Gilead at Leerink Conference: Cell Therapy’s Promising Future

On Tuesday, 11 March 2025, Gilead Sciences Inc (NASDAQ: GILD) shared insights at the Leerink Global Healthcare Conference 2025. The discussion, led by Cindy Perettie, Head of Kite, focused on the promising potential and strategic direction of Kite’s CAR T-cell therapies. While there is optimism about growth in cell therapy, challenges such as competition and manufacturing reliability were also addressed.

Key Takeaways

• Kite’s AnitoCell aims for a 2026 US launch, with a 62% complete response rate in trials.
• Manufacturing reliability in the US is currently at 96%, with turnaround times of 14 days.
• Kite is expanding into autoimmune diseases, with a focus on lupus, myositis, and scleroderma.
• The lymphoma market is projected to reach $10-12 billion by 2034, with multiple myeloma reaching $15-20 billion.
• Kite is developing safer CAR T-cell constructs for outpatient delivery.

Financial Results

• Lymphoma market size is projected to grow to $10-12 billion by 2034.
• Multiple myeloma market size is expected to reach $15-20 billion by 2034.
• Revenue growth is anticipated with the successful commercialization of AnitoCell and expansion into autoimmune indications and solid tumors.

Operational Updates

• Manufacturing reliability has reached 96% in the US.
• Current turnaround times are 14 days in the US and 17 days internationally.
• There are 530 authorized treatment centers globally, with plans for further expansion.
• AnitoCell’s launch is planned for 2026 in the US, with filings in Europe, Asia, Latin America, and the Middle East.
• Focus is on outpatient delivery of CAR T-cell therapies, working with FACT on modular accreditation.

Future Outlook

• AnitoCell’s US commercialization is set for 2026, with plans to expand into autoimmune indications.
• Kite is developing bisistronic CAR T-cell therapies to improve safety and efficacy.
• Continued focus on reducing manufacturing turnaround times and enhancing reliability.
• Exploring collaborations and research in allogeneic and in vivo approaches.
• Significant market growth expected in lymphoma and multiple myeloma by 2034.

Q&A Highlights

• Differentiation of bispecific CAR T-cell therapies from bispecific antibodies was discussed.
• Strategies for designing constructs for autoimmune indications in community-based settings were explored.
• Challenges and opportunities for long-term sustainability in the CAR T-cell therapy business were addressed.
• Emphasis on moving into earlier lines of therapy and potential for outpatient delivery.

For a deeper dive into the discussion, readers are encouraged to refer to the full transcript below.

Full transcript - Leerink Global Healthcare Conference 2025:

Cindy Perettie, Head of KITE, KITE: They’re up there at least. Yeah. Yeah. Yeah.

Dana Grabosch, Senior Analyst, Leerink Partners: Okay. I think we’ll get started. Hi, everyone. My name’s Dana Grabosch. I’m a senior analyst here at Leerink Partners, covering largely immuno oncology and also Gilead, which is broader than immuno oncology.

But today, I have the pleasure of talking about cancer with Cindy, who’s the head of KITE. And thank you for joining us.

Cindy Perettie, Head of KITE, KITE: Thank you for the invite.

Dana Grabosch, Senior Analyst, Leerink Partners: I appreciate the time.

Cindy Perettie, Head of KITE, KITE: Thank you.

Dana Grabosch, Senior Analyst, Leerink Partners: And we are going to jump right in. I’ll also leave maybe about five minutes at the end if anybody in the audience has questions. So let’s start with your BCMA CAR T, which Kite has partnered with Pharcellix on. And I think there is multiple potentially differentiating attributes for anitocell, the BCMA CAR T. And I wonder if which of those you think is going to be most impactful for commercialization as you look forward to a launch next year?

