MacroGenics Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 6, 2023

There are 12 speakers on the call.

Operator

Afternoon, we will begin the MacroGenics 2023 Third Quarter Corporate Progress and Financial Results Conference Call in just a moment. All participants are in a listen only mode at the moment, and we will conduct a question and answer session at the conclusion of the call. At this point, I will turn the call over to Jim Carroll, Senior Vice President and Chief Financial Officer of MacroGenics.

Speaker 1

Thank you, operator. Good afternoon. Welcome to MacroGenics' conference call to discuss our Q3 2023 financial and operational results. For anyone who has not had the chance to review these results, We issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at macrogems.com. You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately 2 hours after the call is completed.

Speaker 1

I'd like to alert listeners that today's discussion will include statements about the company's future expectations, plans and prospects that constitute forward looking statements. For purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the Risk Factors section of our annual, quarterly and current reports filed with the SEC. In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward looking statements at some point in the future, we specifically disclaim any obligation to do so even if our views change except to the extent required by applicable law.

Speaker 1

And now, I'd like to turn the call over to Doctor. Scott Koenig, President and CEO of MacroGenics.

Speaker 2

Thank you, Jim. I'd like to welcome everyone participating via conference call and webcast today. This afternoon, I will provide key updates on our clinical the program. But before I do so, let me first turn the call back to Jim, who will review our financial results.

Speaker 1

Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended September 30, 2023, which highlight our financial position. As described in our release this afternoon, MacroGenics' total revenue was $10,400,000 for the quarter ended September 30, 2023 compared to total revenue of $41,700,000 for the quarter ended September 30, 2022. The decrease reflects the recognition of $30,000,000 in revenue under the Incyte license agreement during 3 months ended September 30, 2022. Revenue for the quarter ended September 30, 2023 included recognition of $4,500,000 in contract manufacturing revenue the marginza net sales of $4,700,000 compared to $4,400,000 for the quarter ended September 30, 2022.

Speaker 1

Our research and development expenses were $30,100,000 for the quarter ended September 30, 2023 compared to $48,200,000 for the quarter ended September 30, 2022. The decrease was primarily related to decreased costs related to discontinued studies, partially offset by increased expenses related to preclinical antibody drug conjugate or ADC molecules and increased clinical expenses related to lorodirumab. Our selling, general and administrative expenses were $12,400,000 for the quarter ended September 30, 2023, compared to $15,400,000 for the quarter ended September 30, 2022. The decrease was primarily related to decreased selling costs for Margenca. During the quarter ended September 30, 2023, MacroGenics received a $50,000,000 milestone payment from Sanofi related to the achievement of a primary endpoint in a tZeal clinical study.

Speaker 1

The accounting treatment for this milestone is consistent with that for the $100,000,000 proceeds received from the sale of our single digit royalty interest on global net sales the tZILT DRI Healthcare Acquisition LP in March of this year. Accordingly, dollars 50,000,000 was included in other income as a gain on royalty monetization arrangement for the quarter ended September 30, 2023. Our net income was $17,600,000 for the quarter ended September 30, 2023 compared to a net loss of $24,800,000 for the quarter ended September 30, 2022. Our cash, cash equivalents and marketable securities balance as of September 30, 2023 was $256,400,000 compared to $154,300,000 as of December 31, 2022. Our cash balance as of September 30, 2023 did not include the $15,700,000 milestone from Gilead subsequently received.

Speaker 1

Finally, in terms of our cash runway, we anticipate that our cash, cash equivalents and marketable securities balance of $256,400,000 as of September 30, 2023, the 15 point the $7,000,000 milestone subsequently received in addition to projected and anticipated future payments from partners and product revenues and should extend our cash runway into 2026. Our anticipated funding requirements reflect the expected expenditures related to the Phase 2 TAMRAC study, the Phase 2 lauriquete study of lauraterolumab in metastatic castration resistant prostate cancer as well as our other ongoing clinical and preclinical studies. And now, I'll turn the call back to Scott.

