Xencor Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 3, 2023

There are 15 speakers on the call.

Operator

Afternoon and thank you for standing by. Welcome to Xencor's Second Quarter 2023 Conference Call. After the speakers' presentation, there will be a question and answer Please be advised that this call is going to be recorded at the company's request. I would now like to turn the call over to your speaker today, Charles Liles, Head of Corporate Communications and Investor Relations. Go ahead, Charles.

Speaker 1

Thank you, and good afternoon. Earlier today, we issued a press release, which outlines the topics we plan to discuss today. It's available at www.zencor.com. Providing comments on the call is Basil Dehjot, President and Chief Executive Officer and Nancy Valente, Chief Development Officer. Afterwards, we will open up the call for your questions and we will be joined by John Desjollet, Chief Scientific Officer and John Cush, Chief Financial Officer.

Speaker 1

Before we begin, I would like to remind you that during the course of this conference call, Centaur management may make forward looking statements, including statements regarding the company's future financial and operating results, Future market conditions, plans and objectives of management, future operations, the company's partnering efforts, capital requirements, future product offerings and research and development programs. These forward looking statements are not historical facts, but rather are based on current expectations and beliefs and are based on information currently available to us. Outcome of the events described in these forward looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from the results anticipated by these forward looking statements, including but not limited to those factors contained in the Risk Factors section of our most recently filed annual report on Form 10 ks and quarterly report on Form 10 Q. With that, I'll pass the call over to Basil.

Speaker 2

Thanks, Charles, and good afternoon. We'll have brief comments and then get to the Q and A because we've received positive feedback on having abbreviated comments on our call the past 2 quarters, so I think we'll keep to that. At Semcore, we're advancing a broad internal development portfolio of antibodies and engineered cytokines in oncology and autoimmune disease that we built with our array of modular continually advancing protein engineering tools. By taking multiple simultaneous shots on goal in the clinic, We can let clinical data guide which programs we advance, which we terminate, which we partner, so that we focus our resources on programs with the greatest potential for And make room in our portfolio for the next wave of innovative biologics. Now before heading into our pipeline, we'll cover some updates Partnerships which provide validation across our suite of XmAb Technologies and revenues which offset our development costs.

Speaker 2

First, the label on ULTOMIRIS continues to expand in the EU and Japan, where it is now also approved to include neuromyelitis optica spectrum disorder. We earned $11,200,000 in royalties in the 2nd quarter and if Ultomiris sales keep up, we would anticipate earning our remaining sales based milestone payments of $20,000,000 this year. Notably, we're enhancing our Xtend patent coverage and term in multiple global geographies and we've begun to see country by country progress in Europe. And we anticipate both of them to advance into clinical testing. Finally, as noted in the abstract titles for the European Society For Medical Oncology, We anticipate data from Amgen study of AMG 509 in prostate cancer at ESMO.

Speaker 2

AMG 509 or now zalaritamig, That's with an X as in XmAb or Xencor utilizes our XmAb 2 +1 bispecific antibody format that allows for multi valency of targeted domains. And Amgen previously presented very encouraging PSA response data in early 2022. In the case of zalaritamig, 2 plus 1 format allows for higher avidity and tighter binding to a receptor that is barely exposed extracellularly. But we also use this highly versatile format to dial into high expressing tumor cells much more selectively over lower expressing normal cells, like we do with our XmAb-eight nineteen and XmAb-eight zero eight programs or to distinguish between nearly identical receptors in the same family like we do with our XmAb-five forty one program. Now for updates this quarter on our wholly owned clinical portfolio, I'll turn it over to Nancy Valente, our Chief Development Officer.

Speaker 3

Thanks, Vasyl. We'll be starting with vedelumab, our PD-one CTLA-four T cell selective checkpoint inhibitor. In light of encouraging competitor data that we saw last fall for PD-one CTLA-four bispecific and our own Phase 1 experience, We are moving vedelumab into frontline treatment for patients with locally advanced or metastatic nonsquamous nonsmallcell lung cancer. First part of this study will randomize patients 1 to 1 at 2 different doses of vedalumab plus chemotherapy. The second part We'll take the recommended dose and randomized 2:one against pembrolizumab with both arms in combination with chemotherapy with the primary endpoint of PFS.

