Q2 2023 Xencor Inc Earnings Call

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Okay.

Good afternoon, and thank you for standing by Lucky's done towards second quarter 2023 conference call. After the speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone you will then hear an automated message advising that your hand is raised to withdraw your.

Question. Please press star one again, please be advised this call is going to be recorded at the company's request I would now like to turn the call over your speaker today, Charles Liles head of corporate Communications and Investor Relations go ahead Charles.

Thank you and good afternoon earlier today, we issued a press release, which outlines the topics. We plan to discuss today is available at www Dot dot com, providing comments on the call. It's doubtful that yet president and Chief Executive Officer, and Nancy Valenti Chief Development Officer. Afterwards, we will open up the call for your questions and we'll be joined by John Desert lately.

Scientific officer, and John <unk>, Chief Financial Officer, before we begin I would like to remind you that during the course of this conference call <unk> management may make forward looking.

Statements regarding the company's future financial and operating results future market conditions plans and objectives of management future operation companies partnering efforts capital requirements future product offerings and research and development programs. These forward looking statements are not historical facts, but I'd 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.

The 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-K.

The report on Form 10-Q with that ill pass the call over to Basil Thanks, Charles and good afternoon.

A brief comments and then get to the Q&A because we've received positive feedback on having abbreviated comments what are called the past two quarters. So I think we'll keep to that.

At Suncor, we are 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 success and make room in our portfolio for the next wave of innovative biologics.

Now before heading into our pipeline, we will cover some updates on partnerships, which provide validation across our suite of <unk> technologies, and revenues, which offset our development costs.

First the label on Ultra mirrors continues to expand in the EU and Japan, where it is now also approved include your my latest optical spectrum disorder, we earned $11 $2 million in royalties in the second quarter in our Baltimore sales keep up we would anticipate earning our remaining sales based milestone payments of $20 million. This year, notably we're enhancing our extend.

<unk> coverage and term in multiple global geographies, and we've begun to see country by country progress in Europe .

Our CD 28 by specific collaborations with Janssen biotech are also progressing well for both the prostate and B cell targeted CD 28 by specific programs 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.

AMG 509, or now salary to Mig.

That's with an X as an ex neighbors EMCORE utilizes our ex map two plus one bispecific antibody format that allows for multi valency of targeting demands and Amgen previously presented very encouraging PSA response data response data in early 2022 in the case of salaried Imig two plus one format allows for higher <unk> and tighter buys.

Two a receptor it is barely explored 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 <unk> 819, and X men 808 programs or to distinguish between nearly identical receptors in the same family like we do other acts.

Slide 41 program.

Now for updates this quarter on our wholly owned clinical portfolio I'll turn it over to Nancy Valenti, Our Chief Development Officer.

Thanks Faisel.

We will be starting with Magellan, our PD, one <unk> four T cell selective checkpoint inhibitor.

In light of encouraging competitor data that we saw last fall for PD, one <unk> four by specific and our own phase one experience, we are moving with allomap into frontline treatment for patients with locally advanced or metastatic.

Non squamous non small cell lung cancer first part of this study will randomize patients one to one at two different doses of the Delaware plus chemotherapy. The second part will take the recommended dose and randomized two to one against timberlands a map with both arms in combination with chemotherapy with a primary endpoint of PFS.

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 two studies in metastatic <unk>.

Castrate resistant prostate cancer in early 'twenty 'twenty four recall, one study is testing for Delaware monotherapy and clinically defined high risk prostate cancer and advanced gynecologic malignancies.

Our study is taking prostate cancer, all comers and we're evaluating the Delaware, having combination depending on subtype.

Moving along.

Two other earlier stage Biospecifics X men 819 R. E N P. P. Three targeted CD three by specific and ex Ma'am 808, our b seven H three targeted CD 28 by specific but what they are.

Strong enrollment and dose escalation with more interest from investigators then available slots per cohort. These are just two examples of novel ex ma'am two two plus one by specifics with unique designs.

Enabling us to potentially fill a gap in treatment approaches.

We also anticipate submitting our I N D for third internal two plus one Bispecific X men 541, Claudia six targeted CD three to be developed in ovarian cancer and other solid tumor types. Later this year and plan to submit an IND for our second internal C. D 28 five specific.

In 2024.

In regard to our cytokines.

We initiated a phase one study this quarter for X man six six to our engineered post potency reduced IL 12 FC fusion protein in oncology.

With that please refer to our press release for financial results and we'll open the call to your questions operator.

Thank you we will now conduct a question and answer session.

As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile our Q&A roster.

Our first question comes from Maria Goldstein of Mizuho. Your line is open.

Yeah.

Great. Thank you. This is Matt call, saying, Hey, I wanted to ask just on the salary to make I understand it's probably limited information that you can share, but given now that the compound has name and we're gonna see more data.

I guess the question is is it fair to assume that this will advance you know we're looking at advancement here and then the second question I just had is on the DAU on Nab and when you well.

We will provide results for the prostate cancer part of the study can you talk a little bit about you know what should the expectations be around the patient numbers and whatnot.

Sure. So I'll take the first one mirror.

So.

We do know that that Amgen has and they've publicly disclosed this.

Expanded their phase one study are quite substantially to include many different cohorts both in combination with <unk>.

Energy Depravation therapy, as well as a subcutaneous.

Dosing format as well as continuing to advance this monotherapy I V.

And.

I think that's a 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, one 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 we're you know we're <unk>.

Watching closely as they keep moving forward.

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 maybe Nancy you could give a little bit of a rough guidance on that.

Yeah, I mean, it's.

Sided yeah. So we're excited about.

I would tell him having prostate cancer. We previously presented data in phase one where there were a few responses to responses with long duration of six and 10 months.

And then in combination with chemotherapy at last years should see again with some responses and duration of about eight months.

These studies are enrolling well.

It's hard to say right now I'm more.

More than that we'll have data in early 'twenty four.

I'm from the from the monotherapy cohort.

And some of the.

