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spk08: Welcome to the ADC Therapeutics Third Quarter 2021 Financial Results Conference Call. My name is Kevin, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press star then 1 on your touch-tone phone. I will now turn the call over to Amanda Hamilton, Investor Relations Manager. Amanda, you may begin.
spk03: Thank you, operator. This morning we issued a press release announcing our third quarter 2021 financial results and business update. This release is available on the ADCT website at ir.adctherapeutics.com under the press releases section. On today's call, Chris Martin, Chief Executive Officer, Jennifer Herron, Chief Commercial Officer, Joe Camardo, Chief Medical Officer, and Jen Creel, Chief Financial Officer, we'll discuss recent business highlights and review our third quarter 2021 financial results before opening the call for questions. As a reminder, this conference call may contain forward-looking statements. Such statements are subject to risks and uncertainties. For additional information concerning forward-looking statements and factors that could cause actual results to differ materially from those expressed or implied in these statements, we refer you to the section titled Cautionary Statement Regarding Forward-Looking Statements in Exhibit 99.3 of our report on Form 6-K filed with the U.S. Securities and Exchange Commission earlier today. Such statements speak only as of the date of this conference call, and we expressly disclaim any application or undertaking to update these forward-looking statements unless required to do so by applicable law. Today's presentation also includes non-IFRS financial measures. These non-IFRS measures have limitations as financial measures and should be considered in addition to and not in isolation or as a substitute for the information prepared in accordance with IFRS. You should refer to the information contained in the company's third quarter earnings release for definitional information and reconciliations of historical non-IFRS measures to the comparable IFRS financial measures. It is now my pleasure to pass the call over to our CEO, Chris Martin. Chris?
spk07: Thanks, Amanda, and thank you, everyone, for joining us today. I'm very pleased to share an update of our progress during the third quarter. We successfully executed on our key objectives, driving the Zynlonta launch, advancing the R&D pipeline, and achieving several important corporate development goals. We are now approximately six months into the Zynlonta launch, and we are encouraged by what we have accomplished to date, delivering $13.1 million in net sales in our first quarter of the launch. We have generated good momentum behind the launch, driven by the unique product profile, the significant unmet need in third-line plus DLBCL, and the strong execution of our highly experienced team of sales and medical professionals. Jennifer Herron, our Chief Commercial Officer, will share more details on our launch a little later in this call. Buoyed by our first FDA approval, we remain committed to expanding our geographic footprint to provide Zynlanta to as many patients as possible worldwide with relapsed or refractory DLBCL. The EMA validated our marketing authorization application and we received orphan drug designation in Europe. The Overland ADCT joint venture also made tremendous progress with the initiation of the pivotal phase two bridging study in China which is intended to serve as a basis for a regulatory filing in China. In addition to geographic expansion, we are also continuing to evaluate Synlonza in combination with other agents in earlier line opportunities in DLBCL and as a single agent in follicular lymphoma. On the R&D front, we continue to advance our pipeline programs, which are important for driving long-term value for the company. We initiated the Phase 1 study for ADCT901 targeting CAC1 and entered into a collaboration with the NCI for the development of ADCT701 targeting DLK1. For CAMI, we continue to advance the Phase 2 trial in relapsed refractory Hodgkin lymphoma and the Phase 1B study in solid tumors. Joe Camardo, our chief medical officer, will elaborate on our key programs in a few moments. Finally, during the quarter, we extended our cash runway by entering into a financing agreement with healthcare royalty partners for up to $325 million for the continued development of the commercialization of Zynlonta and Cami. I would now like to turn the call over to Jennifer to provide some insights on our progress with the Zynlonta launch. Jennifer.
