Fate Therapeutics at Leerink Conference: Strategic Shift to FT-819

On Wednesday, 12 March 2025, Fate Therapeutics (NASDAQ: FATE) presented at the Leerink Global Healthcare Conference 2025, unveiling a strategic pivot towards its FT-819 program, a promising iPSC-derived CAR T-cell therapy for autoimmune diseases. While emphasizing the company’s robust financial health, CEO Bob Vallemer acknowledged a shift in focus that might deprioritize other innovative platforms temporarily.

Key Takeaways

• Fate Therapeutics will allocate 70-75% of its resources to the FT-819 program.
• The company maintains a strong cash position with over $300 million, expected to last through 2026.
• Early clinical data for FT-819 in autoimmune diseases is promising, with plans to expand patient enrollment.
• The company is exploring adaptive trial designs for FT-819, aiming for potential approval.
• Manufacturing capabilities are substantial, with a facility capable of producing 50,000 doses annually.

Financial Results

• Cash runway is projected through the end of 2026, supported by over $300 million in cash.
• Cost reductions are being pursued through renegotiated vendor agreements and purchase orders.
• Non-dilutive funding efforts include grants from the California Institute for Regenerative Medicine, with $8 million for FT-819 and $4 million for FT-830.

Operational Updates

• Prioritization of the FT-819 program will see 70-75% of resources directed towards it.
• Clinical trial amendments include dose escalation up to 900 million cells and exploration of multi-dose regimens.
• Enrollment targets aim to treat an additional 12-18 patients with FT-819 by the end of the year.
• The company operates a single 40,000 square foot facility with a capacity of 50,000 doses per year.
• The FT-522 NK cell program will be combined with monoclonal antibodies in specific disease categories.

Future Outlook

• The FT-819 approval pathway is being explored through adaptive trial design, potentially using the DORIS endpoint for single-arm approval or a comparison to standard care based on renal response.
• Target indications for FT-819 include SLE patients stable with standard care but seeking to discontinue steroids, and patients unresponsive to standard care.
• The estimated trial size for FT-819, if successful with the DORIS endpoint, would be around 50 patients, expanding to 150-200 if requiring renal response comparisons.

Q&A Highlights

• FT-819 data shows a safety profile consistent with oncology trials, with potent B cell depletion observed using cyclophosphamide or bendamustine.
• Physicians show a preference for cyclophosphamide alone due to familiarity.
• The company’s Allo Evasion Domain Receptor technology in T cells is designed to protect itself and expand in vivo.
• The FT-522 strategy involves combining NK cells with monoclonal antibodies for enhanced activity.

Readers are encouraged to refer to the full transcript for a comprehensive understanding of Fate Therapeutics’ strategic initiatives and future plans.

Full transcript - Leerink Global Healthcare Conference 2025:

Dana Graybosch, Analyst, Limerick Partners: Hi, everyone. My name is Dana Graybosch. I’m an analyst here at Limerick Partners. I mostly cover immuno oncology companies and have been following FATE for a number of years now, And I’m excited to host our new CEO, Bob Vallemer. And I think because you’re new in this role, we’ll probably start there.

First, maybe people know, but can you just give us your background and sort of at FAIT and prior to FAIT as well?

Bob Vallemer, CEO, FATE Therapeutics: Sure. Thank you for the invitation, Dana. So I’ve been at FAIT Therapeutics for sixteen years now. Really came in in 2010 focused on starting this IPSC platform. And back in the day, it was more about trying to figure out what to do with it and trying to solve about how to culture these cells, which were very complicated.

So I came in early on to try to start the platform. And since then, I’ve been working through up in R and D leadership as the platform took shape and became the centerpiece of the company. I also developed with it. And I ended my R and D tenure as president of research and development last year. Prior to that, I was at Amgen and UCLA in terms of training at UCLA and previous experience at Amgen.

So really, my career set the stage for the iPSC platform, either working on cell line development at Amgen and trying to understand how to make a master cell bank or looking at oncology, immunology, and pluripotency at UCLA. So a perfect storm came together. And I took the baton from Scott last year, end of last year, and I’m carrying things forward.

