Q3 2023 Fate Therapeutics Inc Earnings Call
Okay.
Welcome to the fate Therapeutics third quarter 2023 financial results Conference call. At this time, all participants are in a listen only mode. The.
The call is being webcast live on the investors section of fates website at fate Therapeutics dotcom.
As a reminder, today's call is being recorded I would now like to introduce Scott Walker.
President and CEO of fate therapeutics.
Thank you.
Good afternoon, and thanks, everyone for joining us for the fate Therapeutics third quarter 2023 financial results call.
Shortly after four P M. Eastern time today, we issued a press release with these results, which can be found on the investors section of our website under press releases.
In addition, our.
Form 10-Q for the quarter ended September 32023 was filed shortly thereafter and can be found on the investors section of our website under financial information.
Before we begin I would like to remind everyone that except for statements of historical facts. The statements made by management and responses to questions. On this conference call are forward looking statements under the Safe Harbor provisions of the private Securities Litigation Reform Act of 995.
These statements involve risks and uncertainties that could cause actual results to differ materially from those in such forward looking statements.
Please see the forward looking statement disclaimer on the company's earnings press release issued after the close of market today.
As well as the risk factors included in our Form 10-Q for the quarter ended September 32023 that was filed with the SEC today.
Undue reliance should not be placed on forward looking statements, which speak only as of the date. They are made as the facts and circumstances underlying these forward looking statements may change.
Except as required by law fate therapeutics disclaims any obligation to update these forward looking statements to reflect future information events or circumstances.
Joining me on todays call are Ed do Lark, our Chief Financial Officer, and Dr. Bob <unk>, Our Chief Research and development Officer.
During today's discussion we will cover several key milestones that we recently achieved for our Ips C product platform.
Including expanding the clinical reach of our Ips derived car T cell platform for solid tumors as well as beyond oncology into autoimmune it.
In reaching these milestones we are now well positioned to achieve important clinical readouts in oncology and autoimmunity across multiple programs in 2024.
We will also discuss our continued focus on controlling costs that has resulted in a significant decrease in cash utilization.
Which we believe enables us to extend our operating runway into the second half of 2025.
Beginning with <unk> are off the shelf <unk> targeted car NK cell program.
I am pleased to announce that our phase one study is open for enrollment and patients with relapsed refractory b cell lymphoma.
Where we intend to assess ft, five Q2 with and without conditioning chemotherapy.
<unk> is the Companys first product candidate to incorporate our proprietary Alloimmune defense receptor for ADR technology.
Which is comprised of a synthetic engineered or sector designed to target <unk> expressed on allo reactive immune cells and induce NK cell proliferation.
In preclinical studies, we have shown that the engagement of the ADR armed car NK cells with allo reactive immune cells mitigated rejection promoted NK cell proliferation and increased anti tumor activity.
These preclinical data suggest that <unk> has the potential to drive clinical responses without administration of intense conditioning chemotherapy to patients.
The phase one study includes two regimens.
<unk> or the conditioning arm, which consists of three days of standard conditioning chemotherapy.
One dose of Rituximab and three doses of <unk>.
And regimen D or the node conditioning arm.
Which consists of one dose of Rituximab and three doses of <unk>, two too without conditioning chemotherapy.
Enrollment into regimen, a or the conditioning warm has now been opened at the first dose level of 300 million cells per dose.
And upon clearance of dose limiting toxicities at this first dose level.
Enrollment into regimen.
Or the no conditioning arm will commence at its first dose level of 300 million cells per dose.
Each regimen may proceed with dose escalation independently.
Today conditioning patients with intense chemotherapy is a necessary component of the treatment course for cell based cancer immunotherapy.
Including for both autologous and allogeneic cell therapies.
Conditioning chemotherapy induced toxicities limit patient access and prevents combination with standard of care Immunotherapies widely used in the community based setting.
We believe we have the opportunity to establish clinical proof of concept for our ADR technology.
Four at <unk> III program without conditioning chemotherapy.
Early in dose escalation.
Turning now to our T cell programs, we believe our multiplexed engineered Ips derived car T cell product platform is uniquely suited to bring a constellation of anti tumor mechanisms to the fight against solid tumors.
I am pleased to announce that we have established a new landmark in the field of cell based cancer immunotherapy.
Our IMD application was cleared by the FDA to initiate clinical investigation of FTE <unk> five in patients with solid tumors.