The chemo combination got worse I remember.

The combination cohort includes combination both with chemotherapy and a PARP inhibitor. So we hope to have some early data from that and as well as longer term data or more data from the monotherapy cohort.

Okay. Thanks I appreciate it.

Okay. Thanks, Thanks, Barbara. Thank you one moment for our next question.

Okay.

Our next question comes from the line of answered to rule of BMO capital markets. Your line is open.

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 youre seeing from the investigators on X Smart 819 is it just really more around sort of the pace of enrollment that youre seeing and then secondly, I'm just wondering if you'd made cost strokes of some of the other PD one CTO the floors that are in the clinic.

And then maybe specifically.

You know lung cancer, if you see anything on 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 ones utility force. Thank you.

Sure. Thanks.

I'll just stay on 819, 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 on that.

Yeah, I mean, we've heard comments.

They are really thrilled that someone is.

Developing a product specific for kidney cancer. So typically kidney cancers included with other solid tumors study.

Studied along with them, but we are really studying the N. P. P. Three in only kidney cancer, because it's highly expressed there it makes scientific sense to go there.

So and knowing I guess no one's ever done that.

And I think that given the mechanistic rationale and the very strong.

Strong and specific expression of <unk> three in in renal tumors I mean, it 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 competitive <unk> four PD ones.

And in lung cancer I'll, just comment maybe on the structural piece and and maybe Nancy you can comment on some of the more clinical rationale for why there's a big unmet need.

Our PD one HLA <unk> was designed to really fully engage well with target T cells that express both antigens, we really dialed down the affinity on each side in particular on the Cta law for binding sites you have to have both.

Targets there to engage our you really don't get much.

<unk> and de repression of the 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 <unk> hundred 75, two at Astrazeneca, which was designed with a very similar rationale and thats. 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 <unk> four so essentially you'll see Chile for engagement.

Conditional on PD, one being there to help is to reduce the scope of cells. The T cells that you're activating but you don't want.

Maybe you want to comment on Wi frontline lung.

Yeah, I love to so you know when we looked at the Medi 5752 data and really compare the patient populations, what we had.

Previously observed in our phase one dose escalation and expansion.

Thought.

It would make sense to go in the frontline lung.

Our patients in particular are really heavily pretreated. So they have a median of three prior lines of therapy. Although one received prior checkpoint inhibitors and 40% actually receive to checkpoint inhibitors.

So a much different population than the <unk>.

Petitor, where those patients are.

Checkpoint naive and not as heavily pre treated so we thought this would be a great place to go they provided a proof of concept and and maybe we'll see something really interesting there.

Great. Thank you.

Yeah.

Thank you one moment for our next question.

Our next question comes from the line of Edward <unk> from Piper Sandler. Please go ahead.

Yes.

Great. Thank you very much I'm excited about the various subtypes versus really cool so when it comes to.

Lung cancer again, a prescreening initially it'll be sort of a.

Reasonable sized study.

The longer term.

This scenario, where you're switching to Parker or how are you guys thinking about that right now.

Yeah, I think right now we want to focus on building value in the program by generating data in this really large population of <unk>.

<unk> in combo with chemo and and demonstrates 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.

<unk> seen so far from PD, one <unk> four combination therapy, I think beyond that initial engagement, sorry, but beyond that initial.

Data that we want to see I think it does make us think about.

Partnering in a different way than we were focusing on smaller populations. In 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 first two years. So there's a lot of opportunity, but it does make us think about how our partnership with the added scope and scale could could accelerate things, but we will consider that when it would accelerate things, which we don't think is now with this critical stage of establishing that we have the right efficacy safety profile.

Well.

Right.

Awesome great. Thank you for me up there.

Thank you Barry.

Please standby for our next question.

Our next question comes from the line of Brian Cheng from J P. Morgan Your line is open.

Hey, guys. Thanks for taking my question. This afternoon, maybe just one on with Allomap.

Every indication in non small cell lung.

Can you give us some color on how youre thinking about the bar for non small cell given the.

The targets that you're shooting for.

I'm interested to see if you have a sense of you know, especially in the second part where your.

I'm trying to compete against PEMCO plus chemo.

How much Delta are you looking for in terms of PFS that you that you would need to.

<unk> pushed test program for and I have a follow up thank you.

Sure.

I think without we don't want to comment on specific deltas were targeting for how we powered the study.

But we do note that it is extension of PFS that.

We saw with the competitive PD, one <unk> four that really seem to potentially differentiate it.

And.

That's why we made that the primary end point, 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.

Okay, and then maybe just.

One more on this.

As a recap on data.

Data flow for the near term.

Can you remind us you know us.

From.

The whole dialogue with Allomap and also 164.

Data updates are more towards the early part of 2024.

What other data tell us are potential catalysts that investors should look out for.

Yes, so as we've sort of been doing this year, we're not guiding on specific timing of data until we get.

To the events, we want to make sure we can offer certainty and not a distraction.

But we do expect in next year, we would have updates on our ex Nab one O for PD, one Iqos program, which has been enrolling really well in.

In microsatellite stable colorectal cancer.

And we are also expansion cohorts. We would also expect to have next year data from our exited 819 program.

Which is R. R <unk> targeting <unk> three and.

We are hopeful also will have some things to say about our <unk> eight Oh wait program, which is our first CD 28 by specific in the clinic by Venezuela. So that's the setup theres a lot of flow from these earlier stage programs for.

For next year, and we're not going to comment on our partners, which obviously will have their own their own news flow. So beyond the <unk> and $5 six four those are the things to watch for it we will give specific guidance as we get a little closer to the dates.

Great. That's helpful. Thank you.

Thank you one moment for our next question.

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

Line is open.

Oh, Great Hey, Thanks, guys. Thanks for taking our questions just a couple from US. The first is on the lung cancer study for every dollar of Mab.

Any additional thoughts around not including a $3 Mab monotherapy cohort in this study.

Is it driven more by the standard of care in non small cell lung or is there something from the.