Cindy Perettie, Head of KITE, KITE: Yeah. So as a reminder, the data looks really compelling. We’ve got a sixty two percent complete response rate, which we know is gonna deepen over time. We have a ninety seven percent overall response rate. And, what we’re seeing from an efficacy standpoint, both in the high risk population as well as, I’ll call it, the general population with myeloma looks very similar.

So high risk doesn’t seem to have an impact on the efficacy. And from a safety perspective, we do see, differentiation as it relates to, we we have for grade one and, I guess, no CRS events were at eighty six percent. So majority of the patients at most get a fever. And then we’re also seeing differentiation on the long term neurotoxicities where we haven’t we have a low rate of ICANS and we haven’t observed any of the long term neurotoxicity. So I think that overall, the safety and efficacy profile, we’re really excited about commercially and think that that’s gonna make a difference.

If you pair that with the relationship between Arcelex and Kite, we have brought in our global manufacturing excellence. We’re bringing the vector in house as well, and we have global manufacturing facilities today, that are allowing us to reproduce the turnaround time similar to what we’re seeing with our existing commercial products. So we think that’s gonna be really helpful. We know that with multiple myeloma today, at least in our discussions informally with centers, they’re not they want that rapid turnaround time that we’re gonna be able to bring. We also have a strong global footprint.

So we’re in a number of countries today, 28 countries and growing. We have five thirty authorized treatment centers around the globe, and we’ll continue to grow that between now and 2026 when we launch. So we would expect to have an even broader footprint at the time of launch. So I think if you couple each one of those things, the the relationship with Arcelex and Kite is a really good one in bringing forward, we think, is a truly innovative product into the market most effectively.

Dana Grabosch, Senior Analyst, Leerink Partners: Not not that this is gonna happen, but maybe we’ll just do a theoretical. Let’s say as you get more patients and more follow-up, you do start to see some neurotox events. Do do you still think how do you think you would compete on more of the kite turnaround time and global footprint if the products ended up being more similar than different on efficacy and safety?

Cindy Perettie, Head of KITE, KITE: Yeah. Maybe I’ll answer that we have today dosed a 50 patients, and we know that those long term neurotoxicity events usually occur in the first thirty. Frankly, by ninety days, you’re seeing those. And we have a 50 patients, a majority of them beyond that time frame that we haven’t observed neurotoxicity. Of course, we’re gonna continue to watch.

Patient safety is most important to us. But we do think that there is a difference. Not all cars are created equal. There is a difference between the constructs. And so, we’ll continue to look for that.

But we feel, you know, the hypothesis that we’re exploring today is that we have a unique d domain binder. And what we’ve observed, we’ve had a chance to look at our Aneta cell construct. We’ve made the other two constructs, and what we see is a much faster off rate. So as the D domain binder binds, it has effective killing of the myeloma cells, but you don’t see the immunotoxicity that we’re that you’re we’re observing with the with the other two. And and our hypothesis is that fast off rate matters.

It mimics more physiological conditions, it also allows us not to see the inflammation, not to see the severe, immunotoxicity. So we feel pretty confident in this. Can we you know, could we observe delayed neurotoxicity? We’re certainly looking for that, so I don’t wanna pretend that, you know, we we absolutely can say today we won’t, but we do think we have a differentiated binder, that will make a difference as we come to market.

Dana Grabosch, Senior Analyst, Leerink Partners: So you’re not even gonna let me have the hypothetical? And so I’m trying to isolate the strength of your commercial infrastructure. Maybe just ask ask you there, like, how much, like, how much upside do you get if if any product in your infrastructure?

Cindy Perettie, Head of KITE, KITE: So if you look at today in myeloma, we know about one out of ten patients in that in that group are being treated. So the class share is at ten percent. We know that there’s a big opportunity to be able to treat more patients, and we know the data is profound, and that that physicians wanna treat their patients, patients wanna receive the therapy. So having the largest commercial footprint, having turnaround times that are the the best in the industry, we think is gonna really make a difference as we come to launch. What we’re hearing anecdotally, many of you probably speak to KOLs, is that, they are looking for those tighter turnaround times.