But multiplexed engineered Ips derived car T cell program.
Which is being co developed under our collaboration with Ono pharmaceutical.
Incorporates seven novel synthetic controls of cell function better designed to harness the potential of both innate and adaptive immunity.
And to overcome the unique challenges in treating solid tumors.
Novel synthetic controls include a CX <unk> two receptor should promote cell trafficking.
A chimeric TGF beta receptor to redirect immuno suppressive signal in the tumor micro environment.
And our highest entity non cleavable CD 16 receptor to promote antibody dependent cellular cytotoxicity.
At the 2023 society for immunotherapy of cancer annual meeting.
We unveiled that up to 85 incorporates a novel <unk>.
Cancer specific antigen binding domain targeting her too.
Which was contributed by <unk> to our collaboration.
Preclinical studies presented at the meeting demonstrated that the binding profile of the cancer specific car construct.
A unique and differentiated from that of Trastuzumab.
Exhibiting similar potency with greater specificity toward her two expressing malignant cells.
The subcutaneous xenograft models at <unk> demonstrated robust anti tumor efficacy against her too high as well as her two low expressing tumor cells.
Additionally, FTA five resisted TGF beta mediated suppression, maintaining robust slate of lytic activity across multiple rounds of tumor challenge.
And suppressed.
<unk> of TGF data exposure.
<unk> showed potent migration to <unk>, which are often expressed in solid tumors.
With the clearance of our IND by the FDA Phase one study startup activities are now ongoing at multiple sites.
The dose escalation schema for the Phase one study includes two treatment regimens.
<unk> regimen, a or the monotherapy arm consists of a standard three day pre conditioning regimen and a single dose of FCA two five as monotherapy.
Enrollment is the monotherapy arm will commence at the first dose level of 100 million cells.
Eligibility includes patients with advanced her two expressing solid tumors.
Regimen D for the combination arm consists of a standard three day pre conditioning regimen and.
And a single dose of <unk> <unk> five in combination with Cetuximab.
Where we seek to additionally, exploit innate immunity by leveraging the product candidates high affinity non cleavable CD 16 receptor target Egfr expressed on solid tumor cells.
Enrollment into regimen.
We will commence at the first dose level of 100 million cells upon clearance of dose limiting toxicities at the first dose level of regimen.
Eligibility includes patients with advanced Egfr expressing solid tumors.
While we have made great strides in advancing our most innovative and differentiated clinical programs in oncology. We also remain committed to pursuing new therapeutic opportunities beyond oncology.
Cell based Immunotherapies can have a profound clinical benefit for patients.
Our initial clinical data initial clinical data are now emerging.
Indicating that CD 19 targeted car T cell therapy.
Has the potential to durably between Ah patients pathogenic immune cells drive immune reset and meaningfully improve quality of life across a wide spectrum of autoimmune diseases.
We believe there is a very strong value proposition for off the shelf cell therapy in autoimmunity, where a relatively short lived sell can eradicate an aberrant cell population and enable rapid reconstitution of a healthy immune system and we're patient safety convenience.
Accessibility as well as cost and scale will be a differentiating factor.
To this end I am pleased to announce the clinical expansion of our Ips heat product platform into autoimmunity.
In July <unk>.
FDA cleared our IND application for clinical investigation of <unk> hundred 93 are off the shelf CD 19 targeted car T cell program.
Patients with SLE in.
Including for patients with active lupus nephritis for active SLE without renal cell involvement.
We have now initiated phase one study startup activities at multiple sites.
The phase one study in SLE is designed to evaluate the safety pharmacokinetics anti b cell activity of a single dose of FCA 19 administered following a standard conditioning regimen, consisting of either Cy flu.
Our bendamustine.
Dose escalation will commence at the first dose level of 360 million cells.
Importantly, we have previously presented clinical data of a single dose of FCA 19 at doses up to 360 million cells in the setting of relapsed refractory b cell lymphoma, where.
Where we reported safety and clinical activity of.
The first 11 patients treated with a single dose of the FTA 19 at up to 360 million cells, we observed a favorable safety profile.
With no immune effector cell associated neurotoxicity.
And mild cytokine release syndrome.
We observed anti tumor activity in heavily pretreated patients.
Including three complete responses.
And we observed car T cell expansion that peaked in the peripheral blood between days eight and 11.
