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spk14: Good morning and welcome to ImmunoGen 3rd Quarter 2020 Financial and Operating Results Conference Call. Today's conference is being recorded. Now I'd like to turn the call over to Courtney Okonek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.
spk12: Good morning and thank you for joining today's call. Earlier today, we issued a press release that includes a summary of our recent progress and third quarter 2020 financial results. This press release and a web stream of this call can be found under the Investor and Media section of Immunogen.com. With me today are Mark Ennedy, our President and CEO, Susan Altshuler, our Chief Financial Officer, and Anna Birkenblit, our Chief Medical Officer. Stacey Cohen, our Chief Business Officer, will also join us for Q&A. During today's call, we will review key accomplishments for the business over the last three months, our financial results, and upcoming milestones. During the discussion, we will use forward-looking statements, and our actual results may differ materially from such statements. Descriptions of the risks and uncertainties associated with an investment in Immunogen are included in our SEC filings. And with that, I'll turn the call over to Mark.
spk02: Thanks, Courtney. Good morning, everyone, and thank you for joining us today. We've generated significant momentum in the business over the last several months, achieving a number of important milestones across the company while managing the challenges of operating in the COVID environment. Starting with our lead program, we were pleased to announce our strategic collaboration with Huadong Medicine to develop and commercialize Mervituximab in Greater China. This is the second largest pharmaceutical market in the world, and Huadong's extensive research, development, and regulatory capabilities along with its access to a large network of local hospitals, will allow us to realize Mervituximab's potential to improve outcomes and bring more good days to women living with ovarian cancer in the region. This partnership further strengthens our balance sheet with an upfront payment of $40 million, additional milestone payments of up to $265 million, and tiered royalties on commercial sales. We look forward to working with Huadong to bring Mervituximab to the market in greater China And I thank the teams at Lazard and Ropes and Gray for their support in bringing this deal to fruition. Beyond Greater China, we are working with a sense of urgency to execute on our pivotal trials and prepare for the first potential launch of Mervituximab in 2022 in the U.S. To this end, we continue to advance site activation and patient enrollment for both Soraya and Mirasol and are on track to report top-line data from Soraya in Q3 next year. In addition to a potential monotherapy label, we are committed to moving into earlier lines of therapy by combining with other agents. With the benefit of the encouraging data we shared at ASCO and ESMO earlier this year, we are working to define the best path to label expansion with our combination regimen and look forward to sharing our approach in a future call. Moving to our earlier stage programs, we were delighted to receive breakthrough therapy designation from FDA for IMGN 632 for the treatment of relapsed or refractory BPDCN, underscoring the need for safe and effective treatments for this rare and aggressive cancer. We are engaged with FDA to further define the development path for BPDCN while continuing to evaluate 632 and AML and other hematological malignancies. Finally, through effective execution and business development and deployment of our ATM facility, We have further strengthened our balance sheet and now expect our existing cash, together with future payments from our partners, to fund our operations into the second half of 2022. With that, I'll turn the call over to Anna to review our clinical programs in more detail. Anna?
