MacroGenics (MGNX) Q3 2023 Earnings Call Transcript

MacroGenics (MGNX 2.45%)
Q3 2023 Earnings Call
Nov 06, 2023, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good 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 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 Karrels, senior vice president and chief financial officer of MacroGenics.

Jim Karrels — Senior Vice President, Chief Financial Officer

Thank you, operator. Good afternoon and welcome to MacroGenics conference call to discuss our third quarter 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 announcement, which is available under the investors tab on our website at macrogenics.com. You may also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed.

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.

And now, I’d like to turn the call over to Dr. Scott Koenig, president and CEO of MacroGenics.

Scott Koenig — President and Chief Executive Officer

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 programs. But before I do so, let me first turn the call back to Jim, who will review our financial results.

Jim Karrels — Senior Vice President, Chief Financial Officer

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 $10.4 million for the quarter ended September 30, 2023, compared to total revenue of $41.7 million for the quarter ended September 30, 2022. The decrease reflects the recognition of $30 million in revenue under the Incyte license agreement during the three months ended September 30, 2022.

Revenue for the quarter ended September 30, 2023 included recognition of $4.5 million in contract manufacturing revenue and Margenza net sales of $4.7 million, compared to $4.4 million for the quarter ended September 30, 2022. Our research and development expenses were $30.1 million for the quarter ended September 30, 2023, compared to $48.2 million 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 lorigerlimab. Our selling, general, and administrative expenses were $12.4 million for the quarter ended September 30, 2023, compared to $15.4 million for the quarter ended September 30, 2022.

The decrease was primarily related to decreased selling costs for Margenza. During the quarter ended September 30, 2023, MacroGenics received a $50 million milestone payment from Sanofi related to the achievement of a primary endpoint in a Tzield clinical study. The accounting treatment for this milestone is consistent with that for the $100 million proceeds received from the sale of our single-digit royalty interest on global net sales of Tzield to DRI Healthcare Acquisitions LP in March of this year. Accordingly, 50 million was included in other income as a gain on royalty monetization arrangement for the quarter ended September 30, 2023.

Our net income was 17.6 million for the quarter ended September 30, 2023, compared to a net loss of 24.8 million for the quarter ended September 30, 2022. Our cash, cash equivalents, and marketable securities balance as of September 30, 2023 was $256.4 million, compared to $154.3 million as of December 31, 2022. Our cash balance as of September 30, 2023 did not include the $15.7 million milestone from Gilead subsequently received. Finally, in terms of our cash runway, we anticipate that our cash, cash equivalents, and marketable securities balance of $256.4 million as of September 30, 2023, the $15.7 million milestone subsequently received, in addition to projected and anticipated future payments from partners and product revenues should extend our cash runway into 2026.

Our anticipated funding requirements reflect expected expenditures related to the phase 2 Tamarack study, the phase 2 Lorikeet study of lorigerlimab 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.

Scott Koenig — President and Chief Executive Officer

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-2022, through our business development efforts, as well as milestone achievements, we have received $335 million of nondilutive capital. This includes $215 million from Prevention DRI Sanofi in connection with Tzield, $75 million from Gilead, and $45 million from Incyte in connection with Zynyz.

Vobramitamab duocarmazine, or vobra duo, is our ADC designed to deliver a DNA-alkylating duocarmycin cytotoxic payload to tumors expressing B7-H3. B7-H3 is a member of the B7 family of molecules involved in immune regulation. Vobra duo was designed to take advantage of this antigen’s broad expression across multiple solid tumor types. We began enrolling in the Tamarack phase 2 study of vobra duo under a modified study protocol during the second quarter.

I am thrilled to tell you that we recently completed enrollment of this study ahead of schedule. As a reminder, Tamarack is being conducted in patients with metastatic castration-resistant prostate cancer, or mCRPC, who were previously treated with one prior androgen receptor axis-targeted therapy. Participants may have received up to one prior taxane-containing regimen but no other chemotherapy agents. This study is being conducted to evaluate vobra duo in patients across two experimental arms of either 2 mgs per kg or 2.7 mgs per kg every four weeks.

