Good afternoon. We will begin the MacroGenics 2023 third quarter corporate progress and financial results conference call in just a moment. All participants are on 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.
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 announcements, 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 2 hours after the call is completed. I would 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. Now I'd like to turn the call over to Dr. Scott Koenig, President and CEO of MacroGenics.
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. Before I do so, let me first turn the call back to Jim, who will review our financial results.
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 subsequently received milestone, 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 II TAMARACK study, the phase II 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.
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 for our business development efforts as well as milestone achievements, we have received $335 million of non-dilutive capital. This includes $215 million from Provention, DRI, Sanofi in connection with TZIELD, $75 million from Gilead, and $45 million from Incyte in connection with ZYNYZ. vobramitamab duocarmazine, vobra duo, is our ADC designed to deliver a DNA alkylating duocarmazine 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 the TAMARACK phase II study 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 agent. This study is being conducted to vobra duo in patients across two experimental arms of either 2 mg per kg or 2.7 mg per kg every four weeks. We anticipate having data from this study to share with you in the first half of 2024.
Next, I'll update you on lorigerlimab, our bispecific tetravalent PD-1 x CTLA-4 DART molecule. We designed lorigerlimab to have preferential blockade on dual PD-1 x CTLA-4 expressing cells, such as tumor-infiltrating lymphocytes or TILs, which are most abundant in the tumor microenvironment. We recently began enrolling the LORIKEET study, a randomized phase II clinical trial of lorigerlimab in combination with docetaxel versus docetaxel alone in second-line chemotherapy-naïve mCRPC patients. 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 I/II dose-escalation study 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×CD3 DART molecule that incorporates a CD3 component designed to minimize cytokine release syndrome while maintaining antitumor cytolytic activity and permitting intermittent dosing through a longer half-life. Our phase I dose-escalation study of MGD024 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 MGD024 at predefined decision points during the phase I 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 II investigator-sponsored study of enoblituzumab in men with prostate cancer prompted our academic collaborators to initiate an investigator-sponsored, randomized, translational 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. Behind these two ADCs, we are exploring additional molecules for potential future IND submissions. 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?
Thank you, ladies and gentlemen. If you have a question or a comment at this time, please press star one, one on your telephone. If your question has been answered, and you wish to move yourself from the queue, please press star one, one again. We'll pause for a moment while we get our Q&A queue in order. One moment. Our first question comes from Charles Zhu with Guggenheim Securities. Your line is open.
Oh, hey, good. Good evening, guys, and, thanks for taking the question, and, congrats on all the progress. Perhaps my, my first one here, how are you guys thinking about, potential longer-term re-registrational development, vobra duo 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.
Thanks for the question, Charles. As you know, there's been some recent updates at the ESMO meeting with regard to PSMAfore. 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 that are currently offered to them.
Got it. Great. Thanks for that. Maybe one quick follow-up on vobra duo with the 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.
Well, as you know, Charles, thanks for that question. We have now a significant data of individual treatment arms 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.
Got it. Great. Thanks for taking the questions.
One moment for our next question. Our next question comes from Kaveri Pohlman with BTIG. Your line is open.
Hey, good evening. Congrats on the progress. So I guess my question is similar to the previous question that was asked. For Vobro, 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?
So, thanks for that question, Kaveri. 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 mg 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 a dose for a controlled study, a phase III 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 II/III original design last year.
Got it. That's helpful. And for lorigerlimab and docetaxel combination trial for chemo-naive patients, how are you thinking about the competition from radiopharmaceuticals? Are you allowing enrollment of patients who have gone through the trial, like PSMAfore 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 atezolizumab, if approved based on CONTACT-02 trial, could impact lorigerlimab's efficacy?
So, lots of questions there. Opportunities for patients who have been exposed to radiopharm is possible in this 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 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?
Yes. If you think that atezolizumab, if it gets approved based on the CONTACT-02 trial, do you think it could impact lorigerlimab's efficacy?
I don't think that that's going to be a
One moment.
That the activity of lorigerlimab, based on the data we report to date, should have a superior outcome in various prostate settings.
One moment for our next question. Our next question comes from Etzer Darout with BMO Capital Markets. Your line is open.
Great, thanks for taking the question. Just a couple of quick ones. So the first one, just was curious, Scott, how much overlap or a trial site overlap do 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.
Okay, 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 2024. But clearly, still-
Are you still there, Scott?
Yeah. Etzer's here. I don't know if Scott's still there.
Hey, I'm here.
Scott, you faded out. Would you mind answering that again?
Okay. I didn't hear the second question with regard for the trial.
Can I ask the second question or?