spk10: Thanks, Mark. We are pleased with the progress of Mervituximab and our earlier stage pipeline as we enroll patients in our Sirea, Mirasol, IMGN 632, and IMGC936 trials. We are on track with Mervituximab monotherapy. For Sirea, we expect top-line data during the third quarter of 2021 and a BLA submission before the end of 2021 to support approval in 2022. For Mirasol, we expect to report top-line data for this study in the first half of 2022. Moving to our Mervituximab combination regimens, We presented final data from our Forward 2 triplet cohort, evaluating mervituximab in combination with carboplatin and bevacizumab at ESMO in September. The platinum-sensitive triplet cohort evaluated 41 patients with recurrent platinum-sensitive ovarian cancer with medium or high levels of folate receptor alpha, who have received up to two prior lines of therapy. We observed a confirmed overall response rate of 83%, with a median duration of response of 10.9 months and median progression-free survival of 12.8 months. I will also remind you of the Mervituximab and Bevacizumab doublet data presented at ASCO in May, where we observed an overall response rate of 64% in patients with high FR-alpha expression, regardless of platinum status. The Merv-Bev data generated to date could support compendia listing, And given the observed responses and favorable tolerability profile, we are working quickly to define a formal path to registration for Mervituximab in combination and seek to expand into earlier lines of therapy. Moving to our earlier stage portfolio, we advanced our programs targeting both hematological malignancies and solid tumors. We continue to progress multiple cohorts with IMGN632, our anti-CD123 ADC, including monotherapy expansions in BPD-CN and minimal residual disease positive AML following frontline induction therapy, as well as combinations with azacitidine and venetoclax in relapsed refractory AML. We look forward to presenting updated data from the IMGN 632 monotherapy BPD-CN expansion cohort in an oral presentation and a trials-in-progress poster on the AML monotherapy and combination cohorts at ASH in December. In the ASH BPD-CN abstract released earlier this week, 23 patients are included, comprising the largest prospective study with a single agent in patients with relapsed refractory BPD-CN. We are pleased with the activity in these heavily pretreated patients with high unmet need, including those with prior intensive chemotherapy, prior transplant, and prior LZONRIS. with an overall response rate of 30% and clinically meaningful durations of response ranging from over three months to 9.2 months. IMGN 632 also demonstrates a favorable safety and tolerability profile without capillary leak syndrome or need for hospitalization for administration. We look forward to Dr. Pemaraju's presentation on Saturday, December 5th. Finally, we are pleased to have enrolled our first patient in a Phase I dose escalation study evaluating IMGC936, our ADAM9-targeting ADC, which is being co-developed with macrogenics in solid tumors including non-small cell lung, colorectal, pancreatic, gastric, and triple negative breast cancer, and look forward to further advancing this trial. With that, I'll turn the call back over to Susan to review the financials. Susan?
spk13: Thanks, Anna. For the third quarter of 2020, we generated $18.2 million in revenue, nearly all of which came from non-cash royalty revenues. Operating expenses were $34.9 million compared with $31.2 million for the third quarter of 2019. This increase was driven by increased R&D expenses from greater clinical trial costs related to advancing our Mirasol, Sirea, and 632 studies, partially offset by lower restructuring expenses. G&A expenses were $10.2 million compared to $9.2 million in the third quarter of 2019, primarily due to increased professional fees. At the end of the third quarter, we had $188.2 million in cash. Importantly, subsequent to quarter end, we brought in $54 million in net proceeds from our at-the-market financing, received $40 million in upfront payments from Huadang Medicine, related to our partnership for the rights to Mervituximab in Greater China, received an upfront payment from a newly executed license agreement with Viridian, and will receive a $5 million payment from Novartis for a development milestone achieved in September. Updating our 2020 financial guidance, we now expect revenues to be between $60 and $65 million, operating expenses to be between $160 and $165 million, and and our cash at the year end to be between $245 and $250 million. Please note that our revenue guidance does not include any potential impact from the agreement with Hwadong Medicine. We are preparing for the potential accelerated approval for Mervetuxibab in platinum-resistant ovarian cancer and are planning for increased investment in 2021 related to manufacturing in support of commercial launch. With the addition of these investments, we expect that current cash and anticipated cash receipts from partners will fund operations into the second half of 2022. With that, I will turn the call back over to Mark.
spk02: Thanks, Susan. Just a few closing remarks. We've made significant progress with the business over the course of 2020 and look forward to a strong finish to the year. We're excited about the future. With the benefit of a strong cash position and an experienced management team, we've positioned the business to execute on a number of important milestones in 2021, including pivotal data and a BLA submission for our lead program, defining the path to registration for 632 and BPDCN, as well as label expansion for merfituximab, generating initial data for IMGC 936, and filing an IND for IMGN 151. So I look forward to keeping you apprised of our progress and what are exciting times for the company. With that, we'll open the call for questions. Operator?
spk14: As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of John Newman from Canaccord. Your line is now open.
spk04: Hey, good morning, guys. Thanks for taking my question. Just had a question on IMGN 632. You know, this asset has become really interesting with the data that you presented for BPDCN as well as the breakthrough status. And just curious about how you're thinking about the registration pathway, especially because if you look at your CR rate, you're basically neck and neck with where Stemline was in the relapse for factory population. So just curious as to how you're thinking about developing this asset in terms of registration. Thanks.