Dana Graybosch, Analyst, Limerick Partners: What changes should investors expect with you as CEO, whether it’s portfolio platform strategy, how you communicate with us and investigators’ development strategy?

Bob Vallemer, CEO, FATE Therapeutics: That’s a great question. The focus right now is on moving FT-eight 19 forward. You know, we did a lot of investigations at the phase one level and got to learn a lot of victories and successes and also failures in terms of making sure the right product is in the right place. I really believe, you know, having made 8.19 and for the reasons we made it I don’t want to get into the details today but it was made to balance safety and efficacy. And I think it’s found its home in autoimmune disease and all the value points that comes in together from a perspective of truly being off the shelf, cost effective, having reduced hospitalization requirements that are probably going to go away over the rest of this year, expansion into other diseases and autoimmune.

Being a great B cell depleter, eight nineteen, it really sets the stage of believing that there is a path to approval here for FT-eight nineteen, and we will obtain more patient data and create the paths to a pivotal study. So that is different than fate of old and not because it’s me versus Scott. It’s more about we have found the right product for the right disease and moving it forward. So there’s going to be a lot of focus on moving 08/19 forward. We will continue with innovation.

That’s near and dear to my heart. There’s a next generation CAR T platform rolling out. But really, the main focus of the company is to push forward with 08/19 and get our first product approved in the near future.

Dana Graybosch, Analyst, Limerick Partners: Got it. So rather than six programs and five indications and so much going on, we used to always publish just this map of everything going on because it was always really complex. Now it’s like, this is it. Let’s all focus on 08/19 and this path forward.

Bob Vallemer, CEO, FATE Therapeutics: Yes. Let’s put a percentage on it, like 70%, seventy five %. There’s still a lot of excitement in the background that we want to prosecute. But it will be in the background, such as next generation CAR T targeting McA McBee or next generation CAR T targeting CD19 and CD38. We still have brilliant scientists in the company, and we’re going to pursue innovation and next generation of products.

But the main focus is gonna be getting 08/19 approved.

Dana Graybosch, Analyst, Limerick Partners: Investors also remain concerned about your cash burn. And now that you are not doing as much programs in the clinic, so how are you thinking about capital allocation? And are there ways to extend your cash runway and sort of bring down the overall burn with your focus strategy?

Bob Vallemer, CEO, FATE Therapeutics: So Scott left me with a nice gift, over $300,000,000 And that’s going to get us through year end ’twenty six. But there are several buckets to take advantage of here. The first bucket is being very diligent with our money. Two years ago, when we went to vendors and tried to renegotiate agreements, they didn’t want to talk. But now times have changed.

They’re feeling it too. So we’re renegotiating a lot of our POs, a lot of our agreements, and really being careful with how we spend money. So that’s the first one. The second bucket is being very deliberate with our programs, as we’ll talk about 05/22 later, making sure that our focus on clinical strategy is something that is going to allow us to have a longer runway as opposed to, like you said, do a lot of things at once. And the third thing is trying to get non dilutive cash.

So we’ve been very fortunate to have California Institute for Regenerative Medicine help us with grants. And we have several grants with them. And we’re talking several million $8,000,000 for example, for FT eight nineteen and $4,000,000 for FT eight thirty And there’s more opportunities there. And also business development opportunities. We’re having a lot of great conversations.

And I think there is a path there as well.

Dana Graybosch, Analyst, Limerick Partners: What is FT836?

Bob Vallemer, CEO, FATE Therapeutics: Sorry, this is a next generation CAR T targeting Meke and McBee. So that will be an IND that we will roll out first half of this year.

Dana Graybosch, Analyst, Limerick Partners: Beyond faith, the equity markets have been really challenging for cell therapy developers. Actually, it’s probably the number one discussion and question I’ve heard at our conference, which is what will actually turn around the negative sentiment for cell therapy, auto and allo overall? What do you think?