From the prostate study that you're seeing.

And then second question is just on expectations around partnership revenues specifically.

Any color around what you expect from the trove of map from from beer. This year given it was a pretty big contributor last year. Thank you.

I'll take this is Trevor that question, we expect none we reported almost none in the second quarter. Yeah. So we expect <unk> to be none maybe on the on the lung cancer and why not monotherapy Nancy can go through the rationale there.

Yeah.

You know most of lung cancer and non squamous non small cell was 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.

PDL one expression on T. P S 50, less than 50%, 49% and lower so that's also sure specifically the chemotherapy.

Yeah.

You know part of the non small cell lung cancer world like.

That's definitely where it's used.

So those are the reasons.

Great. Thank you.

Thank you please standby for our next question.

Yeah.

Our next question comes from <unk> <unk> of <unk>. Your line is open.

Good afternoon, and thanks for taking my questions 4819.

I just wanted to know what makes that kidney cancer attractive for this molecule I know you mentioned E. N. P. P has a strong expression, but do you have T cells to work fairly well off your first line checkpoint inhibitors and are there any other tumor types, where you see opportunity.

I think I'll, let John .

John did you lay our CSO take that question he's expert in all things the MTB three.

Okay.

Yes, yes. Thanks for the question, so I guess maybe.

Maybe the better way to think about it is we like E&P really because we're basically first in class for a CD three by civic.

Very strong.

Wrong, we essentially uniformly expressed in clear cell renal cell carcinoma.

And.

Yes.

Few other histology is where there could be high E. N P. P expression, but we wanted to prioritize for renal cell, mostly just to develop a signal once we establish that they ensure with perhaps a companion diagnostic we could expand it to a few other tumor types.

Yes, John maybe I'll take the other half of.

Of your questions. Yeah. So yeah. 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 histology is for having a T cell presence.

Consistent with the with immune checkpoint inhibitors being very active in renal cell carcinoma, and we don't we don't think there is any scientific reason why.

Pressure on a checkpoint inhibitor would would have much impact on the future.

Got it that's very helpful. Thank you and maybe one on flow mode on that.

Yeah, you you collected a step of dosing to manage.

But can you tell us about the safety profile do you think with the step up schedule you can avoid hospitalization requirement that otherwise have.

So we'll address that in the context of the formulation moving forward or sub Q.

In collaboration with Janssen, which does limit somewhat how much detail, we can give but I don't know Nancy do you want to take that or that's a goal I don't know that we have enough data to say yet yeah, certainly that would be a goal I think theres some bi specifics that.

Require a lot of hospitalization.

Minimal with our goal would be to go for the minimal amount.

It's appropriate.

As we look at the safety.

And then it's really about optimizing.

This step doses to.

Make sure that you have.

Have crs.

The patients primed.

And and.

Not having too much crs such that.

No, it's it's dangerous and requires hospitalization.

Yeah, but so definitely that's our goal and I think a product like planemo given sub Q.

Could probably reach that like having less hospitalizations.

But what we're not we're not we don't have enough information to comment in more detail then we're hopeful and we're making good progress with the sub Q, but we haven't got enough data to share at this moment.

Got it thanks for taking my question.

Thank you one moment for our next question.

Yeah.

Our next question comes from the line of Charles Xu of Guggenheim Securities Charles.

Hey, guys. Thanks for taking the question and for providing.

Progress across your pipeline I'll start with a quick clarifying one.

Tell him that so obviously, an intriguing choice to pursue front line non small cell lung cancer.

One quick one regarding the chemotherapy backbone could you remind us or maybe provide color is this the standard.

Scott schedule or four cycles in maintenance or maybe I call or what have you or is this something that's more like a checkmate <unk> la where they stopped after two cycles. Thank you.

This is a standard schedule for non squamous, it's pemetrexed and a taxane.

On the truck side and a taxane.

I think it's given enforced cycles.

And yeah, and there is a maintenance component as well.

Great and then maybe.

Right.

The Taliban Oh, sorry for the Alabama of course.

Great. Thank you and Charleston went a bit more yes, yes.

My second one maybe a bit more scientific mechanistic one for X months 564.

What's your view on the potential for a differential expression profile of <unk> 25, as you move from healthy volunteers over to atopic dermatitis, and psoriasis patients and could this potentially impact your <unk>.

The clinical profile of your drug thank you.

Gosh, I don't know that Theres any real strong information on CD 25 expression levels on those in those two patient populations maybe.

Maybe John do you want to comment on what is known about CD 25 expression levels in other populations and how that might change things I don't know that that we would expect it to have a profound impact that John but no more.

Yeah I mean.

There is some.

You know when you go into autoimmune diseases. There is some literature, suggesting that the T regs might have.

Slightly lower CD 25 expression.

And you can also have a deficit of T regs compared to T effector cells, but of course, that's exactly why we develop a therapy.

Two to.

Expand that deficit of T regs.

To catch up to the effector cell population.

Have a better suppressive capacity.

But I don't I don't think there's going to be anything prohibitive in terms of the C. D twenty-five expression for five six Florida to actually mobilize it to Rex.

Great. Thank you.

Thank you one moment for our next question.

The next question comes from Charles <unk> of Leerink Partners go ahead.

Jonathan I apologize.

Hey, guys. This is Matt <unk>.

Jonathan Chang just one quick one for me for the 606, two study or are there any tumor types that you are any investigators are particularly keen to evaluate the compound in thanks.

Oh gosh for 606 to the IL 12 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.

And and Tolerability data.

No that there is a particular ones that were even more most excited about I mean, John do you want to correct me on that.

Well, yeah I mean.

We're sort of going on across the board right because we're looking at immune responsive tumors of course.

But on the flip side, we're also very intrigue to look at 662, and and histologist like colorectal cancer, where.

PD, one by themselves or no not to do March and since we're doing a pembroke combination, but if we see something that will be more clear.

For prostate cancer and a few other histology so.

We really want to cash.

Cast a wide net on this one and see where the signals are.