spk10: Thanks, John. Yeah, we're very pleased with the activity we're seeing in relapsed refractory DPD-CN, and we look forward to sharing updated data at ASH. Around the time of ASH, we also will be sharing plans in terms of our registration path forward. You know, as we've discussed previously, our goal this year was to meet with FDA to define a path forward, and we look forward to sharing that around the time of ASH.
spk04: Great. Thank you.
spk14: Thank you. Our next question comes from the line of Michael Schmidt from Guggenheim. Your line is now open.
spk05: Hey, guys. Good morning, and congrats on all the progress from me as well. On IMGN 632, can you maybe provide a little bit more color on how much additional data we might expect here at the ASH conference? And I did note that some of the PRs later converted to CRC. Just wondering if that's a general phenomenon with ADCs in this indication.
spk10: Thanks, Michael. So you may recall at ASH last year we had 10 BPDCN patients enrolled, nine of whom were evaluable. And at the time of the data cutoff for the abstract for ASH, we had enrolled 23 patients, where you see we have a 30% response rate. And now we do have duration of response information, as you saw, over three months to 9.2 months. So those duration of response data is quite nice in this relapsed refractory population. We continue to enroll and we will present updated data on the entire data set at ASH.
spk05: Okay, great. And then an operational question, I guess, you know, should you decide to file a BLA based on these data? How might this affect the JASPharma opt-in rights? My understanding was that they may need to opt-in prior to BLA submission. Just wondering how that might work out, structurally speaking.
spk02: Yeah, thanks, Michael. So the way the agreement works is there are essentially two opt-in periods. The first runs from the time we sign the agreement up until the initiation of pivotal development in AML. And the second opt-in period runs from that day through the BLA filing for AML. There's a little bit of nuance related to an interim filing for BPDCN, which is probably beyond the scope of this call. So the way I would characterize it is simply that they can opt in early up until the initiation of pivotal development for uh for aml and as i said there's there's some nuance around uh vpdcn where if they have not opted in um there's a deferral period okay thank you and then anna i know when you think about market size uh duration of treatment makes a big difference can you maybe comment on how duration of therapy in your study may compare to that that has been seen with alzheimer's
spk10: So Michael, it's a little early for us to start, you know, talking about comparing our results to Aldonrith in terms of duration of response, but I would just remind you that with Aldonrith, duration of response in the absence of transplant is actually rather brief. With Aldonrith, you do develop anti-drug antibodies, and the median duration of response tends to be in the three-month range, again, in the absence of transplant. You know, we're pleased with the patients that we've enrolled thus far, heavily pretreated, you know, post-intensive chemotherapy, some post-transplant, and some post-aldomerous, and we've had durations of response north of nine months.
spk05: Great. Thanks, and congrats on all the progress. Thank you.
spk14: Thank you. Our next question comes in the line of Andy Tsai from William Blair. Your line is now open.
spk03: Oh, great. Thanks for taking my question, and congrats on all the progress. Just a quick one for me. So I guess, you know, the street is not familiar with the China regulatory pathway, so I'm just wondering what needs to be done there in order to gain some sort of, you know, regulatory approval or marketing authorization. Is a full-blown phase three trial needed or just basically a bridging study complementing, I guess, both the forward one, Nercel, and Soraya would be sufficient? So any sort of color on that would be super helpful. Thank you.
spk10: Sure, Andy. One of the reasons we chose Huadong is because of their expertise in developing drugs in China. And so we look forward to really clarifying the regulatory task for Mervituximab in China. We are confident that we will need to generate data in patients in China. and we're working with Wadong to figure out the most expedient path to doing so, and we will get regulatory alignment with the Chinese regulators to do so.
spk03: Got it. Thank you very much.
spk14: Thank you. Our next question comes in the line of Burin Amin from Jefferies. Your line is now open.
spk07: Yeah, hi, guys. Thanks for taking my questions. Maybe on Mervituximab, Do you think FDA will want to wait for the Mirasol data before it considers a BLA that's supported by Soraya?
