Q2 2021 ImmunoGen Inc Earnings Call
Good morning, and welcome to the MB Immunogen.
Operator: morning, and welcome to the immunogen second quarter 2021 financial and operating results conference call. Today's conference is being recorded. At this time, I'd like to turn the call over to Courtney O'Connick, Senior Director of Corporate Communications and Investor Relations. Please go ahead.
The second quarter 2021 financial and operating results Conference call. Today's conference is being recorded at this time I'd like to turn the call over to Courtney <unk> Senior director of corporate Communications and Investor Relations. Please go ahead.
Courtney O'Connick: Good morning, and thank you for joining today's call. Earlier today, we issued a press release.
Good morning, and thank you for joining today's call earlier today, we issued a press release that includes the summary of our recent progress in the second quarter 2021 financial results. The press release and a recording of this call can be found under the investors and media section of our website at Immunogen Dot com.
Courtney O'Connick: includes a summary of our recent progress and second quarter 2021 financial results. This press release and a recording of this call can be found under the Investors and Media section of our website at amunogen.com.
Courtney O'Connick: With me today are Mark Kennedy, our president and CEO, Anna Birkenblit, our chief medical officer, and Susan Altschiller, our CFO. During today's call, we will review
With me today are Mark Kennedy, our president and CEO and the Perkins.
<unk> Medical officer, and Susan Altshuler, our CFO during today's call. We will review key accomplishments for the business over the last 3 months of financial results and upcoming anticipated events. 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.
Courtney O'Connick: Key accomplishments for the business over the last three months include financial results and upcoming anticipated events. 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. Thanks, Courtney.
Our children are included in our SEC filings and with that I'll turn the call over to Mark. Thanks, Gordon and good morning, everyone and thank you for joining us today.
Mark Joseph Enyedy: Thanks, Courtney, good morning, everyone, and thank you for joining us today. Over the past three months, we continue to advance our pipeline of novel ADC candidates and execute on our strategic objectives as we prepare to transition to a fully integrated oncology company with the potential for two innovative products on the market next year. With top-line data from our pivotal Saraya study on track for release next quarter, we've accelerated preparations for the BLA submission and commercial launch of Murgatoxymab.
Over the past 3 months, we can continue to advance our pipeline of novel ADC candidates and execute on our strategic objectives as we prepare to transition to a fully integrated oncology company.
<unk> with the potential for 2 innovative products on the market next year with topline data from our pivotal survey of study on track for release next quarter, we've accelerated preparations for the BLA submission and commercial launch of Mervyn talks of Mab given these near term catalysts. We see this as an opportune moment to briefly review with you the us.
Mark Joseph Enyedy: Given these near-term catalysts, we see this as an opportune moment to briefly review with you the U.S. market opportunity and dynamics in ovarian cancer. Starting with growth, analyst reports and other industry data project that the ovarian cancer market in the U.S. will increase from approximately $1.6 billion today to over $3 billion in 2026, driven largely by the launch of novel targeted agents like myrvituxamab and the continued Looking at epidemiology, each year in the US, roughly 20,000 women are diagnosed with ovarian cancer, and 14,000 will die from the disease.
And of the opportunity and dynamics in ovarian cancer, starting with growth analysts reports and other industry data project of the ovarian cancer market in the U S will increase from approximately $1.6 billion today to over $3 billion in 2026, driven largely by the launch of novel targeted agents.
Mark and I can more of a tuck the mab and the continued uptake of PARP inhibitors look.
Looking at epidemiology, each year in the US roughly 20000 women are diagnosed with ovarian cancer and 14000 will die from the disease with just a 50% 5 year survival rate of ovarian is 1 of the deadliest cancers impacting women.
Mark Joseph Enyedy: With just a 50% five-year survival rate, ovarian cancer is one of the deadliest cancers impacting women today. Based on our clinical experience testing more than 2,000 patient samples, our data suggests that approximately 40% of ovarian tumors express high levels of folate receptor alpha, which is the target patient population from myrvituxumab. Despite advances in earlier aligned settings with PARP inhibitors as maintenance, the majority of ovarian cancer patients relapse and become resistant to platinum-based chemotherapy. Treatment options for these patients are limited, with poor outcomes and diminished quality of life.
Agents.
Based on our clinical experience having tested.
For more than 2000 patient samples our data suggests that approximately 40% of ovarian tumors Express high levels of folate receptor Alpha which is the target patient population from a rituximab.
Despite advances in earlier line settings with PARP inhibitors.
And today versus maintenance the majority of ovarian cancer patients relapse and become resistant to platinum based chemotherapy treatment options for these patients are limited with poor outcomes and diminished quality of life.
Mark Joseph Enyedy: Against this discouraging landscape, our goal is to establish Mervatuximab as the standard of care for FR-Alpha-high advanced ovarian cancer. With positive data from Saraya, we anticipate Mervatuximab's initial indication will cover second to fourth-line patients with FR-A-Lafah High platinum-resistant ovarian cancer who have been previously treated with Avastin. We believe this represents more than 2,000 patients in the U.S. With confirmatory data from Mirosol, our label would expand to over 4,000 as many more naive patients would also be eligible.
Against this discouraging landscape our goal is to establish more of a talks of mab as the standard of care for Fr Alpha High advanced.
Hibbett ovarian cancer with positive data from Surya, we anticipate more of a tux of maps initial indication will cover second through fourth line patients with fr Alpha high platinum resistant ovarian cancer who've been previously treated with Avastin. We believe this represents more than 2000 patients in the us with confirmatory.
Oh for Mirasol, our label would expand to over 4000 as the vast the naive patients would also be eligible.
Beyond the platinum resistant setting we're initiating the piccolo.
Mark Joseph Enyedy: Beyond the Platinum resistance setting, we're initiating Piccolo, a single-arm study of Mervituximab monotherapy and FR-Alpha-high, later-line recurrent platinum-sensitive ovarian cancer aligned with our strategy to generate data that support Mervatuximab displacing single-agent chemotherapy. Anna will share more details on that trial in a minute.
The arm study of merger talks of Mab monotherapy in Fr Alpha High later line recurrent platinum sensitive ovarian cancer.
The data for and with our strategy to generate data that support more of a tux of mab displacing single agent chemotherapy, and who will share more details on that trial in a minute.
Mark Joseph Enyedy: We also continue to generate highly encouraging data supporting the potential of Mervatuximab to become the combination agent of choice for ovarian cancer. We were pleased to share final data from our Mervatuximab plus Avast and Doublet study and an oral presentation last month at ASCO. These data demonstrated compelling anti-tumor activity in patients with FR alpha-high recurrent ovarian cancer regardless of platinum status.
We also continue to generate highly encouraging data supporting the potential of more of the trucks of map to become the combination agent of choice for ovarian cancer. We were pleased to share of final data from.
More of a tux of Mab plus avastin doublet in an oral presentation last month at <unk>. These data demonstrated compelling antitumor activity in patients with fr Alpha high recurrent ovarian cancer, regardless of platinum status. We believe the publication of these data together with the <unk> plus avastin cohort.
Mark Joseph Enyedy: We believe the publication of these data, together with the Mervatuximab plus Avastin cohort published in 2019, could support compendial listing in close proximity to the initial monotherapy approval for Mervatexamab ahead of formal label expansion for this combination. Given this potential, as I mentioned at the start of the call, we've accelerated our work in preparation for the BLA submission and commercial launch of Mervatuximab. To this end, we continue to engage with the ovarian cancer medical community to educate on the robust data sets already generated with Mervatuximab and to increase awareness of foliate receptor alpha as a promising biomarker for patient selection for targeted therapy.
A lot in 2019 could support compendium listing in close proximity to the initial monotherapy approval from more of a text of Mab ahead of formal label expansion for this combination.