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

Thank you one moment for our next question.

Yeah.

Our next question comes from the line of Boris <unk> of TD Cowen go ahead.

Great. Thanks for taking my questions I have two questions on where dollar move in lung cancer. Just curious how do you anticipate safety to compare to the competitor by specific obviously and also to the combo of Keytruda plus chemo and on 564, maybe kind of a broad question. How do you see it as a drug distinguish in psoriasis and atopic derm.

Given kind of a pretty hot competitive landscape in those indications.

And maybe I'll touch on the $5 six for rationale for those indications before I hand, it off to Tim.

To Nancy to talk about <unk>.

Our thinking on on safety, there, which is pretty early so for 564, we selected atopic derm and psoriasis as our phase one b 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 <unk>, where we get a long enough duration of.

A T cell T Reg expansion to cover them throughout the dosing interval and.

And of course that would be tolerable, we saw dramatically improved.

Duration of T cell T. Reg 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 T. Reg Iot programs seem to be act, so that could be a very important differentiator across the board. So we selected psoriasis and atopic.

Term because those are populations, where theres a large number of patients.

And we felt we can enroll them well and you can you can look at the clinical response easily well understood endpoints and even get biopsy samples. If you want because it's in the skin that 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're really really excited by the initial data we had seen out of one of our competitor programs in atopic term showing strong efficacy in there, albeit small population in their phase one b, but durability beyond the end of treatment that that was.

Perhaps surprising a bit, but maybe even consistent with the mechanism of enhancing T. Reg function and perhaps tolerance. 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 Asian agents and <unk> every other week or.

Might be getting to monthly soon.

Now I'll, let Nancy can you restate your question on <unk>, because that was a pretty long winded there sorry.

No that was just asking in terms of safety in lung cancer, how do you anticipate it to compare to obviously a competitor by specifics as well as just the Keytruda plus chemo combo.

Yeah, that's that's a bit hard to answer without any data.

In line.

All of the combination and that's why we're doing that that's always a part one and part two so the part one allows us to look at two different doses of <unk> in combination with the standard.

Chemotherapy, a pen trucks and cargo.

And then we'll see what happens like you know what what does the safety look like when.

When you add.

Specific to that chemo versus just a monoclonal.

PD, one antibody and just to clarify a prior question. It is four cycles of Bhutto Buda.

I'm Gonna have I'm, sorry, we called Buda.

Allomap was carnival and Pemetrexed, and then maintenance with Magellan Nab and Pemetrexed.

It's not unlimited dosing as mentioned by somebody else.

Its full force or cycle.

Great. Thanks for taking my question.

Thank you.

Moment for our next question please.

Yeah.

Our next question comes from Gregory <unk> of RBC capital markets. Your line is open.

Yes, hi, guys its a niche 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 two of your pipeline.

Pipeline assets here, so just kind of wanted to see with with Pomona Mab with multiple CD 20 C. D. Three bi specifics approved how do you believe pomono mab.

Promoter bumps combinations will position among competitors and then just on five six for just kind of building on a previous question.

You know not necessarily in terms of differentiation with approved drugs right now, but in terms of lines.

Lines of care for example, what 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 so took two oh, Tesla scary Z et cetera.

Thanks, so much for the questions and congrats again.

Yes, it would clamor positioning we think the crux of this is the same logic that attracted janssen as a partner for <unk> and they are the ones leading the programme now taking on.

The great majority of it is cost 80% of the AR.

Of the cost.

I think that the key there is the combination with our CD 28 could provide that that differentiation and I will say that our competitors and combining with their CD 20 by specifics are really just at the very earliest stages.

And we plan, though I think showed competitive efficacy safety profile IV, we're moving rapidly on the sub Q that the positioning is really in combo to try to leapfrog with better efficacy.

Just initially established monotherapy can probably seemed to be established chemo combos with the other <unk>.

And so thats why we were excited to get a partner like Janssen, which has.

Outstanding capabilities and scale in and heme malignancy to help drive. This 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 <unk>.

For 564, I just want to emphasize that we haven't we don't have a final indication study. This is phase one b, where we want to demonstrate durability of of action of T. Reg enhancement and hopefully tied that to efficacy, where it's easily seen certainly depending on what we see atopic derm could be a go forward, but we.

Obviously, we are considering other indications and we'd expect to announce if we proposed to advancing any theres a wide range of autoimmune indications, where T regs very likely play a role.

We would expect to announce those later as we nail down our regimen. So this is not a commitment in phase one to an indication strategy I will say that this idea of sequencing and <unk> is going to come up more and more not just for T. Reg enhancers, but all the therapies and that's certainly been a place where we're new additions.

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 it.

In arthritis.

Great. Thanks, so much really appreciate the color there.

Thank you very much.

One moment for our last question.

Our last question comes from Peter Lawson of Barclays.

Your line is open hey.

Hey, good afternoon. Thanks.

This is Alex on for Peter Thanks for taking our questions.

Just one on the <unk> III program. If I was wondering if you could remind us some of the shortcomings of the Astellas ADC going after the same target than what might be the benefits of a bi specific approach. Thank you.

Yes, John do you want to tackle that one.

Yeah sure Yeah.

In fact, it was when we kind of discovered E. M. P. P.

P P three ourselves using a bio informatic approach looking for selectively expressed tumor associated antigen.

And then we became aware of the Astellas programs once we dug.

Doug in the literature.

I have to say that.

Half decent data I mean, they saw responses in phase one.

Of course, because they had a or statin payload they had dosing.

Dose limiting ocular toxicity.

I think that was an interesting time, because it because that was the Genesis program.

That astellas.

It had acquired a genesis.

And from from what we know from from folks that set of work there.

It was more of a strategic decision to discontinue that program, but we thought it was actually excellent validation for the selectivity of the target and the safety of going after the targets.

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

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

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

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[music].

Good afternoon, and thank you for standing by Zen towards second quarter 2023 conference call. After the speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone.