spk10: Well, that's certainly a possibility. That is not our base case assumption. You know, the Soraya data are really on track to be delivered a year ahead to allow us to have a filing before the end of next year. And so, you know, we don't think, unless they have some concern, we don't think there will be any rationale for them to wait for the Mirasol data.
spk02: Yeah, I guess, Bir, and I'd point you to the Tredelvi situation. You know, obviously they had a delay in the sense that they had, you know, manufacturing issues that delayed them, but ultimately, you know, they gained approval on the single-arm study And the phase three study read out shortly thereafter. And so I think the FDA is prepared to take action, particularly where you have a significant unmet need on the basis of the data that are in front of them.
spk07: Got it. And then your strategy for combination, I know in the past you've talked about potential compendia listing, but I think on this call today you mentioned that you would disclose some plans in a future call. Are you, I guess, as a company, reconsidering that strategy, and would you potentially move forward with a registrational study in this setting?
spk02: Yeah, so the way to think about it is additive. So we've generated a lot of good combination data, and it would be those data that are the basis for submitting to the compendia to support a listing and correspondingly reimbursement in the U.S., As you know, in the absence of a label, we would be constrained in terms of the ability to promote those data. And so the goal really is ultimately to gain a label expansion in earlier Lyme patients. And we think the best approach there likely will be through combinations either with Avastin or carboplatin. So that's what we're working through as we speak.
spk07: Okay. And then maybe just a question on the BPD-CN program with 632. Are there any plans in evaluating this in frontline? Because, you know, if I look at your safety profile, you're not seeing any capillary leak syndrome, whereas I think we saw this with ilizondris. And then I guess, you know, what's driving that? Because it seems that we've seen this with other CD123 programs. So, Just want to kind of understand what's driving that safety profile.
spk10: Yeah, so certainly we're excited about further development of IMGN 632 in both relapsed refractory and the frontline setting. And actually the protocol is currently open. We recently amended. It is enrolling in frontline patients. We just started that. So, you know, I think from a safety profile perspective, it's very clear that IMGN 632 is has a very favorable safety and tolerability profile. You know, we're not required to be hospitalized, and we have not had the capillary leak syndrome that has really been seen and can be fatal with L. veneris, and that's in large part due to the diphtheria toxin conjugate. Immunogen stopped working on diphtheria toxin conjugate many years ago. In terms of CD123 and other ways of targeting it, you know, with bispecifics, there's certainly cytokine release syndrome that can be problematic for those bispecifics. So I think at this point we're quite pleased with the safety profile that we're seeing.
spk07: Great. Thank you.
spk14: Thank you. Our next question comes from the line of Jessica Pye from J.P. Morgan. Your line is now open.
spk11: Hey, guys. Good morning. Thanks for taking my questions. I wanted to focus on ovarian for a minute. I know in some of your slides you talk about the number of platinum-resistant ovarian patients, but maybe just drilling into that more specifically, what do you see as the annual incidence of post-Bevacizumab platinum-resistant ovarian cancer with one to three prior lines of therapy?
spk02: Yeah, and to add to one more question, criteria into that, those that are folate receptor alpha positive, you know, at a high level. We think the annual incidence of the market for our proposed label would be 2,500 patients.
spk11: Okay.
spk02: And do you think that... And we think, Jess, that the If you take away the previously treated with Avastin criterion, it jumps to 5,000. So when we looked at the data from ForwardOne, which we think is a reasonably representative sample, about half the patients had prior Avastin and half did not.
spk11: Got it. And is that U.S. or U.S. and Europe?
spk02: Yeah, those are U.S. numbers. So we use a combination of data. So we buy data from DRG. We also have an agreement with Flatiron where we're looking at a longitudinal cohort. And then we supplement that with a physician survey through Ipsos to get at those numbers. But DRG is the starting point. Got it.
spk11: Is there a possibility that the SORAYA trial could support European approval from ribotexamab, or do you anticipate needing controlled data like from Mirasol?
spk02: Yeah, so we will go talk to the EMA about the results of SORAYA for sure. Their appetite for single-arm studies to support approval historically has been limited in oncology. I've seen it done. I've done it with things in my past life at Genzyme. So we will go out to conversation, and if that doesn't bear fruit, then it would be Mirasol that would support full approval in the EU.