spk11: Thank you, Chris, and good morning, everyone. I'm happy to be here today to share an update on the U.S. Zinlanta launch. We are pleased to report Zinlanta net sales in the third quarter of $13.1 million, representing our first full quarter of Zinlanta sales. This early launch performance has been driven by Zinlanta's differentiated product profile, the significant unmet medical need in third-line plus DLBCL, and the strong execution of our seasoned cross-functional team of sales, marketing, market access, and medical affairs professionals. In terms of additional insight into our launch dynamics, our commercial team has made good progress initiating new accounts and driving increased volume from existing accounts, including our prioritized key accounts and NCCN NCI centers. Despite continuing COVID-related challenges, our targeted launch efforts have resulted in significant increases in brand awareness, perception, and intent to prescribe, and we are also competing well in terms of share of voice. The differentiated Zinlanta product profile continues to resonate with both academic and community-based physicians. During the third quarter, not surprisingly, academic center support resulted in greater than 50% of Q3 total volume, with an equal proportion of ordering accounts coming from academia and the community. Recently, we have seen increasing volume from the community, as expected, as payer access and reimbursement turnaround become more reliable. In terms of patient access, we are very pleased with our progress. Our payer and medical teams have achieved broad access for patients with no barriers encountered thus far, and we expect a permanent J-code in January of 2022 to accelerate local community reimbursement, trial, and adoptions. Anecdotally, we hear that the patient experience in the real world is similar to the LOTUS2 trial experience, which supports the broad use of Zynlanta across the third line plus DLBCL patient population. While our initial use has been predominantly in the fourth line patient population, Zynlanta has also been used in the third line setting, including patients who may go on to CAR T after Zynlanta. Recall that in the LOTUS2 trial, 16 patients received CD19-directed CAR-T therapy after treatment with Zinlanta with an investigator-assessed ORR of 44%. The differentiated product profile, which is a unique combination of robust single-agent efficacy with a median time to response of 41 days, a generally manageable side effect profile, and convenient 30-minute infusion every 21 days, makes Zinlanta an incredibly competitive agent in the Third Line Plus setting and why we believe that Zinlanta has the potential to be the Third Line Plus standard of care. As for the launch outlook for the rest of the year, we will be proactively monitoring the impacts of COVID, the opportunities for face-to-face visits, and the variability around patient scheduling with the upcoming holiday season. Specifically, regarding operating in the COVID environment, The cross-functional team, including marketing, sales, market access, and medical affairs have been navigating the hybrid launch with the agility to engage both virtually or in person, depending on geographic guidelines and physician preferences. While institutions and other face-to-face opportunities have not opened up as quickly as we had hoped, our face-to-face engagement has been stable over the last few months at about half of all of our interactions. In summary, We are encouraged by the HCP reception to Zinlanta's differentiated product profile, resulting in positive launch momentum generated to date, while recognizing the incredibly dynamic environment. We acknowledge the uncertainties associated with the evolution of the pandemic, but believe there remains an opportunity to unlock the full potential of Zinlanta as a standard of care in its label indication. And our team is focused on bringing Zinlanta to any patient who may benefit from treatment. We look forward to keeping you updated on our launch progress. Now I'll turn the call over to Joe to provide an update on our pipeline. Joe?
spk09: Thank you, Jennifer. I am very pleased to be able to talk to you today about how ADC Therapeutics is working to move Zynlanta beyond our first indication with studies in combination with other agents in earlier lines of treatment and in different subtypes of non-Hodgkin's lymphoma. Starting with the LOTUS-3 trial, we are evaluating Xenlanta in combination with Ibrutinib for relapse for refractory diffuse large B-cell or mantle cell lymphoma. We are initiating a phase two program with a higher dose and more frequent administration of Xenlanta to determine the complete response rate and durability of response, as well as the tolerability of this combination for potential use in earlier lines of treatment. Our ongoing confirmatory phase three Lotus 5 clinical trial of Xenlanta in combination with Rituximab is intended to support a supplemental BLA filing as a second-line therapy for relapsed or refractory DLBCL patients who are not eligible for stem cell transplant. This trial continues to enroll patients, and we expect to complete enrollment of the safety lead-in of this trial by the end of this year. The Phase II Lotus VI trial in relapsed or refractory follicular lymphoma is ongoing, and our published data from the Phase I study showed that 11 of 14 patients had a response to Zynlanta, including nine patients who showed a complete response. The median duration of response was not reached in that phase one trial. In addition to these trials, we aim to initiate several additional Zynlanta trials by the end of the year, including a study of Zynlanta that evaluates four different combinations