Then here an automated message advising that your hand is raised to withdraw your question. Please press star. One again. Please be advised 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.

Yeah.

Thank you and good afternoon earlier today, we issued a press release, which outlines the topics. We plan to discuss today is available at www Dot <unk> dot com, providing comments on the call is dazzled that he is president and Chief Executive Officer, and Nancy Valenti Chief Development Officer. Afterwards, we will open up the call for your questions and we'll be joined by John Desjarlais Chief scientific.

Officer, and John <unk>, Chief Financial Officer, before we begin I would like to remind you that during the course of this conference call <unk> management may make forward looking.

Statements regarding the company's future financial and operating results future market conditions plans and objectives of management future operation companies partnering efforts capital requirements future product offerings and research and development programs. These forward looking statements are not historical facts, but I'd 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.

These 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-K, and quarterly report on Form 10-Q.

I'll pass the call over to Basil Thanks, Charles and good afternoon, well have brief comments and then get to the Q&A because we've received positive feedback on having abbreviated comments on I'll call. It the past two quarters. So I think we'll keep to that.

At Suncor, we are advancing a broad internal development portfolio of antibodies and engineered cytokines in oncology and autoimmune disease that we've 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 success and make room in our portfolio for the next wave of innovative biologics.

Now before heading into our pipeline, we will cover some updates on partnerships, which provide validation across our suite of <unk> technologies, and revenues, which offset our development costs.

First the label on ultimate risk continues to expand in the EU and Japan, where it is now also approved include your my latest optica spectrum disorder, we earned $11 2 million in royalties in the second quarter in our Baltimore sales keep up we would anticipate earning our remaining sales based milestone payments of $20 million. This year, notably we're enhancing our extend Pat.

<unk> coverage and term in multiple global geographies, and we've begun to see country by country progress in Europe .

Our CD 28 by specific collaborations with Janssen biotech are also progressing well for both the prostate and B cell targeted CD 28 by specific programs 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.

<unk> 509 or now <unk>.

That's with an X as an ex <unk> utilizes our <unk> two plus one bispecific antibody format that allows for multi valency of targeting demands and Amgen previously presented very encouraging PSA response data response data in early 2022 in the case of <unk> two plus one format allows for higher <unk> and tighter by.

In two of receptor. It is barely explored exposed extracellularly, but we also use this highly versatile format to dial in to high expressing tumor cells much more selectively over lower expressing normal cells like we do with our <unk> 819, and X men 808 programs or to distinguish between nearly identical receptors in the same family like we do other acts.

<unk> 541 program.

Now for updates this quarter on our wholly owned clinical portfolio I'll turn it over to Nancy Valenti, Our Chief Development Officer.

Thanks Pavel.

We will be starting with Magellan, our PD, one <unk> four T cell selective checkpoint inhibitor.

In light of encouraging competitor Dana that we saw last fall for PD, one <unk> four by specific and our own phase one experience, we are moving with allomap into frontline treatment for patients with locally advanced or metastatic <unk>.

Squamous non small cell lung cancer first part of this study will randomize patients one to one at two different doses of the Delaware plus chemotherapy. The second part will take the recommended dose and randomized two to one against timberlands a map with both arms in combination with chemotherapy with a primary endpoint of PFS.

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 III studies in metastatic.

Castrate resistant prostate cancer in early 2024 recall, one study is testing the Delaware monotherapy and clinically defined high risk prostate cancer and advanced gynecologic malignancies.

This study is taking prostate cancer, all comers and we're evaluating vidal them, having combination depending on subtype.

Moving along.

Two other earlier stage Biospecifics X men 819 R. E N P. P. Three targeted CD three by specific and ex Ma'am 808, our b seven H three targeted CD 28 by specific.

Strong enrollment and dose escalation with more interest from investigators then available slots per cohort. These are just two examples of novel ex ma'am two two plus one by specifics with unique designs.

Enabling us to potentially fill a gap in treatment approaches.

We also anticipate submitting our I N D for third internal two plus one Bispecific X men 541, Claudia six targeted CD three to be developed in ovarian cancer and other solid tumor types later this year.

Plan to submit an IND for our second internal CD 28 by specific in 2024.

In regard to our cytokines, we've initiated a phase one study this quarter for X ma'am six six to our engineered posts potency reduced IL 12 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.

Later.

Thank you we will now conduct our question and answer session. As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw your question. Please press star one again.

These standby, while we compile our Q&A roster.

Our first question comes from Maria Goldstein of Mizuho. Your line is open.

Okay.

Great. Thank you. This is Matt Baltimore, Hey, I wanted to ask just on the salary of the mix I understand there's probably limited information that you can share, but given now that the compound has name and we're gonna see more data.

Are you at I guess the question is is it fair to assume that this will advance you know we're looking at advancement here and then the second question I just had is on the DAU of Nab and when you.

Will provide results for the prostate cancer part of the study can you talk a little bit about you know what should the expectation there be around the patient numbers and whatnot.

Sure. So I'll take the first one mirror.

So are we.

We do know that that Amgen has and they publicly disclosed this.

Expanding their phase one study quite substantially to include many different cohorts both in combination with <unk>.

Androgen deprivation therapy.

Well as a subcutaneous dosing format as well as continuing to advance this monotherapy IV.

And I.

I think that's a 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, one 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 where we are.

We're watching closely as they keep moving forward.

The results for the prostate cancer that we mentioned we would have in early 2024 from both our monotherapy and combo study.

Roughly maybe maybe Nancy you could give a little bit of a rough guidance on that.

Great.

We're excited.

Yeah. So we're excited about it.

Having prostate cancer, we previously presented data in phase one where there were a few responses to responses with long duration of six and 10 months.

And then in combination with chemotherapy at last years should see again with some responses and duration of about eight months.

Studies are enrolling well.

Hard to say right now I'm more.

More than that well, we will have data in early 'twenty four.

From the from the monotherapy cohort.

And some of the.

The chemo combination cohort so remember.

