Nov 6, 2020
Operator
Good morning, and welcome to ImmunoGen's Third 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 O'Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.
Courtney O'Konek
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 Investors & Media section of immunogen.com. With me today are Mark Enyedy, our President and CEO; Susan Altschuller, our Chief Financial Officer; and Anna Berkenblit, our Chief Medical Officer; Stacy Coen, 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.
Mark Enyedy
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 mirvetuximab 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 mirvetuximab's potential to improve outcomes and bring more good days to women living with ovarian cancer in the region.
Its partnership further strengthens our balance sheet with an upfront payment of $40 million additional milestone payments of up to $265 million in tiered royalties on commercial sales. We look forward to working with Huadong to bring mirvetuximab to the market in Greater China.
And I thank the teams that Lazard and Ropes & Gray for their support and 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 mirvetuximab in 2022 in the U.S.
To this end, we continue to advance site activation and patient's 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 were 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 regimens 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 IMGN632 for the treatment of relapsed or refractory BPDCN underscoring the need for safe and effective treatments for this rare and aggressive cancer. We're engaged with FDA to further define the development task of BPDCN while continuing to evaluate 632 and AML and other hematological malignancies.
Finally, through effective execution in 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?
Anna Berkenblit
Thanks Mark. We are pleased with the progress of mirvetuximab and our earlier stage pipeline as we enroll patients in our SORAYA, MIRASOL, IMGN632, and IMGC936 trials.
We are on track with mirvetuximab monotherapy. For SORAYA, we expect top line data during the third quarter of 2021 and the 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 mirvetuximab combination regimens.
We presented final data from our forward to triplet cohort evaluating mirvetuximab 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 mirvetuximab 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 mirv 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 mirvetuximab 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 BPDCN and minimal residual disease positive AML following frontline induction therapy as well as combinations with azacytidine and venetoclax in relapsed refractory AML.
We look forward to presenting updated data from the IMGN632 monotherapy BPDCN expansion cohort in an oral presentation. And trials and progress poster on the AML monotherapy and combination cohorts at ASH in December.
In the ASH BPDCN abstract released earlier this week, 23-patients are included, comprising the largest prospective study with a single agent in patients with relapsed refractory BPDCN. We are pleased with the activity in these heavily pre-treated patients with high unmet need, including those with prior intensive chemotherapy, prior transplant and prior Elzonris.
With an overall response rate of 30% and clinically meaningful durations of response ranging from over 3 months to 9.2 months. IMGN632 also demonstrates a favorable safety and tolerability profile without capillary leak syndrome or need for hospitalization for administration.
We look forward to Dr. Premraj's [ph] presentation on Saturday, December 5th.
Finally, we are pleased to have enrolled our first patient in a Phase I dose escalation study evaluating IMGNC936. Our atom nine targeting ADC which is being co-developed with macrogenex 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?
Susan Altschuller
Thanks, Anna. For the third quarter of 2020, we generated $18.2 million in revenue, nearly all of which came from noncash 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, SORAYA 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 aftermarket financing. Received $40 million in upfront payments from Huadong Medicine related to our partnership for the rights to mirvetuximab 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. Obtaining our 2020 financial guidance, we now expect revenues to be between $60 million and $65 million.
Operating expenses to be between $160 million and $165 million. And our cash at the year-end to be between $245 million and $250 million.
Please note that our revenue guidance does not include any potential impact from the agreement with Huadong Medicine. We are preparing for the potential accelerated approval for mirvetuximab 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.
Mark Enyedy
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. Define the path to registration for 632 and BPDCN, as well as label expansion from mirvetuximab, generating the initial data for IMGC936 and finally an IND for IMGN151.
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?
Operator
[Operator Instructions]. Our first question comes from the line of John Newman from Canaccord.
Your line is now open.
John Newman
Hi, good morning, guys. Thanks for taking my question.
Just had a question on IMGN632. This assay has become really interesting with the data that you've presented for BPDCN, as well as the breakthrough status.