in separate arms, and a dose-finding study of Zynlanta in combination with R-CHOP in previously untreated DLBCL patients. These trials will explore the expansion of Zynlanta into earlier lines of therapy across B-cell non-Hodgkin lymphomas. And finally, for Zynlanta, we are looking forward to discussing new data to be released at the upcoming ASH conference. Moving to CAMI, we continue to advance both our Hodgkin lymphoma and solid tumor programs. With enrollment in the Phase II trial in Hodgkin lymphoma completed in February 2021, we plan to have preliminary results in the first half of 2022, after which we will share the next steps for a pathway to regulatory submission. We also continue to advance CAMI with our ongoing Phase 1B dose escalation trial in combination with Pembrolizumab in patients with advanced solid tumors. Furthermore, we are supporting our pipeline that leverages our validated ADC platform applied to the treatment of solid tumors. During the third quarter, We dosed the first patient in the Phase 1 study of ADCT901 targeting CAG1, a novel first-in-class candidate for the treatment of patients with advanced solid tumors with high unmet medical need, including platinum-resistant ovarian cancer and triple-negative breast cancer. Another promising pipeline candidate is ADCT601, mipacetamab, zopterine, targeting Axel. Axel is overexpressed in many solid tumors such as lung, breast, prostate, pancreas, glioma, and esophageal cancers. We expect to initiate the Phase 1b combination study in multiple solid tumors in the first half of 2022, and we look forward to sharing more details about this program in the coming months. As Chris mentioned earlier, we entered into a collaboration with the National Cancer Institute to develop ABCT701, targeting DLK1 in neuroendocrine malignancies with high unmet medical need. This includes adrenocortical carcinoma, pheochromocytoma, paraganglioma, neuroblastoma, and small cell lung cancer. And finally, our ADCT602 program targeting CD22 continues to enroll patients in a phase one, two trial for relapsed or refractory acute lymphoblastic leukemia. This is in collaboration with Endy Anderson and City of Hope Medical Centers. We also have a robust R&D pipeline with seven preclinical development programs, and we look forward to keeping you updated on all of these programs. With that, I will turn the call over to Jen to give a financial update.
spk12: Thank you, Joe, and good morning, everyone. As reported in the press release issued earlier today, Zinlanza third quarter net sales were 13.1 million, reflecting the first full quarter of Zinlanza sales. As of September 30th, we had cash and cash equivalents of $530 million, as compared to $372 million as of June 30th of this year. During the third quarter, we used roughly $59 million in cash for operating activities. In August, we entered into a financing agreement with healthcare royalty partners for up to $325 million, including gross proceeds of $225 million received upon closing. R&D expenses were $37 million for the third quarter of 2021, compared to $32 million for the same quarter in 2020. The increase was primarily related to the medical affairs support of the Zenlanta launch and the expansion of the Zenlanta clinical program and our broad portfolio. Selling and marketing expenses were $17 million for the third quarter of 2021, compared to $6 million for the same quarter of 2020. The increase in selling and marketing reflects the expenses for the Zinlanza launch and the ongoing commercial efforts. G&A expenses were $17 million for the third quarter of 2021, compared to $14 million for the same quarter of 2020. The increase was primarily due to increased headcount to support the needs of a commercial stage public company. Net loss was $72 million for the third quarter of 2021, compared to a net loss of $20 million for the same quarter of 2020. Our diluted net loss per share was $0.93 in the third quarter of 2021, compared to a net loss of $0.29 for the same quarter of 2020. Finally, adjusted net loss, a measure that excludes certain items associated with the Deerfield convertible loan, share-based compensation expense, an effective interest expense associated with the royalty financing agreement with healthcare royalty partners was 46 million for the third quarter of 2021, compared to an adjusted net loss of 41 million in the same quarter 2020. The increase in adjusted net loss was primarily driven by the investment in the Zinlanza launch and our clinical programs. The adjusted diluted net loss per share was 59 cents for the quarter, compared to a loss of 58 cents for the same quarter in 2020. With that, I will turn the call back to Chris for closing remarks. Chris?
spk07: Thank you, Jen, Joe, and Jennifer. To conclude, this has been a productive quarter for ADCT. We continue to execute on the Zinlantan launch and to advance our R&D pipeline. Our objectives for the remainder of the year and into 2022 are clear, and we are well positioned to execute on all aspects of the business. We look forward to updating you on the progress of our launch and our advancing pipeline in the coming quarters. I'm pleased to now open the call for questions. Operator.
spk08: Thank you. We will now begin the question and answer session. If you have a question, please press the start and the one key on your touchtone phone. If you wish to be removed from the queue, please press the pound key or the hash key. If you're using a speakerphone, you may need to pick up the handset before pressing any numbers. Once again, if you have a question, please press the start and the one key on your touch-tone phone. Our first question comes from Matthew Harrison with Morgan Stanley.