Speaker 3

Preparations for initiating sites are ongoing and we plan to get this study started by the end of the year. We anticipate having data from our other ongoing Phase 2 studies in metastatic castrate resistant prostate cancer in early 2024. Recall one study is testing vedelimab monotherapy in clinically defined high risk prostate cancer and advanced gynecologic malignancies. The other study is taking prostate cancer all comers and we're evaluating vedelumab in combination depending on subtype. Moving along to other earlier stage bispecifics, XmAb-eight nineteen, our ENPP3, Targeted CD3 bispecific and XmAb-eight zero eight or B7 H3 targeted CD28 bispecific, Both have strong enrollment and dose escalation with more interest from investigators than available slots per cohort.

Speaker 3

These are just two examples of novel XmAb2 +1 bispecifics with unique designs enabling us to potentially fill a gap in treatment approaches. We also anticipate submitting our IND for our 3rd internal 2 +1 bispecific XmAM541, aclaudin6 targeted CD3 to be developed in ovarian cancer and other solid tumor types later this year and plan to submit an IND for our 2nd internal CD28 bispecific in 2024. In regard to our cytokines, We've initiated a Phase 1 study this quarter for XmAb662, our engineered Potency reduced IL-twelve Fc fusion protein in oncology. Now with that, please refer to our press release for financial results, And we'll open the call to your questions. Operator?

Operator

Thank you. We will now conduct our question and answer session. Our first question comes from Maria Goldstein of Mizuho. Your line is open.

Speaker 4

Great. Thank you. This is Mara, Goldstein. Hey, I wanted to ask just on the Xalarinumig. I understand there's probably limited information that you can share.

Speaker 4

But given now the compound has a name and we're going to see more data, Are you I guess the question is, is it fair to assume that this will advance? We're looking at advancement here. And then the second question I just had Is on vedalumab and when you will provide results for the prostate cancer part of the study, can you talk A little bit about what should the expectations there be around the patient numbers and whatnot?

Speaker 5

Sure. So I'll take the first one,

Speaker 2

Mara. So we do know that Amgen has and they publicly disclosed this, Expanded their Phase 1 study quite substantially to include many different cohorts both in combination with In the deprivation therapy, as well as a subcutaneous dosing format, as well as continuing to advance this monotherapy IV. And I think that's a pretty good sign that that's a good commitment to advancement. I think that we should also keep in mind that In today's day and age, in oncology, people stay in Phase 1 and keep adding patients for quite a long time. So I can't speak to their specific tactical approach, but we are very encouraged and we're watching closely as they keep moving forward.

Speaker 2

Session. For the results for the prostate cancer that we mentioned we would have in early 2024 from both our monotherapy and combo study, Roughly, maybe Nancy can give a little bit of rough guidance on that.

Speaker 3

Yes. I mean, we're excited. Yes. So we're excited about vedelimab in prostate cancer. We previously presented data In Phase 1, where there were a few responses, 2 responses with long duration of 6 10 months.

Speaker 3

And then in combination with chemotherapy at last year's SITC, again with some responses and duration of about 8 months. These studies are enrolling well. It's hard to say right now, More than that, we'll have data in early 2024 From the monotherapy, cohort and, some of the chemo combination cohorts. So remember, The combination cohort includes combination both with chemotherapy and a PARP inhibitor. So we hope to have some early data from that, as well as longer term data or more data from the monotherapy cohort.

Speaker 4

Okay. Thanks. I appreciate it.

Speaker 2

Okay. Thanks, Mara.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Etzer DeRue of BMO Capital Markets. Your line is open.