The phase one study of FTA 19, SOA allows for assessment of higher dose levels each.
Each of up to three times, the highest cleared dose level as well as for the opening of multiple dose expansion cohorts each of which may be enrolled in parallel.
We were pleased to receive a favorable review of our <unk> clinical protocol from the clinical experts of the protocol design Committee of Lupus Therapeutics, an affiliate of the Lupus Research Alliance.
We also continue to watch with keen interest the emergence of additional clinical data in autoimmunity.
We are currently evaluating additional clinical expansion opportunities for FTA 19, as well as for <unk> Q2, where we think the potential to reduce conditioning chemotherapy.
And to target and deplete b cells plasma cells and auto reactive T cells with an off the shelf ADR armed CD 19 targeted car NK cell offers a highly differentiated therapeutic profile.
We have remained resilient during these challenging times and focused our attention on building a fully integrated operation that leads in the research development and manufacture of multiplexed engineered Ips derived cellular immunotherapies as.
As we look towards 2024, we are well positioned to achieve important clinical readouts in oncology and autoimmunity across multiple programs.
Clinical activities are now ongoing for our two most innovative oncology programs at <unk> in B cell lymphoma and.
<unk> hundred five in solid tumors as well as for our first Autoimmunity program FTA 19 and SLE.
We also continued to advance our phase one study of <unk> in B cell malignancies, where we are enrolling patients in single dose treatment cohorts at 540 million cells and Bcl.
And at 360 million cells.
Hello.
As well as our phase one study of FG $5 76 in multiple myeloma.
We are enrolling patients in three dose treatment cohorts at 1 billion cells per dose as monotherapy and in combination with CD 38 targeted monoclonal antibody therapy.
Finally, our investment in innovation continues including under our solid tumor collaboration with Ono.
As we continue to advance new multiplexed engineered car T cell programs towards clinical development.
We remain confident in our belief that our proprietary ICSC product platform is uniquely suited to create highly differentiated product candidates with the potential to deliver multiple mechanisms of action and therapeutic benefit to patients with cancer and autoimmune diseases.
Now I'd like to turn the call over to Ed to review, our financial results for the third quarter.
Thank you Scott and good afternoon.
Fate Therapeutics is in a solid financial position to advance our pipeline, our cash cash equivalents and investments at the end of the third quarter for approximately $350 million.
In the third quarter of this year, our revenue declined to $1 $9 million.
Third to $15 million for the same period last year.
As indicated last quarter. Our revenue is now derived exclusively from our collaboration with Ono pharmaceutical and.
And specifically reflects research funding associated with the development of a second product candidate against an undisclosed target consol in tumors.
As a reminder, after opting into a U S and European co development and co commercialization arrangement with Ono for FTA two five in the FERC fourth quarter of last year, we now account for that programs Reimbursable expenses, absolutely offset within our research.
And development costs.
We recognized $2 $1 million of Contra R&D expense in the quarter.
Research and development expenses for the quarter decreased by 57% to $34 $3 million.
The decrease in our R&D expenses was attributable primarily to a decrease in salaries and benefits, including share based compensation expense following the companys restructuring in the first quarter.
And from lower clinical trial costs, and lower demand for R&D materials and equipment.
General and administrative expenses for the third quarter decreased by 12% to $18 9 million.
The decline in our G&A expenses was attributable primarily to a decrease in salaries and benefits including share based compensation expense.
Total operating expenses for the third quarter declined 47% to $53 $2 million, which includes $10 1 million of noncash share based compensation expense.
Note that in connection with the development of our off the shelf Ips C derived car T cell product candidate <unk> thousand 19, we previously achieved the clinical milestone set forth in our amended license agreement with Memorial Sloan Kettering Cancer Center, which.
Which triggered a first milestone payments to <unk> in 2021.
Up to two additional milestone payments may be owed to Mfk based on subsequent trading values of the company's common stock ranging from 100 to $150 per share.
We assessed the fair value of these contingent milestone payments currently valued at $700000 on a quarterly basis.
In the third quarter, we recorded a non cash $1 million non operating benefit associated with the change in fair value.
Our net loss for the quarter was $45 2 million or <unk> 46 per share.
Finally, we reiterate guidance for full year GAAP operating expenses to be in the range of $265 million to $285 million and that our year end cash and investments will exceed $300 million.
I would now like to open the call for questions.