spk01: Great. Good morning. Thanks for taking the questions. I guess two for me. So one on the launch, I know you've commented on sources of business sort of being 50-50 commercial academic. I was wondering if you've seen any changes quarter over quarter in terms of repeat prescribers or where you're seeing anything around duration or any other items like that. And then secondly, on CAMI, do you need to meet with the regulators again once you see the data in the first half of 22? Or maybe you can just outline exactly what the steps are you're going to need to take. Thanks.
spk07: Thank you, Matthew. Jennifer, do you want to take the first question and Joe the second?
spk11: Sure. Yeah, sounds good, Chris. Thanks. Hey, Matthew. So in terms of what we're seeing in the evolution quarter over quarter, we continue to see, as I mentioned, a greater percentage of our volume coming from academia. I will say over the most recent weeks and months that we're getting increasing use in the community, and we would expect that to continue. So I think from a repeat order perspective, the volume – is still predominantly coming from academia, but we're getting newer and newer accounts coming from the community in the recent weeks. From a duration perspective, you know, six months into launch, I think it's too early to say what we're getting from a duration perspective. I mean, in the third line plus setting, what we're hearing from HCPs is, you know, they're looking for patient by patient. It's a very individualized approach. It really depends on where that patient is in their treatment paradigm. So, It's really hard to extrapolate to a general population. I think it's just too early for that right now.
spk09: Okay. This is Joe. We'll follow a pretty standard procedure here. We're going to finish the study, compile the data, put together a briefing book. request a meeting and explain what we want to do next, which is, you know, the possibilities of a submission for accelerated approval as well as a proposal for a confirmatory study. You know, the FDA has, in the last few years, often answered questions and said they don't need a meeting. I have a feeling in this case we'll have a meeting with them sometime in the latter part of next year, and that's pretty standard.
spk08: Thank you. Our next question comes from Tazina Med with Bank of America.
spk04: Good morning and good afternoon. Thanks for taking my questions. I have a few. The first may be to follow up on Matthew's question about use. So for the increased use in community docs, is it that doctors who've had experience with Zymlanta in the community setting are just prescribing it to more patients, or are you getting more of the growth from new users? And then secondly, as it relates to CAMI, for relapse and refractory HL, can you give us a sense of where you would expect to see GBS observations and whether any observation in your mind could be rate-limiting based on what doctor feedback has been so far? And then I have a couple follow-ups. Thanks.
spk07: Thank you, Christine. Okay, Jennifer, do you want to take the first one and Joe the second?
spk11: Yep.
spk07: Okay.
spk11: Yeah, so thanks community. I think we're seeing a really healthy mix of new orders and repeat orders. You know, we're adding new accounts every week. And we're seeing, you know, good repeat orders from the existing accounts and the addition of new accounts. So I it's not in the community, I'm not seeing a concentration of businesses that was your question.
spk09: Okay, with regard to the question about CAMI, the first thing is, based on the data that we're seeing now, the balance of benefit-risk is favorable. We've had no increase in the incidence of GBS over the trial. We have some activities in place to make sure that that particular site can be mitigated, and keep in mind that We're treating patients who have a median of six prior treatments, including patients who failed what I call modern treatment with Brentuximab and Pembrolizumab, and also patients who have relapsed after stem cell treatment. So there's a very high bar, and we've reached that with the complete response rate in the range of 28%. So, you know, we're positive on the benefit-risk ratio. and we're confident that FDA will see that as long as we're able to provide all the data, which we plan to do next year.
spk04: Okay, but are you expecting to see a significant level of TBS, even with the changes that you've made, just the levels that expect to be?
spk09: We have 7%, 7 cases, 6%, sorry, and I expect that's going to be the number, and we have a lot of patients now, and I think that's going to be the number of GPS cases. Could be a little lower when we go into clinical practice, could be a little bit higher, but, you know, that is the number that we expect to see. And as I mentioned, we've been able to mitigate the more serious cases. So, you know, we think that given the benefit here, which is a complete response rate in the 28% range, patients who have a median of six prior treatments and have repeatedly failed, this is an addressable side effect and that's our, you know, and that we have the data to be able to, you know, to be able to demonstrate that and explain it to physicians.
spk04: Okay. Thank you.
spk09: Okay. You're welcome.