Speaker 2

Thank you, Jim. We continue to believe our proprietary pipeline of product candidates has great promise, and I will walk you through each of our key programs momentarily as well as tell you about our plans for upcoming clinical programs. But before I do that, Let me quickly remind you that since mid-twenty 22, through our business development efforts as well as milestone achievements, We have received $335,000,000 of non dilutive capital. This includes $215,000,000 from Provention DRI Sanofi in connection with tZeal, dollars 75,000,000 from Gilead and $45,000,000 from Incyte in connection with Zynas. Bogarimumabduacarmizine or VOBR Duo is our ADC designed to deliver the DNA alkylating durochomycin cytotoxic payload to tumors expressing B7H3.

Speaker 2

D7 H3 is a member of the B7 family of molecules involved in immune regulation. OBERDUO was designed to take advantage of Sandagen's broad expression across multiple solid tumor types. We began enrolling the Tamarac Phase 2 study of OBERDUO under a modified study protocol during the Q2. I am thrilled to tell you that we recently completed enrollment of this study ahead of schedule. As a reminder, Tamarac is being conducted in patients with metastatic castration resistant prostate cancer or mCRPC were previously treated with 1 prior androgen receptor access targeted therapy.

Speaker 2

Participants may have received up to one prior taxing containing regimen, but no other chemotherapy agent. This study is being conducted to evaluate VOBER DUO in patients across 2 experimental arms of either 2 mgs per kg or 2.7 mgs per kg every 4 weeks. We anticipate having data from the study to share with you in the first half of twenty twenty four. Next, I'll update you on loradirlimab, our bispecific tetravalent PD-onexCTLA-four DART molecule. We designed loradilumab to have preferential blockade on dual PD-one CTLA-four expressing cells such as tumor infiltrating lymphocytes or TILs, which are most abundant in the tumor microenvironment.

Speaker 2

We recently began enrolling the LORIKETE study, a randomized Phase 2 clinical trial of loradirlimab in combination with docetaxel versus docetaxel alone and second line chemotherapy naive mCRPC patient. A total of 150 patients are planned to be treated in the 2:one randomized study. The current study design includes the primary study endpoint of radiographic progression free survival or RPFS. Given that we just commenced enrollment, we'll need more time to estimate when we might complete enrollment and have data to share from the study. In addition, we continue to enroll patients in the Phase onetwo dose escalation study of VoverDuo in combination with loradirlimab and patients with advanced solid tumors, including renal cell carcinoma, pancreatic cancer, ovarian cancer, hepatocellular carcinoma, mCRPC and melanoma.

Speaker 2

We anticipate commencing the dose the expansion portion of the study in 2024. Next up, MGD-twenty four is our next generation bispecific CD123xCD3 DART molecule that incorporates a CD3 component designed to minimize cytokine release syndrome, while maintaining antitumorcytolytic activity and permitting intermittent dosing through a longer half life. Our Phase 1 dose escalation study of MGD-twenty four is ongoing in patients with CD123 positive relapsed or refractory hematologic malignancies, including acute myeloid leukemia and myelodysplastic syndrome. Recall that Gilead has the option to license MGD-twenty four at predefined decision points during the Phase 1 study. Also, as part of our collaboration with Gilead and as Jim already mentioned, we received a $15,700,000 mile the time from Gilead related to their nomination of the first of 2 potential research programs that leverage our DART and TRIDENT platforms for bispecific antibodies.

Speaker 2

This nomination grants Gilead an exclusive option upon the achievement of a predefined preclinical milestone to license worldwide rights to this first research program. MacroGenics will conduct the work related to this program on behalf of and funded by Gilead. Next, enoblituzumab is an Fc optimized monoclonal antibody that targets B7 H3. Recently published data from a Phase 2 investigative sponsored study of enoblituzumab in men with prostate cancer prompted our academic collaborators to initiate an investigator sponsored randomized translationally intense prostate cancer clinical trial. The HEAT study is expected to commence enrollment in early 2024 and will evaluate the activity of neoadjuvant enoblituzumab given prior to radical prostatectomy in men with high risk localized prostate cancer.

Speaker 2

Eligible patients will undergo a pretreatment prostate biopsy and conventional imaging, CT and bone scan, as well as PSMA PET and optional prostate MRI as per institutional preferences. Finally, on our Q2 earnings call, I described our ongoing efforts in developing preclinical ADC molecules utilizing linker payload technologies we licensed from Synapix. I'm very pleased to tell you we recently submitted an investigational new drug or IND application to the U. S. FDA for the first of these ADCs, MGC-twenty 6.

