Getting treatment to patients faster by focusing on your strengths: with Keith Wood, COO of argenx
The immune system has extraordinary power to protect and maintain the body - but unchecked, it can also harm and damage.
argenx's first-in-class efgartigimod treats myasthenia gravis and other severe autoimmune diseases by blocking disease-causing IgG antibodies.
About Keith
Keith has a long professional career in the biopharmaceutical sector, ranging from Roche and Amgen to Alexion and his current venture, argenx.
Keith has witnessed the power of pharmaceuticals to change, improve and save lives, and his role as argenx's COO puts him on the frontlines of the fight against autoimmune disease.
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Access the complete transcript of our chat with Keith below.
Kelly
I'm excited to welcome Keith Woods, Chief Operating Officer at argenx, to the show.
I'm excited to welcome Keith Woods, Chief Operating Officer at argenx, to the show.
Keith has been in biopharmaceutical industry for over 25 years in roles that span the globe and have increased in responsibility. You can read his full bio in the show notes, but we're delighted to have him here.
The team at argenx has created an antibody innovation ecosystem where pioneering scientists and antibody engineers work side-by-side to accelerate the discovery of novel targets, disease pathways, and differentiated therapeutic antibodies.
We'll get more into their discoveries, culture and how our listeners can bring about innovation by focusing more and more on the patients. Keith, thanks for joining us today. Welcome to the show.
Keith
We'll get more into their discoveries, culture and how our listeners can bring about innovation by focusing more and more on the patients. Keith, thanks for joining us today. Welcome to the show.
Keith
Thanks, Kelly. Thank you for having me here today.
Kelly
Kelly
First of all, I love how focused argenx is on their patients. There's even a whole section of the website that's just about the patients that you've been served so far. It's the first thing in the website navigation. Tell us a little bit more about how argenx got started.
Keith
Keith
Yeah, first of all, argenx started as an immunology company committed to creating products for people that are suffering with severe autoimmune.
We were founded in 2008 by three scientists, and truly the desire was to utilize our antibody building technology, and do that in combination with academia to develop these type of products. Ultimately every single one of argenix' molecules, whether it's in our hands or in the hands of one of our partners was created in combination with academia.
Now our approved product, VYVGART® efgartigimod was actually partnered with pioneering scientist Professor Sally Ward. And her work on FFC RM research is what led us ultimately to efgartigimod, and then ultimately to our first ever approved FDA date of December 17th, 2020. Now here we are a year later, one year into launch, and we already have earnings next week, but we already shared at the JP Morgan Healthcare Conference that we delivered over $400m in sales and we're serving over 3000 patients living with myasthenia gravis.
Kelly
We were founded in 2008 by three scientists, and truly the desire was to utilize our antibody building technology, and do that in combination with academia to develop these type of products. Ultimately every single one of argenix' molecules, whether it's in our hands or in the hands of one of our partners was created in combination with academia.
Now our approved product, VYVGART® efgartigimod was actually partnered with pioneering scientist Professor Sally Ward. And her work on FFC RM research is what led us ultimately to efgartigimod, and then ultimately to our first ever approved FDA date of December 17th, 2020. Now here we are a year later, one year into launch, and we already have earnings next week, but we already shared at the JP Morgan Healthcare Conference that we delivered over $400m in sales and we're serving over 3000 patients living with myasthenia gravis.
Kelly
Oh, that's so exciting. I've been in the startup space for a long time, myself in my career. I'm in quality and I can't remember what the stats are about the percentage of drugs that don't make it all the way to the market. And so congratulations on that for you guys. That is a huge achievement.
Keith
Keith
Thank you. Thank you. We're really pleased. I have to tell you though it's a tribute to our scientists and to, really, our immunology innovation program, which is actually what we've branded in our partnership with academia. Because our track record of products making it into patients is pretty solid.
If you look at it, whether the product is with us and we kept it in our pipeline, like argenx 117, which is the complemented inhibitor targeting c2, or argenix 119 which is now in healthy volunteers, or some of the products that we've partnered with AbbVie with Leo Pharma and others.
