving forward.
Todd Kays: We look forward to seeing what’s next for ASLAN and for you. I appreciate it.
Stephen Doyle: Thanks, Todd. Thank you.