The combination cohort includes combination both with chemotherapy and a PARP inhibitor. So we hope to have some early data from that and as well as longer term data or more data from the monotherapy cohort.

Okay. Thanks I appreciate it.

Okay. Thanks, Thanks, Barbara. Thank you one moment for our next question.

Okay.

Our next question comes from the line of answered the rule of BMO capital markets. Your line is open.

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 youre seeing from the investigators on X Smart 809 is it just really more around sort of the pace of enrollment that youre seeing and then secondly, I'm just wondering if you'd made cost strokes of some of the other PD one utility floors 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 on PD one's utility for us. Thank you.

Sure. Thanks, Sir.

Well I'll just say on 819, 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.

Yeah, I mean, we've heard comments.

They are really thrilled that someone is.

Developing a product specific for kidney cancer.

Typically kidney cancers included with other solid tumors studied along with them, but we are really studying the N. P. P. Three in only in kidney cancer, because it's highly expressed there it makes it so.

Scientific sense to go there.

So and knowing I guess no one's ever done that.

And I think that given the mechanistic rationale on the very strong.

Strong and specific expression of <unk> three in in renal tumors I mean, it it's a really good fit a targeted agent against the tumor specific or tumor associated antigen in RCC I think it is really is very very timely.

To your question on sort of competitive <unk> four PD ones.

And in lung cancer I'll, just comment maybe on the structural piece and and maybe Nancy you can comment on this you know some of the more clinical rationale for why there's a big unmet need.

<unk> 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 Cta law for binding sites you have to have both.

Targets there to engage our you really don't get much binding and de repression of the 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 <unk> $5 75 to Astrazeneca, which was designed with a very similar rationale and thats. The only one that we're aware of in the clinic with the same kind of highly selected rationale for the cells that are both PD, one and <unk> four so essentially you'll see Chile for engagement.

Conditional on PD, one being there to help us to reduce the scope of cells. The T cells that you're activating that you don't want.

Maybe you want to comment on Wi frontline lung.

Yeah, I love to them. So you know when we looked at the many 5752 data and really compare the patient populations, what we had.

Previously observed in our phase one dose escalation and expansion.

Thought it would make sense to go into a frontline lung.

Our patients in particular are really heavily pretreated. So they have a median of three prior lines of therapy. Although one received prior checkpoint inhibitors and 40% actually received two checkpoint inhibitors.

So a much different population than the competitor where those patients are.

Checkpoint naive and not as heavily pre treated so we thought this would be a great place to go they provided a proof of concept and and maybe we'll see something really interesting there.

Great. Thank you.

Thank you one moment for our next question.

Our next question comes from the line of Edward <unk> from Piper Sandler. Please go ahead.

Great. Thank you very much.

Excited about the various subtypes, which is really cool so when it comes to.

Hmm.

<unk> again, a prescreening initially it'll be sort of a reasonable.

A reasonable sized study.

The longer term.

This scenario, where you might seek to Parker or how are you guys thinking about that right now.

Yeah, 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 and demonstrate that we can have the kind of activity that would get US excited we certainly see astrazeneca was excited by that.

Our initial activity as well as the hopefully differentiated safety profile that we have seen so far from PD. One <unk> four combination therapy, I think beyond that initial engagement, sorry, but beyond that initial.

Data that we want to see I think it does make us think about <unk>.

Partnering in a different way than when we were focusing on smaller populations. In 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 first two years, so theres a lot of opportunity, but it does make us think about how our partnership with the added scope and scale could could accelerate things, but we'll we'll consider that when it would accelerate things, which we don't think is now with this critical stage of establishing that we have the right efficacy safety profile.

Yes.

Alright. So it was also great. Thank you for the update.

Thank you for your inks. Please standby for our next question.

Our next question comes from the line of Brian Cheng from J P. Morgan Your line is open.

Hey, guys. Thanks for taking my question. This afternoon, maybe just one on with Allomap.

Ideally 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.

The part that's what you're shooting for.

I'm interested to see if you have a sense of you know, especially in the second part where you're trying.

Trying to compete against PEMCO.

Chemo.

How much Delta are you looking for in terms of PFS that you that you would need.

To push this program for and I have a follow up thank you.

Sure.

Well I think without we don't want to comment on specific deltas were targeting for how we powered the study.

But we do note that it is extension of PFS that.

That we saw with the competitive PD. One so you feel like for that really seem to potentially differentiate it and that's.

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.

Okay, and then maybe just one.

One more on just as a recap on.

Data flow for the near term.

Can you remind us.

From.

The whole dialogue with Allomap and also 164.

Data updates are more towards the early part of 2024.

What other data tell us are potential catalysts that investors should look out for.

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 a distraction.

But we do expect in next year, we would have updates on our <unk> four PD, one Iqos program, which has been enrolling really well in.

In microsatellite stable colorectal cancer.

And we are also expansion cohorts. We would also expect to have next year data from our <unk> nine program.

Which is R. R <unk> three targeting CD three and.

We are hopeful also will have some things to say about our <unk> eight Oh wait program, which is our first CD 28 by specific in the clinic by that as well. So that's the setup. There is theres a lot of flow from these earlier stage programs for.

For next year, we're not going to comment on our partners, which obviously will have their own their own news flow. So beyond the <unk> and 564 those are the things to watch for it we'll give specific guidance as we get a little closer to the dates.

Great. That's helpful. Thank you.

Thank you one moment for our next question.

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

Line is open.

Oh, Great Hey, Thanks, guys. Thanks for taking our questions just a couple from US. The first is on the lung cancer study for a dollar map.

Any additional thoughts around not.

Not including a three dollar map monotherapy cohort in this study.

Is it driven more by the standard of care in non small cell lung or is there something from the.

From the prostate study that Youre seeing.

<unk>.

And then second question is just on expectations around partnership revenues specifically any.

Any color around what you expect from so so drove him out from from beer. This year given it was a pretty big contributor last year. Thank you.

