Tahi Ahmadi: Yeah. Thank you, and you’re absolutely right, right? And there was a subgroup analysis worked on the combined data in the cycle one study that actually looked at the impact of — in those cases, there are tumor treatment on the CD38 expression which actually gets kind of shredded after surface so to speak to the process called cytosis and then the upregulation of complement inhibitory proteins and that’s absolutely correct. And so this is why the study that we’re conducting is actually in CD38 naive patients with the head-to-head comparison against subcu. We have had some signals of efficacy in daratumumab exposed patients. And the dose escalation there were two patients who had a response. But broadly speaking, that’s not where we’re focusing right now because the focus is right now as in the original agreement with Janssen to generate data that allows us and Janssen frankly to elucidate whether the single point mutation that is underlying the hexamerization really has the impact that we have pre-clinically seen and that we believe to be seeing in the clinical data so far.
And then sorry, the second part of the question was about positioning of EPCORE in follicular lymphoma. So yes, to some degree there is already a Phase 3 in combination with Len and the second line and we have talked about that we are actively working with AbbVie on plans on a frontline study. So there will be some news to come in the near future. That is in follicular lymphoma. And then in Diffuse Large B-cell Lymphoma there are multiple data sets attempted to generate data both to show also the impact of epcoritamab in comparison to CAR T, right? And driving on the point that actually this modality that just bispecific antibody the accessibility of it the ease of the administration and the safety of it compared quite favorably to CAR T therapies in the real-world data.
I hope that answered the question.
Jan van de Winkel: Thanks, Tahi. I think that was a good question Kaveri. Thank you very much for the questions.
Kaveri Pohlman: Thank you.
Operator: Thank you. We will now take the next question from the line of Michael Novod from Nordea. Please go ahead.
Michael Novod: Thank you very much. Just a few follow-up questions especially to timing. If we take GEN1042 first, I just need to understand. So I think Judith said some directional guidance also on GEN1042. When do you expect to sort of have more clear data on GEN1042 and also for some of the potentially larger indications. I think we all had expected it would be around ESMO, but is that also sort of then later in 2024? And to HexaBody-CD38, there was a question earlier on relating to the J&J potential opt-in. Timing-wise, is it most realistic that you need to complete the head-to-head which says October 2024 on clinicaltrials.gov? Or could that happen sort of midway in that trial also? Maybe just to clarify. Thank you very much.
Jan van de Winkel: Thanks, Michael for the question. So I will hand over to Judith for 1042 to give you a bit further drilling for the timing when do we have the data in hand, we believe that in some of the tumors we actually have the data in the coming months if not sooner. But Judith can give you a bit further color Michael. Then for HexaBody-CD38 timing of the potential opt-in for J&J, I mean they have the right to wait for all of the data the head-to-head cohorts, Michael, I don’t know whether they need to make a long story short because we think the data is shaping up very nicely as you can see from the expansion cohorts, but it’s up to them. So, it’s very difficult to actually give you an estimate of when J&J would like to obtain because it’s basically in their corner.
But the full had head-to-head data will likely come in the second half of 2024 not before, but there will be a lot of data already by that time in the first half of whether that’s is up to J&J. But maybe I can hand over the 1042 timing question and some of the tumor cohorts to Judith. Judith?
Judith Klimovsky: Yes. Thank you. So, as you know Michael we are collecting data to assess the hypothesis that checkpoint inhibition pembro ads to 142 and this is fiber potentiated by the addition of chemotherapy and the creation of immunogenic cell This is the basic hypothesis that guided us to collect to address in different tumor types. Among them head and neck and non-small cell lung cancer, squamous and non-squamous mainly. This hypothesis is the same. So, the data sets are complementary from one each other. So, the goal is to have a kind of a good number of patients with some level of durability for more than one cohort because this will make the data stronger. So, this is why there is no firm congress to when we are presenting. But I can tell you that enrollment is going very well. So it will be in 2024 depends on when the abstract is close to submission and the data we have in hand to decide the venue. So, I cannot provide you a firm date at this point.
Jan van de Winkel: Thanks Judith.
Michael Novod: Thanks Jan.
Jan van de Winkel: Thanks Michael.
Operator: Thank you. We will now take the last question from the line of Emily Field from Barclays. Please go ahead.
Emily Field: Great. Thank you so much for fitting me in. I will ask a quick financial question. I believe that for OpEx going into 2024 I think consensus is modeling about half growth rate of OpEx for 2023. Obviously, it’s going to be off of a larger base for next year. But maybe Anthony if you have any comments on just how we should think about modeling OpEx going to 2024 before you officially guide for it?
Jan van de Winkel: Thanks Emily for the question. And Anthony will be delighted Anthony Pagano to answer a question on finances. So, Anthony floor is yours.
Anthony Pagano: Yes thanks Emily. Thanks Jan. Yes, you’re right Emily, of course, we’ll at the appropriate time and end of the year to take the time to really contextualize our overall guidance including our investment levels. I can summarize for you now though really what our message has been consistently throughout 2023 about how we should think about our overall OpEx levels moving forward. So, I’ll take the next minute or two to summarize that. As always, given our strong position we’re going to continue to invest in the significant growth opportunities in a focused and disciplined way. It’s something that we do take very, very seriously. As I think about that investment profile moving forward, particularly as it relates to let’s say call it, the transition from 2023 to next year in the mid-term there are three drivers here now particularly as it relates to R&D.
First, EPCORE R&D is still in growth mode, so I fully expect EPCORE investment to go up as we add new Phase 3 trials, over the coming years. And here it’s really important to remember that this is grounded in our conviction of EPCO’s potential to help a large number of people, living with cancer and of course will continue to be data-driven. And here I mean, looking at the clinical data and the landscape, and also resource and sizing our investment, accordingly given this potential very meaningful opportunity. Second, again, still thinking about R&D and this is kind of the swing factor which additional programs will transition to later-stage development. As a reminder, you heard a lot about this today, we’re doing some significant, let’s call it, Phase 2 work for both CD40/41BB and PD-L1/4-1BB during the course of 2023.