Speaker 2

This molecule utilizes a topoisomerase inhibitor the cytokine based cytotoxic mechanism directed against an undisclosed solid tumor target. In preclinical studies, the activity of this linkertoxin the same time, compared very favorably with that of other topoisomerase inhibitor based ADC technology. We look forward to sharing preclinical data with you at a future scientific conference and telling you more about this molecule in early 2024. In addition to MGCO-twenty 6, we are readying a second topoisomerase inhibitor based ADC for which we currently expect to submit an IND in late 2024. And behind these two ADCs, We are exploring additional molecules for potential future IND submissions.

Speaker 2

Stay tuned. To conclude, we believe we have the technical development and clinical expertise as well as financial resources to support our vision of developing and delivering life changing medicines to cancer patients. We would now be happy to open the call for questions. Operator?

Operator

Thank Our first question comes from Charles Zhu with Guggenheim Securities. Your line is open.

Speaker 3

Hey, good evening guys and thanks for taking the question and congrats on the progress. Perhaps my first one here. How are you guys thinking about potential longer term registrational development for Vobroduo within prostate cancer, particularly with a not only with the potential setting, but also with the potential choice or choices of of a control arm, just given the current shifting landscape. Thank you.

Speaker 2

Thanks for the question, Charles. So as you know, there's And some recent updates at the ESMO meeting with regard to PSMA-four, and clearly we would like to see the results the time of the Tamarac study, which as we described today will occur earlier than we originally announced. We feel that there is great opportunity for treatment of patients in later line therapy and we are evaluating now the potential options for a controlled population. These may include multiple choices by the investigator, but at this this point. Until we finish completion of the current Tamarac study and have further discussions with the regulatory agencies, We will not provide guidance with regard to the specific control group, but it is clear from our interaction with key opinion leaders that this is a very needed treatment advance for later line patients giving them greater options and that are currently offered to them.

Speaker 4

Got it. Great.

Speaker 3

Thanks for that. Maybe one quick follow-up on the vopro duo with lorodilimab combination. Regarding the potential expansion cohorts starting from next year, which tumor types might you prioritize and why? And Would you presumably also need to demonstrate contribution of components for this? And if so, would your current single agent data suffice?

Speaker 3

Or would you need to demonstrate this data for each given individual histology. Thank you.

Speaker 2

Well, as you know, Charles, thanks for that question. We have now a significant data of individual treatment arms for vobraduo and loradrolumab in prostate cancer, for example. So again, this would be a discussion with regard to the design of such study. If we were moving forward with prostate, it is likely that the The prostate would be one of the expansion arms once we have established the final combination dosing for the individual components. As we have said previously, it is likely we will add 1 to 2 other tumor types in addition to prostate cancer.

Speaker 2

At this time, we're not ready to describe the ones we have selected.

Speaker 3

Got it. Great. Thanks for taking the questions.

Operator

One moment for our next question. Our next question comes from Savari Polman with BTIG. Your line is open.

Speaker 5

Hey, good evening. Congrats on the progress. So I guess my question is similar to the previous question that was asked. For Robra, If you can just tell us how you are thinking about its development after readouts from Tamerac trial in the first half of next year. Do you think you will have sufficient efficacy data to directly move into a pivotal study or you would be running another randomized trial?

Speaker 2

So, thanks for that question, Kaveri. The purpose of the current study Was to fine tune the dosing from what we had previously reported on the expansion dosing at 3 mgs per kg. Obviously, the data is still early in the feedback of the current trial, but I'm very pleased on how this trial has both enrolled and is performing. Clearly, we feel that we will the be in a great position to select the dose for a control study, a Phase 3 study with one of those 2 doses. But at this point, as I described previously, We're not in a position to describe the control arm.

Speaker 2

But I imagine it will look similar to what we had previously described in the Phase twothree original design last year.

Speaker 5

Got it. That's helpful. And for lorazirlimab and diltotexol combination trials for chemo naive patients, How are you thinking about competition from Radiopharmaceuticals? Are you allowing enrollment of patients who have gone through the trial like PSMAor Eclipse regimen. And can bone marrow and kidney toxicities from these drugs provide a big market the And maybe a follow-up on that.

Speaker 5

Do you think the prior use of OTEZO, if approved based on CANTT-two trial, could impact lorodilumab's efficacy?