This potential as I mentioned at the top of the call. We've accelerated our work in preparation for the BLA submission and commercial launch of a more of a talks of man to this and.
Public continued to engage with the ovarian cancer medical community to educate.
On the robust datasets already generated with more of a tux of map and to increase awareness of folate receptor alpha as a promising biomarker for patient selection for targeted therapy in parallel we are gearing up to submit the BLA in the first quarter of 2000.
Mark Joseph Enyedy: In parallel, we are gearing up to submit the BLA in the first quarter of 2022 to support potential accelerated approval in the second half of the year, and with commercial inventory in place, we are finalizing plans for distribution.
The 22 to support potential accelerated approval in the second half of the year and with commercial inventory in place. We are finalizing plans for distribution. So we've got a lot going on and look forward to keeping you updated on our progress as we approach the potential launch of more of Rituximab next year, the remainder of our innovative portfolio of ADC.
Mark Joseph Enyedy: So we've got a lot going on and look forward to keeping you updated on our progress as we approach the potential launch of Mervituxababab next year. The remainder of our innovative portfolio of ADCs is also progressing. IMGN 632, our CD-123 targeting ADC, also has the potential to launch in 2022 and BPDCN and is also being studied in combination with AML, with data from our AML cohort expected at ASH next quarter. IMGC 936, an item 9 targeting ADC that we're co-developing with macrogenics, is advancing through dose escalation.
<unk> is also progressing <unk> 6.3 to our CD 123 targeting ADC also has the potential to launch in 2022 and BP DCM and is also being studied in combinations in AML with data from our AML cohort of expected at Ash next quarter.
<unk> 936, and the item 9 targeting.
Getting the ADC that we're co developing with Macrogenics is advancing through dose escalation and IMG and 151 of our next generation anti folate receptor Alpha ADC is on track for an IND submission by year end, so with that I'll turn the call over to Anna to provide some additional insight into our clinical programs and more on our medical education initiatives.
Mark Joseph Enyedy: And IMGN151, our next generation antifolate receptor alpha ADC, is on track for an I&D submission by year end. So with that, I'll turn the call over to Anna to provide some additional insight into our clinical programs and more on our medical education initiatives.
Anna.
Anna Berkenblit: Thanks, Mark. Just a few more details on the final data from our Forward 2 study, evaluating my mermituximab in combination with Avastin, in patients with medium and high f-R-al a expressing recurrent ovarian cancer, for whom a non-flatman-based combination regimen is appropriate. These data were presented during an oral session at Asto in June. The combination demonstrated robust anti-tumor activity in patients with high f-r alpha expression, including a confirmed overall response rate of 64%, a median duration of response of 11.8 months, and a median progression-free survival of 10.6%, with manageable adverse events that were consistent with the side effect profiles of each We are highly encouraged by these findings as we believe they reinforce myrotoxinab's potential to serve as a combination agent of choice in ovarian, and support its use in earlier lines of therapy.
Mark just a few more details on the final data from our forward 2 study evaluating <unk> in combination with Avastin in patients with medium and high fr Alpha expressing the current ovarian cancer non.
The platinum based combination regimen is appropriate these data were presented during the call.
Cash at Astro in June.
The combination demonstrated robust antitumor activity in patients with high fr Alpha expression, including the confirmed overall response rate of 64% of median duration of response of 11.8 months and the median progression free survival of $10.6 months with manageable adverse.
For our sense that were consistent with the side effect profiles of each agent.
Really encouraged by the scientists as we believe they reinforced my other types of that potential to serve as the combination agent of choice in ovarian cancer and support of for use in earlier lines of therapy.
Anna Berkenblit: Additionally, a randomized phase two investigator-sponsored study with Dr. Philip Harder in Germany is now underway evaluating myrbitoxinab plus carboplatin compared to standard of care in approximately 140 recurrent platinum-sensitive ovarian cancer patients. These data, along with the outcomes from the ongoing 70-tacient ISP, led by Dr. Rebecca Arendt at UAB, will further inform our path forward as we consider our label expansion Turning to Mervatuximab Monotherapy Beyond Saraya and Mirosol, this quarter, we plan to initiate patient enrollment in Piccolo, our new single-arm study of Mervatuximab monotherapy in third line plus, F-R-alpha high, recurrent platinum-sensitive ovarian cancer patients, with a primary endpoint of confirmed overall response rate and a secondary endpoint of duration of response.
Additionally, our randomized phase 2 investigator sponsored.
First of the day with Dr. Philip harder in Germany is now underway evaluating <unk> plus carboplatin compared to standard of care in approximately 140 recurrent platinum sensitive ovarian cancer patients.
These data along with the outcomes from the ongoing 70 patient Neo adjuvant <unk> T led by Dr.
Alright at UAB will further inform our path forward as we consider our label expansion option from the Rituximab in combination with Carboplatin.
Turning to more of Rituxan that monotherapy beyond the Saran Mirasol this quarter, we plan to initiate patient enrollment in piccolo, our new cingular.
Rebecca study of more of a tuck the mab monotherapy in third line plus fr Alpha high recurrent platinum sensitive ovarian cancer patients with the primary endpoint of confirmed overall response rate and the secondary endpoint of duration of response.
With the incorporation of PARP inhibitors as maintenance in frontline and in platinum.
Anna Berkenblit: With the incorporation of PARP inhibitors as maintenance in front line and in platinum-sensitive first relapse, more ovarian cancer patients are recurring with later-line disease that is still technically platinum sensitive with a platinum-free interval of greater than six months. But these patients may not be suitable for another platinum-based therapy. This is because of the cumulative risk of hypersensitivity reactions with repeated exposure to platinum, as well as other potential toxicities related to platinum.
Single items first relapse.
For ovarian cancer patients are recurring with later lines of disease that its still technically platinum sensitive with the platinum free interval of greater than 6 months.
Of these patients may not be suitable for any other platinum based therapy. This is because of the cumulative risk of hypersensitivity reactions with repeated exposure.
I understand that and as well as the other potential toxicities related to platinum.
In addition, the patients who recur after their tumors had been under selective pressure from the maintenance PARP inhibitor may not be of sensitive to additional platinum as well the 2 broker in the absence of maintenance therapy.
Anna Berkenblit: In addition, patients who recur after their tumors have been under selective pressure from the maintenance PARP inhibitor may not be as sensitive to additional platinum as those who occur in the absence of maintenance there. The Piccolo trial is designed to address this increasing unmet need for an effective non-platinum option in later lines of platinum-sensitive, As Myrtostomab lives closer to potential approval, we continue to educate the medical community on the importance of establishing folate receptor alpha as an important biomarker in ovarian These medical education efforts include advisory boards with pathologists and oncologists, biomarker workshops and symposia at Congresses, and presentations at upcoming Congress, We're working with Roche Tissue Diagnostics and Roche Diagnostics Corporation to develop and commercialize the companion diagnostic for folate receptor alpha.
The people of the trial is designed to address this inquiry.
For the pricing unmet need for an effective non cotton option in later line platinum sensitive disease.
As another testament of moves closer to potential approval, we continue to educate the medical community on the importance of establishing folate receptor alpha as an important biomarker in ovarian cancer.
These medical.
Education efforts include advisory voices apologists in oncologist biomarker of workshops.
The congresses and presentations at upcoming Congresses.
We're working with Roche tissue diagnostics, and diagnostics corporation to develop and commercialize the companion diagnostic for folate receptor Alpha.
With the groundwork for your lane, we expect physicians to assess folate receptor alpha expression as part of their standard of diagnosis and treatment decision process. Following the approval from the Rituximab and the companion diagnostic.
Moving to our second pivotal program, we continue to enroll the frontline and relapsed refractory.
We think the applications in our phase 2 study of IMG and 632 and expect topline data in the first half of next year.
Recall that 632 is also advancing in the phase 1 of these 2 dose escalation study in combination with a decided to limit the need of class in patients with relapsed refractory AML.