Just curious about how you're thinking about the registration pathway. Especially because if you look at your CR rate, you're basically neck in neck with where stem line was in the relapsed refractory population.
So just curious as to how you're thinking about developing this asset in terms of registration? Thanks.
Anna Berkenblit
Thanks, John. We're very pleased with the activity we're seeing in relapsed refractory BPDCN.
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.
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.
John Newman
Great. Thank you.
Operator
Thank you. Our next question comes from the line of Michael Schmidt from Guggenheim.
Your line is now open.
Michael Schmidt
Hi, guys, good morning and congrats on the progress from you as well. On IMGN632, 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?
Anna Berkenblit
Thanks, Michael. So you may recall at ASH last year, we had 10 BPDCN patients enrolled 9 of whom were evaluable.
And at the time of the data cut off 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.
Michael Schmidt
Okay, great. And then an operational question, I guess.
Should you decide to file a BLA based on these data? How might this affect the Jazz Pharma 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?
Mark Enyedy
Yes, 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 the 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 till the initiation of pivotal development for AML.
And as I said, there's some nuance around BPDCN, where if they have not opted in, there's a deferral period.
Michael Schmidt
Okay, thank you. And then Anna, I know when we think about market size, duration of treatment makes a big difference.
Can you maybe comment on how duration of therapy in your study may compare to that has been seen with Elzonris?
Anna Berkenblit
So Michael, it's a little early for us to start talking about comparing our Elzonris in terms of duration of response. But I would just remind you that with Elzonris duration of response in the absence of transplant is actually rather brief.
And in Elzonris if 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.
So, we're pleased with the patients that we've enrolled thus far, heavily pretreated, post intensive chemotherapy, some post-transplant and some post Elzonris. We've had durations of response north of nine months.
Michael Schmidt
Great. Thanks.
And congrats on all progress.
Mark Enyedy
Thank you.
Operator
Thank you. Our next question comes from the line of Andy Hsieh from William Blair.
Your line is now open.
Andy Hsieh
Great. Thanks for taking my question.
And congrats on all the progress. Just a quick one for me.
So, I guess 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 regulatory approval or marketing authorization?
Is a full-blown Phase 3 trial needed or just basically a bridging study, complementing sites, I guess, both the FORWARD I, MIRASOL and SORAYA would be sufficient. So any sort of color on that would be super helpful.
Thank you.
Anna Berkenblit
Sure, Andy. So one of the reasons we chose Huadong because of their expertise in developing drugs in China.
And so we look forward to really clarifying the regulatory path for mirvetuximab in China. We are confident that we will need to generate data in patients in China.
And we're working with Huadong to figure out the most expedient path to doing so and we will get regulatory alignment with the Chinese regulators to do so.
Andy Hsieh
Got it. Thank you very much.
Operator
Thank you. Our next question goes in the line of Biren Amin from Jefferies.
Your line is now open.
Biren Amin
Yes. Hi, guys.
Thanks for taking my questions. Maybe on mirvetuximab.
Do you think FDA will want to wait for the MIRASOL data before it considers a BLA that's supported by SORAYA?
Anna Berkenblit
There's certainly a possibility that is not our base case assumption. 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 unless they have some concern, we don't think there will be any rationale for them to wait for the MIRASOL data.
Mark Enyedy
And maybe just speaking on play to [indiscernible] situation obviously they had a delay in the sense they had manufacturing issues, there's delay again. But ultimately, they gained approval on the [indiscernible] arm study and the Phase 3 study right out shortly thereafter.
And so I think that FDA is prepared to take action particularly where you can have a significant unmet need on the basis of the data that are in front of them.
Biren Amin
Got it. And then your strategy for combination, I know in the past you've talked about potential compendia listing.
But I think in on this call today you mentioned that you would disclose some plans in a future call. Are you I guess, is the company reconsidering that strategy?
And would you potentially move forward with a registrational study in the setting?