spk11: Okay. And then it sounds like you're kind of thinking about the path forward for Merv-Tuxmab in combination. So what are the most kind of interesting possibilities there in your view, and which of those would best maximize the commercial opportunity?
spk02: Yeah. You know, if you look at ovarian cancer today. Most patients on initial diagnosis following surgical debulking, there's a fair amount of neoadjuvant use. We're actually looking at that in an IST But patients get either a platinum-based doublet or a triplet with the third agent being Avastin. And so we generated some very nice triplet data that we shared at mature data at ESMO. But from a market opportunity perspective, I think obviously substituting mervituximab for paclitaxel in the doublet or the triplet would be the highest market opportunity. The challenge there is that that's going to be a very large study. And so what we're looking at are opportunities to move into earlier line therapy, either using a strategy similar to the data that we shared at ASCO where the patients were platinum agnostic. That is, it was a mix of patients who were either resistant or sensitive, but later Lyme patients. And, you know, the data we saw there in terms of response rate were quite compelling. We had a 64% response rate in those patients with high levels of folate receptor alpha expression. So looking at that sort of you know, third line and later platinum agnostic population are separately going after, you know, a non-platinum-based regimen in platinum-sensitive patients who remain platinum-sensitive. Because what happens is after a couple of lines of platinum, there are a lot of reasons why physicians are not giving platinum to those patients, their hypersensitivity type, bone marrow, etc., And so what we see in our data is a growing population of those patients where a combination regimen that doesn't include platinum, so for example, Mervituximab plus Avastin, could be a very nice alternative for them. So those are our thoughts in terms of label expansion.
spk14: Got it. Thank you.
spk02: Sure.
spk14: Thank you. Our next question comes from the line of Boris Peeker from Cowen. Your line is now open.
spk15: Great. Thanks for taking my question. I'm just curious for the Mirasol as well as the Sirea trial, as you're enrolling it, what fraction of patients are you finding to fall into the folate receptor positive category based on your new assay?
spk10: So for us, it's not a new assay. It's the assay that we have used from the beginning of the program, the PF2 plus assay. And we're tracking exactly as we would expect. We know from testing over 2,000 patients that about 40% are FRAlpha high.
spk15: Great. Thanks for taking my question.
spk10: Sure.
spk14: Thank you. Our next question comes in the line of Joe Catanzaro from Piper Sandler. Your line is now open.
spk06: Hey, guys. Thanks so much for taking my question here. Maybe just one quick one. I guess now with a nice greater China deal under your belt from River Tuximab, how do you think about the potential for additional ex-U.S. partnerships around that asset, I guess, namely Europe? And is that largely consistent on how you view China? you know, your cash needs moving forward and whether maybe you could potentially create more value as Soraya and Mirosol read out in the near future. Thanks.
spk02: Yeah, Joe, I mean, I think you say it well, which is, you know, this is a multivariable equation here, and we're looking at, you know, what resources we would need to bring to bear to launch a product versus, you know, what the value would be of bringing on a partner for, in particular, Europe. We've done the analysis in Europe, and it's a fairly concentrated market in terms of physician targets, treatment patterns, and so on, actually more concentrated than the U.S. That's offset to some degree by the need for national level commercial infrastructure. What you end up with are estimates of commercial and medical affairs infrastructure similar to what you have in Europe when you look at a region to region comparison, but certainly within the ambit of a company like Immunogen, particularly being able to finance on the back of positive pivotal data. That said, there are a lot of advantages to partnering as well, and so that's something that we will evaluate. in particular with positive pivotal data in hand.
spk13: One thing I would add is with the China deal and the $40 million upfront plus the proceeds from the ATM, we've now updated guidance for our cash outlay until the second half of 2022, and we feel that we're in a position of strength. So we want to do the right strategic decision on partnerships because we have that optionality now that we've strengthened the balance sheet this quarter.
spk06: Okay, got it. That's helpful. Thanks for taking my question. Sure.
spk14: Thank you. Our next question comes from the line of Jonathan Chang from SVB Larington. Your line is now open.