I'll take this is Trevor that question, we expect none we reported almost none in the second quarter. Yeah. So we expect <unk> to be none maybe on the on the lung cancer and why not monotherapy Nancy can go through the rationale there.

Yeah.

You know most of lung cancer and 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.

PDL one expression on T. P S 50, less than 50%, 49% and lower so that's also sure specifically the chemotherapy.

Yeah.

You know part of the non small cell lung cancer world like.

That's definitely where it's used.

So those are the reasons.

Great. Thank you.

Thank you please standby for our next question.

Yeah.

Our next question comes from <unk> <unk> of D. T. I G. Your line is open.

Good afternoon, and thanks for taking my questions 4819.

I just wanted to know what makes that kidney cancer attractive for this molecule I know you mentioned E. N. P. P has a strong expression, but do you have T cells to work fairly well off your first line checkpoint inhibitors and are there any other tumor types, where you see opportunity.

I think I'll, let John .

John did you lay our CSO take that question he's expert in all things the MTB three.

Yeah.

Yes, yes. Thanks for the question, so I guess maybe.

Maybe it was a better way to think about it is we like E&P read because we're basically first in class for a CD three by civic.

As a very strongly and essentially uniformly expressed in clear cell renal cell carcinoma.

And.

Yes.

Few other histology is where there could be high E&P feature expression, but we got to prioritize for.

Wholesale mostly just to develop a signal once we establish that they ensure with perhaps a companion diagnostic we could expand it to a few other tumor types.

Yes, John maybe I think the other asking yourself.

Your questions Yeah with your T cells, Yeah. 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 histology is for having a default presence.

Kind of consistent with immune checkpoint inhibitors.

Very active in renal cell carcinoma, and we don't we don't think there's any scientific reason why.

No progression on a checkpoint inhibitor would have much impact on the future.

Got it that's very helpful. Thank you and maybe one on flow mode on that.

Yeah, you you collected a step of dosing to manage but can you tell us about the safety profile do you think with the step up schedule you can avoid hospitalization requirement that otherwise have.

So we'll address that in the context of the formulation moving forward or sub Q and in collaboration with Janssen, which does limit somewhat how much detail. We can give but I don't know Nancy do you want to take that or that's a goal I don't know that we have enough data right say yet yeah. It certainly that'd be a goal I think theres some by specific.

What's that.

Require a lot of hospitalization some minimal with our goal would be to go for the minimal amount.

It's appropriate.

As we look at the safety.

And then it's really about optimizing.

This step doses to.

Make sure that you have.

Crs.

The patients primed.

And and.

Not having too much crs such that.

No, it's it's dangerous and requires hospitalization.

Yeah, but so definitely that's our goal and I think a product like planemo given sub Q.

Could probably reach that like having less hospitalizations.

But what we're not we're not we don't have enough information to comment in more detail then we're hopeful and we're making good progress with the sub Q, but we haven't got enough data to share at this moment.

Got it thanks for taking my question.

Thank you one moment for our next question.

Yeah.

Our next question comes from the line of Charles Xu of Guggenheim Securities Charles.

Hey, guys. Thanks for taking the question and for providing.

Progress across your pipeline I'll start with a quick clarifying one.

Tell him that so obviously, an intriguing choice to pursue front line non small cell lung cancer.

One quick one regarding the chemotherapy backbone could you remind us or maybe provide color is this the standard.

Scott schedule or four cycles in maintenance or maybe I call or what have you or is this something that's more like a checkmate nine L. A where they stopped after two cycles. Thank you.

This is a standard schedule them for non squamous, it's pemetrexed and a taxane.

Truck side and a taxane.

I think it's given four cycles.

And yeah, and there is a maintenance component as well.

Alright, and then maybe.

Right.

Oh man I'm, sorry, with Woodford, Alabama of course.

Great. Thank you and Charleston went a bit more yes, yes.

My second one maybe a bit more scientific mechanistic one for X months 564.

What's your view on the potential for a differential expression profile of <unk> 25, as you move from healthy volunteers over to atopic dermatitis, and psoriasis patients and could this potentially impact the <unk>.

The clinical profile of your drug thank you.

Gosh, I don't know that Theres any real strong information on CD 25 expression levels on those in those two patient populations maybe.

Maybe John do you want to comment on what is known about CD 25 expression levels in other populations and how that might change things I don't know that that we would expect it to have a profound impact that John would know more.

Yeah I mean.

There is some.

When you go into autoimmune diseases. There there is some literature, suggesting that the T regs might have.

Slightly lower CD 25 expression.

And you can also have a deficit of T regs compared to T effector cells, but of course, that's exactly why we develop a therapy.

Two to.

Expand that deficit of T regs.

To catch up to the effector cell population.

Have a better suppressive capacity.

But I don't I don't think there's going to be anything prohibitive in terms of the C. D twenty-five expression for five six Florida to actually mobilize it to Rex.

Great. Thank you.

Thank you one moment for our next question.

The next question comes from Charles Xu of Leerink Partners go ahead.

Jonathan I apologize.

Hey, guys. This is Matt <unk>.

Jonathan Chang just one quick one for me for the 606, two study or are there any tumor types that you are any investigators are particularly keen to evaluate the compound in thanks.

Oh gosh for 606 to the IL 12 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.

And and Tolerability data I don't know that there is a particular ones that were even more most excited about I mean, John do you want to correct me on that.

Well, yeah I mean.

We're sort of going on across the board right because we're looking at immune responsive tumors of course.

But on the flip side, we're also very intrigue to look at 662, and and histologist like colorectal cancer, where.

PD ones by themselves or no not to do March and since we're doing a pembroke combination, but if we see something that will be more clear.

Likewise for prostate cancer and a few other histology so.

We really want to cast.

Cast a wide net on this one and see where the signals are.

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

Thank you one moment for our next question.

Yeah.

Our next question comes from the line of Boris <unk> of TD Cowen go ahead.