Speaker 2

So lots of questions there. Opportunities for patients who have been exposed to radiopharm It's possible in this study of the large German docetaxel. As you know, this is a randomized study, 2:one, 100 of the combo, and 50 of the controlled docetaxel. We do believe that there will be great opportunities for patients. It expands the opportunity here despite the fact of encouraging data for Plavicto in the earlier line therapy.

Speaker 2

Clearly, we are not curing these patients even from that treatment. As you know, there was some question with regard to the overall survival benefit because of the high crossover of Plavicto and certainly there will be challenges for patients who have history of bone marrow toxicities from the radiopharmaceutical or from other agents going forward. Clearly, at this point, we're still in the early phases of enrolling in this study and we'll have more to speak about this in 2024. I didn't catch your last question. Could you repeat that one?

Speaker 5

Yes. You think that atezo, if it gets approved based on the contact O2 trial. Do you think it could impact large oralimab efficacy?

Speaker 2

I don't think that that's going to be a

Operator

at the

Speaker 2

that the activity of Lord Jilinab based on The data we report to date should have a superior outcome In various prostate settings.

Operator

One moment for our next question. Our next question comes from Esther Draught with BMO Capital Markets. Your line is open.

Speaker 6

Great. Thanks for taking the question. Just a couple of quick ones. So the first one, just was curious, Scott, how much overlap the trial side overlap you have between Tamarac and sort of the Lorquette trial and could we sort of see maybe a similar sort of trajectory the in terms of enrollment for that study, if sites are sort of similar between those two studies. And then for the Vobra, Laurie Duo for the combination.

Speaker 6

Just curious as to sort of maybe where you are currently with the dose escalation and sort of the drivers here For the expansion start in 2024? Thanks.

Speaker 2

Okay. Esther, you cut out. Let me answer the first question, which was on the trial overlap. There is some sites that are enrolling in both studies, but largely separate sites. But I think we're in very good shape with the current sites that are set up for LORAKEET to have a good enrollment in late this year and into 24, but clearly still

Operator

Are you still there, Scott?

Speaker 6

Yes. Ed, sir, is here.

Speaker 2

I'm here.

Speaker 1

Scott, you faded out. Would you mind answering that again?

Speaker 2

Okay. I didn't hear the second question for the trial.

Speaker 6

Can I ask the second question or?

Speaker 2

Yes, please.

Speaker 6

Yes, sorry. Yes, so just was curious sort of where you are with sort of the vogreloride dose at escalation and sort of the pushes and pulls here for the start of the expansion trial in 2024.

Operator

One moment please stand by. Are you back, Scott?

Speaker 2

Hello?

Operator

You're back now, Scott. We can hear you.

Speaker 2

Okay. I switched computers.

Speaker 1

Yes, we can hear you. Yes, we can hear

Speaker 4

you.

Speaker 6

Okay. Should I ask the question again? I'm not sure if you heard me this

Speaker 2

Please, please. No, I didn't hear that.

Speaker 6

Yes. No, just curious to see sort of where you were with the dose the escalation of the Lori, Vorbra combination. What sort of triggers here the the expansion start in 2024. If you

Speaker 4

can just maybe provide a little bit more color on

Speaker 6

where you are with the escalation?

Speaker 2

Yes. We're pretty close to selecting the doses now. We're fine tuning the individual doses. We expect that to occur by the end of the year and then would move into the expansion in early 2024.

Speaker 6

Got it. Thank you.

Operator

One moment for our next question. Our next question comes from John Miller with Evercore. Your line is open.

Speaker 7

Hey guys, thanks so much for taking my question and congrats on all the progress. I guess one on lauriquete. This is a phase randomized Phase 2 here, but you were previously guiding to a Phase 2 expansion after the ongoing Phase 1. Are we still expecting to see a meaningful mCRPC dataset here in an expansion setting in first half twenty four or is this taking the place of that? And then secondly, on the 24 program, are Gilead opt ins, I mean, I know there are unspecified the points in Phase 1, but are we going to see public facing data from that Phase 1 before Gilead has opt in rights or is possible they have opt in rights before even Phase 1 data is available.

Speaker 2

So let me start with the second one. They can opt in any time during Phase 1 or so. Again, they will control the data with regard to public presentation. But they can they have to do it before the data Phase 1 is complete. With regard to the LORIKED and the expansion study, that study is complete, But for the fact that several of the patients, 3 of the patients are still on lorodilumab, This is now coming on almost 2 years from enrollment in that study.

