Genmab A/S (GMAB) Earnings Call Transcript & Summary

Good morning, and good afternoon. I'm James Gordon, JPMorgan European Pharma and Biotech analyst. And today, at the JPMorgan Conference, I have the pleasure of introducing the Genmab presentation and Q&A. So Genmab President and CEO, Jan van de Winkel, joining us for a 20-minute presentation, and then we're going to do 20 minutes of Q&A. And so with that said, thanks a lot for joining us today, Jan, and over to you for the presentation.

Thanks, James, for the introduction. It's a pleasure to be with you all again at the Annual JPMorgan Healthcare Conference as we kick off 2022. Slides from today's presentation will be available for download on our website immediately after the event. So let's get started. Next slide, please. I'm now on Slide #2. This presentation may contain forward-looking statements and as such may contain certain risks and uncertainties. Next slide, Slide 3. Throughout our -- over 20-year history now, we have had a laser sharp focus on harnessing the power of human antibodies to develop differentiated cancer therapies. This slide provides a review of what is behind that focus, our core purpose, it's guides our work, our extremely successful strategy and our inspirational vision for the company. Next slide. Genmab has never been in a better position to achieve this ambitious vision of transforming cancer treatments. We have a consistent and solid track record of success and a world-class team that is super experienced, dedicated and motivated to make a difference to patients. One of the results of that drive is our proprietary antibody technologies, it's a fueling of first-in-class and/or best-in-class pipeline. Our expertise makes us a funnel of choice as we have a large variety of partnerships with industry leaders across the innovation ecosystem. Importantly, our work is supported by extremely strong financials that allow us to invest in growth opportunities. Taken together, we have built a solid foundation that has supported our evolution into a fully integrated biotech innovation powerhouse. So let's look at some of the many successes that have propelled this growth. Next slide. I'm now on Slide 5. The 39 INDs created by Genmab over our technologies have led to a robust and expanding clinical pipeline with 5 approved medicines that were created by leveraging our innovations, including TIVDAK, the first Genmab-owned product on the market, which we are codeveloping and co-promoting in the U.S. with Seagen. Royalties from partner-owned medicines plus key partnerships with companies like AbbVie have expanded our revenue significantly. This strong recurring revenue allows us to continue to invest in next-generation technologies and truly differentiated new antibody therapies and in our company where we added commercialization capabilities and are further strengthening our world-class R&D with key talents. These growing internal competencies are enabling us to become an end-to-end biotech with a global presence, led by an experienced and diverse leadership team. Next slide, please. Our successes have been possible because of what makes us unique. At Genmab, we firmly believe in the natural ability of the immune system to fight against disease, use of deep understanding of disease mechanisms, targets and antibody biology to invent our proprietary technologies. This in-house expertise is matched with strategic partnerships that help us take our products further than we could do on our own. And that give us access to high-quality and unique disease targets as well as additional cutting-edge technologies that can be combined with our own. We leverage this combination of cutting-edge scientific capabilities an innovative scientific approach, expertise in translational research and strategic partnerships to create a robust pipeline of investigational medicines. Next slide, I'm now on Slide 7. Here is a summary of our innovative clinical pipeline as it exists today. First, we have the investigational medicines created by Genmab science or technologies, clearly in active clinical development. In green, on top, you see 7 owns by Genmab with at least 50% ownership, including DuoBody-CD3B7H4, which has just entered the clinic this month. Most of these investigational medicines either are or have the potential to be first or best-in-class, including epcoritamab in Phase III development, and tisotumab vedotin approved for certain patients with cervical cancers, among many others. Next slide. Let's turn to the future of our pipeline. Our maturing pipeline is the result of a world-class R&D answer. We are confident that our unique next-generation antibody technology platforms will continue to grow our pipeline because we have already been doing this. In the chart on the right, you can see a comparison of the number of clinical trials running for our proprietary products. In 2019, there were only 12 trials running with our products. We closed 2021 with almost double that number. And as we anticipate further growth, especially in Phase III studies for this year for 2022. Now let's take a deeper look at some of the exciting antibodies in our pipeline. Next slide, please. The improvement of TIVDAK in September 2021 introduces a critically needed treatment option for patients with advanced cervical cancer with disease progression on or after chemotherapy. TIVDAK represents a significant scientific advancement as the first and only approved ADC for treatment in this patient population, as well as the first Genmab-owned therapy to receive regulatory approval. Along with our partner, Seagen, we have a broad development plan for TIVDAK, including earlier lines of therapy for cervical cancer as well as in other solid tumors. And in this context, I'm very pleased to inform you that Phase II data from the innovaTV 207 study is scheduled to be presented in a plenary oral session at the upcoming ASCO, Head and Neck Cancer Symposium in Arizona on February 25. Next slide. Epcoritamab is part of our collaboration with AbbVie and is being studied in diffuse large B-cell lymphoma and follicular lymphoma, the 2 most common types of non-Hodgkin lymphoma. This exciting bispecific antibody has the potential to be used in a broad range of other B-cell malignancies. We believe that the mechanism of effective T-cell redirection against CD20 that we see with epcoritamab has the potential to fundamentally disrupt and transform the treatment paradigm for patients with B-cell malignancies across all lines of therapy. Epcoritamab continues to show data that supports its potential to be best-in-class, as most recently seen at ASH last December. In addition to the excellent data we have seen, epcoritamab is also differentiated by its convenient subcutaneous route of administration, and its off-the-shelf production offers timely treatment and consistency. Next slide, please. This brings me to Slide 11. Together with AbbVie, we