Bob Vallemer, CEO, FATE Therapeutics: So I think what I believe is by end of the year, as multiple CAR T companies roll out their data, it is going to look impressive. Because when you look at historically an autoimmune, what’s been approved, while there is success there, the bar has been pretty low. You know, just most recently in the New England Journal of Medicine by Roche, the percentages are very different than what CAR T is expected to deliver. And I think, while monoclonal antibodies will have some data there and T cell engagers will also have some data, there’s still going to be a lot of concerns with T cell engagers. Do you want to, in a promiscuous way, activate every T cell in the body?

The toxicity profile may not be ideal. Meanwhile, I think CAR T is going to show that we shouldn’t be expecting shit like numbers all the time, but we should be expecting improved outcomes over previously approved or currently trajectory approved programs in autoimmune. So I think with time and hopefully that’s just this year we will see the romance come back with CAR T. And because it is working, there is activity there, not just for us but for our peers. We just believe we’re a little different because we’re off the show.

Dana Graybosch, Analyst, Limerick Partners: I guess let’s talk about your data in autoimmune. You had data with FT819 last year at ACR and ASH. And could you in three patients. And I wonder if you could summarize that. And what were the most important takeaways for the potential of your program from those early data sets?

Bob Vallemer, CEO, FATE Therapeutics: So the first takeaway was that this balance between safety and activity really paid out in this disease specific setting. All three patients, the safety profile was as expected, similar with the 50 patients in oncology. So minimal adverse effects and just really just a preferred safety profile there. On the efficacy, we originally set up the protocol to have combination with cyclophosphamide and fludaramine as a conditioning agent or cyclophosphamide alone or bendamustine alone. And we noticed that physicians did not gravitate to Cy flu but more so to Cy or Benda, especially Cy because patients have been treated with cyclophosphamide.

Rheumatologists know cyclophosphamide. So seeing activity, seeing B cell depletion in all three patients with either only bendamustine or only a single dose of cyclophosphamide really did show us what we knew all the time, what eight nineteen is a potent B cell depleter. So we got that one checked off. And with the first patient over the course of six months progressing toward DOORS clinical remission, it was very satisfying to see that by depleting the B cells and inducing immune reset, you’re able to now help the kidney recover and help the patient recover in general. And those trends are we’re hoping to continue the updates at ULAR with those first three patients, really focusing in on those individual patients, the case studies, and also give an update on our site initiation and activation projections, which are very different than last year.

Last year, when we went to sites, they were overwhelmed by the big pharmaceutical companies and also by other biotechs to a point where, when we said off the shelf, they didn’t have a true understanding of what that meant. And now they’re seeing that, Okay, autocar T is very challenging to make. There is this dependency on the oncologists and the beds that they have. And really, off the shelf may alleviate them and break the dependency, which is appreciated both ways. The oncologists also want to have time to work on their own patients.

So we’re really seeing an uptake in discussions with sites to activation, which will lead to more enrollment of patients, And a EU LAR will update on those trajectories as well. So you’re

Dana Graybosch, Analyst, Limerick Partners: going to have the three case studies and an update, really, on the trajectory of your enrollment.

Bob Vallemer, CEO, FATE Therapeutics: Yes. Setting the stage for end of the year update on what’s going on with those three patients, but also in all the other patients that are treated.

Dana Graybosch, Analyst, Limerick Partners: And so end of the year, sort of ACR ASH, how many patients might we expect then?

Bob Vallemer, CEO, FATE Therapeutics: So what we’re hoping is, be able to treat something close to an additional 10 to 15 patients. So probably something closer to fifteen, twelve to 18 patients by end of the year.

Dana Graybosch, Analyst, Limerick Partners: With significant follow-up?

Bob Vallemer, CEO, FATE Therapeutics: With, some of them may not be six months. But I think at that point, because we want to talk about our path to pivotal, we’ll probably give updates that are shorter than six months, three months, and maybe even one month, because now is a collective discussion as opposed to the case studies that we will talk about at Euler.

Dana Graybosch, Analyst, Limerick Partners: Can you help me understand why Cy only or bendamustine are working? So you have, you know, traditionally we think about, you know, use lymphodepletion with auto because you want to provide the homeostatic cytokines or room. But then also with allo, you need to protect rejection. So you have multiple reasons why you need lymphodepletion, and some alloes use really companies use really intense lymphodepletion. So why, scientifically, why is this working?