Thank you I'd like to ask a question. Please press star one one if your question has been answered and you'd like to remove yourself from the queue. Please press star one again.
Our first question comes from Yigal <unk> with Citi. Your line is open.
Hi, guys. This is <unk> on for Yigal. Thanks for taking my questions I just have a couple <unk> five Q2 and the phase one I'm just curious if you think.
There is a certain threshold and drop off in <unk> or maybe activity that you believe would be acceptable between patients who receive pre conditioning versus those that don't or does it really need to be no drop off for you to utilize the reconditioning for your regimen future studies.
I think when we look at the data I think the data is really going to be driven by at the end of the day.
Patient outcomes and responses were definitely interested in understanding the PK profile of ft, five Q2 with and without conditioning.
And I think that will be help guide dose escalation, but ultimately I think it's about patient benefit in driving patient benefit.
Potentially with no conditioning.
That being the important element of <unk> with respect to its unique profile.
Okay I understood well just after that we'll just have to see I guess for <unk>.
I know you have the Cetuximab combo, but are you also planning to combine with trastuzumab or maybe trastuzumab <unk> Mccann given given the differences in binding dynamics you're showing.
I'm just curious if you think on ADC combo might be something thats actually viable from a safety standpoint, given your comments around the her two low opportunity. Thanks.
Yes, absolutely we've started the study with combination with Cetuximab, but we certainly think there's opportunity to broaden the clinical profile to include other monoclonal antibodies.
There are several that we're looking at one of those possibly is actually trastuzumab. Since there does not appear at least pre clinically to be competition between the binding domains and in fact, we've actually seen and I believe we presented this publicly we've seen quite nice synergy in.
Fact, with FCA to five and Trastuzumab.
Okay, great. Thanks very much.
Thank you. Our next question comes from Michael Yee with Jefferies. Your line is open.
Yes.
Hi, This is Jennifer on for Mike. Thanks for taking our question. We wanted to get your latest take on the landscape with CD 19 car T is moving into earlier lines and there are new players coming into the market.
It's hard to ongoing ASCAP CD 19.
The complex of all of that where do you see the Nextgen car NK program.
Ultimately into that landscape.
And secondly are you able to comment how youre doing Goldman.
Have you enrolled any patients and how soon you think you may be able to start can you Nelson. Thank you.
Sure.
Comment on enrollment other than to reiterate the comments, we made on the call where the studies are open for enrollment we've.
We have not announced the first patient the.
First.
No conditioning patient if you will that patient has could be enrolled as as early as patient Florida.
Our required to clear the first dose level in the conditioning arm before opening the no conditioning arm. So first assuming no DLT.
First three patients would receive conditioning and then two events can occur simultaneously number one you can dose escalate the conditioning arm.
As well as open the node conditioning arm.
And so the fourth patient could be a new conditioning patient.
In terms of landscape completely agree it's a super competitive landscape and I think there.
I think at the same time, there are multiple opportunities that can exist for an off the shelf cell therapy I've talked extensively in the past that I absolutely believe there will be a line of therapy that is of the allogeneic or off the shelf on that 10 existing will exist post auto car T cell therapy, I think there is significant need that.
Exists, whether it be lymphoma or myeloma in post the auto car T cell patients.
In addition, I think one of the exciting elements of cell therapy again to be explored determined is the potential, especially with NK cell is keep plugging two standard.
Immunotherapy regimens for instance, like in our shop or in earlier line regimen in myeloma.
I think those opportunities exist I think one of the challenges that exist with.
Whether it be autologous or allogeneic cell therapy is today those regimen to bring Cy flew along for the ride.
So if you want to combine with an existing regimen and reach patients early including in the community setting one of the hurdles to overcome potentially in <unk> and Thats. One of the reasons, we're very excited about <unk> and the ABR and the potential to reduce significantly reduce the dependency.
On conditioning and enable a more seamless combination with off with standard regimens that are used earlier and care in the community.
Understood. Thank you very much.
Thank you. Our next question comes from Tyler Van Buren with TD Cowen Your line is open.
Hey, guys as we think about the next six to 12 months, we'll have a one or two major value creating events be in your view and what should investors expect from them.
Yes, I think I think the three that I think are worth.
Just noting.
I highlighted with my comments I think we have an opportunity to develop to demonstrate proof of concept with ft, 500, Q2, including in those cycles regimen I think thats.