They’re not getting exactly that out of the existing products today, and it often means they have to bridge their patients or do a number of other things. So I know there’s excitement about it coming. I can tell there’s excitement, just from the conversations we have, but also as we think about the IMAGINE three study and what we’re seeing for interest and enrollment in that.

Dana Grabosch, Senior Analyst, Leerink Partners: Can you help us understand? You talked about the global footprint. In terms of approval, how soon could you have global approval follow The US approval?

Cindy Perettie, Head of KITE, KITE: So today, we’re talking about launching in 2026 in The US. And, obviously, every country is different. We would seek EMA approval, but following that, you also have to have HTA conversation. So we’re not necessarily committing to what the time frame would be around the globe. But suffice it to say, we will be filing in all of our, you know, all of the countries that we operate in today in in Europe as well as in Asia, Latin America, and in The Middle East.

Dana Grabosch, Senior Analyst, Leerink Partners: Got it. Maybe let’s talk about your current business, Yuskarta and Tecardis. I think, I wonder if you could contextualize the in class competition. Mhmm. And we know that you faced some headwinds from that last year.

Mhmm. Do you expect to continue to face those headwinds into this year and in future years?

Cindy Perettie, Head of KITE, KITE: Yeah. So what we’re observing with in class competition over the course of 2024, we saw one of the in class competitors, get three new indications, follicular lymphoma, mantle cell. We also see, new ALL indication. And when there’s new indications in, oncology, physicians are always excited to try those therapies. So we’re we are seeing, you know, physicians interested in giving a try to the new products we have.

So we have a combination of the new indications. We’ve also seen with one of the in class competitors, improvements in in turnaround times and manufacturing reliability. Today, our reliability is at 96%. In The US, our turnaround time is fourteen days. Outside of The US, it’s seventeen days.

So we’re continuing to make those improvements, but we’re also seeing, some of the in class competition getting better with their manufacturing, not quite to the level we’re at, but, improving. And I think it’s a combination of both the new indications coupled with that and, physician interest in trying trying these therapies.

Dana Grabosch, Senior Analyst, Leerink Partners: Have you seen, like, an arc of, like, were there physicians that tried it out earlier? Are they coming back to Yescarta? I think the worry is they really like the new products and the services around that,

Cindy Perettie, Head of KITE, KITE: and that we’ve been back. We have seen that, and we’ve observed it globally. We I just returned from Europe where we saw, without going into detail, a couple of the countries actually go from trying the new product to coming back. And I think, you know, when we talk to them about what is it that brought you back, I think components are the reliability of the product. They also there’s a belief that the efficacy with Yaskarta is strong.

We have we’re the only company today that’s got statistically significant overall survival, and that’s something that that resonates. And in in The US, we’re observing the same. It’s early days right now. So many of these, concerts are being are being tried today, but we are seeing, I think the word would be loyalist that that come back. Right.

Dana Grabosch, Senior Analyst, Leerink Partners: I think let’s come back to The US on the core business, and that is the authorized treatment center capacity, which I know that you’re diligently working, alone, but also in the industry industry wide to help expand. Is the capacity we have today in the system, is that sort of a zero sum game? Do you is there a negative impact, let’s say, on Yescarta from people wanting to use InedoCell for instance? Or how should we think about it?

Cindy Perettie, Head of KITE, KITE: We don’t necessarily see it that way. So I’m gonna break it down into a couple things. So we have the authorized treatment center footprint that we have today, that we continue to grow. We also are looking at we’ve shared bringing community practices up and being able to either, if you’re in a if you’re in a smaller community practice that you would be encouraged to do referrals, we have a whole education component around that, and there’s a lot happening at an industry level around that education as well. But we also have for the large integrated community practices, a chance for, those practices to actually deliver CAR T.