Bob Vallemer, CEO, FATE Therapeutics: I think scientifically, the effector to target ratio is very different. So in this disease setting, we are seeing that you take a great a very good B cell depleter with eight 19. And potentially, you all need to create a tuned down version of creation of space, a tuned down version of enhancement of cytokine surplus, a tuned down version of avoidance, of rejection. That the things that were required to get rid of five pounds of tumor are not required here, where the cells are speculated to be magnitudes less, the disease cells that are being targeted. So I think starting with a potent CAR T cell, it may not have the same requirements for space and cytokine as you did in a different setting where the battle is going to be more aggressive.

Dana Graybosch, Analyst, Limerick Partners: Do you have cytokine support on board in this? Or can you remind us of the construct?

Bob Vallemer, CEO, FATE Therapeutics: So FT-eight 19, no, we don’t. And FT-eight 19 was built by simply having a CAR, a chimeric antigen receptor that’s been fine tuned to balance safety and activity embedded into the track locus for biological expression to prevent exhaustion as opposed to a synthetic promoter that would push for exhaustion. So here, yeah, there is no cytokine support. There’s no ADR. And so this is where it’s a very unique setting.

And obviously, we have the next generation coming. But again, because of the disease burden being lower, I think you are able to now combine first generation iPSC derived CAR T cell with either Cy or BenDe and have an effect.

Dana Graybosch, Analyst, Limerick Partners: In your recent earnings update, you did report some trial amendments that we read as intensifying FT819 dose. So you’re going up to 900,000,000 cells. You were at seven twenty million earlier, and you’re also trying some more intensive dosing regimens, so multi dose cycles, a retreatment. We wonder, sort of, what’s driving that? If you need less like, we just talked about why you need less why are a lot of your amendments doing more?

Bob Vallemer, CEO, FATE Therapeutics: Sure. So I’ll separate the two. One, dose level two was a mere discussion with my team, where I made sure you know, we really wanted to focus on a path to pivotal. So we only want to pursue two doses. Dose level one is working.

And we want to we are expanding and want to make sure that it stays that continues with expansion in dose level one. But we’re going to escalate to dose level two. And because the number of cells is not an issue for us, the team offered a suggestion where, if we’re only going to do two doses, let’s make dose level two a little bit higher so we can get a good breadth of three sixty and then two and a half x more to nine hundred. So it was a matter of seven twenty or nine hundred. And since we were going to limit ourselves to two doses, we went with the higher end.

So nothing to read beyond the fact of, let’s just have dose level two be significantly different enough to then be able to see whether a higher dose does anything different. On the multi dose and dosing after relapse, these are follow ups from the type D meeting that we had with the FDA in December. We asked five questions and had favorable outcome. Part of that was expansion into three additional autoimmune diseases with FT-eight nineteen. The other part was that eight nineteen has always been limited to a single dose per cycle.

So we asked, can we multi dose? And they granted that. And also we asked if you can dose upon relapse. So the multi dose, we’re not applying here in regimen A. The multi dose will be applied if needed in regimen B.

So remember, there’s a second regimen where eight nineteen is going to be added on top of standard of care therapy, whether it’s MMF, AZA, methotrexate. So here, we may need a larger quantity of the product or multiple doses of the product to drive a deeper response.

Dana Graybosch, Analyst, Limerick Partners: Why, when you’re on top of standard of care, shouldn’t it be easier? Well,

Bob Vallemer, CEO, FATE Therapeutics: we went back and talked about avoiding rejection, avoiding or needing space, the cytokine surplus. While we speculate that with steroids, you might get a little bit of that, it is very different than conditioning. So you might need to come in with higher dose. Or you might need ADR, which we’ll talk about later. But here, this is very much like a biologic monoclonal antibody, which is given many times over a course of six months.

With the Type D meeting and the new amendment, FT-eight 19 can now provide that dosing paradigm as well in regimen B.