Speaker 2

I'm encouraged by the activity and the ability to retreat patients over long periods of time. With regard to RDE, the Laurie Keith, Phase 2. The plan is to complete that study, make decisions not only for the chemo naive population, but also look at the opportunity of LORIKED in other prostate settings and what people described There is opportunities to test this in other tumor settings and we should provide some updates very soon with regard to additional indications that we would like to pursue with Virgil.

Speaker 7

Great. Thanks for the color there, Scott. But maybe I missed it. Are we still expecting a LORI expansion update, an actual data set the coming first half next

Speaker 2

year? Well, from the prostate study at That we presented that, as you know, last February. There is for that particular cohort, There's just the longevity of the prostate. With regard to the non prostate indications, What we have said is that once we have decided to move forward with other indications, They may provide opportunities to present the data from which we face the decision to move forward.

Speaker 7

Okay. Thanks so much. And maybe one on the deeper pipeline then. You mentioned a topo payload on 26, but you You previously talked about multiple payloads and linkers. So how diverse are those next couple of molecules that you mentioned coming just behind 26?

Speaker 7

Are they also representative of that multiple payloads, multiple linkers programs that you got?

Speaker 2

So we continue to look at the options. This will be In terms of the linker payload, and because the way the Synastix BioSpacer and toxin is set up, we can select 1 of several. What we've said, this first one is a topoisomerase inhibitor. The second one will be a topoisomerase inhibitor. We're evaluating not only atoboy somarisinibtib, but other toxins associated with other targets going forward, but are not in a position yet to to discuss either the targets or the particular payload that we'll use

Operator

Thanks so much guys. Okay. One moment for our next question. Our next question comes from Peter Lawson with Barclays. Your line is open.

Speaker 8

Great. Thanks, Scott. Thanks for taking the questions. Just on Temeract, just where did that enroll faster than expected? And How much data should we expect to see from that in the first half since next year?

Speaker 2

Well, I have to say that we're In Europe, the U. S. And in Asia, we So a great enthusiasm from the investigator, the patients on the study. I the can't give you a little bit any more color than they have the opportunity here with Vopra Duo in helping their patients. And the rationale why we're doing that resonated very well with the investigators as well as the patients.

Speaker 2

What the study was as 100 patients, 50 in each arm. We've actually exceeded that. It is an overall strategy. So we expect a fairly sizable amount of data to come out in 2024.

Speaker 8

Okay. And then on ADAM-nine, any details why that readout was nudged back from the second half of this year to 2024.

Speaker 2

The study is completing is being completed out finalizing and will as ImmunoGen has said, they will report out in the beginning the Colorado 24. As I've indicated to you, one of the challenges has been always with identifying the appropriate dose moving forward. They are finishing out the the patients that are in the non small cell lung cohort currently and we'll report on that in the 1st part of the year and with regard to next steps for that program.

Speaker 8

Great. Okay. Thank you so much.

Operator

One moment for our next question. Semsevant Turkan with JMP Securities. Your line is open.

Speaker 9

Hi, good evening. Congrats on the update and thanks for taking my question. Maybe a more big picture question. Can you comment maybe on some key takeaways from Esmon, SITC on B7 H3 as a checkpoint that the more and more presentation also what we can learn from the Daiichi partnership. And then a second question is, what is your role in the HEAT study on Eno?

Speaker 9

I know that's investigator related and it's earlier stage prostate cancer, but what is your role here and what's your involvement? Thank you.

Speaker 2

So with regard to the data on Esmejo, first of all, as you commented on the partnership now with Daiichi, the concludes 7,300 molecule. I have to think that we're very encouraged that the way that, that Partnership was constructed and the value that Merck placed on that relationship with the 7,300 With being a very important part of the 3 target deal, it only heightens, I think, the value we see for VOBR Duo and our whole B7 H3 program. With regard to the system that Daiichi presented in their poster session. If you recall, It was not more in terms of improved activity in the prostate cohort that they tested. They were seeing about 5 months of our PSS.