It can be a pretty game changing the game changing potential if you can deliver cell therapies without conditioning chemotherapy.
And essentially for all intents and purposes make a cell therapy look like a monoclonal antibody therapy in terms of how it can be delivered.
Reach patients I think thats pretty game changing if we can demonstrate that with 502 to <unk>.
<unk> built in and no side flow.
Also very excited about <unk> 85, FTA part as you are probably well aware there's been a lot of challenges.
In the solid tumor setting with car T cells historically.
I think there certainly have been toxicities of note and I think the activity has been modest at least compared to hematologic malignancies.
<unk> 5 billion to eight pointed edited cell therapy in what ill just sort of considered to be a fine tuned.
Binding domain against her too I think early on in that study given that we're starting at a 100 million cells. We do have the opportunity potentially to show responses and I think I'd safely show responses and I think that would be.
A significant breakthrough with respect to the use of off the shelf cell therapies in solid tumors and then finally I'll note and I did noted in our call moving into Autoimmunity I think we are one of the first companies to pioneer and off the shelf strategy in autoimmunity I realize we're all sort of beginning this journey at the <unk>.
Same time, both autologous and allogeneic.
And I think the potential.
To show for instance, what's been shown with the autologous programs and a small number of patients that ETE Durably deplete.
An aberrant T cell population.
The ruble.
Reconstitution of the healthy immune system and do that.
<unk> could be really powerful.
Thank you.
Next question comes from Dana <unk> with Leerink partners. Your line is open.
Yeah, I Wonder if you can talk about for autoimmunity why start with FTE 19, rather than going to F. T. Five Q2.
And how you think about both of those products and their potential ultimately in autoimmunity.
I think the FTA 19, obviously.
We sort of alluded to this has human clinical experience.
To date has a highly differentiated what we consider to be safety profile, it's readily available off the shelf.
And.
There is certainly strong proof of concept for autologous car T cell therapy, and as you know we have shown anti tumor activity, including complete responses with a 19.
So I think there is a very strong rationale for off the shelf cell therapy in autoimmune.
And at least in the cancer setting we have seen all the sort of safety and activity hallmarks that we believe can have a differentiated profile in autoimmunity.
We've talked about Q2.
And potentially the benefits of an NK cell, which again.
There hasnt exquisite safety profile in oncology.
I think with Ft. Five Q2, there is potentially.
A broader therapeutic appeal, including and especially if the ADR technology allows for reduction or elimination of conditioning chemotherapy, which I think is.
Somewhat of a barrier obviously in autoimmunity.
More so than in oncology.
And with that <unk> Q2, as you know we have the potential to combine with monoclonal antibody therapy, and I think with <unk>, we're looking at.
Let's call it just sort of a broader array.
Potential autoimmune diseases that we could target, giving given the multiple mechanisms of action that are built in <unk> beyond 2019 targeting so whether that be for instance, targeting CD 20.
With a monoclonal antibody.
CD 38, with a monoclonal antibody.
Or potentially even targeting auto reactive <unk> expressing our T cells. So I think the <unk> profile has the <unk> two product candidate has potentially much broader reach than.
And then a CD 19 targeted cell therapy.
Okay.
Thank you.
Thank you. Our next question comes from Michael Schmidt with Guggenheim. Your line is open.
Hey, this is kelsey on for Michael Thanks for taking our question.
I guess, specifically for eight to five.
Her to solid tumors I guess, what types of tumors should we expect data in the phase one and I guess, what kind of efficacy benchmark or are you thinking about as we kind of get those patients. Thank you.
Yes, I think the efficacy is going to be judged by the particular patients that were looked at that we will ultimately enroll there is a fairly broad enrollment.
<unk> criteria in the study.
It's not limited to for instance, <unk>.
Q3, so we can certainly enroll patients that are both high and low expresses or two into that study.
Thank you. Our next question comes from Peter Lawson with Barclays. Your line is open.
Great. Thank you.
Update thanks for taking my questions.
So the chamber program and circling back on.
The learnings from your prior.
<unk>.
NK cells in solid tumor.
Brought over to the current program with several buildings, there and then Q2.
<unk> directed T cell, where do you think that rich fit in the treatment paradigm.
Okay.
Yes, so I think while we've shared some of the data that we've seen in NK cells with solid tumors in the setting of solid tumors, including car NK cells.
Sure.