We anticipate having data from the study to share with you in the first half of 2024. Next, I’ll update you on our lorigerlimab, our bispecific, tetravalent PD-1 by CTLA-4 Dart molecule. We designed lorigerlimab to have preferential blockade on dual PD-1 CTLA-4 expressing cells such as tumor-infiltrating lymphocytes, or TILs, which are most abundant in the tumor microenvironment. We recently began enrolling to Lorikeet study, our randomized phase 2 clinical trial of lorigerlimab in combination with docetaxel versus docetaxel alone in second-line chemotherapy-naive mCRPC patient.

A total of 150 patients are planned to be treated in the 2-to-1 randomized study. The current study design includes a 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 1/2 dose escalation study of vobra duo in combination with lorigerlimab in patients with advanced solid tumors, including renal cell carcinoma, pancreatic cancer, ovarian cancer, hepatocellular carcinoma, mCRPC, and melanoma.

We anticipate commencing the dose expansion portion of the study in 2024. Next up, MGD024 is our next-generation bispecific CD123 by CD3 Dart molecule that incorporates a CD3 component designed to minimize cytokine-release syndrome while maintaining anti-tumor cytolytic activity and permitting intermittent dosing through a longer half-life. Our phase 1 dose escalation study of MGD024 is ongoing in patients with CD123-positive relapsed or refractory immunologic malignancies, including acute myeloid leukemia and myelodysplastic syndrome. Recall that Gilead has the option to license MGD024 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 $15.7 million milestone from Gilead related to their nomination of the first of two potential research programs that leverage our Dart and Trident platforms for bispecific antibodies. This nomination grants Gilead an exclusive option upon 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 investigator-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. 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 second quarter earnings call, I described our ongoing efforts in developing preclinical ADC molecules utilizing linker payload technologies we licensed from Synaffix.

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, MGC026. This molecule utilizes a topoisomerase inhibitor-based cytotoxic mechanism directed against an undisclosed solid tumor target. In preclinical studies, the activity of this linker-toxin combination compared very favorably with that of other topoisomerase inhibitor-based ADC technology.

We look forward to sharing the preclinical data with you at a future scientific conference and telling you more about this molecule in early 2024. In addition to MGC026, 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 submission. 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.

Questions & Answers:

Operator

Thank you. [Operator instructions] Our first question comes from Charles Zhu with Guggenheim Securities. Your line is open.

Charles Zhu — Guggenheim Partners — Analyst

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

Scott Koenig — President and Chief Executive Officer

Thanks for the question, Charles. So, as you know, there’s been some recent update at the ESMO meeting with regard to PSMA4. And clearly, we would like to see the results of the Tamarack 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 control population.

These may include multiple choices by the investigator. But at this point, until we finish completion of the current Tamarack 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 than are currently offered to them.

Charles Zhu — Guggenheim Partners — Analyst

Got it. Great. Thanks for that. Maybe one quick follow-up on the vobra duo with lorigerlimab 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 or would you need to demonstrate this data for each given individual histology? Thank you.

Scott Koenig — President and Chief Executive Officer

Well, as you know, Charles, thanks for that question, we have now a significant data of individual treatment arms for vobra duo and lorigerlimab 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 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 one to two other tumor types, in addition to prostate cancer.

But at this time, we’re not ready to describe the ones we have selected.

Charles Zhu — Guggenheim Partners — Analyst

Got it. Great. Thanks for taking the questions.

Operator

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

Kaveri Pohlman — BTIG — Analyst

Hey. Good evening. Congrats on the progress. So, I guess my question is similar to the previous question that was asked for vobra.

If you can just tell us how you are thinking about its development after readouts from Tamarack 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?

Scott Koenig — President and Chief Executive Officer

So, thanks for that question, Kaveri. I — you know, 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 be in a great position to select the dose for a control study, a phase 3 study with one of those two doses.