have an ambitious passion for the development of epcoritamab. We are working on a broad and comprehensive development program across aggressive and indolent histologies. Building on both its single-agent activity and its combination with current or emerging standard of care therapies in several B-cell malignancies. Also that epcoritamab can realize its full potential, we look forward to initiating multiple additional Phase III studies in this year. Next slide. Two of our other promising product candidates, our DuoBody-PD-L1x4-1BB and DuoBody-CD40x4-1BB being developed in collaboration with BioNTech. Both are first-in-class bispecific antibodies in development for the treatment of solid tumors, and we are very excited about the data we have seen from these programs so far. Both also progressed in the clinic last year with the first Phase II study of DuoBody-PD-L1x4-1BB and expansion cohorts in the Phase I/II study of DuoBody-CD40x4-1BB, including therapy with pembrolizumab, a combination supported by strong preclinical proof-of-concept data. The alliance of Genmab's expertise in antibody biology and development and biotech immuno-oncology know-how creates a very powerful partnership. We are actively expanding our collaboration with BioNTech and look forward to working with them on additional investigative medicines. And this includes our next 50-50 partner therapeutic candidates, a truly exciting HexaBody molecule that we plan to move into the clinic in the coming months. Next slide. I'm now on Slide 13. Three additional investigational medicines are on Phase I dose escalation, DuoHexaBody-CD37 is part of our collaboration with AbbVie. And just last month, the first in-human trial for DuoHexaBody-CD37 was updated to include an arm combining it with epcoritamab. HexaBody-CD38 in the middle and to the clinic in March of 2021. And we are developing this in an exclusive worldwide license and option agreement with Janssen. Our most recent investigational medicine in the clinic is another DuoBody-based product DuoBody-CD3xB7H4 on the right. Initial preclinical data was presented at SITC last year, and we look forward to providing you with updates for all the 3 antibodies here in the future as well as additional innovations that we anticipate joining our clinical pipeline soon. Next slide, please. This brings me to Slide 14. Our expanding and maturing pipeline is possible because of our investment in key areas that you see here. First, in research, where we are building on a strong track record. We have state-of-the-art R&D facilities now in both the Netherlands and in the U.S., and we continue to invest in new technologies and formats. Second, for development in the middle, we are focused on scaling up so that we can rapidly move from early to late-stage development. And third, on the right, we are investing significantly in commercialization. We put strong leadership in place and are expanding the team to enable us to effectively launch our own products. Underpinning all of this is investment in key enabling functions to support growth and to manage risk. Finally, we see significant potential to drive insights through data sciences. We believe that data sciences and real-time integration of translational research are key to accelerate product development and ensure the right therapies get to the right patients more effectively. Next slide. We own the old pipeline, validation of our investment in innovation is found in 4 medicines currently on the market. DARZALEX on the left, as redefine the treatment of multiple myeloma, Kesimpta for relapsing MS is the first B-cell therapy that can be self-administered by patients at home. TEPEZZA is the first and only FDA approved to medicine for the treatment of thyroid eye disease. And most recently, RYBREVANT on the right, which is both the first bispecific antibody approved in lung cancer and the first product that was created using Genmab's DuoBody technology platform to receive regulatory approvals. There is not the potential for a second DuoBody product on the market. Janssen's recent BLA submission for teclistamab last December. These medicines which leverage our technology and innovation exemplify our commitment to applying our world-class antibody expertise to create truly differentiated antibody therapeutics with the potential to fundamentally improve patients' lives. Next slide. These approved products provide us with a recurring revenue stream. And we anticipate that 2021 will be Genmab 9th year of profitability, driven primarily by consistently strong sales of DARZALEX, we improved our guidance twice in 2021, the second time in last November. Our current guidance for the year is, as you can see here, and significant underlying profitability for Genmab. We look forward to sharing our 2022 guidance with you when we published our 2021 Annual Report on February the 16. Next slide. We own strong revenue, 2021 was an exceptional year for Genmab. As we continue to focus on our core purpose, we are preparing for an equally momentous 2022, starting with epcoritamab, which we are developing with AbbVie. We are very much looking forward to expanding development with multiple additional Phase II and Phase III studies and excitingly the potential for the submission of a BLA subject, of course, to support the feedback from the FDA. We plan to work with our partner, Seagen, to continue to broaden the clinical development program for TIVDAK and establish it as a clear choice for patients with metastatic cervical cancer with disease progression on or after chemotherapy. We very much look forward to data from clinical expansion cohorts and progress to next steps for both of our product candidates in development with BioNTech. And we anticipate an expanding and advancing our other early stage set programs, including the potential for additional INDs or CTAs in this year. Finally, we intend to continue to scale our organization based on our planned portfolio developments using solid financial base to support this growth. And taken together, we have a lot to look forward to in the next 12 months. Now to my final slide, to Slide 18. Our laser sharp strategy has brought us very close to reaching our inspirational 2025 Vision. This vision has acted as on guiding lights and capacities in our core purpose to fundamentally improve the life of patients. As of today, our first medicine has been launched, and we are anticipating a second one in the near term. This gives us a strong rationale to make focused investments so we can make the most of the opportunities that are ahead of us. We continue to be disciplined in our approach and we are confident that as we look to the future, we will see the realization of our continued evolution into a fully integrated biotech innovation powerhouse. We have never been in a better position to achieve our vision of transforming the lives of cancer patients. Thank you all. Back to you, James.