Anna Berkenblit: With the groundwork we are laying, we expect physicians to assess folate receptor alpha expression as part of their standard diagnosis and treatment decision process following approval of myrotoxymab and the companion diagnosis. Moving to our second Pivotal program, we continued to enroll frontline and relapse-refractory BPDCN patients in our phase two study of IMGM 632 and expect top-line data in the first half of next year. Recall that 632 is also advancing in a phase 1B to dose escalation study in combination with Acididine and Benetoclast in patients with relapsed refractory AML and as a monotherapy in patients with MRD positive AML.
The <unk>.
And at the monotherapy in patients with <unk> positive AML.
We look forward to presenting initial AML combination data for <unk> with the need of cracks in the decitabine at Ash in December.
As Mark mentioned, we are also excited about the advancements of IMTT $90.6 and IAG in 1.
The M at 1 and look forward to updating you on our progress with both of these adcs with that I'll turn the call over to Susan to cover the financials.
Anna starting with our results for the second quarter of 2021, we generated $16.9 million in revenue, which consisted primarily of noncash royalty revenue.
Anna Berkenblit: We look forward to presenting initial AML combination data for IMGM632 with Benetoclastinaseocytidine and ash in December. As Mark mentioned, we are also excited about the advancement of IMGC 936 and IMGN151, and look forward to updating you on our progress with both of these agents.
Operating expenses were $44.3 million comprised of $34.6 million of R&D expenses, compared with $22.9 million in $2029.7 million of G&A expenses compared to $9.8 million in 2020.
We ended the second quarter with $239.5 million.
Susan Altschiller: To that end, I'll turn the call over to Susan to cover the financial results, thanks, Anna. Starting with our results for the second quarter of 2021. We generated $16.9 million in revenue, which consisted primarily of non-cash royalty revenue. Operating expenses were $44.3 million, comprised of $34.6 million of R&D expenses compared with $22.9.7 million of GNA expenses compared to $9.8 million in 2020. We ended the second quarter with $239.5 million in cash and cash equivalence on the balance.
Cash and cash equivalents on the balance sheet.
Our financial guidance for 2021 remains unchanged, we expect revenues to be between 65 and $75 million operating expenses between $200.210 million in cash and cash equivalents at year end to be between 140 and $150 million.
Our current cash runway continues to be sufficient to fund operations into the second half of 2022 with that we'll open the call for questions operator.
Thank you as a reminder, task of question you'll need the press. The Star then the 1 key on your Touchtone telephone.
To withdraw your question press the pound.
Susan Altschiller: Our financial guidance for 2021 remains unchanged. We expect revenues to be between $65 and $75 million, operating expenses between $200 and $210 million, and cash and cash equivalents at year end to be between $140 and $150 million. Our current cash runway continues to be sufficient to fund operations into the second half of 2020. With that, we'll open the call to questions. Thank you.
<unk>.
And our first question comes from John Newman with Canaccord.
Your line is open.
Hi, guys. Thanks for taking my question.
Wondering if you could talk a bit more about.
The rationale behind the pick of a study.
Also curious if you could talk.
About how that will mesh with your strategy for <unk>.
Expanding from.
Protects the mab and.
In other lines of therapy.
Operator: Thank you. As a reminder, to ask a question, you'll need to press the star, then the one key on your touchtone telephone. To withdraw your question, press the pound key. And our first question comes from John Newman with Canacord.
Going forward after approval. Thank you.
Yeah, So maybe I'll ask Anthony to talk about the medical rationale and what we're seeing in terms of.
And the increasing population of these patients in the why that might be the case and that could talk a little bit more about the broader strategy.
Unknown Speaker: Hi guys, thanks for taking my question. I was just wondering if you could talk a bit more about the rationale behind the Piccolo study. Also curious if you could talk about how that will mesh with your strategy for expanding Virotoxymab in other lines that there would be going forward after approval. Yeah, so maybe I'll ask Anna to talk about the medical rationale and what we're seeing in terms of an increasing population of these patients and why that might be the case, and that can talk a little bit more about the broader strategy.
Yeah. So.
We know the platinum historically has been the most active agents in ovarian cancer and therefore when patients recur after platinum based therapy, if they're platinum.
And free interval of greater than 6 months, they typically get another line of platinum and unfortunately for patients with each line of platinum. There's a law of diminishing returns if you will and there are.
<unk> disease for your progression free survival gets shorter and shorter and at some point day developed platinum resistant disease.
Unknown Speaker: Yeah, so we
Unknown Speaker: We know that platinum historically has been the most active agent in ovarian cancer, and therefore when patients recur after platinum-based therapy, if their platinum-free interval is greater than six months, they typically get another line of platinum. Unfortunately, for patients with each line of platinum, there's a law of diminishing returns, if you will, and their disease-free or progression-free survival gets shorter and shorter. And at some point, they develop platinum resistance.
<unk>.
As more and more patients are being treated with PARP inhibitors in maintenance.
After.
Achieving of CR or PR from platinum based therapy.
This is extending their platinum free interval and so patients may now have.
Still have technically platinum sensitive recurrent disease.
<unk> disease, but they're platinum free interval. If you will has been artificially extended by PARP inhibitor maintenance and the selective pressure that that has been putting on the tumor. So this emerging population of patients may not be the same as patients in the olden days, if you will who head of platinum free interval.
Unknown Speaker: However, as more and more patients are being treated with PARP inhibitors in maintenance after achieving a CR or PR from platinum-based therapy, this is extending their platinum-free interval. And so patients may now still have technically platinum sensitive recurrent disease, but their platinum-free interval, if you will, has been artificially extended by PARP inhibitor maintenance and the selective pressure that that has been putting on the tumor. So this emerging population of patients may not be the same as patients in the olden days, if you will, who had a platinum-free interval of six to 12 months, but their tumors saw nothing in the interim. And so we anticipate that there will be more data out there as more patients become part of this category that will guide a further understanding of what the benchmark in this population is.
Of 6 to 12 months, but there are tumors.
<unk> saw nothing in the interim.
So we anticipate that there will be more data out there as more patients are becoming part of this category that will guide us for their understanding of what the bench Mark in this population is but what I can tell you right now is based on anecdotal data from earlier in the market.
Of that program, where patients with recurrent platinum sensitive disease did receive from America toxin that monotherapy member touch the Nab is quite active and so that's why we are beginning the piccolo study this quarter and that will help us further understand the efficacy profile of <unk> and have in the later line.
Current platinum sensitive.
<unk> population that is growing with an increasing unmet need.
So John maybe just to frame this in the broader in the context of the broader development plan and expected labels for the products. So our initial label comes in platinum resistant disease and there we're looking to displace single agent chemotherapy.
Unknown Speaker: But what I can tell you right now is based on anecdotal data from earlier in the Mervitoxinab program where patients with recurrent platinum-sensitive disease did receive Mervatuxam monotherapy, Mervatuxinab is quite active. And so that's why we're beginning the Picolo study this quarter, and that will help us further understand the efficacy profile of Mervatuxinab. in this later line recurrent platinum sensitive population that is growing with an increasing unmet need. So John, maybe just to frame this in the wider context of the broader development plan and expected labels for the product.
Therapy single agent Chemo is about half the market.
In platinum resistant disease today. So the goal is to us to supplant that the.
Remainder of the platinum resistant spaces treated with generally a range of of combination specifically avastin based chemo combinations.
So the data that we published the Vasco in June really speaks to the opportunity there.
We think we've got compelling data.
Unknown Speaker: So our initial label comes in platinum-resistant disease, and there we're looking to displace single-agent chemotherapy. Single-agent chemo is about half the market for platinum-resistant disease today, so the goal is to, you know, supplant that. The remainder of the platinum-resistant base is treated with a range of combinations, specifically Avastan-based chemotherapy combinations. And so the data that we published at ASCO in June really speaks to the opportunity there, and we think we've got, you know, compelling data to support a compendial listing for that indication.