But at this point, you know, as I described previously, we’re not in a position to describe the control arm. But I imagine it’ll look similar to what we had previously described in the phase 2/3 original design last year.

Kaveri Pohlman — BTIG — Analyst

Got it. That’s helpful. And for lorigerlimab and docetaxel combination trial for chemo-naive patients, how are you thinking about competition from radiopharmaceuticals? Are you allowing enrollment of patients who have gone through these trial like PSMA4 or Eclipse regimen and can bone marrow and kidney toxicities from these drugs provide a big market opportunity? And maybe a follow-up on that, do you think the prior use of atezo, if approved based on Contact-02 trial, could impact lorigerlimab efficacy?

Scott Koenig — President and Chief Executive Officer

So, lots of questions there. Opportunities for patients who had been exposed to radiopharm is possible in the study of the lorigerlimab-docetaxel. As you know, this is a randomized study, 2-to-1, 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 Pluvicto in the earlier-line therapy. 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 Pluvicto. And certainly, there will be challenges for patients who have a 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?

Kaveri Pohlman — BTIG — Analyst

Yes. If you think that atezo, if it gets approved based on the Contact-02 trial, do you think it could impact lorigerlimab efficacy?

Scott Koenig — President and Chief Executive Officer

I don’t think that that’s going to be a [Audio gap]

Operator

One moment.

Scott Koenig — President and Chief Executive Officer

That the activity of lorigerlimab based on the data we’ve reported to date should have a superior outcome in various prostate settings.

Operator

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

Etzer Darout — BMO Capital Markets — Analyst

Great. Thanks for taking the question. Just a couple of quick ones. So, the first one, just was curious, Scott, how much overlap — trial side overlap you have between Tamarack and sort of the Lorikeet trial? And could we sort of see, you know, maybe a similar sort of trajectory in terms of enrollment for that study if sites are sort of similar between those two studies? And then for the vobra-lori duo — for the combination, 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.

Scott Koenig — President and Chief Executive Officer

OK. Etzer, 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 Lorikeet to have a good enrollment in late this year and into ’24. But clearly, still [Audio gap]

Operator

Are you still there, Scott?

Etzer Darout — BMO Capital Markets — Analyst

Yeah. Etzer is here. Still here.

Scott Koenig — President and Chief Executive Officer

Yeah. I’m here.

Operator

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

Scott Koenig — President and Chief Executive Officer

OK. I didn’t hear the second question with [Audio gap] for the trial.

Etzer Darout — BMO Capital Markets — Analyst

Can I ask the second question or —

Scott Koenig — President and Chief Executive Officer

Yes, please. Please.

Etzer Darout — BMO Capital Markets — Analyst

Yeah. Sorry. Yeah. So, just was curious to sort of where you were with sort of the vobra-lori dose 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? Ladies and gentlemen, please stand by.

Scott Koenig — President and Chief Executive Officer

Hello.

Operator

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

Scott Koenig — President and Chief Executive Officer

OK. I switched computers.

Operator

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

Scott Koenig — President and Chief Executive Officer

OK. OK.

Etzer Darout — BMO Capital Markets — Analyst

Should I ask the question again? I’m not sure if you heard me.

Scott Koenig — President and Chief Executive Officer

Please. No, I didn’t hear.

Etzer Darout — BMO Capital Markets — Analyst

Yeah. No, just curious to see sort of where you were with the dose escalation of the lori-vobra combination.

Scott Koenig — President and Chief Executive Officer

OK.

Etzer Darout — BMO Capital Markets — Analyst

And what sort of triggers here the expansion start in 2024. If you can just maybe provide a little bit more color on where you are with the escalation.

Scott Koenig — President and Chief Executive Officer

Yeah. 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 we’d move into the expansion in early 2024.

Etzer Darout — BMO Capital Markets — Analyst

Got it. Thank you.

Operator

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

Jon Miller — Evercore ISI — Analyst

Hey, guys. Thanks so much for taking my question and congrats on all the progress. I guess one on Lorikeet. 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 data set here in an expansion setting in first half ’24 or is this taking the place of that? And then secondly, on the 024 program, are Gilead opt-ins — I mean, I know they’re at unspecified 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 it possible that they have opt-in rights before even phase 1 data is available?