Kelly
If you look at it, whether the product is with us and we kept it in our pipeline, like argenx 117, which is the complemented inhibitor targeting c2, or argenix 119 which is now in healthy volunteers, or some of the products that we've partnered with AbbVie with Leo Pharma and others.
Kelly
That's exciting. Looking into the next few years with this treatment and others that you have in the pipeline, what would you say you're most excited about?
Keith
Keith
I think that the part that excites me the most, and it's really the reason why I joined this organization back in 2017 when our CEO called me up and said, "Keith, we have this asset called efgartigimod and we went through the mechanism of action and it was first in class, but ultimately what it is doing is it is connecting to the FcRn receptor. And it is therefore outcompeting IgG and pathogenic IgG, sending them into the lysosome for degradation."
And we know there are so many IgG-mediated diseases. And so what excited me is that this product truly looks like it can be a pipeline in a product. We currently have numerous studies going on. We're in 13 different indications with efgartigimod right now. And we've committed to being in 15 by 2025.
So it's the totality of the patient communities that we can serve that excites me the most.
Kelly
And we know there are so many IgG-mediated diseases. And so what excited me is that this product truly looks like it can be a pipeline in a product. We currently have numerous studies going on. We're in 13 different indications with efgartigimod right now. And we've committed to being in 15 by 2025.
So it's the totality of the patient communities that we can serve that excites me the most.
Kelly
That's amazing. Onto one of the other things, you talked about being first in class treatments. Can you talk a little bit about what it's been like to work with the FDA being first in class? You guys working on a collaborative pathway? How's that working?
Keith
Keith
We've had a very good relationship with the FDA from the time that we first sat down with them in person, which was after our proof of concept study in phase two, we brought forward an innovative design for a phase three because VYVGART® in myasthenia gravis has individualized dosing.
I'm glad you called out the patients on our website, because individualized dosing was not an argenx invention. It actually came from the patients. We went and shared the data from the proof of concept phase two, and we gave different alternatives of how we believe this phase three could be set up and could be utilized, and the patients truly selected the individualized dosing.
What they ultimately told us is, it looks based on the data, I can take this product in four weekly infusions, but there's a sustained benefit that continues to last even after you've stopped, even after you've finished your fourth infusion. And they basically said I would rather go for re-treatment when I feel that I need it, not just go on a fixed schedule.
So they liked the idea of that. And, as one said to me, look, I can go on, I can go on vacation and not have to worry about it. I don't want to take a medication when I feel fine. But then lastly, one said, every time I have to take medication, the patient said to me, it reminds me that I'm ill.
And so I can have this break in between these cycles and customize this just for me. I love this idea. And so then we took it to the KOLs and they said, to be honest with you guys, we would wind up doing that in real world practice anyway. We wind up customizing dosing intervals and stretching them and such.
And then we went and worked with the payers. And the payers really loved this approach because they're paying for a product when the patient's really benefiting from it.
Kelly
I'm glad you called out the patients on our website, because individualized dosing was not an argenx invention. It actually came from the patients. We went and shared the data from the proof of concept phase two, and we gave different alternatives of how we believe this phase three could be set up and could be utilized, and the patients truly selected the individualized dosing.
What they ultimately told us is, it looks based on the data, I can take this product in four weekly infusions, but there's a sustained benefit that continues to last even after you've stopped, even after you've finished your fourth infusion. And they basically said I would rather go for re-treatment when I feel that I need it, not just go on a fixed schedule.
So they liked the idea of that. And, as one said to me, look, I can go on, I can go on vacation and not have to worry about it. I don't want to take a medication when I feel fine. But then lastly, one said, every time I have to take medication, the patient said to me, it reminds me that I'm ill.
And so I can have this break in between these cycles and customize this just for me. I love this idea. And so then we took it to the KOLs and they said, to be honest with you guys, we would wind up doing that in real world practice anyway. We wind up customizing dosing intervals and stretching them and such.
And then we went and worked with the payers. And the payers really loved this approach because they're paying for a product when the patient's really benefiting from it.