Dana Graybosch, Analyst, Limerick Partners: So So regimen B doesn’t have lymphodepletion?

Bob Vallemer, CEO, FATE Therapeutics: No. It’s just on top of standard of care therapy. Yes. And a different population. Regimen B are SLE patients that are stable with standard of care therapy but want to come off because nobody wants to be on steroids for too long, where regimen A will be, basically patients that are now have not responded, no longer responded to standard of care therapy.

Dana Graybosch, Analyst, Limerick Partners: Got it. What does a path to approval look like? And are there scenarios?

Bob Vallemer, CEO, FATE Therapeutics: Yes. So for us, the variables are few when it comes to dose level one versus dose level two, combination with Benda or cyclophosphamide. So those are a few variables that will work out to the rest of the year. The endpoint is something that we need to know. And obviously, that’s going to dictate the size.

Novartis’ phase two trial is actually I’m very impressed by it. It’s a very smart, intelligent design that appears to be adaptive. You have a standard of care arm, but your primary endpoint is Doris. So most likely, if you hit that, the standard of care will fall off. But if you may not be able to hit DORS, then you go to complete renal response there.

And then now you can compare it to standard of care arm. So following that playbook, you might be able to now create an adaptive design. And that’s the conversations we will be having with the FDA on alignment on the pivotal path. So you

Dana Graybosch, Analyst, Limerick Partners: think you could get a single arm approval on a DORS endpoint? And if you can’t hit that, then you go to a little bit still where you could show benefit on renal response, but that’s versus standard of care. I understand that.

Bob Vallemer, CEO, FATE Therapeutics: Yes. I will have to run that through discussions with the FDA and our own internal data, but that would be the hope today, an adaptive strategy that will take advantage of both endpoints.

Dana Graybosch, Analyst, Limerick Partners: How big are these studies, you think? I’m going

Bob Vallemer, CEO, FATE Therapeutics: to speculate. But I think if we were able to pull off the Doris, I think that’s probably somewhere in the mid double digits, let’s say 50 plus or minus. And otherwise, we’ll probably have to go to 150 to 200 patients. But again, let me get a little bit more clarity, and I’ll provide more update on that. But that’s kind of the range that we’re thinking.

Dana Graybosch, Analyst, Limerick Partners: So your hypothesis So your hypothesis around being able to use Cy alone or Bendesh, shouldn’t that apply to all T cells? So do you expect that we’re gonna see all the auto programs actually shift to similar strategies? Definitely.

Bob Vallemer, CEO, FATE Therapeutics: I think there’s a possibility there. What really separates this, though, is when we have FT-eight nineteen with cyclophosphamide alone, that’s still very different than AutoCAR T. Because where we hope that our seventy two hour hospitalization requirements will go away by the end of the year that’s another discussion that we plan to have with the FDA we really become outpatient setting. And outpatient setting with sigh alone really becomes a true biologic in terms of how rheumatologists can treat their patients without the need of hospital beds. So yes, in fact, I think if we can pull off with scythe only a single dose of scythe, there’s no reason to think why AutoCAR T can’t do that.

But when it comes to the entire operational feasibility of that in terms of being off the shelf, cost effective, no hospitalization requirements, it still really fully takes advantage of the situation where ROCRT, I don’t think, today can say the same.

Dana Graybosch, Analyst, Limerick Partners: So let’s talk about so I understand the off the shelf and sort of the process improvements. Let’s talk about the toxicity versus auto. Yes, I’ll take you versus some of the first gen, but some of the, you know, next gen autologous programs, let’s say, autoluses or others, are pretty safe too. So is like, what’s the true what gives you confidence you are still differentiated over those second gens, which are also going to autoimmune on safety?

Bob Vallemer, CEO, FATE Therapeutics: Yeah, so that’s a great question. But keep in mind, second gen continues to be heterogeneous population of edited cells with not fully defined location of integration. So whether you’re talking about heterogeneous population of randomly engineered cells or secondary malignancies, you’re not going to be able to walk away from that. And so where we have a master cell bank where a single clone has been fully characterized, that clearly separates us from everyone else when it comes to understanding your product and creating a uniform product that is safe and effective.