And I think a year ago, I was hopeful that this would happen quite quickly. What we found out, maybe I can break down the dynamics there, is many of these large integrated practices are located within a hospital, next to a hospital, so they already have a hospital relationship. But what it requires to deliver CAR is that they formalize that relationship, and part of that is sharing the economics. And so the conversation between the community practice and the hospital working through that sharing of economics didn’t go as quickly as I had hoped, and it takes a little bit of time for them to establish that, that relationship. I think the second component, that goes along with that is fact accreditation.

So today, some of our national payers tie reimbursement to fact accreditation. In fact, it was started as a it’s a very important accreditation that is linked to, transplant. And as we know, CAR T is not transplant necessarily. And if you’re sitting in a community practice, we had one of the large practices say to us, we want to leapfrog transplant. We think transplant isn’t going to be here ten years from now and that CAR could replace it, and we wanna become a CAR T center, not a transplant center.

And today, the way FACT is set up, you you’re both in the way in which the accreditation runs. So we have a great relationship with FACT. We’re working at an industry level between the Community Oncology Alliance and FACT to really create a modular accreditation for CAR T. And that’s something that will be piloted hopefully the second half of this year across three large practices. And once that’s piloted, it can be refined and then rolled out more broadly.

But that fact accreditation becomes really important. In parallel, we’re not waiting for that. We’re having conversations with national payers to really educate them on the difference between CAR T and transplant and why fact accreditation shouldn’t necessarily be the only link that they’re drawing as to why they would reimburse. So those are the components that we’re working on. There’s a number of other things, with making community practices successful that we are working at either as Kite or at an industry level to make that happen, but I’m highlighting kind of the big three things that we’re looking at.

Now let’s talk about what we can do. So part of, part of the pieces that we’re thinking about at KITE is how do we create constructs that enable outpatient delivery? And that goes to the to the bed question or, you know, are we at capacity? And so whether you’re in a community center or an academic center, how do we make these therapies outpatient? What does outpatient mean in CAR?

It’s very different than kinda how I would have defined it prior to working in CAR T. Outpatient means that the therapy can be delivered, and then the patient can go home. And if the patient has a CRS event or an ICANN event, they can come back into the center for a couple of days while that resolves or just to be observed. And and if it’s fever, they may be observed for eight or ten hours and then sent back home. But it’s getting the patient closer to home.

Right? No patient wants to travel three hours for delivery. So we’re working at each level to say, how do we create constructs that have that safety profile? And if I give you examples today with Yescarta and Tarkartis, we’re seeing about 35 of patient or centers being using it in the outpatient setting. We know with Anida Cell, because of the onset being at four days, it’s ideally situated to be an outpatient therapy.

We studied that in Imagen one in about ten percent of the population. We are studying that in an even broader population, including community practices in Imagen three. So really looking at how could outpatient. And then all of the constructs that we’re coming forward with is next generation constructs or new approaches, let’s say, in autoimmune or solid tumors, we’re thinking about that outpatient mindset. How do we create the level of efficacy we wanna see with autologous, you know, better than the products we have today, but also have that safety profile that it can be delivered in the outpatient?

And it’s each one of those pieces, that are gonna help us unlock the community and unlock these therapies being delivered closer to home. The last piece is the regulatory components of it. So as you know, some of these products have REMS, others are now being approved without REMS. So how do we approach the REMS piece and how do we approach the thirty day follow-up of those patients? So what, what you’ve seen is changing care at least in the last six months is now patients who are treated can actually move not thirty minutes or an hour from the center, but they can be further away from the center and actually receive care at their their home practice.

And so we’re working through some of the logistics on that from a care model.

Dana Grabosch, Senior Analyst, Leerink Partners: Wait. So that actually changed regulatory wise?

Cindy Perettie, Head of KITE, KITE: So regulatory wise, you can now be a little bit further away, and they still believe you can make it back to the centers in time, or you can be at an approved authorized treatment center closer to your home.