Speaker 6

Great. Thanks for taking my questions. I guess the first one, just wanted to know if you could comment a little bit more on some of the interest That you're seeing from investigators on XmAb-eight nineteen, is it just really more around sort of the pace of enrollment that you're seeing? And then secondly, Just wondered if you'd made constructs of some of the other PD-one CTLA-four that are in the clinic? And then maybe Specifically, about lung cancer, if you see anything differentiating about your molecule and how that May do in non small cell lung cancer versus what we've seen from some of these other PD-one CTLA-four.

Speaker 6

Thank you.

Speaker 2

Sure. Thanks, Hetzer. I'll just stay on 8/19, I think, yes, just to be clear, the interest is from really strong enrollment and strong engagement. And maybe the rationale for that and why investigators think this agent has a place, maybe Nancy, you want to comment on that?

Speaker 3

Yes. I mean, we've heard comments that they are really thrilled that someone is developing a product specific for kidney cancer. So typically, kidney cancer is included with other solid tumors, studied along with them. We are really studying the ENPP3 in only kidney cancer because it's highly expressed there. It makes

Speaker 2

Chanel, on the very strong and specific expression of ENPP3 in renal tumors, I mean, It's a really good fit, a targeted agent against the tumor specific or tumor associated antigen in RCC, I think it's really is very, very timely. To your question on sort of competitor CTLA-four PD-1s and lung cancer, I'll just comment maybe on the structural piece And maybe Nancy can comment on this, some of the more clinical rationale for why there's big unmet need. Our PD-one hundred and twenty four vedalumab was designed to really Only engage well with target T cells that express both antigens. We really dialed down the affinity on each side, in particular On the CTLA-four binding side, so you have to have both targets there to engage or you really don't get much binding and de repression of T cell response. I think that's important, really when we think about how we're looking at competitor data, in particular, the molecule formerly known as METI-five thousand seven 52 at AstraZeneca, which was designed with a very similar rationale.

Speaker 2

And that's the only one that we're aware of in the clinic with the same kind of highly selective Rationale for the cells that are both PD-one and CTLA-four. So essentially, your CTLA-four engagement is conditional on PD-one being there. The hope Is to reduce the scope of cells, the T cells that you're activating that you don't want. Maybe you want to comment on why frontline lung?

Speaker 3

Yes. I'd love to. So when we looked at the MEDI-five thousand seven hundred and fifty two data And really compare the patient populations, what we had previously observed in our Phase 1 Dose escalation and expansion. We thought it would make sense to go into frontline lung. Our patients in particular are really heavily pretreated.

Speaker 3

So they have a median of 3 prior lines of therapy. Although one received prior checkpoint inhibitors and 40% actually received 2 checkpoint inhibitors. So a much different population than the competitor where those patients are Checkpoint naive and not as heavily pretreated. So we thought this would be a great Place to go, they provided a proof of concept and maybe we'll see something really interesting there.

Speaker 6

Great. Thank you.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Edward Tenthoff from Piper Sandler. Please go ahead.

Speaker 7

Great. Thank you very much. I'm excited about the various updates. This is really cool. So when it comes to Lung cancer, again appreciating that initially it will be sort of a reasonable size study.

Speaker 7

Longer term, is this an area where you think you might seek to partner or how are you guys thinking about that right now? Thanks.

Speaker 2

Yes. I think right now we want to focus on building value in the program by generating data in this really large population of frontline lung in combo with chemo and demonstrate that we can have the kind of activity That would get us excited. We certainly see AstraZeneca was excited by their initial activity as well as the hopefully differentiated safety profile that we Have seen so far from PD-one CTLA-four combination therapy. I think beyond that initial engagement sorry, beyond that initial Data that we want to see, I think it does make us think about partnering in a different way than when we were focusing on Smaller populations and later line patients, certainly the opportunity is huge to try to do better than standard of care therapy because again the majority of patients Do relapse within or don't respond at all within the 1st 2 years. So there's a lot of opportunity, but it does make us think about how a partnership With the added scope and scale could accelerate things, but we'll consider that when it would accelerate things, which we don't think is now at this Critical stage of establishing that we have the right efficacy safety profile.

Speaker 7

Right. That makes sense. Awesome. Great. Thank you for the update.