spk08: Hey, good morning, guys. This is David Ruchon for Jonathan. Thanks for taking our questions. First question, for 632, have you guys presented or do you have plans to present any duration of response data from the 71 patients treated with monotherapy at ASH of last year? And then second, could you provide any color on the enrollment progress in the combination cohorts and when we might see initial data from the ACE event combos in AML, please?
spk10: So for the AML monotherapy data that we presented at ASH last year for IMGM 632, we anticipate that when we write a manuscript for that, we will provide duration of response data. Moving to the combinations, we look forward to, we're in the midst of planning an investor conference call event around the time of ASH, and that would be the appropriate time for us to provide a progress update on the combinations for IMGN 632. We do have a trials in progress poster at ASH describing the study design combining with azacitidine with venetoclax and as a triplet, and we are in the midst of that dose escalation.
spk08: Got it. Thank you. And then just second, I noticed on the IGF-1R collaboration with Viridian slash Miragen, we've seen some impressive sales figures already this year from Tepeza, and I was just wondering if you could provide any further specificity on your economics within the thyroid eye disease opportunity and timing of potential regulatory filing, and I guess anything else here that you'd highlight about the promise of this opportunity. Thanks a lot.
spk09: Sure, so we're not divulging upfront numbers on that deal, but the structure is upfront milestones and royalties in a traditional type of fashion. And we do have the opportunity to recognize approximately $50 million in development milestones and up to $95 million in sales milestones on that program. We do think it's well-placed with Viridian. They're in a position to move that forward. As you know, we're focused on cancer here at Immunogen, and we think that it's complimentary to have them pursuing this asset in the thyroid eye disease indication, which has a very promising potential.
spk08: Great. Thanks a lot, and congrats on the progress. Thanks.
spk14: Thank you. Our next question comes from the line of Kenan McKay from RBC. Your line is now open.
spk00: Hey, thanks so much for taking the question, and congrats on what's been a really remarkable year here. I had another BD question. Mark, I was wondering, where are you fielding the most incoming interest these days? Is it from strategics relating to Mervituximab or Uh, potential combination therapies for and additional trials or cohorts that can be run there, or earlier pipeline out of 9, or more sort of platform interest, looking to accessing linker and payload tech similar to the birdie and deal that we recently heard about.
spk02: Yeah, so what I would say is we get it at the two ends of the spectrum. What I mean by that is, you know, there's inbound interest in Mervatoxin. Obviously, we've signed a deal for Greater China, but, you know, it's a late-stage oncology asset, and as you can imagine, that tends to attract a lot of attention. At the other end of the spectrum, it is around the platform. You know, with the recent success in terms of approvals, in the ADC space, there is a lot of interest in the underlying technology. We are fielding inbound similar to what catalyzed the discussion with Viridian. Those are the kinds of things we're entertaining. see the progress for example with 936 which really integrates a number of important innovations that came out of our labs over the last half decade or so in terms of payload linkers and also some antibody engineering. People see that and I think as that program progresses that will probably engender even greater interest and so we're excited about those things and being able to deploy the technology platform more broadly. So that's where it is. In the middle, both the 632 and Adam9 are our partners, so we're not getting any interest there. But what those programs do have is innovation that has intrigued others to come knocking.
spk00: Gotcha. And Mark, maybe just elaborating on that a little bit. Obviously, there's been a lot of strategic interest in ABCs after the immunomedicine, competitive immunomedicine acquisition. And, you know, some of the deals that we've seen, Seattle, CIGEN rather now, inking relating, you know, interest in combination of ABCs with checkpoints. Maybe In ovarian cancer, I'm wondering, you know, if there are specific checkpoints that stand out as maybe the better sort of combination partners, or really, you know, if there's been any evolution in thinking around the field of a potential immuno-oncology partner in ovarian cancer. Partner in a combination drug sense, not a... Yeah, yeah.