Dana Grabosch, Senior Analyst, Leerink Partners: Yeah. And are those the same ATCs like FACT accredited, or is that a different type of approved centers?

Cindy Perettie, Head of KITE, KITE: So let’s say, you you end up receiving your care in New York City, but there’s a fact accredited center in Central New Jersey. You could actually get the the a portion of your care at the fact accredited center. We wanna get to a place where we have more centers that have this modular FACT accreditation, and it’s not just transplant units.

Dana Grabosch, Senior Analyst, Leerink Partners: Got it. And then people can go back and sort of mix

Cindy Perettie, Head of KITE, KITE: up or they can receive their network. They can receive their therapy close to home. Close to home. Yeah.

Dana Grabosch, Senior Analyst, Leerink Partners: I I you said it really quickly. You said AnitoCell has the ideal outpatient with the early onset. And I wonder, both from the AnitoCell perspective and as you’re designing new construct, what is the sort of target threshold on safety to really enable outpatient? What are the elements?

Cindy Perettie, Head of KITE, KITE: So the elements are you want patients to be able to receive the therapy and have a little bit slower onset. So as you think about the rapid expansion of the cells, how do you have the expansion but not so rapid that it has a punch right up front, but that you still get to those peak levels you’re looking for? And that’s what we see with Aneta cell. So by day four, that’s when you start to observe CRS events, or ICANN events. If you think about the eighty six percent of the patients that have grade one CRS or no CRS at all, they would go in and be monitored for their fever and probably sent home, never admitted to the hospital, but rather sent home after the the fever subsides.

We have some hospital systems that are using watches that essentially monitor your fever, and they can tell you when to come in or not, and you’ve got triage units. So that’s that’s a component of the care. You have four days where the patient can go home, return to regular, life, and then come back in. And and part of that is getting a second DRG code if you think about The US, what they’re looking for, and that’s how they’re defining kind of that outpatient setting. So ideally, the patient would be able to go home for some period of time, and they would have low grade one, let’s say, CRS events as a majority of what their challenges are when you’re saying what’s the ideal profile and obviously low IKANES.

Dana Grabosch, Senior Analyst, Leerink Partners: And so when you design new constructs, how do you design for that

Cindy Perettie, Head of KITE, KITE: kind of Yeah. So I would, you know, I’d love to talk about our bistrionics because we thought a lot about that in the bistrionic design. So we have, essentially, one arm of it is a CD 19 with CD 28. So the escarta, essentially. The second is a CD 20 with four one BB.

And what it allows you to do is have fairly rapid expansion so you’d get that, what I call a punch, if that makes sense, to your tumor. But then you have the persistence from the four one BB. And so what we’re seeing in the phase one studies, and we’ll share that data later this year on those bisistronic, constructs is exactly that. We have two. We have one that has a traditional manufacturing of six days, and then we have a second one that has three day manufacturing.

So we have more juvenile cells, and we can dose at one tenth or one twentieth the dose of Yosgara today, but still see the levels of efficacy we wanna see with a with a much improved safety profile. So those are the types of things we’re looking at.

Dana Grabosch, Senior Analyst, Leerink Partners: Is the more juvenile cell that you also you get that slower expansion up? You get their juvenile on lower dose?

Cindy Perettie, Head of KITE, KITE: You you do get a slower expansion, but you also have a much lower dose. So I I won’t say slower expansion. You get a you you get a little bit slower expansion, not a lot slower, but you also are dosing at such a, you know, one tenth or one twentieth of the dose. So that’s helpful too, but still seeing the same level of efficacy. Those cells are very active.

Dana Grabosch, Senior Analyst, Leerink Partners: I’m gonna ask one more I’m gonna come back to the BICE’s drive. Next question. I’m gonna go back one more thing on the fact accreditation. What are they looking for in these pilots that would validate that this is a process?

Cindy Perettie, Head of KITE, KITE: Yeah. So I think part of it is if they’re designing it in a modular fashion that really goes to the institution and what they wanna deliver. So if I’m a academic institution, I can take the whole thing. Does that make sense? I wanna do stem cell transplant.