spk04: Lastly, for the CAV1 that you just mentioned moving into the clinic starting a study this year, should we expect to see any data next year? And then as it relates specifically to platinum-resistant ovarian, can you just remind us what the other options are? currently for patients and, you know, what level of efficacy are you looking for? Thank you.
spk09: Yeah, you know, I have a – I'm sorry, I can't hear your question very well. Were you asking about CAG? Yeah. Or about CAG?
spk07: Yeah, we're looking here. Yeah, Joe, the quick – sorry, the question was with CAG1, do we expect to see any data this year? And for ovarian cancer patients, what alternative – therapies are there for this stage of treatment and what level of activity would you expect to see?
spk09: Well, okay, thanks. Thanks, Chris. I didn't hear the – I heard everything except which of our products you wanted to hear about. So, you know, with CAG, we're not going to have any data this year to share. I mean, we just started phase one, and it's proceeding at exactly the right pace, which is, you know, a careful dose escalation in patients with refractory cancers. We, you know, generally, depending on how, you know, how the safety proceeds, we can advance according to our regular schedule. So I'm thinking maybe sometime in the latter part of next year, we could have some data on the safety and develop a plan to proceed. The short answer to your ovarian cancer question is there really aren't any alternatives, which is why CAG is an attractive option here. ovarian cancer continues to be a serious and high refractory illness once it reaches that late stage of relapse. So at this point, there are other novel, maybe not novel, but there are other products in development, but nothing as novel as CAG. And there is this interesting expression of CAG on ovarian tumors, which is why we chose that, but right now the field of options is pretty limited.
spk04: Okay, thank you.
spk07: You're welcome. Kazin, it might just be worth mentioning that we haven't seen any GBS in the solid tumor setting with Kami.
spk04: Yes. Okay. Thank you.
spk08: Our next question comes from Boris Peeker for Cowan.
spk06: Great. My first question is on Zolanta. Can you comment on the data we should expect to see at ASHE?
spk09: Well, I can't be specific about the data you're going to see, Ash, because it's still under embargo, but I will tell you that as commonly done, we will have longer-term follow-up. We will have some subgroup analyses. As you recall, we have patients in our Zinlanda trial that were not eligible for some of the other trials going on at the same time, and so we're going to be reporting it on those kinds of analyses. in addition to some longer follow-up. And we do have other products also available now that have been submitted to the ASH Conference.
spk06: Got it. And also, what is the timing of the data readouts from LOTUS 3 and LOTUS 5 when you anticipate top-line data for those?
spk09: Yeah, I can't really tell you that. We just started the amendment for LOTUS 3. We're likely to have some data from the completed part of Lotus 3 by this time next year. That's about right. How the amendment proceeds will determine when we will have some data, but it will not be probably before 2023. Just when you asked about Lotus 5, we're just at the point where we're finishing the lead-in. we'll start the randomized part of this. We expect that to take 18 to 24 months. And then I just remind you, it's an event driven trial. So predicting when we'll have the events that will determine the, uh, the difference between, um, Xenolab to rituximab and rituximab genox depends on the occurrence of progression. So it's hard to make a prediction, but, um, like I said, I can tell you what the enrollment period is probably going to be 18 to 24 months.
spk06: Great. Thank you very much for taking my question. You're welcome.
spk08: Our next question comes from Brian Chang with Cantor Fitzgerald.
spk10: Hey, Tim. Thanks for taking my call, and congrats on a great quarter. It seems that you're tracking well against the historical sales trajectory for some of the competitive product in DLBCLs. Do you have a sense of where you stand on market share in third-line plus DLBCL? And then I have one more follow-up. Thanks.
spk07: Jennifer.
spk11: Yeah, thanks, Brian. Thanks for the question. Yeah, we are pleased with this quarter's performance. In terms of metrics, as I mentioned in my remarks, we've made some significant increases in awareness and familiarity and intent to prescribe. We're also holding our own in terms of shared voice, so we're happy with that. You know, we are monitoring the market quite closely to make sure that we remain competitive and that we can adapt our hybrid launch plan as the local conditions require. Q4 is looking better in terms of COVID, but again, that could change on a dime as we get into the winter months. One of the things that we are watching carefully is face-to-face interactions because of the importance of engaging nurses, pharmacists, and physicians about the differentiated product profile of Zinlanta. And, of course, this is going to be our first Q4 in terms of any kind of seasonal effects with patient visits. So, you know, we're cautiously optimistic about Q4, and we'll be looking forward to updating you as that quarter wraps.