Scott Koenig — President and Chief Executive Officer

So, let me start with a second one. They can opt in any time during phase 1. 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 Lorikeet and the expansion study, that study is complete but for the fact that several of the patients, three of the patients are still on lorigerlimab.

This is now coming on almost two years from enrollment. And that’s encouraged by the activity and the ability to retrieve patients over long periods of time. With regard to the Lorikeet phase 2, the plan is to, you know, complete that study, make decisions not only for the chemo-naive population but also look at the opportunity of Lorikeet in other prostate settings. And [Technical difficulty] described 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 lorigerlimab.

Jon Miller — Evercore ISI — Analyst

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

Scott Koenig — President and Chief Executive Officer

Well — but, you know, from the prostate study that, you know, we presented that, as you know, last February, there is — for that particular cohort, there — you know, just the longevity of the prostate. With regard to the nonprostate indications, what we have said is that once we have decided to move forward with other indications, they may provide opportunities to present the dating for which we base the decision to move forward.

Jon Miller — Evercore ISI — Analyst

OK. Thanks so much. And maybe one on the deeper pipeline then. You mentioned the topo payload on 026, but you previously talked about multiple payloads and linkers.

So, how diverse are those next couple of molecules that you mentioned coming just behind 026? Are they also representative of that multiple payloads, multiple linkers programs that you’ve got?

Scott Koenig — President and Chief Executive Officer

So, I’ll continue to look at the options. This will be in terms of the linker payload and because the way the Synaffix [Technical difficulty] bio spacer and toxin is set up, we can select one of several. What we’ve said in this first one is that topoisomerase inhibitor. The second one will be a topoisomerase inhibitor.

We’re evaluating not only topoisomerase inhibitor, but other toxins associated with other targets going forward, but are not in a position yet to discuss either the targets or the particular payload that we’ll use for the number 3, 4, and beyond.

Jon Miller — Evercore ISI — Analyst

Thanks so much, guys.

Operator

One moment for our next question. Our next question comes from Peter Lawson with Barclays. Your line is open.

Peter Lawson — Barclays — Analyst

Great. Thanks, Scott. Thanks for taking the questions. Just on Tamarack, just why did that enroll faster than expected and how much data should we expect to see from that in the first half of next year?

Scott Koenig — President and Chief Executive Officer

Well, I have to say that we’re thrilled [Technical difficulty] in the U.S. and in Asia. We saw great enthusiasm from the investigators for the patients on the study. I can’t give you a little bit — any more color than they have [Technical difficulty] in the opportunity here with vobra duo in helping their patients, and the rationale why we’re doing that was — resonated very well with the investigators, as well as the patients.

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

Peter Lawson — Barclays — Analyst

OK. And then on ADAM9, any details why that readout was nudged back from second half of this year to ’24?

Scott Koenig — President and Chief Executive Officer

As the study is completing — is being completed out, finalizing, and we’ll — as ImmunoGen said, they will report out in the beginning part of 2024. 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 patients that are in the non-small cell lung cohort currently and will report on that in the first part of the year and with regard to next steps to that program.

Peter Lawson — Barclays — Analyst

Great. OK. Thank you so much.

Operator

One moment for our next question. Our next question comes from Silvan Tuerkcan with JMP Securities. Your line is open.

Silvan Tuerkcan — JMP Securities — Analyst

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 ESMO and SITC on B7-H3 as a checkpoint? The [Inaudible] presentation also, what we can learn from the Daiichi-Merck partnership? And then a second question is what is your role in the Heat study on eno? 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.

Scott Koenig — President and Chief Executive Officer

So, with regard to [Technical difficulty] and ESMO, first of all, as you commented on the partnership now with Daiichi-Merck includes 7300 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 7300 — with being a very important part of the three-target deal. It only heightens, I think, the value we see for vobra duo and our whole B7-H3 program. With regard to the [Technical difficulty] that Daiichi presented in their poster session, if you recall, there was not more in terms of improved activity in the prostate cohort that they tested.