Yes, please. Please.
Yeah, sorry. Yeah. So just was curious to sort of where you were with sort of the vobramitamab duocarmazine lorigerlimab dose escalation and sort of the pushes and pull here for the start of the expansion trial in 2024.
One moment. Please stand by. Are you back, Scott? And ladies and gentlemen, please stand by.
Hello?
You're back now, Scott. We can hear you.
Okay. I switched computers.
Yeah, we can hear you. Yeah, we can hear you.
Okay. Okay.
Should I, should I ask the question again? I'm not sure if you heard me-
Please.
Heard me this-
Please. No, I didn't hear the... I didn't hear.
Yeah. No, just curious to see sort of where you were with the dose escalation of the lorigerlimab vobramitamab duocarmazine combination.
Okay.
Sort of, 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.
Yeah, we're pretty close to selecting the doses now. We're fine-tuning on the individual doses. We expect that to occur by the end of the year and then would move into the expansion in early 2024.
Got it. Thank you.
One moment for our next question. Our next question comes from Jon Miller with Evercore. Your line is open.
Hey, guys. Thanks so much for taking my question, and congrats on all the progress. I guess one on lorigerlimab. This is a randomized phase II here, but you previously got into a phase II expansion after the ongoing phase I. Are we still expecting to see a meaningful mCRPC data set here in an expansion setting in 1H 2024, or is this taking the place of that? And then, secondly, on the MGD024 program, are Gilead opt-ins—I mean, I know they're at unspecified points in phase I, but are we gonna see public-facing data from that phase I before Gilead has opt-in rights? Or is it possible they have opt-in rights before even phase I data is available?
So let me start with the second one. They can opt in any time during phase I, so again, they will control the data with regard to public presentation. But they can have to do it before the data phase I 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 study are being encouraged by the activity and the ability to retreat patients over long periods of time.
With regard to the LORIKEET phase II, the plan is to, you know, complete that study and make decisions not only for the chemo-naive population but also look at the opportunity of LORIKEET in other prostate settings. And what we will describe 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.
Great. Thanks for all the color there, Scott, but maybe I missed it. Are we still expecting a lorigerlimab expansion update, an actual data set, coming first half next year?
Well, you know, from the prostate study that, you know, we presented that, as you know, last February. There is, for that particular cohort, there's, you know, 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 base the decision to move forward.
Okay, thanks so much. And maybe one on the deeper pipeline then. You mentioned a topo payload on MGC026, but you previously talked about multiple payloads and linkers. So how diverse are those next couple of molecules that you mentioned coming just behind MGC026? Are they also representative of that multiple payloads, multiple linkers, programs that you've got?
Typically, and I'll continue to look at the options. This will be in terms of the linker payload, and because the way the Synaffix spacer and toxin is set up, we can select one of several. What we've said, the first one is a topoisomerase inhibitor. The second one will be a topoisomerase inhibitor. We're evaluating not only a 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 three, four, and beyond.
Thanks so much, guys. One moment before our next question. Our next question comes from Peter Lawson with Barclays. Your line is open.
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?
Well, I have to say that we're thrilled in Europe, the U.S., and in Asia. We saw great enthusiasm from the investigators, the patients on the study. I can't give you a little bit any more color than they have in the opportunity here vobra duo in helping their patients. And the rationale why we're doing that resonated very well with the investigators as well as the patients. The study was originally as 100 patients, 50 in each arm. We've actually exceeded that. It is an overall study. So we expect a fairly sizable amount of data to come out in 2024.
Got you. Okay, and then on ADAM9, any details why that readout was nudged back from second half of this year to 2024?
The study is completing, is being completed out, finalizing, and will, as ImmunoGen has 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 on the non-small cell lung cohort currently, and we'll report on that in the first part of the year and with regard to next steps for that program.
Great. Okay, thank you so much.
One moment before our next question. Our next question comes from Silvan Türkcan with JMP Securities. Your line is open.
Hi, good evening, comment 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 you know, checkpoint, there's been more and more presentation, also what we can learn from the Daiichi Merck partnership? And then a second question is: What is your role in the, 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.
So with regard to the data, first of all, as you commented on the partnership now with Daiichi, 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 the 7300, with being a very important part of the, the three-target deal, it only heightens, I think, the value we see vobra duo and our whole B7-H3 program. With regard to the data that, Daiichi, presented in their poster session, if you recall, it was not more in terms of, improved activity in the, in the prostate cohort, that they tested.