Our most recent version of <unk> in solid tumors with the Ft, 536, which was the climate they make the products product candidate, we certainly saw activity.
At 100 million cells per dose.
So I do think there is.
Yes.
Interesting interesting activity that we've demonstrated in the past with off the shelf cell therapies I think it would be premature for me to say comment on gosh.
What do we know with respect to an NK cell versus the T cell I think they're just very different sort of cellular.
Cellular vehicles, if you will so I don't necessarily think Q10.
Extrapolate what we've seen in a small number of patients with NK cells to the sort of the T cell vehicle. If you will so I don't we don't.
Do that sort of cross comparison between NK cells versus T cells, especially in the solid tumor setting.
And milling quite honestly, all the incremental innovation that's building to a two five.
And then I guess follow up question was just call them.
Where do you think this two directed to you said would be positioned in.
I think it's too early I think it's too early to I think it's too early to comment on that I think as we look at the Hershey landscape. Obviously, what's been demonstrated with the adcs are pretty remarkable but I think what we're excited about at the same time is that again.
Solid tumor settings patients are relapsing, where significant unmet need.
And I think what we're excited about as well is there seems to be activity in her two expressing tumors.
That cover a breadth of different types of solid tumors. So I think that we're now seeing <unk> starting to become validated, especially if youre able to target <unk> to low <unk>.
Not in what you would think of just the traditional setting for instance of breast cancer. So I think the opportunity for safely targeting or two in the solid tumor space is significantly expanding.
Great. Thanks, so much.
Yes.
Thank you. Our next question comes from Andrew <unk> with Goldman Sachs. Your line is open.
Hello. This is Tony on for Andrea. Thank you for taking our questions. Firstly for FTE, 19 reminder, sharing a bit more about the rationale for choosing lupus as the initial autoimmune indication and then secondly, if you could provide a bit more details around the clinical trial design for the phase one study. Thank you.
Yeah, I think the.
Rationale for starting in lupus.
There is strong clinical precedent.
For CD 19 targeted therapy, and there is significant enthusiasm.
From the lupus community in treating patients with cell therapy.
So I think it's a terrific place to I think it's a terrific place to start.
The trial design.
I alluded I alluded to on the call.
A pretty standard design with respect to a cell therapy that we are seeing that others are exploring.
Its a dose escalation study.
We can treat at multiple escalating doses.
<unk> up at three times.
Previously cleared dose level, each dose level, each and every dose level that clears DLT is able to expand and enrolled 10 patients in expansion. So you can explore multiple different dose levels and multiple different expansions.
Assuming that that dose level has clear DLT.
We are able to enroll patients with <unk>.
Lupus nephritis as well as patients with other organ involvement.
Okay.
Thank you. Our next question comes from your non Xu with Wells Fargo. Your line is open.
Great. Thanks for taking our questions.
First on the LUPA.
Lupus study for FDA or nine I was wondering I think you mentioned that depletion regimental is standard.
Wondering how does it compare with the German groups.
Sure.
Depletion regimen and also ICU.
It's exactly the same rhythm.
Great that's very very helpful. Thank you.
And another.
Another question on FTE 522 for the no links with depletion regimen.
I was wondering it's $300 million.
<unk> III that dose regimen at the starting dose.
What's your expectation in terms of how much T cells and that does remove.
Do you think.
It could be possible that that's enough to remove all the T cells or <unk>.
You might need to dose escalate simply on the basis of.
Accordingly, more T cells as opposed to <unk>.
Optimizing for anti tumor activity.
Difficult for me to answer that question today, we're certainly going to prioritize translational data in understanding the differences between the doses.
Keep in mind that this is not all about at the end of the day, it's not really about lymphoseek conditioning through ADR. It's.
It's about the ADR technology potentiate, the NK cell.
And so the.
The mechanism of action is not necessarily tier two conditioning remove all T cells.
Not all T cells Express for one DB.
In fact, only for instance, E allo reactive T cell compartment is the primary expression of <unk>.
So this is not really a lymphoma conditioning approach it's meant to defend the cell.
From potential forces of rejection, it's also a receptor.
It is a car.
<unk> so it potentiate the NK cell and provides us additional activating signal.
And at least in preclinical models, we've seen synergistic activity between NK cells and T cells and increased anti tumor activity.
Got it.
Very helpful.
And then lastly in terms of your customer consideration for FTE <unk> for autoimmune and autoimmune disorders.