They were seeing about five months of rPFS first reported about a year of overall survival and a 25% PSA SITC response, the latter of which is not any different than previously reported. So, we feel, again, very good about where vobra duo sits right now. Having this additional data that will come out in early ’24 on the Tamarack study to be able to move forward with a very active drug with a 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 [Technical difficulty] and had a lot [Inaudible] with discussions with them on where the value we see for enoblituzumab in settings like a neoadjuvant use of this drug.

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, 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 ennobling another B7-H3 molecule in the treatment [Technical difficulty]

Silvan Tuerkcan — JMP Securities — Analyst

Thank you.

Operator

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

Unknown speaker

Hi, guys. This is [Inaudible] on for Jonathan. Thank you for taking our questions. So, congrats on the Tamarack 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 vobra duo in this setting?

Scott Koenig — President and Chief Executive Officer

Well, I mean, as we’ve indicated that we were looking to achieve a similar range of activity that we had previously, where we were seeing about half the patients achieving PSA 50. I’ve said that we would look for a 40% to 60% range on PSA 50. Obviously, looking hopefully for some of these patients to have PSA 90. With regard to the objective responses here, again, what we have reported and what I just described for Daiichi was approximately a quarter of those patients have objective responses [Technical difficulty] with even higher levels, and we think that there is an opportunity there given [Technical difficulty] has improved these patients will say 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 Pluvicto, on [Technical difficulty] etc. Again, as I just reported to you with rPFS from the [Technical difficulty] in the range of five months, we obviously would be looking hopefully for longer rPFS in the six months or greater. So, I would say those are sort of, you know, 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.

Unknown speaker

Got it. That’s super helpful. Thank you. And then recently, there was data presented for a PSMA ADC and also a STIP1 T-cell engager like phase 1 data in prostate cancer.

Just curious your thoughts in the competitive landscape and how you see your assets positioned.

Scott Koenig — President and Chief Executive Officer

Well, I think, actually, we’re in wonderful shape [Technical difficulty] opportunities for patients. For PSMA ADCs, if you look at the data that has been presented at various meetings, the actual express patterns of PSMA and B7-H3 are not identical. They overlap in some tumors, but there are clearly select parts of the tumors which will express one or the other. As I pointed out previously, as patients progress to later line, PSMA tends to drop significantly, whereas B7-H3 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 for [Technical difficulty] versus an ADC for PSMA, PSMA is going to be largely limited to prostate cancer. Where with a broad expression of B7-H3 across most solid tumors, I think that we are in a 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 has been overwhelming in that regard.

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 eliminate prostate cancer.

Unknown speaker

Thank you.

Operator

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

Ashiq Mubarack — Citi — Analyst

Hi, guys. This is Ashiq Mubarack on for Yigal. Thanks for taking my questions and congrats on all the progress. Just a couple of quick ones.

Will there be an interim look in Lorikeet? 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 between the arms. Thanks.

Scott Koenig — President and Chief Executive Officer

So, there is a plan [Technical difficulty] Lorikeet. They will likely be a futility analysis. We have not provided the statistics around that — I mean, of that. I should point out that historical data in multiple control trials in chemo-naive population has shown rPFS is around eight months.

So, we’re looking, obviously, to be able to beat that milestone in our end mark.

Ashiq Mubarack — Citi — Analyst

OK. Got it. And then maybe one on MGD024. 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 in a phase 1 dose escalation set of domain that we move on to expansion of phase 2.

Thanks.