To support the companion listing for the indication when you look at the platinum sensitive space as Andrew was talking about you know Ah.
Ah patients.
As the first line therapy are treated with <unk>.
Carbo.
Carbo Pac for Carbo gem combinations, often as the triplet with the vast and followed by <unk>.
Part of maintenance, although the share of patients getting maintenance it might be smaller than 1 would imagine.
When you get the third line platinum However, third line therapy, what you see us only about 30% of patients are receiving platinum based chemo and so there's a big gap the remainder of that population that we could target either with the mirv Bev combo and again some of the data that we had at.
Unknown Speaker: When you look at the platinum-sensitive space, as Anna was talking about, patients as their first-line therapy are treated with, you know, carbopac or carbogem combinations, often as a triplet with Avastin followed by part maintenance, although the share of patients getting maintenance is maybe smaller than one might imagine. When you get the third-line platinum, however, or third-line therapy, what you see is that only about 30% of patients are receiving platinum-based chemo.
Pascal we had of 69% response rate with the Mirv Bev combo in platinum sensitive patients, but this is really a GAAP, where we think of monotherapy could fit in.
The data in terms of patient numbers is a little sketchy in terms of the third line platinum sensitive of our best estimate based on DRG and.
Unknown Speaker: And so there's a big gap, you know, the remainder of that population that we could target either with the MRV-Bev combo or, again, some of the data that we had at ASCO, we had a 69% response rate with the MRV-BV-BF combo in platinum-sensitive patients. But this is really a gap where we think a monotherapy could fit in. You know, the data, in terms of patient numbers, is a little sketchy in terms of third-line platinum sensitive.
The <unk> surveys there of about 2000 patients in the third line.
And as I said about 30 of the 30% of those patients get.
Our platinum based chemo regimen, so that leaves us the remainder of that population.
To go after.
Excellent. Thank you.
Okay.
Thank you. Our next question comes from Michael Schmidt with Guggenheim Securities. Your line is open.
Unknown Speaker: Our best estimate, based on DRG and some physician surveys, is there are about 2,000 patients in third line. And as I said, about 30% of those patients get a platinum-based chemo regimen, so that gives us the remainder of that population to go after.
Hey, Good morning, guys. This is ebay on for Michael Thanks for taking all the questions.
I think.
1 of them more.
More of it took the map.
Do you think of re treatment with Merck.
Operator: Excellent. Thank you. Thank you. Our next question comes from Michael Schmidt with Guggenheim Securities. Your line is open.
Or if it's possible with some of other backbones of the combo therapies and if so with various combo regimen is currently being evaluated how good the each mirv combo regimens sequenced.
Unknown Speaker: Hey, good morning, guys. This is I-Gay-On for Michael.
Unknown Speaker: Thanks for taking our questions. I think we'll have a quick one on Mervit TuxMap. Do you think a retreatment with MIRF is possible with some of the other backbones of combo therapy? And if so, with various combo regimens currently being evaluated, how should each MRF combo regimen be sequenced? Yeah, so there certainly is precedent for retreatment, even with non-targeted cytotoxics in ovarian cancer. And obviously, we just talked about retreatment with platinum in a lot of detail.
Yeah. So there's certainly is precedent for re treatment even.
The non targeted cytotoxic in ovarian cancer. So obviously, we just talked about re treatment with platinum and a lot of detail.
Re treatment with tubular and directed inhibitor like Paclitaxel actually also is beneficial in ovarian cancer, there's very nice data showing that patients who receive prior.
Even with the 3 week Paclitaxel may benefit from us.
<unk> weekly Paclitaxel and as you know the payload from the Rituxan that is of tubular director of inhibitor. So there certainly is the potential for repeated treatment with Merck attack the math.
Unknown Speaker: Retreatment with tubulin-directed inhibitors like pachlaxil is actually beneficial in ovarian cancer. There are very nice data showing that patients who received prior Q3-week pachlaxil may benefit from subsequent weekly pachlaxil. And as you know, the payload for myrvotoxymab is a tubular-directed inhibitor. So there certainly is the potential for repeated treatment with myrvotoxymab, based on the mechanism of action of the payload. Switching to the target, we did show in our biopsy cohort several years ago now that patients who receive myrvotoxinab and then have a subsequent biopsy, after a couple cycles of maripotoxymats still express folate receptor alpha, so it's not quickly downregulated that would suggest resistance.
Based on the mechanism of action of the payload.
Switching to the target.
Did show in our biopsy cohort several years ago now.
That patients who received more of a toxin that and then have a subsequent biopsy.
After a couple of cycles of the merit of of toxin. That's still express folate receptor alpha. So it is not quickly down regulated that would suggest resistance.
Got it that's that's that's very helpful. Thank you.
Yes.
Thank you. Our next question comes from Boris <unk> with Cowen Your line is open.
Operator: Got it, that's fair, very helpful. Thank you. Thank you. Our next question comes from Boris Peaker with Cowan. Your line is open.
Oh good morning, maybe 1 question on Margaret talked for a number of another on fixed or 2 on Margaret talked some of them can you just comment on the.
The Piccolo study timeframe and when would be getting any kind of updates from it I would overlap for some of the other clinical studies ongoing.
Unknown Speaker: Good morning. Maybe one question on Mervitoxm, but another on 632. On Mervitoxum, can you just comment on the Piccolo study timeframe and when we'll be getting any kind of updates from it, how it will compare with some of the other clinical studies ongoing? Yeah, so Piccolo's on track to start this quarter. And I think it's a little too early to say, Boris.
Yeah, So piccolo the contract to start this quarter.
And I think it's a little too early to say for US certainly you know once the trial is up.
Running.
Future calls, we can certainly provide some guidance regarding timing right now are our key focus is the survey of the L. A.
Unknown Speaker: Certainly, you know, once the trial is up and running, you know, at future calls, we can certainly provide some guidance regarding timing. Right now, our key focus is the Suraya BLA and Mirosol, and we're getting Piccolo up and running, and we look forward to the data from that study because we think it's a really increasing population with unmet needs.
Mirasol and we're getting people up and running and we look forward to the data from that study because we think it's a really increasing population with unmet need.
Got it.
<unk> 3.2 so can.
Can you maybe touch on our guidance expectation at Ash and also just the 1 I understand from the regulatory perspective as monotherapy in <unk> positive disease, what's the Fda's view on them already positive mark the negative conversion as the regulatory endpoints.
Unknown Speaker: On 632, can you maybe set some data expectations at Ash and also just want to understand from the regulatory perspective, as monotherapy and MRD positive disease, what's the FDA's view on MRD positive to MRD negative conversion as the regulatory endpoint? Yeah, so at Ash, we anticipate presenting all the data that we have for the triplet of 632 with Azocidididine and Venetoclac. You may recall we started off with Doublet, combining Azacididine and Venetoclast, and then we moved into the triplet dose escalation. So we will have, I would say, a robust data set at Ash, dose escalating, exploring 632 with Azacididine and Vanita Class that will give us.
Yeah, so at Ash, we anticipate presenting.
<unk> all of the data that we have for the triplet of 632 with a society of Dean and the need of class you May recall, we started off with double that combining what they've decided and with many of the class and then we moved into the triplet dose escalation. So we will have I would say of robust dataset at ash.
The.
Dose escalating exploring 632 with either side of the Dean and the need of class.
We will give a good sense of the safety profile of the triplet.
The tolerability of the triplet as well as the anti leukemia activity that we're seeing at this point that supports further development in the relapsed refractory setting and ultimately perhaps.
From the frontline setting.
