Q2 2020 MacroGenics Inc Earnings Call
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Operator: Good afternoon. We will begin the MacroGenics 2020 second quarter corporate progress and financial results conference call in just a moment. All participants are in a listen-only mode at this time, and we will conduct a question and answer session at the conclusion of the call. At this point, I will turn the call over to Anna Krasowska, Vice President, Investor Relations, and Corporate Communications, MacroGenics. Thank you.
All participants I listen only mode.
At this moment and we will conduct a question and answer session.
Conclusion on the call.
At this point I will turn the call lower the analysts out there like President Investor Relations and corporate communications a Mac.
[music]. Thank you good afternoon, and welcome to the Macrogenics come from coal to discuss our second quarter 2022 financial and operational result for anyone with.
Anna Krasowska: Good afternoon, and welcome to the MacroGenics conference call to discuss our second quarter 2020 financial and operational results. For anyone who has not had the chance to review these results, we issued a press release this afternoon outlining today's announcements, which is available under the Investors tab on our website at macrogenics.com. You may listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately two hours after the call is completed. I would like to alert listeners that today's discussion will include statements about the company's future expectations, plans, and projects that constitute forward-looking statements for purposes of the Safe Harbor Provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change, except to the And now, I'd like to turn the call over to Dr. Scott Koenig.
I don't have the jumped to review these results we issued a press releases often outlining today's announcement, which is available under the investors top.
Macrogenics Dot Com may listen to this conference call by webcast on our website, where they are kind of for 30 days beginning approximately two hours after the college completed I.
I would like to alert listeners that today's discussion will include statements about the company's future expectations plans.
Constitute forward looking statements.
As of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995 actual results may differ materially from those indicated by these forward looking statements as an adult various important.
Including those discussed in the risk factor section of our annual or quarterly reports filed with the FCC.
In addition, any forward looking statements represent our views only as of today and should not be relied upon as representing our views as with any subsequent date, while we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if on mute change except to the extent to required by applicable.
No.
Now I'd like to turn the call over to Dr., Scott Smith, President and Chief Executive Officer of Macrogenics.
Scott Koenig: Thank you, Anna. I'd like to welcome everyone participating via conference call and webcast today. This afternoon, I will provide key highlights from our clinical programs, but before I do so, let me first turn the call over to Jim Carroll, Senior Vice President and Chief Financial Officer, who will review our financial results for the quarter.
Thank you out now I'd like to welcome everyone participating via conference call a webcast today.
The news I will provide key highlights from our clinical programs.
Before I do so let me first turn the call over to John Carroll Senior Vice President Chief Financial Officer, who will review our financial results for the quarter.
Thank you Scott This afternoon Macrogenics reported financial results for the quarter ended June 30, 2020, which highlight our financial position as well as our recent progress.
Jim Carroll: Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended June 30, 2020, which highlight our financial position as well as our recent progress. As described in our release, MacroGenic's total revenue, consisting primarily of revenue from collaborative agreements, was $20.3 million for the quarter ending June 30, 2020, compared to $10.6 million for the quarter ending June 30, 2019. This increase was primarily due to the recognition of a $12 million payment from Boehringer Ingelheim under a 2010 license and collaboration agreement. Our research and development expenses were $57.4 million for the quarter ended June 30, 2020, compared to $51.4 million for the quarter ended June 30, 2019. This increase was primarily due to an increase in development and clinical trial costs for multiple programs.
As described in our release Macrogenics total revenue consisting primarily of revenue from collaborative agreements was $20.3 million recorder ended June 30, 2020 compared to $10.6 million for the quarter ended June 32019.
This increase was primarily due to the recognition of a 12 million dollar payment from Boehringer Ingelheim under a 2010 license and collaboration agreement.
Our research and development expenses were $57.4 million for the quarter ended June 30, 2020 compared to $51.4 million for the quarter ended June 32019.
This increase was primarily due to an increase in development and clinical trial costs for multiple programs.
General and administrative expenses were $10.2 million for the quarter ended June 30, 2020 compared to $12.1 million for the quarter ended June 32019.
Jim Carroll: General and administrative expenses were $10.2 million for the quarter ended June 30, 2020, compared to $12.1 million for the quarter ended June 30, 2019. This decrease is primarily due to a decrease in consulting costs with a smaller decrease in travel-related costs due to COVID-19. MacroGenics' net loss was $46.9 million for the quarter ended June 30, 2020, compared to a net loss of $31.8 million for the quarter ended June 30, 2019. Our cash, cash equivalents, and marketable securities as of June 30, 2020 were $232.8 million, compared to $215.8 million as of December 31, 2019. During the quarter ended June 30, 2020, we received $96.5 million in net proceeds from the sale of approximately 4 million shares of our common stock pursuant to an at-the-market or ATM offering.
This decrease is primarily due to a decrease in consulting costs with smaller decrease in trouble related costs due to covered 19.
Macrogenics net loss was $46.9 million for the quarter ended June 30, 2020, compared to a net loss of $31.8 million for the court ended June 30 2019.
Our cash cash equivalents and marketable securities as of June 30, 2020 were $232.8 billion.
Compared to 215.8 million as of December 31, 29 team during the quarter ended June 30, 2020, right. We have received $96.5 million net proceeds.
The sale of approximately 4 million shares.
Our common stock pursuant to an aftermarket or ATM offering.