Dana Graybosch, Analyst, Limerick Partners: Yeah, but the secondary malignancies, the more common ones, I think are probably caused by the lymphodepletion. So if everybody’s going to sigh only, you’re talking about this really low risk of T cell lymphoma conversion, right? You think that’s going to actually change commercial decisions?

Bob Vallemer, CEO, FATE Therapeutics: I think that collectively, absolutely. If you want to lean this way on safety or lean that way on heterogeneity, you still have cost of goods. You still have the availability right now. In a single facility of 40,000 square feet, what we have today, we can make fifty thousand doses per year. That’s very different than others.

And so collectively, it just becomes the only paradigm that is like a biologic. And, you know, yes, safety obviously, innovation is there. And others, over time, will be able to, like you said, improve their safety. But how about cost of goods? How about availability?

How about scale and production? All those things add up.

Dana Graybosch, Analyst, Limerick Partners: Yeah. So let’s say, I mean, you still have risk even though it’s lower of acute toxicity. And so even if you can get into the outpatient and get away from the seventy two hours, do you not still remain tethered to these academic centers? Because they need to monitor and admit patients, even if it’s a low risk.

Bob Vallemer, CEO, FATE Therapeutics: So I think because of the risk profile will always be there in the initial stage. You probably want to be in proximity to a hospital, not the CAR T center. Because right now, even rheumatologists give TOSI all the time themselves. So I think it’s going to be manageable. And with time, I think even that concern will go away.

But let’s say you have to be within sixty to one hundred and twenty one or two hours away from a hospital. That’s still pretty broad in terms of the number of people that fall into that category. SPEAKER one: Got it.

Dana Graybosch, Analyst, Limerick Partners: Let’s talk about the ADR. So we’ve liked your ADR. It’s the aloe of Asian edit that’s active, by going after four-1BB. And you’re first featuring it and looking at it clinically in your NK cell chassis and FT-five 22. Can you talk about, like, where are you with that edit, aloe evasion in general?

Because it’s not an FT819. Like, do you need it? Where do you need it? And how are you thinking about developing that going forward?

Bob Vallemer, CEO, FATE Therapeutics: Great question. And you know that’s very close to my heart. So when we rolled out avoidance of conditioning, it wasn’t to avoid rejection. What it was to completely replace the need for conditioning chemotherapy. So here, the goal was not to go and become stealth and hide.

It was to actually to make up the difference for creation of space, the cytokine surplus that’s necessary, and avoidance of rejection. So ADR was built very uniquely. And it does not depend on class one, class two knockout. That actually makes itself a little wonky and a huge target for NK missing self. So instead, we created a signaling cascade that upon engagement with a T or NK cell that’s going to kill you, you kill it first.

So you create yourself. You protect yourself. You create space. And you give a signaling cue to expand in vivo. Now, to your point, if eight nineteen doesn’t have it in this very unique setting of autoimmune disease, why do you need it?

Well, there are more aggressive diseases out there, such as solid tumor, such as more complex autoimmune diseases, and he malignancies, where if you can’t avoid the need for conditioning chemotherapy and have a CAR T like activity, then you’re going to be sitting in a very unique place. And this is where I think our Sword and Shield technology sets us apart, protect the cell, evade detection, but also create space, give your cell the signaling cue, and completely replace the need for conditioning chemotherapy.

Dana Graybosch, Analyst, Limerick Partners: Okay. Last question, maybe. We’ll see how long it takes. So sort of reading the tea leaves of your recent announcements and what you’ve said today, it feels like you’re deprioritizing NK cells and FT-five 22. Is that a fair read and why?

Bob Vallemer, CEO, FATE Therapeutics: So one of the things that is very apparent in our hands and, I think, in the community as well is that NK cells don’t have the same antigen mediated expansion as T cells do. And so a CAR T responds very differently to an antigen stimulating Q versus a CAR NK. And K cells kill very effectively, but they don’t expand. And so this effector to target ratio concern becomes something that we need to think about. And so because we have a T cell, we work so hard to make a T cell like product that’s made in a Petri dish, we’re taking full advantage of the potency that comes to the table with FT-eight nineteen.