Speaker 2

It's first reported about a year of overall survival and a 25% PSA50 response, The latter of which is not any different than previously reported. So we feel again very good about where Vopaduo sits right now, having this additional data that will come out in Note 24 on the Tamarac study to be able to move forward with a very active drug with a the proper dosing to mitigate some of the side effects we were seeing. With regard To the HEAT study, again, we had always had a very close relationship with in discussions with them on where the value we see on nolblatuzumab in settings like a neoadjuvant use of this drug. And we're also And we're also looking at opportunities for enoblituzumab in other settings as well. With regard to this being a collaborative study, it is mostly an IST, the so they have full control over the execution and providing the data, But we have constant conversations back and forth with regarding the opportunity for Enobly and other B7 H3 molecules in the treatment of the

Operator

Thank you. One moment for our next question. Our next question comes from Jonathan Chang with Leerink Partners. Your line is open.

Speaker 4

Hi, guys. This is Fazil on for Jonathan. Thanks for taking our questions. So congrats on the Tamarac enrollment. I guess now that you sort of know what kind of patients you've enrolled, what do you see as the right benchmarks for VORBRA DUO in this setting?

Speaker 2

Well, I mean, as Tim indicated that we were looking to achieve a similar range of activities that we've asked previously where we were seeing about half the patients achieving PSA 50s, I said, we're going to look for a 40% to 60% range on PSA 50s. Obviously, looking hopefully for some of these patients that have PSA 90s. With regard to The objective responses here, again, we have reported and what I just described to Daiichi with Approximately a quarter of those patients have objective responses without delay even higher levels, And we think that there is an opportunity there given as our quality has improved these patients We'll stay on drug potentially longer when they don't have to come off for side effects that are problematic for them. With regard to RPFS, again, we look to the historical data on both Plavicta, on cabozitaxel, the cardiogenic, etcetera. Again, as I just reported to you, with RPSS from the 70 to 200 in the range of 5 months, We obviously would be looking hopefully for longer RPSFS in the 6 months Or greater.

Speaker 2

So I would say those are sort of general ranges, Nothing absolute here with regard to decisions. It's the totality of the data which will decide our next steps for this program.

Speaker 4

Got it. That's super helpful. Thank you. And then, recently there the data presented for a PSMA ADC and also a steep one T cell engager like Phase 1 data in prostate cancer. Just curious your thoughts on the competitive landscape and how you see your assets the

Speaker 2

Well, I think actually we're in wonderful shape. Many of you have greater opportunities for patients. For PSMA, ADCs, if you look at the data that has and presented at various meetings. The actual spread patterns of PSMA and B7 H3 are not identical. They overlap with some tumors, but there are clearly select parts of the tumors which will express one or the other.

Speaker 2

As I pointed out, As patients progress to later line, PSMA tends to drop significantly at are maintained. So we think that it provides greater opportunity and choices for treating particularly late stage patients. But most importantly, with regard to this particular program, having an ADC the versus an ADC for PSMA. PSMA is going to be large limited to prostate cancer, where with a broad expression of B7 H3 across most solid tumors, I think that we are in great opportunity not only to improve treatment for patients with prostate cancer, But through a whole host of other tumors. With regard to other platform technologies, again, None of the data I've seen is overwhelming in that regard.

Speaker 2

But again, we'll have to see how that pans out. In most of these cases, again, the point I was making with regard to the PSMA specificity, It will limit any product cancer.

Speaker 4

Thank you.

Operator

One moment for our next question. Our next question comes from Ygal Nochomovitz with Citi. Your line is open.

Speaker 10

Hi, guys. This is Ashik Mubarak on Seagull. Thanks for taking my questions and congrats on all the progress. Just a couple of quick ones. Will there be an interim look in lower key?

Speaker 10

And if so, what might trigger that interim look? Also curious if you're able to share any color on powering assumptions and remind us what the trial is designed to show in terms of separation PFS between the arms? Thanks.

Speaker 2

So there is a plan at Lorike, there will likely be a the utility analysis. We have not provided the statistics around that. I should point out that the historical data in multiple control trial in the placebo naive population Has shown RPFS is around 8 months. So we're working on this to be able to to beat that milestone and that landmark.

Speaker 10

Okay, got it. And then maybe one on MGD-twenty four. I guess can you remind us what you view as an acceptable CRS profile for this program? And then maybe on the efficacy side, what you would see as a worthwhile complete response rate and a Phase 1 dose escalation set of domain we move on to expansion at Phase 2. Thanks.