Great. Thanks for taking my questions I have two questions on where dollar move in lung cancer. Just curious how do you anticipate safety to compare to the competitor by specific obviously and also to the combo of Keytruda plus chemo and on five six for maybe a kind of a broad question. How do you see it as a drug distinguish in psoriasis and atopic derm.

Given kind of a pretty hot competitive landscape in those indications.

And maybe I'll touch on the $5 six for rationale for those indications before I hand, it off to Tim.

To Nancy to talk about <unk>.

Our thinking on on safety, there, which is pretty early so for 564, we selected atopic derm and psoriasis as our phase one b 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 <unk>, where we get a long enough duration of.

A T cell T Reg expansion to cover them throughout the dosing interval and.

And of course that would be tolerable, we saw dramatically improved.

Duration of T cell T. Reg expansion for 564 relative to what we saw from competitors for single dose studies. So we are hoping to exploit that to see if we can exceed the every other week dosing that the competing T. Reg IL two programs seem to be asked so that could be a very important differentiator across the board. So we selected psoriasis and atopic.

Because those are populations, where theres a large number of patients.

And we felt we can enroll them well and you can you can look at the clinical response easily well understood endpoints and even get biopsy samples. If you want because it's in the skin 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're really really excited by the initial data we had seen out of one of our competitor programs in atopic derm showing strong efficacy in there, albeit small population in their phase one b, but durability beyond the end of treatment that that was.

Perhaps surprising a bit, but maybe even consistent with the mechanism of enhancing T. Reg function and perhaps tolerance. So we wanted to chase that down because that could be an exciting area to differentiate in atopic derm, that's sort of long durability post treatment that we know current Asian agents in a D or every other week or might be getting to monthly.

Sure.

Now I'll, let Nancy can you restate your question on <unk>, because that was a pretty long winded there sorry.

Yes, no that was just asking in terms of safety in lung cancer, how do you anticipate it to compare to obviously competitive specifics as well as just the Keytruda plus chemo combo.

Yeah, that's that's a bit hard to answer without any data.

In lung.

Of the combination and that's why we're doing that that's why we have a part one and part two so the part one allows us to look at two different doses of <unk> in combination with the standard came.

Chemotherapy, a pen trucks and cargo.

And then we'll see what happens like you know what what does the safety look like when.

When you add.

You know a bi specific to that chemo versus just a monoclonal.

Yeah.

PD, one antibody and just to clarify a prior question. It is four cycles of Bhutto Buda.

Definitely have I'm, sorry, we called Buda.

Allomap was carnival and Pemetrexed, and then maintenance with food element and Pemetrexed.

It's not unlimited dosing as mentioned by somebody else so its full force or cycle.

Great. Thanks for taking my question.

Thank you.

Moment for our next question please.

Yeah.

Our next question comes from Gregory <unk> of RBC capital markets. Your line is open.

Yeah, Hi, guys its a niche 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 two of your <unk>.

Pipeline assets here, so just kind of wanted to see with with Pomona Mab with multiple CD 20, CD three bi specifics approved how do you believe Pomona Mab.

A lot of bumps combinations will position among competitors and then just on five six for just kind of building on a previous question you.

You know 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 so took two oh, Tesla <unk> et cetera.

Thanks, so much for the questions and congrats again.

Yes, it would clamor positioning we think the crux of this is the same logic that attracted janssen as a partner for <unk> and they are the ones leading the programme now taking on the.

The great majority of its cost 80% of the.

Of the cost.

I think that the key there is the combination with our CD 28 could provide that that differentiation and I will say that our competitors and combining with their CD 20 by specifics are really just at the very earliest stages and we plan, though I think showed competitive efficacy safety profile IV, we're moving rapidly.

On the sub Q.

The positioning is really in combo to try to leapfrog with better efficacy.

Just initially established monotherapy can probably seemed to be established chemo combos with the other <unk>.

And so that's why we were excited to get a partner like Janssen, which has.

Outstanding capabilities and scale in and heme malignancy to help drive. This 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 <unk>.

For 564, I just want to emphasize that we haven't we don't have a final indication study. This is phase one b, where we want to demonstrate durability of of action of T. Reg enhancement and hopefully tied that to efficacy, where it's easily seen certainly depending on what we see atopic derm could be a go forward, but we.

Obviously, we are considering other indications and we'd expect to announce if we proposed to advancing any theres a wide range of autoimmune indications, where T regs very likely play a role.

We would expect to announce those later as we nail down our regimen. So this is not a commitment in phase one to an indication strategy I will say that this idea of sequencing and <unk> is going to come up more and more not just for T. Reg enhancers, but all the therapies and that's certainly been a place where were new.

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.

And arthritis.

Great. Thanks, so much really appreciate the color there.

Thank you very much.

One moment for our last question.

Our last question comes from Peter Lawson of Barclays.

Your line is open hey.

Hey, good afternoon.

Thanks. This is Alex on for Peter Thanks for taking our questions.

Just one on the <unk> III program. If I was wondering if you could remind us some of the shortcomings of the Astellas ADC going after the same target than what might be the benefits of a bi specific approach. Thank you.

Yes, John do you want to tackle that one.

Yeah sure Yeah.

In fact, it was when we kind of discovered E. M. P. P. R. P. P. Three ourselves using a bio informatic approach looking for selectively expressed tumor associated antigen.

And then we became aware of the Astellas programs once we.

Doug in the literature.

I have to say that.

Half decent data I mean, they saw responses in phase one.

Of course, because they had a or statin payload they had dosing.

Dose limiting ocular toxicity.

I think that was an interesting time because that was the Genesis program.

That astellas.

It had acquired a genesis.

And from from what we know from from folks that set of work there.

It was more of a strategic decision to discontinue that program, but we thought it was actually excellent validation for the selectivity of the target and the safety of going after the targets.

Thank you very much at this time I would now like to turn conference back over to Basil diet for closing remarks.

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

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

Q2 2023 Xencor Inc Earnings Call

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Xencor

Earnings

Q2 2023 Xencor Inc Earnings Call

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Thursday, August 3rd, 2023 at 8:30 PM

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