They were seeing about 5 months of rPFS first reported about 1 year of overall and a 25% PSA50 response, the latter of which is not any different than previously reported. So we feel again very good about vobra duo sits right now, having this additional data that will come out in 2024 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 have always had a very close relationship with—w e had a lot of confidence 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 of providing the data, but we have constant conversations back and forth with regarding the opportunity for enoblituzumab and other B7-H3 molecules in the treatment of prostate cancer.
Thank you.
One moment for our next question. Our next question comes from Jonathan Chang with Leerink Partners. Your line is open.
Hi, guys. This is Faisal Khurshid for Jonathan Chang. Thanks for taking our question. 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 for vobra duo in this setting?
Well, I mean, I indicated that we were looking to achieve a similar range of activity as we had previously, where we were seeing about half the patients achieving PSA50. I'd said we would look for a 40%-60% range on PSA50, obviously looking hopefully to some of these patients at PSA90. 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 with obviously even higher levels, and we think that there is an opportunity there, given as quality has improved, these patients will 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 PLUVICTO, on cabazitaxel, CARD, et cetera. Again, as I just reported to you, with rPFS from the 7300 in the range of five months, we obviously would be looking hopefully for longer rPFS in, you know, in the six months or 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.
Got it. That's super helpful. Thank you. And then, you know, recently there was data presented for a PSMA ADC and also a T cell engager, like phase I data in prostate cancer. Just curious your thoughts on the competitive landscape and how you see your assets positioned?
Well, I think actually we're in wonderful shape, your opportunities for patients. For PSMA, ADCs, if you look at the data that is been presented at various meetings, the actual express patterns of PSMA and B7-H3 are not identical. They overlap some tumors, but there are clearly select parts of the tumors which will express one or the other. As I pointed it out, as patients progress to later line, PSMA tends to drop significantly, whereas are maintained. So we think that it provides greater opportunity and choices for treating particularly aged patients.
But most importantly, with regard to this particular program, having an ADC versus an ADC for PSMA, PSMA is gonna be largely 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, 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 be limited to prostate cancer.
Thank you.
One moment for our next question. Our next question comes from Yigal Nochomovitz with Citi. Your line is open.
Hi, guys. This is Ashiq Mubarack on Citi. 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 and PFS between the arms. Thanks.
So, there is a plan looking at LORIKEET. There 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 the chemo-naive population has shown our PFS is around 8 months, so we're working on to be able to beat that milestone and that landmark.
Okay, got it. And then maybe one on MGD024. I guess, can you remind us what you view as an acceptable CRS profile for, for this program? And then maybe on the efficacy side, what you would see as a worthwhile complete response rate in a phase I dose escalation study to maybe move on to, expansion in phase II. Thanks.
Well, as you know, this is a study, as we pointed out, that has— is associated with Gilead, so I can't speak to them in terms of what their bar for this study. Yeah, we described historically in late line patients with the precursor of this molecule. We were seeing at that time in the primary induction failure population north of 20% response rates for CRS. Clearly, we would like to see higher rates as now we think that we have both a super base on the reduced CRS profile and as well as the ability to give this dosing on a interim intermittent basis on and rather than continuous 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.
Okay, got it. And then, the last one for me, just a very high level. We're just wondering if you've received a lot of inbounds for potential partnerships on with vobra duo , and if so, maybe when you'd entertain partnerships, would that be more on a phase III, or is that something you'd rather do sooner rather than later?
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 opportunity here for vobra duo to treat many, many different tumors, that is something we as MacroGenics by ourselves.
And so at the appropriate time, I would envision, if developments continue to fail typically, and indicate that we're proceeding with, we could entertain 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, the resources and capabilities to support it, along with us.
Got it. Very helpful. Thanks very much.
One moment before our next question. Our next question comes from Stephen Willey with Stifel. Your line is open.
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 a novel anchor and payload to these things? 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 gonna be kind of maybe a little bit more differentiated and unique? Thanks.
Thanks, Steve. 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 the antigen, and also like given what Synaffix has already shown with regard to what we believe is superiority to other platform, the ability of using a DAR of, in this case, close to 4, increase potency of the exatecan 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 targets that are validated to some degree, but not necessarily have any approved product on 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's some scanty data, and where a lot 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 from presentations at scientific meetings, and then later in 2024 and going out in 2025, we'll be adding on more of these targets. 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 pipeline, but also given the importance of bringing in non-dilutive capital, the opportunity for partnerships there. I should also point out that because Synaffix also has partnerships with other companies, there's going to be using their linker toxins.
Having that validation early, later this year 2024, from other molecules as well as our own, will give a lot more encouragement for the value of the platform.
Great. Thanks for taking the question.
Again, ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. 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.
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 programs. I hope you have a good day.
Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.