Speaker 2

As you know, this is a study, as we've pointed out, that has is a graphite with Gilead, so I can't speak to them in terms of what their bar for this study. Historically, in late line patients, with the Flozamab, the precursor of this molecule. We were seeing at that time in the primary induction failure population north of 20% response rates Clearly, we would like to see higher rates. As now, we think that We have both a separate based on the reduced CRS profile and as well as the ability to give this dose dosing on a the intermittent basis and resident to the infusion. With regard to the specific the Tolerance for safety profiles, clearly, the absence or markedly reduced low grade CRS and limiting it to potentially initial dosing and not later dosing Would be, I think, a favorable profile that will allow the use both in early line and late line patients.

Speaker 2

But again, this is a decision that Gilead would make based on their expectations.

Speaker 10

Okay, got it. And then last one for me, just a very high level. We're just wondering if you received a lot of inbounds for potential partnerships on with VovaDuo. And if so, maybe when you'd entertain partnership, would that be more around the Phase 3 or is that something you'd rather do sooner rather than later?

Speaker 2

So the answer is we've had very encouraging discussions the historically about VovaDuo with many large companies, both pharma and biotech companies. What we have described to them is our interest in getting additional data in the Tamarac study before we would engage in further discussions on potential partnerships. Back to the point I was making earlier because of the opportunity here for Vopraduo to treat many, many different tumors. That is something we as macrogestinib, And so at the appropriate time, I would envision if developments continue favorably Which would both expand the opportunity, not only in prostate cancer and other tumor types as well, with a partner who has the resources and capabilities to support it along with us.

Speaker 10

Got it. Very helpful. Thanks very much.

Operator

One moment for our next question. Our next question comes from Stephen Willey with Stifel. Your line is open.

Speaker 11

Yes, good afternoon. Thanks for taking the questions. Maybe just a quick one on the next gen ADC efforts. And Scott, I know you're not going to be disclosing target antigens anytime soon. But Just wondering philosophically how you're kind of thinking about selecting target antigens for this next round of ADCs that you put into the clinic.

Speaker 11

And I guess how far out on the risk curve are you willing to step considering you are tethering novel anchor and payload to these things. And

Operator

I guess when you declared the target for

Speaker 11

the first candidate in the first half of next year, is this something that we should expect to all into kind of the highly competitive buckets of ADC antigens that we've seen across the landscape? Or is this thing going to be kind of maybe a little bit more differentiated and unique. Thanks.

Speaker 2

Thanks, Steve. And we put a lot in the selection at both the targets as well as the linker payloads. Clearly, there is lots of competition that had before. We want to be thoughtful in the selection of both. We feel that Given what Synaptics has already shown with regard to what we believe is the superior priority

Speaker 4

of their

Speaker 2

platform, the ability of using a DAR in this case close to 4. At the exit can in various configurations and our own preclinical data showing the favorable aspects of this. With regard to the specific target, I think what you'll be pleased to see is, I would say a mixture of markets that are validated to some degree, but not the have any approved product market where we can be very competitive. There's opportunities for the clearly novel targets that NOL is pursuing. And in some cases, where there's some scanty data and where our clients have been pursued, but have been disappointing, which could be described due to the the design of the particular molecules that have been tested.

Speaker 2

So I think over the course of the next 6 months. You will certainly see the first looks at some of these targets the presentations at scientific meetings. And then later in 'twenty four and going out in 'twenty five, We'll be adding on more of these targets. And I think that the pace We are at right now is quite favorable where we're pushing the team to be able to have a new IND on an annual or slightly longer basis. So that would provide both opportunities for organic growth of our pipeline, but also given the importance of bringing in non dilutive capital, the opportunity for partnerships there.

Speaker 2

I should also point out that because Synaptics also has partnerships with other companies, they're going to be using their linker the toxins. So having that validation early, later this year, we're going to explore from other molecules as well as our own will give a lot more encouragement for the value of the plant.

Speaker 11

Great. Thanks for taking the question.

Operator

And I'm not showing any further questions at this time. I'd like to turn the call back over to Scott for any closing remarks.

Speaker 2

Well, thank you, operator, and thank you all at the time. We look forward to providing updates in 2024, both on our clinical and pre the We hope you have a good day.

Operator

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

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Earnings Conference Call
MacroGenics Q3 2023
00:00 / 00:00
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