spk10: Great, Jennifer. Maybe just on your Excel targeted 601 program, can you give us an update on the manufacturing front? And what is your latest thoughts on patient selection and the initial set of indications? And then ahead of the upcoming update from the competitor Axotarda, ADC, and sarcoma at the CTOS meeting later this month, how should we think about the potential read-through from their update to your 601 program? Thank you.
spk07: Ronald, the manufacturing side is the thing. As you know, we're using the Synifex site-specific conjugation in the Axle program. We did the phase one dose escalation study as we normally do using frozen product. And we're now moving to manufacturing lyophilized product. So the manufacturing is well underway. to supply the clinical study that we will start in the first half of next year. I'll hand over to Joe to address the clinical aspects. Joe.
spk09: Okay. Okay, thanks, Chris. Good. Thanks. You won't be surprised to hear that we're also interested in sarcoma. There are a lot of reasons why those of us doing work in Axel find sarcoma to be an attractive target. But we don't have our protocol finalized yet, and we're working out a couple of details with investigators and with FDA to try to determine how we can do better than just selecting a literature-based tumor and try to get the population a little more likely to respond to Axel. So I just don't have the final details to share, but when we have that protocol final, then I'll be able to share some data. That's probably gonna happen in the first half of next year. That's the current plan. And, you know, with regard to the competitor, I mean, I tend to try to learn what we can from our competitors, but, you know, we have a unique PVD toxin, and we think that, you know, we have very high potency here, so we think that, with the expression levels that we're going to be able to determine in the trial, we'll be able to get entry of the toxin into the malignant cells. That's our proposal now. And I think that it really does depend on the potency of the toxin and our ability to help enhance the chances of finding a highly expressed axiled tumor. So there's a couple of details to be filled in, but we're doing it now, and I'll be able to give you more on this in the first half of next year.
spk10: Great. We look forward to that. Thanks for taking my question. Thank you. Thank you.
spk08: Our next question comes from Kelly Shee with Jefferies.
spk02: Thank you for taking my question. Congrats on the great quarter. So on goes to Nat for Zalanta, is it staying around the same at 83% as mentioned in Q2? Are we going to expect some change? And I'll have follow-ups on Kami.
spk12: Hey, Chris, this is Jen. I can jump in there. Jen, Jennifer, confusing. Thanks, Kelly, for the question. So, you know, our gross net details you can see in our 6K we filed this morning. But, you know, the Q3 gross net, the deductions were right around 14%. And that's really right in the general range that we'd expect for an infusion drug in this kind of specific patient population. But it's early days, and we do expect this to fluctuate. We really only have a few months of actuals at this point, and we still have some estimates included in our sales deduction. So we'll continue to monitor this as we move forward and let you know if there's any updates. Thanks for the question. Thank you.
spk02: Thank you. And also for Kami, could you share the possible hypothesis regarding the incidence of GBS tox? Do you think the prior PD-1 antibody treatment has some association with GBS? We have seen some documented cases for PD-1 treatment that trigger GBS in heavily pretreated patients. And also, we will be able to rule out the possibility this will happen to solid tumors based on what you have learned. Thank you.
spk09: Joe, do you want to take that? Sure. It's a very good question. It's, you know, we, first of all, we know that the Hodgkin lymphoma patients have a bit more of a predisposition to Gambre, so that's one thing that we have to keep in our minds when we consider this. You know, and we do know that it's, you know, it has to be related to some kind of enhancement of immune system, but right now it's all speculative for us at this point. We can't find exactly the trigger that that activates the immune system specifically to, you know, against the nervous system. We just don't know that yet. It's not inconsistent with data from the checkpoint inhibitors that the, you know, these kinds of immunoinflammatory side effects can happen. So it, you know, it it's a reasonable hypothesis that the activation of the immune system, that's about as far as we can go. We cannot say anything specific or unique about the CAMI activity. With regard to the shallow tumors, we saw Guillain-Barre pretty early in the program for Hodgkin's lymphoma. And as I mentioned, Hodgkin's lymphoma patients have a predisposition to this. We've done enough patients now in the solid tumor that we're getting a very high level of confidence that this is not something that will happen with the solid tumor patients. And that's just based on comparative observation of when we saw this in Hodgkin's lymphoma and how many patients we have in the solid tumor program. And we're continuing to look into what's actually happening. with this, but it's difficult, and a lot of people are trying to help to work on this as well, even with the checkpoint inhibitors. Thanks for the question.