I wanna do aloe, and I wanna do CAR T. So can I do the whole bucket? And then if you look at a center that that’s a community practice, they may only want to deliver CAR T, so they may not need the same level of infrastructure. Does that make sense? Even down to freezers that you would need, on those various, delivery models.

So it really is taking into account your infrastructure and your care model.

Dana Grabosch, Senior Analyst, Leerink Partners: And so the the pilot is to say, okay. This site has less infrastructure and then making sure that

Cindy Perettie, Head of KITE, KITE: that’s where we’re going. Deliver it to to patients.

Dana Grabosch, Senior Analyst, Leerink Partners: Got it. Okay. Let’s go back to the by Sistronic and your the CD 19 CD 20. A couple questions. Just one, when will we see the data and what kind of outcomes are you looking for to make the decision between the constructs?

Cindy Perettie, Head of KITE, KITE: So, we’ve called it, I think, a bake off, a horse race. We have three constructs. We have the two by Sistronics I described. We also have Yaskarta in a three day manufacturing, which again, one tenth or one twentieth the dose. And so what we’re looking for is obviously improvements in efficacy as well as improvements in safety so that we can able enable that outpatient profile.

If you can imagine, we kinda have an idea now of what the other CAR Ts in this space look like, and we wanna be better in both aspects.

Dana Grabosch, Senior Analyst, Leerink Partners: How how do your constructs compare to the other sort of leading bispecific? I think J and J has one that’s had a lot of data they licensed from AbleZetta, for instance.

Cindy Perettie, Head of KITE, KITE: You’re talking about the bispecifics? The bispecifics.

Dana Grabosch, Senior Analyst, Leerink Partners: Not that’s not necessarily bispecific. The difference

Cindy Perettie, Head of KITE, KITE: is and I probably should have started with this. The piece about CAR T and the reason I joined KITE is that the curative potential. Look, we haven’t seen in lymphoma since our CHOP, cure rates at this level. So although sixty percent of patients with lymphoma will get our CHOP in the frontline and have a great response and potentially be cured, another forty percent are not. We know with YASGARDA today that we can cure over half of those patients.

And so with the with the bispecifics, we’re not seeing that same curative potential today. And so to me, that’s why I I separate why I think autologous is is a much better approach.

Dana Grabosch, Senior Analyst, Leerink Partners: That’s a I I actually didn’t ask that. I meant the bispecific cars.

Cindy Perettie, Head of KITE, KITE: The bice the bicycle Like,

Dana Grabosch, Senior Analyst, Leerink Partners: how your Bicystronic is differentiated from the competing bispecific cars.

Cindy Perettie, Head of KITE, KITE: Differentiation is really we spend a lot of time on the design looking at not just having dual targeting, but also having dual costimulatory domains and how we design it. And so what we’ve noticed is the dual costimulatory domains really play an important role as you think about safety and efficacy. And and so we believe that you need the CD 28 to have that impact on efficacy, rapidly. But we also recognize the four one b b is something that’s super important to persistence. And so you’ll see the data.

You had asked when we’ll share the data. We’ll be sharing the data at congresses this year. Our three six three construct study is fully enrolled, and seven five three and one nine seven, we’re continuing to enroll. So you’ll you’ll see data throughout the year. We’re excited to share it, so please make time to see it.

I I’m super excited.

Dana Grabosch, Senior Analyst, Leerink Partners: You’ve also announced, I think it’s three six three as a product you’re gonna take forward in autoimmune. Yep. And I think until you announced that, it was still ambiguous whether you would bring an internal product or you’d license and it’s something. So why did you decide to do this internally and why that construct in autoimmune?