Kelly
That's incredible. That's an incredible story, 'cause among the myriad reasons why drugs can't get to market or don't perform well once they get there, having the patient feedback, the quality of life measures, all those kinds of things is one aspect. And then certainly the payer. The payer aspect. I was talking with another gentleman on the pod last week and we talked about this whole idea of understanding: what's the payer pathway look like?
What is your reimbursement? All that kind of stuff. On the medical device side, I feel like we just don't do enough upfront to consider that. I love that you guys have brought that all in. Did you bring that in as part of, that's part of your phase three or was this sort of specialized study pathways that didn't necessarily fit that?
Keith
What is your reimbursement? All that kind of stuff. On the medical device side, I feel like we just don't do enough upfront to consider that. I love that you guys have brought that all in. Did you bring that in as part of, that's part of your phase three or was this sort of specialized study pathways that didn't necessarily fit that?
Keith
So we actually took it to the FDA and the FDA said to us in the meeting, they said, don't you wanna make this easier on yourself and potentially just dose your product every other week or however you see fit? And one of the neurologists that was at the FDA, he said, actually, this is how we use other medications in this disease.
We customize the dosing interval. They just want to do it on label, which is a big deal for my commercial team, because we can speak to individualized dosing. You see it happen with other products, but most of the time it's because, the physician and the patient have created it themselves, not the company.
Kelly
We customize the dosing interval. They just want to do it on label, which is a big deal for my commercial team, because we can speak to individualized dosing. You see it happen with other products, but most of the time it's because, the physician and the patient have created it themselves, not the company.
Kelly
Definitely. Yeah. I feel like people don't... obviously the regulatory people understand very well this whole notion of, what you study is what ends up on your label and you can't do anything outside of that. But I feel like the broader public doesn't understand that, right? Why can't I just take this when I need to?
It's not how it was proven out in the clinical studies, right? I don't mean to rabbit hole too much here, but this is really incredible to me, given what I know about how clinical studies normally work. So I love that you guys are innovating here. That's really exciting.
Keith
It's not how it was proven out in the clinical studies, right? I don't mean to rabbit hole too much here, but this is really incredible to me, given what I know about how clinical studies normally work. So I love that you guys are innovating here. That's really exciting.
Keith
Yeah. Thank you.
Kelly
Kelly
Let's see, so I guess, we talked a little bit about the pipeline and you've got, man, you've got a huge pipeline going. How are you prioritizing that? Or, did the pandemic have any impact on the speed of your pipeline and the decision making around what things you were gonna try to get through?
Keith
Keith
Yeah, a couple things. I think first of all, with our pipeline, what we have began to do is we've began to develop our organization all the way from our R&D all the way through commercial into franchises. As we are, we're currently in the neurology franchise with myasthenia gravis.
We're expecting a readout on another neurology issue, CIDP in quarter two of this year. And so it fits into this neurology franchise. We've also started a franchise in derm(atology) for blistering skin disorders, whether that's pemphigus vulgaris or bullous pemphigoid. We now have one in hematology where we've already had a successful phase three ITP study with efgartigimod, and now we're waiting for the readout of our subcutaneous efgartigimod in ITP.
That'll be in the second half of this year, and that will fit into our hematology franchise. And then the last one is an nephrology franchise. We are currently studying both efgartigimod and argenx 117 into various nephrology disorders.
Kelly
We're expecting a readout on another neurology issue, CIDP in quarter two of this year. And so it fits into this neurology franchise. We've also started a franchise in derm(atology) for blistering skin disorders, whether that's pemphigus vulgaris or bullous pemphigoid. We now have one in hematology where we've already had a successful phase three ITP study with efgartigimod, and now we're waiting for the readout of our subcutaneous efgartigimod in ITP.
That'll be in the second half of this year, and that will fit into our hematology franchise. And then the last one is an nephrology franchise. We are currently studying both efgartigimod and argenx 117 into various nephrology disorders.
Kelly
Nice. That's very exciting. Again, drawing on my own experience in the startup space you guys stayed focused on getting the one into market and then have expanded your indication bins and that's a good study in how it should be done, in my opinion.
Keith
Keith
Yeah. It's been a beachhead, right? We took a beachhead strategy and get established and then grow from your strength instead of having to go back and recreate the wheel.