I'm wondering what might be there.
The catalyst that.
That decision whether it be the observation in the in this.
Cancer study and see how the non life with accretion ration managed dream or is it something else. Thank you.
Yeah, I think the <unk> study in oncology certainly can inform how we design.
The study in autoimmune either study in autoimmunity with 502 to I think quite honestly at least as I sit here today I could imagine study with 5% between autoimmunity that actually would have something very similar to what we're doing in oncology plus or minus platform.
Got it thank.
Thank you very much.
Yes.
Thank you.
Our next question comes from Ed <unk> with BMO capital markets. Your line is open.
Great. Thanks for taking the question just a quick question here on the <unk>.
Systemic lupus program.
Are you there.
The preclinical data that.
You are assuming you've generated win.
Could we see data there.
Dana if you R&D generating that type of data and then ultimately just getting us trying to get a sense of how you think that the.
Platform here with 809 compares to sort of some of the emerging data around.
They're assets that are exploring sort of systemic lupus. Thank you.
Sure I mean, there is a slide is a slide in our presentation deck.
Yesterday.
I think the trial, but it does look at and I'll, let Bob talk to it a little bit. It does certainly looked at for instance, the b cell depletion with both by 2019 compares them head to head against for instance, a primary T cell if I'm not mistaken.
Yes. So our initial study does it attractive that it is taking samples from healthy patients are healthy donors SMA patients and rheumatoid arthritis patients and we can clearly see very distinct and specific elimination of the T cell compartment within those three populations.
Also reference you back to Michelle cell lines. The collaboration publication that we've had about a year ago and major biomedical engineering, where.
There's a whole slew of in vitro and in vivo studies, showing the durability of the activity of FTE 19 targeting DSO.
And then the final thing that we've talked to the other thing that we've talked to in the past, which we've not presented yet publicly.
We're looking for an opportunity to do that.
In terms of clinical proof of concept, we have looked at cohorts of patients in both the 819 oncology study as well as the prior 596 study in oncology where in some of those patients we were able to detect these cells in those patients at baseline and.
We were able to go back and look at for instance, the kinetics and gap of B cell depletion in patients and in oncology, receiving <unk> or receiving a T five onset.
Okay. Thank you for the color.
Sure.
Thank you.
Last question comes from Mara Goldstein with Mizuho. Your line is open.
Great. Thanks.
I just wanted to.
I'll go back to that.
Question really maybe to understand.
Not so much FCA 19 versus high 22, but 819 versus the rest of this year with cars.
And.
And then the other question is do you think of <unk> 19, as a bridge into looking at other cost Jackson Auto man in the same way you went through that process with MKS.
Yes, I think that's it.
It's a little too early to know.
<unk> is very enthused by the potential of taking cell therapies into autoimmunity.
And in it.
Small number of patients and I would potentially say in a carefully selected number of patients.
In some academic studies.
You've seen some pretty remarkable results I think it's really early for the field and ultimately what are the therapeutic requirements that.
Best serve patients and induce long term drug free remissions, which I think is the excitement in particular about cell therapies.
I think we're all going to learn a lot about that quite honestly in the next three 612 months 18 months as we explore at least the first versions of autologous and allogeneic <unk> targeted car T cell therapies.
And just on Ireland.
Iron Man study how many thank you again.
In the U S.
Yeah, we're working through that I can think one of the strategies quite honestly with respect that we have heard.
In speaking with folks in the field is that they.
In these early days, they really do like to partner.
As much as they can with an oncologist that has significant experience.
In part T cell therapy.
And so for us.
As you know we are running a <unk> study in oncology in I think somewhere between 12% to 15 sites are open and so as we think about how to most effectively get it 19 off the ground in autoimmunity.
We're excited to partner with some of those sites as an example, who are very familiar with 819 are currently enrolling patients.
And.
Provide that sort of partnering opportunity with the oncologist and the rheumatologists to treat patients.
Alright, Thanks, Scott I appreciate it.
Sure sure.
Thank you that concludes the question and answer session I'd like to turn the call back over to Scott Wasco for closing remarks.
Thank you and thank you all for participation in today's call.
Hope all of you make it out there for ash in San Diego and happy to sit down and spend some time ago.
Thank you very much.
Thank you. This concludes the program. Thank you for your participation you may now disconnect everyone have a great day.
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