Cindy Perettie, Head of KITE, KITE: You know, we took our time in autoimmune because we wanted to make sure we understood the space and what would be the, appropriate approach. So obviously, the SHET data is super compelling. Anybody who saw that and saw what they could do for lupus and lupus nephritis patients, it’s a game changer. And many of these patients were hospitalized, bedridden, and they’ve got their life back, and many of them in their twenties. Right?

And and that’s really hard to to see patients. If you think about autoimmune disease, this is a chronic disease. These patients are gonna live with their disease for thirty, forty, fifty years. And so the piece that that autologous approaches give you is these patients are on therapy for fifty years of their life. Fifty years of your life.

So can you imagine every day from when you’re 25 until you you pass away, you’re on therapy for your chronic disease? And and the piece that the autologous constructs offer is a disease free, treatment free period. I won’t say disease free. I’ll say treatment free period. My hope is that we get to a point where we see these as actually something that can offer potentially cure and shift shift your immune system so that that can be the case.

But that isn’t the data we have today, and we’ll keep we’ll keep studying it. But you could imagine even two years, five years with no treatment is a game changer for these for these patients. So CD 19 data looks great. Right? We’ve all seen the data.

We were super excited about it as well. But we also know in some of these diseases, CD 20 plays a role in b cell inhibition, and we know that because there’s antibodies that are approved in that space. So Ocrevus in multiple sclerosis, as an example, can be very effective therapy. So being able to hit CD 19 and CD 20 in some of these diseases, we think is gonna be really important. But we also need to think about safety because in the autoimmune space, these patients, because they have chronic disease, are ninety percent of the time seen in a community setting.

Right? They’re going to their local physician. They’re not going to academic centers until they get absolutely refractory from the therapies that are available. And so how we create something that can be delivered in the community is the other piece that we have been paying a lot of attention to. So we’re excited to advance three six three.

We’re really looking forward to what we saw in our phase one studies, and the data we’ll share later this year, in oncology in oncology looks like this is a great profile for an autoimmune therapy, particularly because we don’t know how deep a response you need. We know in oncology, you need a really deep response to be able to see curative potential. And we think in autoimmune that as long as it’s getting into the tissue, it may not need to be as deeper response. And that’s why the the three six three, the traditional manufacturing made a lot of sense for us to move there. But we’ll continue to keep looking at the external space.

We’re not gonna lose sight of that.

Dana Grabosch, Senior Analyst, Leerink Partners: We have five minutes. I’m going to put it out to the audience if anybody has a question, and then I’ll move on. As you think about autoimmune, is there particular indications that you’re most excited about for

Cindy Perettie, Head of KITE, KITE: your internal? There are. So we’re studying we we just filed an IND for a basket study where we’re going to be looking at lupus and lupus nephritis, myositis, and scleroderma. We’ll be coming forward later this year with a basket study in neurology where we’ll also be looking at MS and myasthenia gravis. So we’re excited about the possibility.

And again, feel like for some of those indications, having that CD 19 and CD 20 will be really impactful.

Dana Grabosch, Senior Analyst, Leerink Partners: Maybe one more business question. We had dinner last night, and I thought some of the most interesting comments, discussion we have were about this the long term business of CAR T and sort of the barriers to entry. Mhmm. And I wonder if you could talk about how you’re currently thinking about the durability of this business, for Gilead and what the barriers are that might keep this a pretty small focus set of companies in the future.

Cindy Perettie, Head of KITE, KITE: So so we really see the cell therapy business as a as a long term growth driver for Gilead, and you probably heard that from Andy and others. And if I think about the business today with Yescarta and Tecartis, in lymphoma, this is a really important business for us. So we believe in 2034, we think that lymph lymphoma market will be somewhere between ten and twelve billion. So we know that there’ll be growth there. And part of that is the pieces I talked about earlier on how do we unlock the use of autologous CAR T more into community and getting patients closer to home.

And so the work that we’re gonna do there, super important. If you think about multiple myeloma, myeloma, we see that in 2034 as a 15 to $20,000,000,000 business. So why the difference? In lymphoma, patients are cured. As I said, sixty percent are cured with R CHOP.