Unknown Speaker: have a good sense of the safety profile of the triplet, the tolerability of the triplet, as well as the anti-lupemia activity that we're seeing at this point that supports further development in the relapse refractory setting and, ultimately, perhaps in the front line setting. Moving to your question regarding MRD positive to negative conversion, clearly that is not yet a precedent for approval in the AML setting. There is a precedent in the ALL setting, but that was a bit different because there was prior phase three data with overall survival benefit for the drug, which then allowed for subsequent consideration of approval in terms of MRD conversion.
Moving to your question regarding <unk> positive to negative conversion.
Clearly that is not yet a precedent for approval in the AML setting there is a precedent in the a L. L setting that that was a bit different because there was a prior.
3 data with overall survival benefit for the drug where we're at.
Then allowed for subsequent consideration of approval in terms of MRV conversion I think it's a little premature to assume that it would be an appropriate endpoint for FDA I would also note.
Note that on the Red did get their approval. That's the oral is aside of D. A.
Unknown Speaker: I think it's a little premature to assume that it would be an appropriate endpoint for FDA. I would also note that Onyereg did get its approval; that's oral azocytide in a broader population in maintenance, so not just MRD positive patients. And when you look at the subset data for on your reg, the MRD positive subset in their study doesn't do so well. And so there is certainly, I would say, a remaining unmet need there. I hope that that is clarified for us. Great. Thank you very much for that.
In a broader population in maintenance so not just <unk> positive patients and when you look at the subset data for on your edge of the MRV positive subset in the study doesn't do so well and so there is certainly I would say of remaining.
The phasing that need their book that clarified for us.
Great. Thanks, so much for taking my question.
Okay.
Thank you our next question comes from.
Sorry I'm the.
Rama Khan with H C. Wainwright your line is open.
Thank you this is RK from HC Wainwright.
Operator: Thank you. Our next question comes from Sua on Pakuta Ramakan with H.C. Wainwright. Your line is open. Thank you. This is our care from here to Wainwright.
The.
Couple of quick questions from.
The press release, you have and noticing that M. Gs items, you see 96.
Unknown Speaker: Thank you. This is RK from Hitsi Wainwright. A couple of quick questions.
Being looked at in multiple solid tumors.
Unknown Speaker: In the press release, you have a note saying that IMGC-936 is being looked at in multiple solid tumors. Is it possible for you to enumerate at least, you know, some of the major tumors that you're looking at? Sure, so IMGC-9 targets Adam 9, which is a member of the matrix metalloproteinase and disintegrating family, and it is expressed highly across multiple solid tumors, including pancreatic cancer, gastroasophageal cancer, triple negative breast cancer, and lung cancer.
It.
Is it possible for you to.
At least.
You know some of the major to us that Youre looking at.
Okay.
Sure. So IMTT 93, 6 targets, Adam 9 which is a member of the matrix metallic Coty, Nathan disintegrating family and it is in expressed highly across multiple solid tumors.
Including a pancreatic.
Grab of cancer, gastroesophageal cancer Triple negative breast cancer and lung cancer. It's also expressed in other tumor types as well and so we've already generated very nice preclinical data showing the distribution of the expression across the solid tumors supporting their inclusion in the phase 1 dose escalation study.
Unknown Speaker: It's also expressed in other tumor types as well, and so we've already generated very nice pre-clinical data showing the distribution of expression across solid tumors supporting their inclusion in the phase one dose escalation study. We are enrolling all comers, given the anticipated atom nine expression in these tumor types. We're collecting tumor tissue from all patients so that, retrospectively, we can look at atom nine by immunohistochemistry, and then we'll be well positioned to develop a companion diagnostic for patient selection should we need it.
We are.
Enrolling all comers given the anticipated Adam 9 expression in the tumor types, we're collecting tumor tissue on all patients. So that retrospectively. We can look at out of 9 by Immunohistochemistry, and then we will be well positioned to develop a companion diagnostic for patient selection should we need it.
Just a follow.
Unknown Speaker: Just a follow-up on that, any timing at all in terms of data, and then also regarding 151, you know, what work needs to be done before, you know, we can launch it into the clinic. Yeah, so timing for IMGC 936, we're in dose escalation, and we anticipate data early next year, you know, at which point we'll have recommended phase two doses, you know, safety, and a sense of the tumor types that are of greatest interest.
The up on the any any timing at all in terms of data and then also regarding 1 fly 1 what.
What work needs to be done.
Before we can launch it into the clinic.
Yes, the timing for <unk> 93, 6 we're in dose escalation.
And we anticipate data early next year.
At which point, we will have a recommended phase II dosing.
Safety and a sense of the tumor types that are of greatest interest.
Unknown Speaker: Moving to 151, we're on track to file the IND before the end of the year. We're doing, you know, the last bits and bouts of what we need to from a talk perspective and a CMC perspective.
Moving to 151, we're on track to file the IND before the end of the year, we're doing the the last.
<unk> fits in box of what we need to from a top of perspective and the CMC perspective.
Thank you very much on us thanks for taking all of my questions.
Sure.
Unknown Speaker: Thank you. Our next question comes from Andy Sy with William Blair.
Thank you. Our next question comes from Andrew Tsai with William Blair. Your line is open.
Unknown Speaker: Great, thanks for taking away the questions, and congratulations on all the progress. So, regarding the Picklell study that you are planning to start this quarter, I am just wondering how much enrollment optimization you can achieve with a study, just given your existing network of clinical trial sites for Saraya and Marisol. I think the short answer is a lot, given that, you know, we've studied myrvituxinamad now at well over 100 sites, closer to around 200 sites throughout the globe.
Okay.
Great. Thanks for taking my questions and congratulations on all of the progress so.
Regarding.
The pick of a study that you're planning to start this quarter.
Im just wondering.
How much enrollment optimization can you achieve.
With the study just.
Sure existing network of clinical trial sites for the rail and Mirasol.
I think the short answer is a lot.
Given that.
The studied more of a toxin that now in well over 100 sites closer to around 200 sites throughout the globe.
Unknown Speaker: So, you know, we're, again, like we did with Suray and Mirosol, picking the best of the best sites who have high patient volumes, participate in clinical trials with high data quality following GCP, and, you know, have the patient population that's appropriate.
Again like we did with the ran Mirasol, we're picking the best of the best sites.
Who have high patient volume.
Participate in clinical trials with high data quality of following G. C. P M.
And you now have the patient population that's appropriate for here and experience with our book Yes.
Unknown Speaker: And experience with our drugs. Right, that's helpful, thank you. And also, maybe taking a macro view on the folder receptor ADC space, maybe Mark or Anna, perhaps you can comment on the Bristol-Myers and E-Sai collaboration that was announced earlier this month. And also kind of looking at the pipeline, you know, you have four assets right now. In the event of a successful Saraya trial, how should we think about future R&D investment going forward? Sure, so maybe I'll let Anna tackle the competitive landscape, and then we can talk about where we're going as a business.
Alright Thats helpful. Thank you and also.
Maybe picking of a macro view on the photo you said for ADC space, maybe mark.
Perhaps you can opine on the.
The Bristol Myers, the ESI collaboration that was announced earlier.
Of this month and.
And also kind of looking at the pipeline you have for assets right now.
In the event of the successful survey of trial, how should we think about future R&D investment going forward.
Sure So maybe I'll, let anna tackle the competitive landscape.
And then we can talk about where we're going into the business.
Unknown Speaker: Yeah, so we consider the BMS-A-ZI deal really, you know, validating in terms of them recognizing, as we do, that folate receptor alpha is an important target in the treatment of cancer. However, what I would say is that the publicly available data for their compound Morab 2O2 are at this point limited to a single site in Japan. As you may recall, they have linked up their failed farlatutumab naked f-r-alpha antibody with ribulin, which is their cytotoxic that is approved for later-line breast cancer. And so based on the data from dose escalation in the data, that one site in Japan. They have certainly seen activity in tumor types that are known to express folate receptor alpha.