Great. Thanks a lot, Jan, for the presentation. And we'll now move to the Q&A portion. So we're going to take questions. And as a reminder, you can register your questions through the website, and I'll be able to see it. Great. So the first thing I've been asked is about epco, which you touched on your presentation. So you said subject to regulatory feedback that you would look to potentially file epco this year. Is it clear what you would be filing for? Would it only be filing for 1 thing? Or could you even file it for multiple things?

Yes, that's a good question. And I mean, filing this year is only possible based on the expansion cohorts in the Phase I/II study. These expansion cohorts are recruiting really, really well, James. And we anticipate that we can file at least in one of these cohorts and the others is basically depend on the data. And now quickly, we can actually collect the data sets within 2022. So we anticipate 1 BLA filing. And of course, that is contingent upon the feedback from the regulators, and we have already had feedback with the FDA, of course, a number of times on all of these cohorts, but they need to give us firm feedback based on the data, and we'll, of course, then be delighted, James, to share the data with all of you probably at a medical conference. So more updates this year. I think a lot of activity in epcoritamab. This year, we will -- will materialize basically, James, what we have been speaking about since June 2020, when we did a deal with Abbvie, now this big machine, this big ship is really getting on traction, and we will -- we look forward to commit more trials in the public domain, which will be consisting of combining epco with existing treatment regimens, and with novel ones based on our preclinical evaluations. We believe that epcoritamab has unique attributes, which could make a very good combination drug for a number of new approaches, and we are very excited about that. I'm biting my tongue, James, believe it or not, because I'm super excited about some of the data I already gave you. One, we are going to combine it with a HexaBody-CD37 pretty quickly. CD37 and CD20 I covered stressed on many of these cancers, so that makes sense. And I'll remind you that last ASH, we of course, had a preclinical data set and CLO where we actually showed combinability with venetoclax in the preclinical setting, and that also makes complete sense to me to explore that clinically. But there are many, many others we're going to move into [indiscernible]. So this year will be, I think, a fantastic -- I think, fantastic year for epcoritamab and hopefully building, I think, a fantastic future for treatment of B-cell cancer patients. I think this molecule has the potential to potentially transform that fields.