So you really only have forty percent of those patients line. In multiple myeloma, there is not necessarily curative, options upfront or very few options. Some patients on transplant will have a really good response. And so you have a majority of those patients advancing to second line, third line, fourth line. And for myeloma, we know those patients can go through nine or 10 lines of therapy and live for many years over a decade with their disease.

And so even entering in with an Edocell in the fourth line, we still see that as a really great opportunity for the company and a chance to start off with an Edocell with our global footprint and our manufacturing and the great construct that it is to really grow that. But we’ll come behind it really quickly with with second line our second line study, IMAGINE three, and then we’re also designing a study to go into the front line. So we see, again, Aneta cell is another opportunity for growth. We see that market being 15 to to 20,000,000,000. So all the work we’re gonna do in lymphoma today matters because we won’t see the success in myeloma or an autoimmune unless we’re able to unlock some of the things we talked about.

And then autoimmune, as you think about expanding, starting similar to how you approach an oncology in that refractory setting And how do we continue to expand into earlier lines is something that the that market shaping is gonna matter what we do in oncology and will be directly applicable to what we see there. We have a number of, we did an an acquisition of a company called TImmunity, which was looking in the solid tumor space. So we have studies ongoing there in GBM and neuroblastoma. We’re also looking at other solid tumors. We think that solid tumors are tricky.

This takes a lot of work. It’s gonna require two or three targets. We’re looking at armoring and decoys, and we have an opportunity to advance some solid tumor programs, two in the clinic today, as I noted from T immunity, but more coming in the future. So that’s autologous. But then we also know that there’s other approaches in this space, whether it is aloe, in vivo.

There’s a lot of exciting things heating up right now, so we continue to keep our eye on that as well. We either have some that we’re doing through collaborations, some we’re doing in our own internal research, as well as just keeping an eye on the external landscape. So we see this again as a long term growth driver for Gilead, and see the ability to move beyond just blood cancers, which is, you know, if you I will say that I was a skeptic five or six years ago, and it’s super great to be a kite. I was wondering myself, was it gonna have the curative potential? Were you gonna be able to do this beyond blood cancers?

And it’s great to see the data we see today in autoimmune and solid tumors.

Dana Grabosch, Senior Analyst, Leerink Partners: So the infrastructure you build in the community, those are an oncology those those are oncology practices. Would that apply to room, or it’s more about that model It’s about replicating it for room or or neurology?

Cindy Perettie, Head of KITE, KITE: It’s about in the long term room or or neurology? It’s about in the long term replicating the model. In the near term, what we found is that, entertaining centers that have strong relationships between oncologists and their rheumatologists or their neurologists or those CAR T treaters who are have enough foresight to say this looks really great in lupus, and I’m gonna go down the hall and introduce myself to the rheumatology practice is really important. So as we get our clinical trials up in the existing authorized treatment centers, what we’re finding is, we want the centers that have that rapport, that are willing to just say, I’m not an oncology treater only. I’m gonna establish a relationship with the neurology unit, with the rheumatology unit.

But long term, these patients are seen, you know, in the community, and being able to replicate what we learn in oncology to those practices will be important. And the therapies have to get safer. Right? Safer and safer so you don’t have lymphodepletion down the road and that you have an opportunity to truly deliver these in a in a community setting.

Dana Grabosch, Senior Analyst, Leerink Partners: Do you have, anything on the horizon on not using lymphodepletion or using reduced lymphodepletion?

Cindy Perettie, Head of KITE, KITE: We have efforts. We have ongoing efforts from a research perspective in that space.

Dana Grabosch, Senior Analyst, Leerink Partners: Awesome. So we went a minute over time. Okay. Thank you so much. Thank you.

It was a great conversation. Thank you for everybody’s attention.

Cindy Perettie, Head of KITE, KITE: Thank you.

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