Yeah. So we consider the BMS ASI deal really you know validating in terms of the recognizing as we do that folate receptor Alpha is an important target in the treatment of cancer.
What I would say is that.
The publicly available data for their compound more at 2 of <unk>.
Or at this point limited to a single site in Japan.
As you may recall, they have linked up their sales Harlan <unk> Mab naked fr Alpha antibody with of revealing which is their cytotoxic debt.
Is approved for later line breast cancer.
And so based on the data from dose escalation in the.
At 1 site in Japan, they have certainly seen activity.
In the tumor types that are known to express folate receptor alpha.
Unknown Speaker: And so certainly, I think that formed the foundation for their agreement. They are currently in a U.S. study open at a handful of sites. And they're dose escalating.
And so certainly I think that formed the foundation.
Foundation for their agreement. They are currently in a U S study it opened at a handful of sites on their dose escalating they don't yet have a recommended phase II.
Unknown Speaker: They don't yet have a recommended phase two dose and schedule, but, you know, we'll follow them. And I think from our perspective, not only is it validation for FR alpha, but it makes us that much more excited to get IMGN151 in the clinic as soon as possible because we really know from our preclinical data that it's designed to address a broader population of FR alpha positive tumors and really has the chance to really move the field even further than myrbitoxymatic.
Dosing schedule, but you know, we'll follow them and I think from our perspective.
Not only the validated for fr Alpha, but it makes us.
That much more excited to get <unk> and 151 in the clinic as soon as possible because we really know from our preclinical data that it's designed to address the broader population of fr Alpha positive tumors and really has the chance to really move the field, even further than mere botox for Nab will.
So in the Andy in terms of the future direction for the business. So you may recall, when we restructured back in 2019, we chose for programs to move forward and given the progress over the last 2 years I would say we chose well.
Unknown Speaker: So Andy, in terms of the future direction for the business, you may recall when we restructured back in 2019, we chose four programs to move forward. And given the progress over the last two years, I'd say we chose well. But at that time, we had programs that we shelved.
At that time.
We had programs that we shelved and in particular.
Unknown Speaker: And in particular, we have a new class of Campathesan payloads that have been internally developed. And so as we look ahead and with some success in Saraya, the objective will be to move those programs off the shelf and, in particular, pursue additional development of this Camp to Feast and payload. We have a fair amount of inbound interest with respect to the immunogen platform broadly in terms of linkers and payloads and specific interest in the new class.
Particular, we have a new class of Camptothecin payload that had been internally developed and so as we look ahead and with some success and survey of the objective will be.
To move those programs off the shelf and in particular pursue additional development of this camptothecin payload.
We.
We have a fair amount of inbound interest with respect to the immunogen platform broadly in terms of Winkers and payloads and specific interest in this.
New class in addition to that okay.
Unknown Speaker: In addition to that, akin to the relationship that we have with macrogenics, we continue to have folks approach us about co-development collaborations where they've identified an antibody that they think would be a good candidate for an ADC, and so those discussions are ongoing as well. And so we do expect, following a positive outcome in Saraya, to begin to expand the portfolio, levering our existing technology and our ability to combine with antipodies to generate novel ADCs, so that's absolutely the direction that we're headed. That's very helpful. Thanks for answering my questions, Mark and Anna.
The the relationship that we have with Macrogenics we continue.
To have folks approach us.
US about co development collaborations where they've identified an antibody that they think would be a good candidate for an ADC and so those discussions are ongoing as well and so we do expect following a positive outcome and so rates begin to expand the portfolio leave range.
Our existing technology and our ability to combine.
With the antibodies.
Generates the novel ADC, So that's absolutely the direction that we're headed.
That's very helpful. Thanks for answering my questions.
Marketing and I'm.
Operator: Thank you. Our next question comes from Kenan McKay with RBC Capital Markets. Your line is open.
Sure.
Thank you. Our next question comes from Kennan Mackay with RBC capital markets. Your line is open.
Hi, This is Sudan Logan Nathan on for Mark Ken and Steve. Thanks for taking the other questions. So first wanted to ask kind of what the benchmark is.
Unknown Speaker: Hi, this is Sudan Logan Nathan on from Kenan's team. Thanks for taking the question. So first, I wanted to ask kind of what the benchmark is kind of discussed, you know, amongst the physician population for the single-on-pickal lo-study from every tax map as a monotherapy. So, you know, kind of what would kind of give physicians the confidence to use that as a monotherapy class? And then kind of where are they?
Kind of discussed.
The.
Population for the single arm Piccolo study for me of Rituxan Mab as a monotherapy. So you know kind of what you know what.
And of what would kind of give the confidence to the physician physicians to use that as a monotherapy class and then kind of where the conviction comes from you guys on the F. R.
Unknown Speaker: Conviction comes from you guys on the FR alpha, you know, a target for oberian cancer, then, you know, how that could grow, you know, into a mod to be for other indications. And then secondly, just kind of a large picture question just on any headwinds that you see from COVID-19, uh, the kind of macro environment to enrollment for some of the other pipeline studies that's already been kind of determined, or could there be some headwinds there going forward. So, thanks.
Our Alpha you know our target for of ovarian.
Ovarian cancer, then you know how of that could grow.
The amount that would be for other indications and then secondly, just kind of of a large picture question just on any headwinds that you see from out of the COVID-19, they are debt.
Kind.
The macro environment of 2 enrollment for some of the other pipeline studies, if that's already been kind of determined or.
Could there be some headwinds there going for it.
Unknown Speaker: Yeah, so the benchmark question regarding Piccolo is an important one. So, you know, we're targeting laterline platinum sensitive disease, and these are patients who, didn't really exist in the past, or if they did at very small numbers, and actually, frankly, they were mostly BRCA mutants because those patients whose tumors have BRCA mutations are exquisitely sensitive to platinum, and they're the ones who can get, you know, multiple lines of platinum, and continue to get benefit, again, each with a diminishing return.
Thanks.
Yeah, so the bench.
Mark question regarding Piccolo is an important 1.
No.
We're targeting later line platinum sensitive disease, and these are patients who.
Didn't really exist in the past or if they did at very small numbers and actually frankly, they were mostly the RCA mutant patients because those patients whose tumors have the ERP of mutations are exquisite.
You are sensitive to platinum and they're the ones, who can get multiple lines of platinum.
For you to get benefit again without diminishing our return.
So now that part maintenance is being incorporated not just for the RCA mutations, but also for HRD and even.
Unknown Speaker: So now that heart maintenance is being incorporated, not just for BRCA mutations but also for HRD, and even in an untargeted fashion where, admittedly, the benefit is less, there are still, more patients with this later-line platinum sensitive disease, and there are, to our knowledge, no, I would say, level one evidence papers to support a firm benchmark. I'm very personally interested in the data that will be coming out over the next year or so that will shed light on what the appropriate. The benchmark is.
The targeted fashion, where admittedly the benefit of less there are still there are more patients with US later line platinum sensitive disease and there are to our knowledge no I would say level, 1 evidence papers to support of firm benchmark.
I am very personally interested in the day.
And in Unbilled, the coming out over the next year or so that will shed light on what the appropriate benchmark us guardrails wise. The the data that are out there admittedly from older populations that are less relevant now include response rate.
Unknown Speaker: You know, guardrails wise, the data that are out there, admittedly, from older populations that are less relevant now, include response rates in second, third line, platinum sensitive disease for non-platinum single agents of 10 to 12 percent. And in those later lines, you know, three to four priors who are platinum sensitive and have a BRCA mutation, the response rate is about 30%. If you look at platinum doulet, in patients who've just had one prior line, the response rate is about 40, 45%. So imagine it dropping, you know, with each line of therapy.
In.
The second and third line platinum sensitive disease.
That were non platinum single agents of 10% to 12%.