Kelly
Kelly
You touched on it earlier a little bit about the culture there at argenx. Everyone's a co-owner. Even the name comes from an ancient myth about teamwork, right?
Keith
Keith
Yeah, it sure does. argenx was created from the ancient myth about the Argonauts. And if you're familiar with the Argonauts story, this was a group of people that set out in a very small boat on a mission to capture the golden fleece.
And what this story is about, it's about not having any stars, having all team players, and together a group of people aligned and focusing as a team can accomplish the unthinkable and ultimately the Argonauts did. And that's how we built our company. Our culture is not about rock stars. Our culture is really about, we are all in this together as a team, and this goes from all the way from the bench, all the way to the bedside with the patients.
And then it's cyclical cuz it, we take it from the patients right back to the bench. It's been one of the most positive experiences I've had in over 30 years in the industry of really seeing a group of people. There's none of, this is my department and that's your department. It really is the group working together in the best interest of the end result.
And the end result is ultimately to serve patients.
Kelly
And what this story is about, it's about not having any stars, having all team players, and together a group of people aligned and focusing as a team can accomplish the unthinkable and ultimately the Argonauts did. And that's how we built our company. Our culture is not about rock stars. Our culture is really about, we are all in this together as a team, and this goes from all the way from the bench, all the way to the bedside with the patients.
And then it's cyclical cuz it, we take it from the patients right back to the bench. It's been one of the most positive experiences I've had in over 30 years in the industry of really seeing a group of people. There's none of, this is my department and that's your department. It really is the group working together in the best interest of the end result.
And the end result is ultimately to serve patients.
Kelly
Absolutely. And you can see that all over the website with the company information for sure. It's a beautiful thing. What advice would you give others who are early in their biopharmaceutical careers or are trying to start a company in this industry?
Keith
Keith
Yeah, the first thing that I think about starting this is, don't put everything on your own shoulders. Really look to learn and collaborate with others. We can't all be experts at everything. If you pick your area of expertise, for example, our scientists are expert in creating antibodies.
This is what we've done for our company and for others. But we are not experts on the actual disease biology. That's why we team up and truly partner, don't just use the word partner, but we become partners with the experts in these various disease areas. They help us even select what is gonna be our lead antibody that we will then move forward with into a various disease.
So that would be the first thing that I would advise. The second thing, and what attracted me to argenx, is you gotta follow the science. It can't be based on emotion, it's gotta be following the science. It's data driven. And that was the two methods that the company talked about before I joined, which was science-based, data driven.
When I came here and joined the group, most of our employees at that time, 82 people in Belgium they were all working in the lab.
It's been really special because bringing the patients back to our scientist, when we started doing this, they were like, okay, that's interesting. Now they're hearing from patients that are on VYVGART® and having tremendous results, and now they've connected the dots all the way through and it gives them great pride in the work that they are doing to see the difference that they're making.
Somebody that told us, I was in a wheelchair and was brought in to get my infusion in a wheelchair. In my second infusion, I was brought in my wheelchair. The doctor told us this was a lady in Germany. She rode her bike to her third appointment. You're talking about really having a serious impact for people.
Kelly
This is what we've done for our company and for others. But we are not experts on the actual disease biology. That's why we team up and truly partner, don't just use the word partner, but we become partners with the experts in these various disease areas. They help us even select what is gonna be our lead antibody that we will then move forward with into a various disease.
So that would be the first thing that I would advise. The second thing, and what attracted me to argenx, is you gotta follow the science. It can't be based on emotion, it's gotta be following the science. It's data driven. And that was the two methods that the company talked about before I joined, which was science-based, data driven.
When I came here and joined the group, most of our employees at that time, 82 people in Belgium they were all working in the lab.
It's been really special because bringing the patients back to our scientist, when we started doing this, they were like, okay, that's interesting. Now they're hearing from patients that are on VYVGART® and having tremendous results, and now they've connected the dots all the way through and it gives them great pride in the work that they are doing to see the difference that they're making.