spk02: Thank you so much for the caller. One last question, if I may, regarding the AXL XO program. So from competitors, some of the programs actually be able to show the correlation between the XO expression and tumor response, but some Not able to. I wonder, would you be able to comment on ADC Therapeutics biomarker study or maybe clinical design? Like what's your expectation on that front?
spk09: Yeah, I can't really give you any commentary on the clinical design because it's not finalized yet. But as you know, once we do finalize this, the protocol will be listed on clintrials.gov. So it's not like you'll never hear about it. You certainly will. But one thing to point out is that, You know, for companies that are pursuing axial overexpression as a way to determine response, they're looking at, you know, how axial is driving the tumor. We're looking at how axial is a door to get our toxin into the cell. That's a little bit different. Now, you know, there may be some activity of our antibody to depress the activity of axial, but what we're really looking at is getting a highly potent toxin into the cell. And so it's not really a very good comparison to look at Axel as a specific target driving the malignant cell as it is to look at Axel as a way of, you know, getting our toxin into the cell. They're totally different mechanisms. And you'll see more data in the future. Okay.
spk02: Okay. That's very helpful. Thank you.
spk08: You're welcome. Our next question comes from Kenneth McCabe with RBC Capital Markets.
spk05: Hi, thanks for taking the question, and congrats on the quarter. Very impressive commercial result there. I have three questions on CAMI here. First, I just wanted to clarify, have you requested or had a pre-BLA meeting with the FDA for CAMI yet? And then second, another question on the etiology of GBS. Have you identified any factors that are associated with risk of recurrence, whether it's treatment history or any biomarkers? And can that GBS-like effect be replicated in animal models? And then lastly, just wanted to see how the CAMI and PEMBRO combo trial in solid tumors was going and when we could expect to see data from that trial. Thanks and congrats again. Okay.
spk09: Good questions. Good questions. First of all, with regard to the FDA request, we have not requested a meeting yet. We agreed with them when we proceeded with our Phase II program that we would wait for the one-year follow-up on data before we compiled the data and request a meeting. The one-year follow-up will be in February of 2022. Then we'll compile the data and request a meeting. The reason for that is the the duration of response was considered to be an important variable. So we don't want to submit data until we have the one year follow up showing, you know, good, good, good duration of response. And just a reminder, we still, um, in the, in the data we've been showing, we still not, um, yet, uh, reach the, um, you know, the median duration of response has still not been reached in these patients. So that's a good thing, but we're going to wait until the one year follow up. The second question, um, To my knowledge, we can't replicate this phenomenon in animals because it's like you have to have a Hodgkin conformal model in animals, and really, maybe with a transplant tumor, I'm just speculating here, we can't really replicate this in an animal model. We can replicate some of the immunoinflammatory activities that happen when you depress the Treg cells, but that's a long way from an actual animal model. of Guillain-Barre syndrome. And so far, it's a great question to ask because we are looking exactly at what you suggest, which is how about, what about the treatment history? Is there a biomarker? And it hasn't yet yielded a specific answer for us, but we're still looking. And a reminder, these are very complicated treatment histories, so it's not a big surprise that you can't sort out something that There's not something obvious, but we're continuing to look. So you're right on target with what kinds of research we have to do to try to mitigate the side effect, given that there's such a promising response rate in these patients. And the third thing, the CAMI program in solid tumors is proceeding very well. That, I think, reflects the high need for new drugs in the solid tumors that we are studying. But I can't tell you exactly when we're going to finish because we're still doing dose escalation. And as you know, you got to do that carefully. So we're making sure that we get the right combination of CAMI with PEMBRO. And then once we expand, we'll be able to, um, to show what we've learned in terms of safety, what dose we've chosen and what kind of responses we're getting. So it's still a little bit uncertain, but proceeding very well in terms of enrollment. Okay. Did I lose everybody?
spk08: Okay. And I'm not showing any further questions at this time. I'd like to turn the call back over to Chris.
spk07: Thank you. Thank you very much, everyone, for joining the call today. We look forward to keeping you updated on our progress. And have a nice day. Bye. Thank you.
spk08: Ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.
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