Thank you. And is it the case that you would have to choose just one indication to file for the first and then couldn't file subsequent indications until the first one have been approved or not? Or is there a way that theoretically things could happen in parallel?

Well, theoretically, they could happen in parallel. I mean, of course, it depends on the data, but it's up to the feedback of the regulator to see how we can actually establish a market for epcoritamab, James. But in theory, they can all go in parallel.

Thank you. And I had one question, which was for epco beyond DLBCL and FL, which other studies might we see data for in the next 12 to 18 months?

What is actually a number of studies we have like basket studies where we combine test new combinations. And I think from these paster studies, I think you already saw some art shop combination data at ASH and some ask clear data in follicular lymphoma, at ASH there was many, many new cohorts being put into [indiscernible] and some of them are already recruiting, James. And it's, I think, too early, a bit too early in the year, to tell you what data sets could become available, but there will definitely be multiple data sets becoming available for sure, some of the expansion cohort data could become available this year. Then some of the basket data could become available. I think there will be a lot more preclinical data becoming available. And also, I think the existing data, I think one of the questions I've seen analysts ask and investors ask about is durability. How deep are they responding, how responses are robust are in response? So there will be a lot of, I think, more longer-term data with some of these combinations, especially the combination data, I think, will be very important towards this year, and we'll probably use multiple medical conferences, James, to really give you updates on that. And we have not even decided that today. But I think the most meaningful and significant data is probably the expansion cohort data in some of the B-cell cancers because that could lead to an early product approval in certain settings.

Thank you. And if a filing was to occur, you would presumably only announce to us when the filing have been accepted for review? And would that be more likely to be a second half event within the year?

Yes. I think it's highly likely, James, that will be a second half event of the year. That is, I think, likely.

Thank you. And the other -- the final one I got on epco was just for combination therapy, when is the earliest you can have combination Phase III data?

Phase III data, I think that will be a few years from here actually, because Phase III trials tend to be much larger. And we, of course, go forward and opiate so that we can get the label based on the earlier stage data. And it depends on the speed of recruitment, James. What we know is that we're still in the -- but what I hope for. I'm an optimistic or realistic optimist that we are in the last part of the pandemic now, but what I do know is that especially B-cell cancer patients are quite sensitive to coronavirus disease. So that the recruitment, I think, has been impacted, I think, last year. By the flare-up of the pandemic, I think right now in the Netherlands, we are in a third lockdown right now, which is not really helpful, I think, for recruitment of patients and trials. So that's why I'm a bit hesitant to give you time lines, but it will be years rather than months. I think for the combination data in Phase III before you can expect to see them. But hopefully, we can give you a continuous updates on the Phase II -- Phase I, II and Phase II settings because we run many of these trials in parallel here.

A final, final epco question, which would be, when is the earliest that you could potentially file for frontline use?

For frontline use, this will be a number of years from now. And I think it very much depends on the speed of recruitments and the final size of the trials that we are moving into gear right now. I can tell you that you will see multiple Phase IIIs move into gear very quickly, and that includes topline studies, but I think it depends on the recruitment. So it's a bit too early, James, to give you some guidance and color on the filing date, but we will do that in due time. We'll definitely be very open and transparent on that.

Thank you. Another question has been about the arbitration with J&J with relation to DARZALEX. And so the question is, when do you now expect us to hear an update on this?

Yes, we hope soon. Most of the materials have been exchanged. This has been a very active process over last year, which took a lot of our time. I can assure you, James, now it's up to the 3 arbitrators to come with a verdict, combining verdict, and we hope to see that soon. I cannot say anything further on timing because it's not my influence at all. It's up to the panel right now.