Mark Enyedy
Yes. The way to think about it is attitude.
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 the 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 line patients.
And we think the best approach there likely will be two combinations, either with Avastin or Carboplatin. So that's what we're working through as we speak.
Biren Amin
Okay. And then maybe just a question on the BPDCN program with 632.
Are there any plans in evaluating this in front line? Because if I look at your safety profile, you're not seeing any capillary leak syndrome or as I think, we saw this with those an Elzonris?
And then I guess, what's driving that because it seems that we've seen this with other CD123 program. So just want to kind of understand what's driving the safety profile?
Anna Berkenblit
Yeah. So, certainly we're excited about further development of IMGN632 in both relax refractory and the frontline setting.
And actually the protocol is currently open. We recently amended, it is enrolling in the frontline patients.
We just started that. So I think, from a safety profile perspective it's very clear that IMGN632 has a very favorable safety and tolerability profile.
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 Elzonris.
And that's in large part due to the diphtheria toxin conjugate. ImmunoGen has stopped working on diphtheria toxin conjugate many years ago.
In terms of CD123 and other ways of targeting it with biospecifics there's certainly cytokine release syndrome that can be problematic for those biospecifics. So I think at this point, we're quite pleased with the safety profile that we're seeing.
Biren Amin
Great. Thank you.
Operator
Thank you. Our next question comes on the line of Jessica Fye from JP Morgan.
Your line is now open.
Jessica Fye
Hey guys, good morning, thanks for taking my question. One is focused on ovarian for minute.
I know in some of your slides you talked about the number of ovarian patients. But maybe just drilling into that more specifically.
What do you see as the annual incidence of post [indiscernible] platinum resistant ovarian cancer with 1 to 3 frontline therapy?
Mark Enyedy
Yeah. To add one more criteria into that, those that are fully receptor alpha positive at a higher level, we think the annual incidence of the market for our proposed label would be 2,500 patients.
Jessica Fye
Okay. And do you think that…
Mark Enyedy
And we think Jess, if you take away the previously treated with Avastin criterion it jumps to about 5000. So when we look at the data from FORWARD 1 which we think is a reasonably representative sample, about half the patients had prior Avastin and half did not.
Jessica Fye
Got it. And is that in US or in Europe?
Mark Enyedy
Yes, those are US numbers. We use a combination of data.
So we buy data from DRG. And 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. The DRG is the starting date and starting point.
Jessica Fye
Got it. And is there a possibility that the SORAYA trial could support European approval for mirvetuximab?
Or do you anticipate meeting control data like from MIRASOL?
Mark Enyedy
Yes. So we will go talk to the EMA about the results of SORAYA for sure.
Their appetite for a single arm study is to support through historically has been limited in oncology. I've seen it done it with things in my past life at genzyme.
So we will go out the conversation. And if that doesn't, if that doesn't bear fruit, then it would be MIRASOL that would support full approval in the EU.
Jessica Fye
Okay. And then it sounds like you're kind of thinking about the path forward for mirvetuximab 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?
Mark Enyedy
Yes. If you look at ovarian cancer today, most patients on initial diagnosis following surgical de-bulking, and there's a fair amount of neo-adjuvant use.
And we're actually looking at that in IST. But patients get either a platinum-based doublet or triplets with the third agent been Avastin.
And so we generated some very nice triplet data in that we shared at mature data at ESMO. But from a market opportunity perspective, I think, obviously, substituting firma mirvetuximab for Paclitaxel, and the doublet or the triplet would be the highest market opportunity.
The challenge there is that that's going to be a very large, large study. And so what we're looking at our 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. It was a mix of patients who are the resistance or sensitive but later Lyme [ph] patients.
And 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 full a receptor alpha expression.
So, looking at that sort of third line later, platinum agnostic population or separately going after a non-platinum based regimen in platinum sensitive patient pays to 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 that are hypersensitivity, tired, bone marrow, etcetera.
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, mirvetuximab plus Avastin could be a very nice alternative for them.