Somebody that told us, I was in a wheelchair and was brought in to get my infusion in a wheelchair. In my second infusion, I was brought in my wheelchair. The doctor told us this was a lady in Germany. She rode her bike to her third appointment. You're talking about really having a serious impact for people.
Kelly
That's incredible. Yeah. And there's no better motivator or feedback for anyone at a company to feel like you've really I think a lot of us get into life sciences because we wanna help others. We do wanna change the world in some way. Maybe we don't all wanna be doctors, but that's a really powerful story.
If you could go back to the start of your career, what would you tell yourself based on what you know now?
Keith
If you could go back to the start of your career, what would you tell yourself based on what you know now?
Keith
Oh boy. What would I tell myself? You know what? I really don't have regrets on how I've gone through my career.
I started my career in mass market with Roche, and I think it was a wonderful place to learn about the business and really rock solid training and learn a great deal about that. And then I wanted to make the change from Roche and get out of because at the time it wasn't Roche Genentech, it was Roche, and we were into more of mass market pharma.
And I decided to make the move to go to Amgen. And the reason why I did that was, genetic based medicine and I thought that was the cutting edge. And I guess the advice I would always give myself is always challenge yourself. Don't sit still and take things for granted. Always challenge yourself to stay more to the cutting edge. So I have thoroughly enjoyed whether it was with Amgen or with Alexion, or now with argenx having first in class products and in some cases only in class product. And that makes it exciting for what I do on a daily basis.
Kelly
I started my career in mass market with Roche, and I think it was a wonderful place to learn about the business and really rock solid training and learn a great deal about that. And then I wanted to make the change from Roche and get out of because at the time it wasn't Roche Genentech, it was Roche, and we were into more of mass market pharma.
And I decided to make the move to go to Amgen. And the reason why I did that was, genetic based medicine and I thought that was the cutting edge. And I guess the advice I would always give myself is always challenge yourself. Don't sit still and take things for granted. Always challenge yourself to stay more to the cutting edge. So I have thoroughly enjoyed whether it was with Amgen or with Alexion, or now with argenx having first in class products and in some cases only in class product. And that makes it exciting for what I do on a daily basis.
Kelly
That is exciting. So one more fun question about you. If I walked into Barnes and Noble, where would I find you? What section?
Yeah, probably anything that has to do with the ocean, water, fishing, diving, boating, just that in general.
Kelly
Yeah, probably anything that has to do with the ocean, water, fishing, diving, boating, just that in general.
Kelly
Nice. I love it. Yeah. Mine would be anything to do with horses. So I appreciate the passion there. Where can folks go to connect with you and follow along with argenx' progress?
Keith
Keith
Yeah, obviously they can go to our website at argenx.com. You're able to follow our progress there or reach out and connect with us. We firmly believe that so many people and companies have helped us out along the way from the beginning in 2008, all the way through into this launch.
I believe in networking within this industry. And I network with a number of chief operating officers and chief commercial officers. And now that we've just gone through our first launch, and by the way, not just in the US. In 2022, we launched in the US, we launched in Japan and we launched in Germany. So a pretty nice accomplishment for a company that's commercializing for the first time ever.
We are open to network and help others that are getting ready to go through a similar experience.
Kelly
I believe in networking within this industry. And I network with a number of chief operating officers and chief commercial officers. And now that we've just gone through our first launch, and by the way, not just in the US. In 2022, we launched in the US, we launched in Japan and we launched in Germany. So a pretty nice accomplishment for a company that's commercializing for the first time ever.
We are open to network and help others that are getting ready to go through a similar experience.
Kelly
Definitely. And I think it would be an amazing case study on the, again, the collaboration with the FDA in those pathways. I feel like as an industry, we don't talk about that enough. Being such a powerful tool to help get things through especially when you're first in class or you're treating rare diseases or any of that sort of activity, that's an amazing accomplishment and a really stellar example of collaboration with the industry.
Keith
Keith
Yeah. Agreed. Thank you.
Kelly
Kelly
Thank you so much for your time today. It's been really fun hearing your story.
Keith
Keith
I appreciate you having me. It's been a pleasure. Thank you, Kelly.