Thank you. I've been asked about HexaBody-CD38, which is on your slides. So and there's 2 different data points. One is the dose escalation data and the other one is the head-to-head versus DARZALEX. So I understand correctly the dose escalation dates this year, but the question is the head-to-head data versus DARZALEX, has that started yet that trial? And is that likely to be a 2023 data point?

So the dose escalation will for sure this year, James, we haven't decided yet on which conference we are going to bring that data, as I explained to you last year in December. I think general is now at the stage that we -- I think we should give you more complete data sets rather than to give this very small data sets the whole time also not to overlong you all so if you get a good feeling for a different program because the pipeline gets so robust. The head-to-head against SubQ Dara will start this year. We could probably give you a limited number of patients' worth of data this year, but then certainly the full data will slip into '23, James. I think you're right about that.

Great. And in terms of the risk profile around that, how confident are you in the efficacy and perhaps more importantly, on the tolerability profile?

I mean we have given you a short update on December the 14, the ASH update session from Genmab and there we talk so that actually it looks very clean from a safety perspective up to the levels where we are right now. And also, we have very clear signals of biological activity. I think I should leave it like that right now, James, and then wait for the full disclosure of the data. But you can hopefully hear a bit of my optimism when I speak about HexaBody-CD38, and it has been a topic which is very actively discussed yesterday during your conference with several investors. So I think there's a lot of focus on that molecule now. And the reason is, of course, that CD38 is a very well validated therapeutic target. And we did that with the work of DARZALEX. And I think when you have a next-generation CD38 targeted antibody product that could become a very, very meaningful medicine in the future for helping more and more patients because this program has the potential games to go potentially beyond multiple myeloma into other cancers like diffuse large B-cell lymphoma, acute myeloid leukemia, where we have seen some very good preclinical data, where daratumumab is clearly less effective than in multiple myeloma and potentially because the model antibody CD38 antibody in HexaBody-CD38 is different from the one in DARZALEX. It could actually be an attractive molecule also to -- for again to explore treatment in solid tumors to actually see whether we can actually activate the immune system by targeting CD38. And I think the mechanism of action of this molecule is actually far more optimal in theory from preclinical and mechanistic perspective, James, than DARZALEX is for testing that. So this could become a meaningful product, and I'm sure that Janssen will look at this very, very eagerly. We are already in very active contact with Janssen. This is still a very good collaboration. I mean, despite the arbitration is, of course, I dislike very actively. And I think the development people at Janssen probably as well, but this is basically what it is. There has been a very, very keen interest in HexaBody-CD38. And also, I think, some very positive news, of course, at ASH on teclistamab, which is combining very well with daratumumab or [indiscernible] which is not a DuoBody-based molecule also coming from Genmab's technology base, also combining very well with daratumumab. So I think this is a partnership between Genmab and Janssen. This is arguably, I think, one of the most successful partnerships J&J in its 136-year history has ever entered into at any company. So we are very excited about working with them. And hopefully, in the future, work with them also on HexaBody-CD38 and further developing that moment.

Just one follow-up there, which would be I know J&J, they've got a BCMA CAR-T until they've got the bispecific in CD3 and GPRC5D. And they've spoken quite positively about those 2 assets for multiple myeloma. If you have those 2 and you've got DARZALEX, might not be enough already, would there still be an unmet need if those look as good as they seem [indiscernible] with DARZALEX?

I mean, preclinically, James, HexaBody-CD38 at least tenfold and more potent than DARZALEX there are still patients, remembering, remember who don't respond to DARZALEX, and they may respond to the combination of a CAR-T plus DARZALEX or a anti-TPRC5D plus with DARZALEX. But I think CD38 such a well-validated target now because it's actually remarkably safe to target CD38 in patients with very, very good efficacy. And still, some patients stop responding or don't respond at all. So I think there's still an unmet medical need, and that is what drives me and my team to really try to find for all of these patients' options to really live better lives. And yes, I think there is a need for new agents also in the CD38 area and also in the multiple myeloma area. Of course, remember, James, this is still a deadly incurable cancer. I mean we get to longer and longer duration of the sponsors in frontline with wonderful updates from daratumumab studies in MAIA last year, et cetera, from POLLUX in second line. But still, we don't know whether these patients can basically survive until the life ends because of other reasons and then better disease rather than from the disease in the future. So I think we have a need for more medicines. And that is, I think, also the ambition for J&J, and they hear them speak. They wanted the end to create cures for diseases like cancer. And I think we're not in any position right now. James, to say that we have cures. But I think the more possibilities we have to work together and 3 patients more effectively, the better it will be for the cancer patients and their families. And then I'm also very confident, James, that will create a good business for the company is working on that as well.