Like I said earlier, it’s a very powerful B cell depleter. But NK cells are a perfect partner for a combination of monoclonal antibodies. And we’re not going to forget that because we’ve seen that time and time in our own clinical trials as others have seen it in theirs. And so for FT522 and autoimmune, there will be specific categories in disease where there’s a monoclonal antibody. An enhancement of that monoclonal antibody’s activity, such as combining with an anti CD20 or anti CD38, can really benefit the patients in that unique setting.

So 05/22, we are obviously, we have a cleared IND, and we’re in discussions with investigators for various investigator initiated trials to find these specific places to combine with mAbs and really enhance the activity in combination.

Dana Graybosch, Analyst, Limerick Partners: Can you tell us any of those indications that are top of your list for consideration?

Bob Vallemer, CEO, FATE Therapeutics: We’re working through it now. But, yes, we’ll give an update, perhaps at Euler. We’ve submitted a series of abstracts. One of them has discusses 05/22, and we’ll give an update there. Got

Dana Graybosch, Analyst, Limerick Partners: it. And this isn’t new, about NK cells not expanding. And I guess it’s a challenge, but it’s also people, including fate, have described it as an opportunity because you can control the dose. And so in the past, fate has said, well, you can give these really high doses, and indeed that’s what you did to provide the killing you need. And in autoimmune, you need less killing, as we talked about previously.

So why is that not a viable strategy anymore, simply to use these higher doses?

Bob Vallemer, CEO, FATE Therapeutics: I don’t think I mentioned it’s not a viable strategy. But I think when it comes to B cell depletion, pound for pound eight nineteen is more potent than five twenty two. And so we want to pursue that. And again, if five twenty two in these unique indications prevails, maybe we will move into a monotherapy arm as well. But in a world of being diligent with our money and being very focused with our plans, for now, five twenty two will be combined in unique settings with a monoclonal antibody.

Dana Graybosch, Analyst, Limerick Partners: There’s a skeptical bear thesis out there that, that it’s just very expensive to make such high doses of NK cells and that you haven’t been able to work out a really cheap, scalable way so that expense in manufacturing is underlying this decision?

Bob Vallemer, CEO, FATE Therapeutics: No. Not for us. I mean, we dosed in some programs, three doses of two point five billion cells. We have plenty of inventory of those cells left. That was FT596, for example.

So for us, making cells is not a challenge. And the scale is literally based on how much volume we carry forward, not based on the starting material, the cost. But it does at some point, you do wonder if the effector to target ratio is the most important thing in aggressive disease. Can you ever tilt that balance mechanically, or you have to pursue it biologically?

Dana Graybosch, Analyst, Limerick Partners: Meaning just getting that cell

Bob Vallemer, CEO, FATE Therapeutics: dose And people expansion, yes. Exactly, yes. Can you come in mechanically with billions and billions of cells versus allow the T cell to do its thing? But for us, no. I mean, there is always going to be a certain threshold.

Making trillions of cells per patient may not make sense. But, but no, the decision was not based on the number of cells that we could or could not make.

Dana Graybosch, Analyst, Limerick Partners: I know one more time to ask one last question on your T cell. Are all your T cells going to be the CD8, like FT819? Or are you going to have some CD4, CD8?

Bob Vallemer, CEO, FATE Therapeutics: So today, the focus has been to make a CD8 cell. CD4s are typically helper cells, and so they support the CD8 activity. We’re doing that. We’re compensating that through engineering the cells. So our CAR Ts are autonomous, and we wanted to keep them autonomous.

They’re just dependent on their engineer strategy. So the next generation that I’m talking about is going to have nine edits. And some people say, oh, well, you’re cheating. You have nine edits. We’re not cheating.

We could just put nine edits in. And so through these nine edits, we’re completely autonomous of anything else, and we can basically target and kill the designated disease.

Dana Graybosch, Analyst, Limerick Partners: SPEAKER one: Awesome. Thank you very much. I appreciate it. A great conversation. Thank you everyone for your attention.

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