And in those later line 3 to 4 prior who are platinum sensitive and have of BRC a mutation of the response rate is about 30%.
If you look at platinum doublets in patients who've just had 1 prior line.
The response rate is about 40%, 45%, so imagine it dropping with each line of therapy and.
Unknown Speaker: And this is why we really believe there's a high unmet need for these patients. And again, based on the anecdotal data that we have, we're quite excited about the potential for myurbituxinab in this population. That was your first question.
And this is why we really believe there's a high unmet need for these patients and again based on the anecdotal data that we have we're quite excited about the potential for America <unk> in this population.
That was your first question your second.
Unknown Speaker: Your second question was about other indications. So for Mervitopsamab, we are supporting a couple of investigator-sponsored trials in endometrial cancer. One is a monotherapy for high-grade cirrus endometrial cancer and one in combination with temporalizumab.
Second question was the other indications so for <unk>, we are supporting a couple of investigator sponsored trials in endometrial cancer, 1 of the monotherapy in high grade serous endometrial cancer and 1 in combination with <unk>.
Unknown Speaker: You know, we have some data for Mervitopsamab monotherapy in endometrial cancer already that suggests that could be an interesting additional target. I think we're saving lung cancer and triple negative breast cancer for IMGN151.
We have some data from of Rituxan that monotherapy in them.
The endometrial cancer already that suggests that the an interesting additional.
Targets, I think we're saving lung cancer and triple negative breast cancer for <unk> in the 151.
Unknown Speaker: And then your last question was regarding COVID-19 headwinds. Yes, there are COVID-19 headwinds. I mean, you know, with the Delta variant emerging now and the recent CDC guidance around masking, it will be interesting to see, frankly, how hospitals and, you know, clinical sites may be changing their working policies. But I don't think it's going to necessarily impact patient care because patients with recurrent ovarian cancer need
And then your last question was regarding COVID-19 headwinds.
Yes, there are of COVID-19 headwinds I mean with the Delta variant.
Emerging now and the recent CDC guidance around masking it will be interesting to see frankly, how hospitals and.
The clinical sites may be changing there.
Working policies I don't think it's going to necessarily impact patient care to patients with recurrent ovarian.
Oriented for knee treatment, but.
Unknown Speaker: But I wouldn't be surprised if, you know, there are, like we've already experienced some delays in contract turnover, IRB meetings, you know, the paperwork aspect of clinical trials, people are working from home. But what I'd also say is during COVID, over this past year, we've gotten really good at managing through those with our contingencies. Great. Thank you so much for all the color on those questions. I appreciate it. It's good. Thank you. Our next question comes from Kelly Shee with Jeffries. Your line is open.
I wouldn't be surprised if.
There are like we've already experienced some delays.
The contract turnover of IRB meetings.
The paperwork aspect of clinical trials.
People are working from home, but what I'd also say us during COVID-19.
For us over this past year, we've gotten really good at managing through those through.
Through those with our contingencies.
Great. Thank you so much for all of the color I appreciate it.
Okay.
Thank you. Our next question comes from Kelly she.
Jeffrey Your line is open.
So for taking my question I also have a question for Piccolo trial, what are the drivers what are out of this stage in the stage of what drives the deferred until only quota fr Alpha high patients.
Unknown Speaker: I also have a question for you.
Unknown Speaker: Piccolo trial, what drives, what at this stage, what drives the decision to only include FR alpha high patients, given that you mentioned there are large online needs in the third line of platinum sensitive patients, and also based on the previous experience, Merv is active in the FR alpha intermediate patients. Thank you.
Given that you mentioned of their large all my.
All of my needs in the third long question in the sense of Tam of patients and also based on the previous experience tomorrow the.
He is actually in the of.
Of all of our intermediate patients.
Yeah.
Yeah, we know now having studied <unk> in well.
Unknown Speaker: Yeah, we now know, having studied Mervituximab in well over 800 patients, the higher the F-R-Alpha expression, the deeper and more durable the tumor shrinkage. So you are absolutely right that Mervituximab is active in patients with medium F-R-A-Lpha expression, which is about 20% of the population. We know from the Forward One study that it's probably about the same in terms of its activity with single-agent chemotherapy. But, you know, we're really trying to move the field forward and have the potential to be the agent of choice.
My Labor 800 patients the hire of the fr Alpha expression of the deeper and more durable the tumor shrinkage. So you are absolutely right that the mayor of a toxin that is active in patients with medium fr Alpha expression, which is about 20% of the population.
We know from the forward 1 study that it's.
Probably about the same in terms of its activity with single agent chemotherapy.
But you know, we're really trying to move the field forward and have the potential to be the the agent of choice and we want to go where we can benefit patients for the most and that's really the 40% with high fr Alpha expression and that's.
Unknown Speaker: And we want to go where we can benefit patients the most. And that's really the 40% with high FR alpha expression. And that's, you know, based on archival tumor tissue; it's irrespective of platinum sensitivity or resistance. Thank you.
<unk> done archival tumor tissue.
Irrespective of.
Platinum sensitivity or resistance.
Yes.
Thank you for the color.
Operator: Thank you. Our next question comes from Joe Cantanzaro with Piper Sandler. Your line is open.
Okay.
Thank you. Our next question comes from Joe Kim from Zero with Piper Sandler Your line is open.
<unk>.
Unknown Speaker: Hey guys, thanks so much for taking my questions here. Anna, you mentioned the phase one experience with Myrotoximab and platinum sensitive patients. Just wondering the extent of prior PARP exposure in that population and whether there's any reason to think that extended part maintenance could potentially impact subsequent sensitivity to myrotopsimab. And then, just with regard to cash guidance and it being sufficient into the second half of 2022, what is that inclusive of, and I guess specifically around the potential commercial launch? of both myrbitoxymab and 632. Thank you.
Hey, guys. Thanks, so much for taking my questions here and then you mentioned the phase 1 experience with Merck Rituximab in platinum sensitive patients just wondering the extent the prior PARP exposure in that population and whether theres any reason to think that extended PARP maintenance could potentially impact.
Subsequent sensitivity.
Activity to remember it took the Mab and then just with regards to the cash guidance and it being sufficient into the second half of 2022, what is that inclusive of.
And I guess, specifically around the potential commercial launches of both mayor of it talks of Mab and 6.3 too. Thanks.
Unknown Speaker: Yeah, so, the anecdotal data that we have, Joe, is, I would say, limited but quite encouraging. And there are certainly patients in our experience who've had a prior PARP inhibitor and have recurrent platinum sensitive disease and do very nicely with myrbitumab. You know, throughout our program, when we've looked at patients who've had a prior PARP inhibitor, you know, whatever trial we look at, we see very nice activity for Mervitumetumet. And that's not surprising because, you know, there's no reason to believe there's a cross-resistance mechanism.
Yeah. So you know the anecdotal data that we have Joe.
I would say limited, but quite encouraging and and there are certainly patients in in our experience who've had the prior PARP inhibitor and have recurrent platinum sensitive disease, and do very nicely with more of a tuck the math.
Throughout our program when we've looked at pace.
Patients who've had a prior PARP inhibitor whatever trial, we look at we see very nice activity from <unk> and that's not surprising because theres no reason to believe there's cross resistance mechanism for <unk>.
Unknown Speaker: You know, PARP inhibitors interfere with the ability to repair DNA damage if it is a tubulent directed agent. And so, again, prior PARP use really doesn't seem to impact the efficacy of MRFF. Great, and on the guidance that goes into the second half of 2022, that includes spend for pre-launch prep and BLA filing commercialization work for both Mervatuxmap and 632. We feel that we're in a strong place.
Of inhibitors interfere with the ability to repair DNA damage, where tubule indirect of agents and so again.
Prior PARP us really doesn't seem to impact the efficacy of mirth.
Great and on the guidance.