Thank you. Maybe shifting gears. Can I ask a question about platforms? So you've clearly got a great bispecific platform, DuoBody. And you do have some antibody drug conjugates now in the market and in the pipeline, but the ADCs are partnered with other people rather being 100% Genmab. And I saw you today deal with Synaffix. So I guess the question is 2 things, one is, what did you get there? And are you now able to do ADCs clearly yourself? And if not, is that an area that Genmab might want to do more?

We are already pretty active in the ADC area. To remind everybody, I mean, we had -- we have a program with Seagen, which is on the market now. And I told you today that we will go to earlier line therapies of online therapy this year in Phase II. We will go to other cancers. And I told you about the head and neck cancer symposium, but we have an oral plenary presentation with the TV there. Then we closed the deal with AbbVie in June of 2020, where we also have preclinical program where we work together, combining AbbVie's ADC technology with Genmab bispecific expertise to create novel molecules. We did a deal with Bolt Biotherapeutics last year to actually not go for the warheads on ADC's, James, but for immune activators, like TLR7, TLR8 activators with immune stimulating molecules where Bolt has some very good expertise with. I think we have more than 10 programs ongoing at Genmab now, preclinical programs ongoing to select the ones which we could potentially take to the clinic. So -- and then on top of that, we have the interaction with Synaffix, and Synaffix actually could give us access to novel linker technology, which is already clinically tested by other companies. and novel payload technologies like topoisomerase 1 block of which that concept is, of course, already validated now by Daiichi Sankyo, but this is another molecule. And we got everything out of that into action, which we wanted, and that means that we can work together, and we get basically -- we get that licenses for the molecules we want to work on with those type of inhibitors, James, that we keep all the commercial rights because Genmab is now developing into a end-to-end biotech where we want to do the commercial association ourselves. And I think that is exactly what we got out of that Synaffix interaction and that works well with their business model as well because they actually want to provide these technologies to pharma and biotech companies. So I think we are going to do a number of more deals in that area because we believe that we need to create differentiated drugs, James. We don't have a single unmodified naked antibody in our pipeline right now. And what we want to do is actually create differentiated molecules, which are truly differentiated in treatment of different diseases. And we look now at antibody-based works as multimodal molecules where we can actually combine antibodies with different payloads, which can either be an immune activator or a warhead basically to kill a target cell. And we think that by having access to a bigger tool kits, we can actually select the best molecules going to the clinic in the coming years. I want to remind you, but in the -- now close to 23 years that we exist, James, we had 39 INDs with our partners and then 24 molecules are full spin clinical development. And of the 24, 5 on the market, soon 6 or 7 will be on the market. That is an amazing track record, and I think we can get better because the molecules we now bring to the clinic are far better tested and the earlier stage molecules we worked on some years ago. And I think we really want to get broader, not only in having more components for ADC-type concepts, but we're also now working on modifications of the HexaBody technology. This year, James, we will see a big, big year for HexaBody. I already announced a 50-50 partner HexaBody with BioNTech, which will soon go to the clinic. But we also get data for the CD37 HexaBody program for the CD38 HexaBody program this year. And I think there will be HexaBody problems from other partners also moving to the clinic pretty soon. So Genmab is one of the most innovative antibody-focused companies. And we are also looking at other delivery technologies, not to use proteins as the basis for our therapies, but potentially mRNA and other types of approaches. And we are working on that very hard preclinically. So we're going to broaden the footprint of our technology base and remain a science-focused data-driven company. And I think the best is yet to come. So we're only at the beginning, I think, of the development of the company.

Thank you. If I can ask one more question about bispecific. So 4-1BB, you've got 2 things going on. You've got 4-1BB-PD-L1 and CD40. And we saw some data for both from last year, which do you now think, is more promising. And I believe combo is now the way forward, what combo data will we actually see this year?