So, those are our thoughts in terms of label expansion.
Jessica Fye
Got it. Thank you.
Sure.
Operator
Thank you. Our next question comes from the line of Boris Peaker from Cowen.
Your line is now open.
Boris Peaker
Great, thanks for taking my question. I'm just curious for the MIRASOL as well as SORAYA 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?
Anna Berkenblit
So, Boris, it's not a new assay. It's an assay that we have used from the beginning of the program, the TF 2 plus assay.
And we're tracking exactly as we would expect, we know from testing over 2000 patients that about 40% are [indiscernible].
Boris Peaker
Great. Thanks for taking my question.
Mark Enyedy
Sure.
Operator
Thank you. Our next question comes from the line of Joe Catanzaro from Piper Sandler.
Your line is now open.
Joe Catanzaro
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 over mirvetuximab. 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 your cash needs moving forward?
And whether maybe you could potentially create more value as SORAYA and MIRASOL readout in the near future? Thanks.
Mark Enyedy
Yeah, Joe. I mean, I think you say it well, which is this is a multi-variable equation here, and we're looking at what resources we would need to bring to bear to launch the product versus what the value would be if 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.
So what you end up with our estimates of commercial and medical affairs, infrastructure, similar to what you have in the Europe when you look at a sort of region to region comparison. But certainly within the ambit of a company like ImmunoGen, particularly been able to finance on the back of positive pivotal data.
So 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.
Susan Altschuller
One thing I would add is, with the China deal and $40 million upfront proceeds from ATM, we've now updated guidance for 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 spent technology this quarter.
Joe Catanzaro
Okay, got it. That's helpful.
Thanks. Thanks for taking my question.
Mark Enyedy
Sure.
Operator
Thank you. Our next question comes from the line of Jonathan Chang from SVB Leerink.
Your line is now open.
David Ruch
Hey, good morning, guys. This is David Ruch on 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 adjuvant combos in AML, please?
Anna Berkenblit
So for the AML monotherapy data that we presented at ASH last year for IMGN632. We anticipate that when we write a manuscript for that, we will provide duration of response data.
Moving to the combinations, 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 IMGN632.
We do have a trial in progress poster at ASH, describing the study design combining with an azacytidine with the needed class and as a triplet. And we are in the midst of that dose escalation.
David Ruch
Got it. Thank you.
And then just second, I noticed on the IGF when our collaboration [indiscernible]. We've seen some impressive sales figures already this year from Topezla [ph].
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.
Susan Altschuller
Sure. So we're not supposing 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.
David Ruch
Great, thanks a lot, and congrats on the progress.
Operator
Thank you. Our next question comes from the line of Kennen MacKay from RBC.
Your line is now open.
Kennen MacKay
Hey, thanks so much for taking the question. And congrats on what's been a really remarkable year here.
And another big question. Mark, I was wondering, were you fielding the most incoming interest these days?
Is it from your strategics relating to mirvetuximab? Or potential combination therapies for mirvetuximab and additional trials or cohorts that can be run there?
Or earlier pipeline out of nine or more sort of platform interests looking to access the linker and payload tech, similar to the birdie and deal that we recently heard about?
Mark Enyedy
Yes. So what I would say is, we get it at the two ends of the spectrum.
What I mean by that is, there's inbound interest in mirvetuximab. Obviously, we've signed a deal for Greater China, but it's a late stage oncology assay.
And as you can imagine, that tends to attract a lot of a lot of attention. At the other end of the spectrum, it is around the platform, that with the recent success in terms of approvals.
In the ADC space, there is a lot of interest in the underlying technology. So we are fielding inbound, similar to, but catalyze the discussion with Veridian.
And so, those are the kinds of things we're entertaining. And I think it as we 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 of those that program progresses, we probably, that will 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 on both the 632 and [indiscernible] are our partner and so we're not getting any interest there.
But what those programs do have is innovation that has intrigued others to come knocking.