Operator

Our next question comes from the line of Brian Chang from JPMorgan. Your line is open.

Speaker 8

Hey, guys. Thanks for taking my questions this afternoon. Maybe just one on boudalumab in your new indication in non small cell lung. Can you give us some color on how you're thinking about the bar for non small cell given the targets that you're shooting for? I'm interested to see if you have a sense of especially in the second part where you're trying to compete against pembro Plus chemo.

Speaker 8

How much delta are you looking for in terms of PFS that you would need to push this program forward. And I have a follow-up. Thank you.

Speaker 2

Sure. I think without we don't quite want to comment on specific deltas we're targeting for how we powered the study. But we do note that it's extension of PFS that we saw with the competitor PD-one CTLA-four that really seemed to potentially differentiate it. And that's why we made that the primary endpoint, but I don't think we're quite ready to comment quantitatively on the bar for success. We will absolutely address that a little bit later.

Speaker 8

Okay. And then maybe just one more on just as a recap on Data flow for the near term, can you remind us aside from the vodalumab and also the 564 Data updates more towards the early part of 2024. What other data callers or potential callers that investors should look out for?

Speaker 2

Yes. So as we've sort of been doing this year, we're not guiding on specific timing of data until we get closer to the events. We want to make sure we can offer certainty And not distraction, but we do expect in next year we would have updates on our XmAb-one hundred and four PD-one ICOS program, which has been enrolling really well in microsatellite stable colorectal cancer. And we are also that's expansion cohorts. We would also expect to have next year data from our X5819 program, which is our ENPP3 targeting CD3.

Speaker 2

And we are Hopeful also we'll have some things to say about our XmAb-eight zero eight program, which is our first CD28 bispecific in the clinic by then as well. So that's the setup. There's a lot of flow from these earlier stage programs for next year. We're not going to comment on our partners, which obviously will have their own news flow. So beyond the, boudalumab and 564, Those are the things to watch for.

Speaker 2

We'll give specific guidance as we get a little closer to the dates.

Speaker 8

Great. That was helpful. Thank you.

Operator

Our next question comes from the line of Alex Stranahan from Bank of America. Your line is open.

Speaker 9

Great. Hey, thanks guys. Thanks for taking our questions. Just a couple from us. The first is on the lung cancer study for vedolumab.

Speaker 9

Any additional thoughts around not including a fudalumab monotherapy cohort in the study? Is this driven more by the standard of care in non small cell lung or is there something Expectations around partnership revenues, specifically, any color around, what you expect from sotrovimab from Veer this year, given that it was a pretty big contributor last year. Thank you.

Speaker 5

I'll take the sotrovimab question. We expect none. We reported almost none in the Q2.

Speaker 2

Yes. So we expect sotrevimab to be none. Maybe On the lung cancer and why not monotherapy, Nancy can go through the rationale there.

Speaker 3

Session. Most of lung cancer, non squamous, non small cell is treated with chemotherapy. Even patients, it turns out that should be eligible for just checkpoint inhibitor alone. And so we decided we'd go there. We're going to look at PD L1 expression or TPS less than 50%, 49% and lower.

Speaker 3

So that's also Sure. Specifically the chemotherapy, part of the non small cell lung cancer world, like That's definitely where it's used. So those are the reasons.

Speaker 1

Great. Thank you.

Operator

Thank you. Please standby for our next question. Our next question comes from Kaveri Pullman of BTIG. Your line is open.

Speaker 10

Good afternoon. Thanks for taking my questions. For 819, I just want to know what makes Is kidney cancer attractive for this molecule? I know you mentioned ENPP has a strong expression, but do you T cells to work fairly well after first line checkpoint inhibitors. And are there any other tumor types where you see opportunities?

Speaker 2

I think I'll let John DesJarlais, our CSO take that question. He's expert in all things eMPP3.