spk02: So... Ken, you may remember that we moved forward with Merck combining with Keytruda in the ovarian cancer setting in platinum-resistant patients. And the initial responses were quite encouraging. However, when we expanded out the cohort, we didn't see a significant contribution in terms of efficacy beyond what we typically see in that population. with single-agent Mervituximab. And so we have not pursued that further. There have been some really interesting preclinical data. I would point you to a paper by Alfred Zipalius, which is a lab, I think, based in Switzerland. And what they showed was synergy, in particular, between these tubulin acting agents and the checkpoint inhibitors. And as I say, the It's an encouraging early data, which didn't pan out, but what I would say is we're not adverse to it, but Anna has a few other words to add here.
spk10: Yeah, I think, unfortunately, ovarian cancer is unlike many other tumors where checkpoint inhibitors have revolutionized the treatment paradigm. There have been several phase three failures for checkpoint inhibitors at this point in ovarian cancer, with avelumab in the javelin studies, and with the Tessalizumab most recently in the IMAGINE50 study. So, you know, these tends to be not very mutationally driven tumors. I would even go so far as to say that checkpoint inhibitors have not really achieved proof of concept in ovarian cancer. So, I think it would be unlikely, unless there's a new target that's identified and the biology is strong for us to pursue combinations with the currently available checkpoint inhibitors.
spk02: Right, so, but if we look at the earlier part of the portfolio, for example, with the IMGC936, the ADAM9 program, where we are moving into tumor types that have shown activity with checkpoint inhibitors, I think that creates the opportunity. So we're absolutely open to it. So we ran the experiment with Mervituximab in ovarian cancer, and for the reasons that Anna identified, you know, didn't see anything that, you know, made us say this is a place we want to bet heavily.
spk00: Got it. Thank you very much. Sir?
spk14: Thank you. Our next question comes from the line of Suayama Pakula Ramankan from HC Wainwright. Your line is now open.
spk01: Thank you. This is RK from HC Wainwright. Most of my questions have been asked. Just have a A question on 936. This is the item 9 targeting ADC that you have partnered with Macrogenics. Could you just give us some color as to the progress of the trial and also anything regarding timing for data release?
spk10: Yeah, R.K., we're delighted to have announced on our earnings call that we've dosed the first patient. And so the trial is on its way. You know, it's a standard 3 plus 3 dose escalation study. The beauty of ADAM9 is that it is highly expressed in a multitude of solid tumors and not on normal tissue, so there's a nice differential there that is allowing us to go after non-small cell lung cancer, colorectal, pancreatic, gastric, and triple negative breast cancer. So we anticipate that the 3 plus 3 design should enroll well, and when we have sufficient data, we look forward to sharing it.
spk01: Thank you. Thanks for taking my question.
spk14: Thank you. Our next question comes from the line of John Newman from Canaccord. Your line is now open.
spk04: Hi, guys. Thanks for taking the follow-up. So, I just wondered if you could maybe elaborate a bit on how we should think about use of Mervituximab longer term in the frontline in combination I know, obviously, that's down the road. That would be a bigger study, but just curious as to how you might get there. If that would be a study that down the line immunogen can put together and run, if that would maybe be a study to look at with co-op groups. Just curious, given the activity that you're seeing in combination with not just platinum, but also with Avastin. Thanks.
spk02: Yeah, so just to revisit the conversation we had with Jess, we are looking at combination regimens to expand the label that could include recurrent platinum sensitive patients or these platinum agnostic patients that I described. And so I think that is the likely next step. To get to a frontline indication I think would likely involve a cooperative group study given the scale of that effort. So what we really want to do for the next step in label expansion is to move into earlier lines and address some of these recurrent platinum-sensitive or platinum-agnostic patients. And also, going right up to the top of the queue, we also started this IST in neoadjuvant and see what the impact is there. I can't tell you sitting here today what the exact path to registration would be for a neoadjuvant study. That's something we would need to think through. So I think in terms of near term from us, you know, look for that patient segment where we're in, you know, later line platinum sensitive or platinum agnostic patients and stay tuned.
spk04: Great. Thank you.
spk14: Thank you. At this time, I'm showing no further questions. I would like to turn the call back over to the team for closing remarks.
spk02: Great. Thanks very much. Well, we appreciate the interest today and look forward to, uh, seeing you all at ASH and in the new year and as we make further progress with the business. So thanks very much.
spk14: Ladies and gentlemen, this concludes today's conference call. Thanks for participating. You may now disconnect.
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