Kennen MacKay
And maybe just elaborating on that a little bit. Obviously, there's been a lot of strategic interest in agencies after the minimization, competitive ImmunoMedics acquisition.
And some of the deals that we've seen [indiscernible] rather now on anything relating with interest and combination of ADCs with checkpoints. Maybe in ovarian cancer, I'm wondering if there are specific checkpoints that stand out as maybe the better sort of combination partners are really, send any evolution in thinking around the field of potential immuno-oncology partner in ovarian cancer?
Partnering a combination drug sense, not a-
Mark Enyedy
Yes. So, Ken you may remember that we move forward with Merck combining with Keytruda in ovarian cancer setting and 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've typically seen in that population with single agent mirvetuximab.
And so we have not pursued that further. There have been some really interesting preclinical data.
I was pointing to a paper by Alfred Paleo. It's the lab, I think, based in Switzerland.
And what they showed was synergy in particular between these tubulin acting agents and the checkpoint inhibitors and saying that 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 to this.
Anna Berkenblit
Yeah. I think unfortunately, ovarian cancer is unlike many other tumors where checkpoint inhibitors have revolutionized the treatment paradigm.
There have been several Phase III failures for checkpoint inhibitors at this point in ovarian cancer with [indiscernible] in the javelin studies and with the [indiscernible] most recently in the [indiscernible] So we tend to not very mutational consumers. I would even go so far as to say checkpoint inhibitor could not really achieve proof of concept in ovarian cancer.
So I think would be unlikely. Unless there's a new target that's identified in the biology strong for us to pursue combinations with the currently available checkpoint inhibitors.
Mark Enyedy
If we look at the earlier part of the portfolio for example with the IMGC936, the ADAM9 program where we are moving in tumor types that have shown activity with checkpoint inhibitors, I think that creates the opportunity. So we're absolutely open to it.
As I said, we ran the experiment with mirvetuximab and ovarian cancer and for the reasons that Anna identify, didn't see anything that made us say this is a place we want to bet heavily.
Kennen MacKay
Got it. Thank you very much, sir.
Operator
Thank you. Our next question comes from the line of [indiscernible] from HC Wainwright.
Your line is now open.
Unidentified Analyst
Thank you. This is RK from HC Wainwright.
Most of my questions have been asked. Just have a question on 936.
This is the ADAM9-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?
Anna Berkenblit
Yes, RK we're delighted to have announced on our earnings call that we dosed the first patient. And so the trial is on its way.
It's a standard three plus three dose escalation study. And the beauty of ADAM9 is that it is highly expressed in a multitude of solid tumors and not on normal tissues.
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 three plus three design should enroll well.
And when we have sufficient data, we look forward to sharing it.
Unidentified Analyst
Thank you. Thanks for taking my question.
Operator
Thank you. Our next question comes from the line of John Newman from Canaccord.
Your line is now open.
John Newman
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 mirvetuximab longer term in the front line in combination in ovarian.
I know, obviously, that's down the road that will be a bigger study. But just curious as to how you might get there.
If that will be a study that down the line ImmunoGen can put together and run, if that would maybe be a study to look at with cooperative groups? Just curious, given the activity that you're seeing in combination with not just platinum, but also with Avastin?
Thanks.
Mark Enyedy
Yes, so just to revisit the conversation we have 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 into the top of the queue was also started this IST and [indiscernible] and see what the impact is there.
I can't tell you sitting here today what the exact path to registration would be for [indiscernible] study. That's something we would need to think through.
So I think in terms of near term from us look for that patient segment wherever in later line platinum sensitive or platinum agnostic patients. And stay tuned.
John Newman
Great, thank you.
Operator
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.
Mark Enyedy
Great, thanks very much. Well, we appreciate the interest today and look forward to seeing you all at ASH and in the New Year and as we make further progress with the business.
So thanks very much.
Operator
Ladies and gentlemen, this concludes today's conference call. Thanks for participating.
You may now disconnect.