Speaker 5

Yes, yes. Thanks for the question. So I guess maybe the better way to think about it is We like eMPP3 because we're basically 1st in class for CD3 bispecific. It is Very strongly and essentially uniformly expressed in clear cell renal cell carcinoma. And Yes, there's a few other histologies where there could be high eNPP3 expression, but we wanted to prioritize for Renal cell, mostly just to develop a signal.

Speaker 5

Once we establish that, then sure with perhaps a companion diagnostic, We could expand it to a few other tumor types.

Speaker 2

Yes. Ogan, and John, maybe the question of your question. Yes.

Speaker 5

It was your T cells. Yes, it's interesting you asked that. It turns out that kidney cancer, if you look at RNA expression levels for T cell markers, It's actually one of the highest histologies for having a T cell presence, kind of consistent with the immune checkpoint inhibitors being very active in renal cell carcinoma. And we don't think there's any scientific reason why Progression on a checkpoint inhibitor would have much impact on the CD3.

Speaker 10

Got it. That's very helpful. Thank you. And maybe one on plamodimab. So you selected a step of dosing to manage CRS, But can you tell us about the safety profile?

Speaker 10

Do you think with this step up schedule, you can avoid hospitalization requirement that other by Specifics have.

Speaker 2

So we'll address that in the context of the formulation moving forward, our subcu In collaboration with Janssen, which does limit somewhat how much detail we can give. But I mean, I don't know, Nancy, do you want to take that or that's a goal. I don't know that we haven't updated

Speaker 3

Right. Say it. Yes. Certainly, that'd be a goal. I think there's some bispecifics that require a lot of hospitalizations, some that are minimal.

Speaker 3

Our goal would be to go for the minimal amount, that's appropriate, as we look at the safety. And then it's really about optimizing the step doses to make sure that you have CRS, The patient is primed and not having too much CRS such that session. It's dangerous and requires hospitalization or yes, but so definitely that's our goal. And I think a product like Flamo, given sub Q, could probably reach that, like having less hospitalizations?

Speaker 2

We're not we don't have enough information to comment in more detail than we're hopeful and we're making good progress with the subcu, but we haven't got enough data to share at this moment.

Speaker 10

Got it. Thanks for taking my questions.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Charles Zhu of Guggenheim Securities. Charles?

Speaker 11

I'll start off with a quick clarifying one on uvutelimab. So obviously an intriguing choice to pursue frontline non small cell lung cancer. One quick one regarding the chemotherapy backbone. Could you remind us or maybe provide color? Is this the standard session.

Speaker 11

Schedule of 4 cycles and maintenance or maybe I cut or what have you? Or is this something that's more like a CheckMate 9LA where they stopped after 2 cycles? Thank you.

Speaker 3

This is a standard schedule, for non squamous. It's Pemetrexate and ataxane, I think it's given 4 cycles And yes, and there is a maintenance component as well.

Speaker 11

Great. And then maybe in my another more

Speaker 3

sign With fidelumab, sorry, with fidelumab, of course.

Speaker 11

Great. Thank you. And maybe my second one a bit more. Yes. And my second one maybe a bit more scientific mechanistic one for XmAb564.

Speaker 11

What's your view on the potential for a differential expression profile of CD25 as you move from healthy volunteers Over to atopic dermatitis and psoriasis patients and could this potentially impact the clinical profile of your drug? Thank you.

Speaker 2

Gosh, I don't know that there's any real strong information on CD25 expression levels In those two patient populations, maybe John, do you want to comment on what is known about CD25 expression levels in Other populations and how that might change things? I don't know that we would expect it to have a profound impact, but John would know more.

Speaker 5

Yes. I mean, there is some, when you go into autoimmune diseases, there is some literature suggesting that the Tregs might have slightly lower CD25 expression. And you can also have a Deficit of Tregs compared to T effector cells, but of course that's exactly why we developed a therapy to Expand that deficit of Tregs, to catch up to the effector cell population and have a better suppressive capacity. But I don't think there's going to be anything prohibitive in terms of CD25 expression for our 56 for us to actually mobilize the 2x.

Speaker 11

Great. Thank you.