And that goes into the second half of 2022 that includes spend for prelaunch prep and BLA filing of commercialization work for both more of a <unk> <unk>.
We feel that we're in a strong place we've been adding additional capital from our ATM facility.
Unknown Speaker: We've been adding additional capital from our ATM facility. That said, we're, you know, I focus on the year-end cash now. We're looking for ways to supplement that between now and then, but with a positive readout, we don't think capital formation will be initially. Yeah, maybe just to put a little finer point on some of what Susan was saying in terms of what we're doing from an operational perspective. So those numbers include Salesforce build.
That said were.
Focus on the year end cash now we're looking for ways to supplement that between now and then.
But with the positive readout, we don't think of capital formation will be an issue.
Maybe just to put a little finer point on some of what Susan was saying in terms of what we're doing from us.
The operational perspective, so those numbers include sales force build it includes.
Unknown Speaker: It includes, you know, production of additional launch inventory for the business, and the build out of the medical affairs function. So baked into that number is, you know, a fully formed organization ready to launch the drug in the second half of the year.
Production of additional launch inventory for the business build out of the medical affairs function so baked into.
Does that number is fully formed the organization ready to launch the drug in the second half of the year.
Okay. Thanks, that's helpful.
Unknown Speaker: Okay, thanks, that's helpful. Yep. Thank you. Our next question comes from Jessica Phi with J.P. Morgan. Your line is open.
Yes.
Yes.
Thank you. Our next question comes from Jessica Fye with Jpmorgan. Your line is open.
Operator: Hi, good morning. This is Daniel Ritcha Kaffai.
Hi, Good morning. This is Daniel for just took of Fi. Thanks for taking my question, maybe a question for Anna.
Unknown Speaker: Thanks for taking your question. Maybe I have a question for Anna. Targeting CD-1-2-3 in AML hasn't been as effective as the anti-timmer benefits we've observed in BPDCN. Could you maybe frame for us what could be driving a differentiated outcome in those two settings and how 62 can be differentiated here in AML? Yeah, so I think what you're referring to is the activity of Algonres or Tagraxifus or SL401, which is approved for BPDCN. It's a CD-123 fusion protein with a diphtheria toxin.
And the CPT 1 code.
Do you want your 3 in AML hasn't been as effective as the anti tumor beneficiary of all observed in the P. P. D C and could you maybe frame for us what could be driving of differentiate it all come in the most 2 settings.
And how 62 can be differentiated here in ammo.
Yeah. So I think what you're referring to is the activity of Alzheimer's or to graphics of for us.
SL 401, which is approved for <unk>, it's the CD 123 fusion pro.
And with the diphtheria toxin.
Unknown Speaker: And BPDCN has the highest levels of CD-123 expression, so if it's going to work anywhere, it's going to work there. And I think their, you know, monotherapy experience in AML was quite disappointing. They really didn't have appreciable monotherapy activity in AML, which contrasts with our experience with IMGN632. You may recall at Ash, we've had a couple oral presentations now showing actually quite reasonable monotherapy activity for IMGN632 in relapse-refractory AML with very nice CRIs.
And the <unk> has the highest levels of CD 123 expression. So if it's going to work anywhere it's going to work there and.
And I think they're mono therapy.
<unk> and AML was quite disappointing they really didn't have appreciable monotherapy activity in AML.
Protein.
That contrasts with our experience with IMG and 632, you may recall at Ash, we've had a couple of oral presentations now showing actually quite reasonable monotherapy activity for <unk> in relapsed refractory AML with very nice CR Cri.
Unknown Speaker: Didn't quite meet our bar for a single arm, you know, fast to approval strategy in the relapse refractory setting, but certainly highly active. Our drug is highly active as a monotherapy in AML, and I think it's just because we have a better drug, frankly.
Didn't quite meet our book for a single arm fast to approval strategy in the relapsed refractory setting, but certainly highly active our drug is highly active as a monotherapy in AML and I think it is just because we have a better drug frankly.
Unknown Speaker: Thank you. Our next question comes from John Newman with Canacord. Your line is open.
Thank you.
Thank you. Our next question comes from John Newman with Canaccord. Your line is open.
Unknown Speaker: Hi guys, I have a little noise. Thanks for taking the follow-up. Question for Mark and Anna. Probably a difficult question to answer, but, you know, there's been a lot of conversation on prior calls about the accelerated approval pathway to remember Chuck some ads. But given the current timing for the program, BLA submission in early 2022, and then top line data for Mirr saw, I believe in the third quarter of 2022. Isn't it reasonable to assume that the FDA will be able to take a look at the top line data from Mirosol, which could give them more confidence in the accelerated approval based on Saraya? Thanks.
Hi, guys.
Thanks for taking the follow up.
For Mark and then this is probably the difficult questions the answer but.
We also still of lot of.
Attrition on the first of all about.
The accelerated approval pathway for Chuck.
But given the current timing for the program.
The likes of submission in early 2022.
Okay.
The topline data from here.
But.
I believe in the third quarter of 2022.
Is it reasonable to assume that the SBA.
We will be able to give a look at the top line data for Mirasol, which.
Give them more confidence and the XL.
The latest approval.
Okay.
Yes.
Yeah. So.
Unknown Speaker: Yeah, so I think you have to deconstruct this and ask the question, you know, what is the regulatory environment here? and then ask the question about practical considerations that overlay that. But from a regulatory perspective, we file under sub-participant looking for accelerated approval. The standard there is to demonstrate a substantial improvement over available therapy. The FDA gave us the benchmark in terms of overall response rate, which is the primary endpoint for our study, and then, secondarily, duration of response.
Okay.
You have to deconstruct us.
And ask the question.
What is the regulatory environment here and what.
When asked the question about practical considerations that overlay of that but from a regulatory.
Inventory perspective, we file under subpart of the looking for accelerated approval of the standard there is to demonstrate the substantial improvement over available therapy. The FDA gave us the benchmark in terms of overall response rate, which is the primary endpoint for our study and then secondarily looking at duration.
<unk> of response, and so if we meet those criteria under Subpart E with the data that we generate from so range Theres no basis for the FDA to delay regulatory action on the filings. So I think that's the first point, yes, if mirasol data.
Unknown Speaker: And so if we meet those criteria under subpara-E with the data that we generate from Saraya, there's no basis for the FDA to delay regulatory action on the filing. So I think that's the first point. Yes, if Mirosol data are available at the time of the regulatory decision, and those data are positive, we think they'll be positive, yes, that would certainly bolster their ability to make a decision on Mervitoxamab. But again, I think the, you know, the basic criteria here is: what are the applicable regulatory standards for accelerated approval? And we think we're going to meet those with Saraya, and that will be the basis for regulatory action. Okay, great. Thank you.
Available at the time of the.
The regulatory decision and those data are positive we think that will be positive, yes that would certainly bolster.
Their ability to make a decision on the unaware of it talks of the map, but again I think the the.
Base.
Writing in here is what.
What are the applicable regulatory standards for accelerated approval and we think we're going to meet those with whats array of and that will be the basis for the regulatory action.
Okay, great. Thank you.
Operator: Thank you, and I'm showing no other questions in the queue. I'd like to turn the call back to Mark Enity for any closure and remarks. Great. Well, thank you.
Thank you and I'm showing no other questions in the queue I'd like to turn the call back to Mark.
Mark <unk> for any closing remarks, great well, thanks very much for your time today, and we look forward to keeping you updated on our progress.
Mark Joseph Enyedy: Great, well, thanks very much for your time today, and we look forward to keeping you updated on our progress and for the fourth quarter with a Saraya readout and also data on 632 at Ash. Thanks very much, and have a nice weekend.
To the fourth quarter with the survey of readout and also data on 632 at Ash, Thanks, very much and have a nice weekend.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
This concludes today's conference call. Thank you for participating you may now disconnect.
Okay.
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Yeah.
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