Scott Koenig — President and Chief Executive Officer

So, as you know, this is a study, as we’ve pointed out, that has [Technical difficulty] with Gilead, so I can’t speak for them in terms of what their bar for the study. As we described historically in late-line patients with the [Technical difficulty] the precursor of this molecule, we were seeing at that time in the primary induction failure population north of 20% response rates [Technical difficulty] Clearly, we would like to see higher rates. As now, we think that we have both a super [Technical difficulty] on the reduced CRS profile and as well as the ability to give this dose — dosing on an interim — intermittent basis on — and rather than infusion. With regard to the specific tolerance for safety profiles, clearly, the absence or markedly reduced low-grade CRS and limiting it to intentionally initial dosing and not later dosing would be, I think, a favorable profile that would allow the use both in early line and late-line patients.

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

Ashiq Mubarack — Citi — Analyst

OK. 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 vobra duo.

And if so, maybe when you entertain partnership, would that be more around the phase 3, or is that something you’d rather do sooner rather than later? Thanks.

Scott Koenig — President and Chief Executive Officer

So, the answer is we’ve had very encouraging discussions historically about vobra duo with many large companies, both pharma and biotech companies. What we have described to them is our interest in getting additional data in the Tamarack study before we would engage in further discussions on potential partnerships. Back to the point I was making earlier, because of the [Technical difficulty] here for vobra duo to treat many, many different tumors, that is something we as MacroGenics [Technical difficulty] ourselves. And so, at the appropriate time, I would envision if development continues favorably and indicating members are receiving with [Technical difficulty] that could end in a partnership, which would both expand the opportunity not only in prostate cancer but in other tumor types as well with a partner who has the resources and capabilities to support it along with us.

Ashiq Mubarack — Citi — Analyst

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.

Steve Willey — Stifel Financial Corp. — Analyst

Yeah. 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 any time 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? And I guess, how far out on the risk curve are you willing to step considering you are tethering novel linker and payload to these things? And I guess, when you declare the target for the first candidate in the first half of next year, is this something that we should expect to fall 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.

Scott Koenig — President and Chief Executive Officer

Thanks, Steve. And we put a lot in the selection of both the targets, as well as the linker payloads. Clearly, there is lots of competition. And therefore, we want to be thoughtful in the selection of both.

We feel that [Technical difficulty] given what Synaffix has already shown with regard to what we believe is superiority to the other platform, the ability of using a DRI, in this case, close to four [Technical difficulty] in various configurations, and our own in 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 [Technical difficulty] that are validated to some degree, but not necessarily have any approved product market where we can be very competitive. There’s opportunities for, clearly, novel targets that no one else is pursuing, and in some cases where there are some scanty data and were not have been pursued but have been disappointing, which could be described due to the design of the particular molecules that have been tested. So, I think, over the course of the next six months, you will certainly see the first looks at some of these targets in presentations at scientific meetings.

And then later in ’24 and going out in ’25, we’ll be adding on more of these targets. And I think that the pace we are at right now is quite favorable where, you know, 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 pipe, but also given the importance of bringing in nondilutive capital, the opportunity for partnerships there. I should also point out that because Synaffix also has partnerships with other companies, they’re going to be using their linker toxins.

So, having that validation early — later this year or ’24 from other molecules, as well as our own, will give a lot more encouragement for the value of the platform.

Steve Willey — Stifel Financial Corp. — Analyst

Great. Thanks for taking the question.

Operator

[Operator instructions] And I’m not showing any further question at this time. I’ll turn the call back over to Scott for any closing remarks.

Scott Koenig — President and Chief Executive Officer

Well, thank you, operator, and thank you all for joining us today. We look forward to providing updates in 2024, both on our clinical and preclinical trials. We hope you have a good day.

Operator

[Operator signoff]

Duration: 0 minutes

Call participants:

Jim Karrels — Senior Vice President, Chief Financial Officer

Scott Koenig — President and Chief Executive Officer

Charles Zhu — Guggenheim Partners — Analyst

Kaveri Pohlman — BTIG — Analyst

Etzer Darout — BMO Capital Markets — Analyst

Jon Miller — Evercore ISI — Analyst

Peter Lawson — Barclays — Analyst

Silvan Tuerkcan — JMP Securities — Analyst

Unknown speaker

Ashiq Mubarack — Citi — Analyst

Steve Willey — Stifel Financial Corp. — Analyst

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