Operator

Thank you. One moment for our next question. Next Question comes from Charles Zhu of Leerink Partners. Go ahead.

Speaker 9

This is Matt On for Jonathan Chang. Just one quick one for me. For the 662 study, are there any tumor types that you or any investigators are Are you keen to evaluate the compound in? Thanks.

Speaker 2

Oh, gosh. For 662, the IL-twelve program, I think we're just really at this point exploring a range, making sure we can get a dose where we get the right kind of pharmacodynamics And tolerability data, I don't know that there is particular ones that we're even more most excited about. I mean, John, do you want Correct me on

Speaker 5

that. Well, yes, I mean, we're sort of going across the board, right, because we're looking at immune responsive tumors, of course. But on the flip side, we're also very intrigued to look at 662 and histologists like colorectal cancer, where PD-1s by themselves are known not to do much. And since we're doing a pembro combination, if we see something, the signal will be more clear. Likewise for prostate cancer and a few other histology.

Speaker 5

So we really want to cast a wide net on this one and see where those signals are.

Speaker 9

That's really helpful. Thanks for taking my question guys.

Operator

Thank you. One moment for our next question. Our next question comes from the line of Boris Peaker of TD

Speaker 12

Great. Thanks for taking my questions. I have two questions. On vedalimumabid lung cancer, just curious how do you anticipate safety to compare To the competitor, bispecific obviously and also to the combo of KEYTRUDA plus chemo. And on 564, maybe kind of a broad question.

Speaker 12

How do you see this drug distinguishing in psoriasis and atopic derm given kind of the pretty hot competitive landscape in those indications?

Speaker 2

And maybe I'll touch on the 564 rationale for those indications before I hand it off to Nancy to talk about the vedalumab. Our thinking on safety there, which is pretty early. So for 564, we selected atopic term and psoriasis as our Phase 1b Population because it is a multiple ascending dose study where our key goal is to understand what kind of dosing interval can we treat patients with where we get a long enough duration of T cell of Treg expansion to cover them throughout the dosing interval, and of course, that would be tolerable. We saw dramatically improved duration of T cell Treg expansion for 564 relative to what we saw from competitors for single dose studies. So we're hoping to exploit that to see if we can exceed the every other week dosing that the competing Treg IL-two programs seem to be at.

Speaker 2

So that could be a very important differentiator across the board. So we selected psoriasis in atopic derm because those are populations where there's a large number of patients And we felt we could enroll them well and you can look at the clinical response easily, with well understood endpoints And even get biopsy samples if you want because it's in the skin and the tissue is easily accessible. So that was the rationale. I think in particular for psoriasis that was really the mostly the entire rationale. For atopic dermatitis, we were really, really excited by the initial data we had seen out of 1 of our competitor programs And atopic derm showing strong efficacy and then albeit small population in their Phase 1b, but durability beyond the end of treatment that was perhaps surprising a bit, but maybe even consistent with the mechanism of enhancing Treg function And perhaps tolerance.

Speaker 2

So we wanted to chase that down because that could be an exciting area to differentiate in atopic term that sort of long durability post treatment that We know current agents in AD are every other week or might be getting to monthly soon. Now I'll let Nancy, can you restate Question on VUDAB, Boris, because I was pretty long winded there, sorry.

Speaker 12

Yes. No, that was just asking in terms of safety in lung cancer, how do you anticipate it to compare to obviously Competitor bispecifics as well as just the KEYTRUDA plus chemo combo?

Speaker 3

Yes. That's a bit hard to answer without any data In line of the combination, and that's why we're doing the that's why we have a Part 1 and a Part 2. So the Part 1 allows us to look at 2 different doses of vedelimab in combination with the standard chemotherapy of pemetrexed incarvo. And then we'll see what happens, like what does that safety look like when you add No, bispecific to that chemo versus just monoclonal PD-one antibody. And just to clarify to a prior question, it is 4 cycles of vudelimab, I'm sorry, we call it vudelimab, Videlumab plus carbo and pemtrexate and then maintenance with videlumab and pemtrexate.