So I think both products are very, very exciting for the PD-L1 program, 4-1BB program. What we learned last year at SITC, James, is that basically 2 things. One is, you need a bit of PD-L1 expression in order for to see good activity on that molecule in multiple tumors, not only in lung cancer. And that makes sense mechanistically. I think that you need to have that arm bond to the tumor in order to activate the T-cells via the 4-1BB arm. That molecule also is dosed because all of these molecules have bell-shaped curves at 100-milligram dose every 3 weeks. And at that dose, it doesn't block the PD-1/PD-L1 access completely. We now know that you probably need something more to really block that access completely to keep T-cell responses going against the cancer, right now, we are doing multiple arms with PD-L1x4-1BB, including ours where we combine it with pembro or use different dosing strategies so that we can actually get only PD-L1x4-1BB in different phases of the therapy activate T-cells and block the PD-1/PD-L1 access in multiple tumors. So you will see multiple cohorts worth of data. I think the most important data is the Phase II study where we combine pembro with PD-L1x4-1BB versus PD-1 -- PD-L1x4-1BB by itself. And that's I think it depends on how much -- how quickly we can recruit that which is dependent on the pandemic, but we are very excited about that molecule, but it is also a bit more challenging from a safety perspective because we have seen some liver docs, which is manageable, then let's switch to the other program, the CD40 4-1BB. We never thought that this would be a stand-alone type of therapy. We always thought that we needed a block of the PD-1/PD-L1 access with that. And despite that, we saw some very, very good data in over half of the patients, disease stabilizations a number of very good responses, a number of very good tumor shrinkages with that molecule, we know how to dose that. And that molecule is now in frontline in 4 different cancers in melanoma, in lung cancer, in head and neck cancer and in pancreatic cancer, either with combination with pembro -- pembro and chemo. And I can tell you, James, but those [indiscernible] and safety cohorts are very quickly fill, so that was our superb enthusiastic about that molecule. I this molecule is cleaner in the sense of safety; it seems to be easy to manage with CD40x4-1BB. And with this remarkable co-file in combination with pembro, I think it may create some firework, I think during this year. And I think you may see some of these combination arms work of data. But then likely, James, in the second half of the year, not in the first half. Of course, what you need is both 2 things. One is responses. We want to see which ones respond and you want to see a bit of durability. How long do they respond because we saw in the PD-L1x4-1BB, but you can get responses, but the responses were relatively short lasting? So we think we need -- what we needed there with that molecule is a more effective blockade of the PD-1/PD-L1 access for getting durability of the responses. So I think this will be a very important year for those 2 programs and potentially multiple data sets in the second half of this year.

Thank you. I think maybe I'll try to squeeze in the last question, which would just be CD37 DuoBody. So this is for refractory NHL. What data are we going to see this year? And where do you think this might fit in amongst with the other therapies for that disease?

CD37 is a DuoHexaBody, so it's a bispecific we're targeting different epitopes on CD37, with the HexaBody mutation, you will see the complete dose escalation and maybe some early patients of the combination with epco, but that has to start in the coming months basically. We have not yet decided in which of the conferences we're going to target that data too. But I can tell you the data is very clean. We clearly have an active molecule. We clearly have a manageable safety with that molecule. And I think some of the B-cell cancers are really top candidates for combination therapy with epco because remember, but we hope to aim for, James, is that we get to chemo-free regimens in the coming years, which are as good or better than chemo containing regimens because we want to actually turn B-cell cancers into diseases, which you can actually live it, but with, with high quality of life. And I think in order for that to happen, we probably need multiple modalities. And I think the CD37 molecule is a wonderful candidate to make that happen in some of the B-cell cancers. It's still a bit too early because we used a mix of B-cell cancer patients in the first set of data for the dose escalation. I think now this year, we can hopefully be good at in a more streamlined regimented format.

Great. Thank you very much. With that, I believe we're out of time. So again, thanks a lot for joining us today, and enjoy the rest of the conference.

Okay. Thank you for having us, James, and looking forward to see you soon in person. That would be great.

Likewise. Thanks, everyone.

Thank you all. Bye.