Speaker 3

It's not a limited dosing as mentioned by somebody So it's full force for cycles.

Speaker 12

Great. Thanks for taking my question.

Operator

Your line is open.

Speaker 13

Yes. Hi, guys. It's Anish on for Greg. Congrats on the quarter and thanks for taking my question. Just wanted to ask a couple on sort of your views on positioning of 2 of your pipeline assets here.

Speaker 13

So Just kind of wanted to see with pylinumab, with multiple CD20, CD3 bispecifics approved, how do you believe Polonavam's combinations will position among competitors. And then just on 564, just kind of building on a previous question, Not necessarily in terms of differentiation with approved drugs right now, but in terms of lines of Care, for example, would you guys see 564 being slotted in for patients with poorly controlled atopic derm or psoriasis that might be being treated with drugs like Sotyc2, Otezla, SKYRIZI, etcetera. Thanks so much for the questions and congrats again.

Speaker 2

Yes. With Plamo positioning, we think the crux of this is the same logic that attracted Janssen as a partner for Plamo. And they are the ones leading the program now taking on, the great majority of its cost 80% of the cost. I think that the key there is the combination with our CD28 could provide that differentiation. And I will say that Our competitors in combining with their CD28 bispecifics are really just at the very earliest stages.

Speaker 2

And with Clamo, I think showed competitive Efficacy safety profile IV, we're moving rapidly on the subcu. The positioning is really in combo to try to leapfrog with better efficacy. We just initially established monotherapy and probably soon to be established chemo combos with the other CD20, CD3s. And so that's That's why we were excited to get a partner like Janssen, which has outstanding capabilities and scale in heme malignancy to help drive This strategy, because that's a strategy that is tough to do alone as a small company. So I think hopefully that addresses the positioning for Plamo.

Speaker 2

For 564, I just want to emphasize that we haven't we don't have a final indication study. This is Phase 1b where we want to demonstrate Durability of action of Treg enhancement and hopefully tie that to efficacy where it's easily seen, certainly depending on what we see, atopic derm could be Go forward, but we are obviously we are considering other indications and would expect to announce if we propose to advance in any, And there's a wide range of autoimmune indications where Tregs very likely play a role. We would expect to announce those later as we've nailed down our regimen. So This is not a commitment in Phase 1 to an indication strategy. I will say that this idea of sequencing in AD is going to come up more and more, not just for Treg enhancers, but all the therapies and that's certainly been a place where new additions Have had a huge impact in other autoimmune indications and we do expect that to happen more and more in skin, like it has, say, for example, in arthritis.

Speaker 13

Great. Thanks so much. Really appreciate the color there.

Operator

Thank you very much. Our last question comes from Peter Lawson of Barclays. Your line is open.

Speaker 14

Hey, good afternoon. Thanks. This is Alex on for Peter. Thanks for taking our questions. Just one on the ENPP-three program.

Speaker 14

I was wondering if you could remind us some of the shortcomings of the Astellas ADC going after the same target and what might be the benefits of a bispecific approach? Thank you.

Speaker 2

Yes. John, do you want to tackle that one?

Speaker 5

Yes, sure. Yes, in fact, it was when we kind of discovered EMP PP3 ourselves using a bioinformatic approach looking for selectively expressed tumor associated antigens. And then we became aware of the Astellas programs once we dug into the literature. I have to say, They had half decent data. I mean, they saw responses in Phase 1.

Speaker 5

Of course, because they At an orastatin payload, they had dose limiting ocular toxicity. I think that was an interesting Because that was an AgenSys program that Astellas had acquired Agenesis. And from what we know from folks that have worked there, it was more of a strategic decision to discontinue that program. But we saw it as to do that program. But we thought it was actually excellent validation for the selectivity of the target and the safety of going after the target.

Operator

Thank you very much. At this time, I would now like to turn the conference back over to Basil Dayat for closing remarks.

Speaker 2

Thanks very much everybody for joining us this afternoon. Have a great evening and we look forward to updating you again in the near future.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.

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