Subsequent to June 30, 2020, we received an additional $21.3 million net proceeds from sales of approximately 726000 shares pursuant to the ATM as well as the earlier mentioned $12 million from Boehringer Ingelheim I'll point out that as of June 30, 2020, the 12 million from B.
Jim Carroll: Subsequent to June 30, 2020, we received an additional $21.3 million in net proceeds from the sale of approximately 726,000 shares pursuant to the ATM, as well as the earlier mentioned $12 million from Boringer Ingelheim. I'll point out that as of June 30, 2020, the $12 million from BI was reflected on our balance sheet as a receivable. Finally, we anticipate that our cash, cash equivalents, and markable securities as of June 30, 2020, plus the additional proceeds just described, which we subsequently received, combined with anticipated and potential collaboration payments, should enable us to fund our operations into 2023, assuming the company's programs and collaborations advance as currently contemplated. This represents an extension of our previously reported cash one-way guidance. I'll now turn the call back to Scott.
It was reflected on our balance sheet as a receiver.
Finally, we anticipate that our cash cash equivalents marketable securities as of June 30, 2020, plus the additional proceeds just described which we subsequently received combined with anticipated and potential collaboration payments should enable us to fund our operations into 2023, assuming the company's programs.
Collaboration dances currently contemplated.
This represents an extension of our previously reported cash when we guidance.
I'll turn the call back to Scott.
Thank you Jim we're excited about the momentum we have built to date and 2020 as well as the events. We are anticipating during the remainder of the or and then to 2021.
Scott Koenig: Thank you, Jim. We are excited about the momentum we have built to date in 2020, as well as the events we are anticipating during the remainder of the year and into 2021. I would like to begin by introducing Stephen Eck. As we announced, Stephen joined us at the beginning of July as our Senior Vice President of Clinical Development and Chief Medical Officer. Stephen is a hematologist oncologist by training with broad leadership experience in the development and commercialization of oncology therapeutics, and we are excited to have him on the team. Assets that he has managed include Enzolidomide, Relatinib, and Gilteritinib. Stephen is with us on the call today and will join us for the Q&A portion. Thank you, Stephen.
To begin by introducing Stephen there.
As we announced Stephen joined US at the beginning of July Senior Vice President clinical development and Chief Medical Officer.
Even as the Hematologist oncologist by training, we brought leadership experience in the development and commercialization of oncology Therapeutics and we're excited to have them on the team.
So he is magic food and so what about.
A lot and then a guilds oriented.
Steve is with us on the call today and will join us for the Q when they portion welcome Steven.
Scott I'm delighted to have joined Macrogenics is such an exciting time its history.
Thank you Stephen I.
Well start with close to them.
Stephen Douglas Willey: Thank you, Scott. I'm delighted to have joined MacroGenics at such an exciting time.
Investigational Biospecific CD 123 by Tdthree Dart molecule and our most <unk> most recent product candidate today in registration study.
Scott Koenig: Thank you, Stephen. I will start with Plototuzumab, an investigational biospecific CD123 molecule by CD3-DAR molecule and our most recent product candidate to date in a registration study. Informed by discussions with the FDA, this trial will be a single-arm study in up to 200 AML patients whose disease is either refractory to induction treatment, which we refer to as primary induction failure, or has relapsed early, within 6 months after an initial response. The study will be conducted as an expansion of the ongoing Phase 1-2 study.
And form part of discussions with the FDA. This trial will be a single arm study in up to 200 ammo patients with diseases, either refractory to induction treatment, which we referred to as part of a reduction failure or as we watched early within six months. After an initial response.
The study will be conducted as an expansion of the ongoing phase one two study.
Very important is response rate.
Comprised of complete remission.
And complete remissions with partial haematological recovery or CRH.
We plan to submit updated study data for presentation at the scientific conference the fourth quarter 2020.
Scott Koenig: The primary endpoint is response rate comprised of complete remission and complete remissions with partial hematological recovery or CRA. We plan to submit updated study data for presentation at a scientific conference in the fourth quarter of 2020. In June, research led by Dr. Sergio Rutella at the Van Geest Cancer Research Center in the UK was published in Science Translational Medicine and describes an immunological signature related to interferon gamma gene expression in the tumor microenvironment. In patients with primary refractory or early relapsed AML, this gene signature appears to be predictive of resistance to chemotherapy, yet associated with response to closituzumab treatment. These data provide a molecular basis to understand why AML patients who are refractory to chemotherapy may be responsive to immunotherapy with float-a-tuzumab.
In June research led by Dr. surgery.
At the back East Cancer Research Centre in the UK was published in Science translational Medicine and describes in immunological signature related to interferon gamma gene expression in a tumor micro environment.
In patients with partner refractory or early we watch stand now there's gene signature appears to be predictive of resistance to chemotherapy, yet associated with response to close to them that treatment.
These data provide a molecular basis to understand why AML patients worth refractory to chemotherapy they'd be responsive to meet a therapy with qualities.
Moving on to actually C. O 18, our investigational antibody drug conjugate designed to deliver a DNA escalating to optimize inside it's hard to pay loved it sells at express disseminate story.
Initial dose escalation data from the ongoing phase one study was very well received.
Oh virtual annual meeting.
Particular interest was the early evidence of clinical activity observed in patients with metastatic castration resistant prostate cancer or M.C. our PC.
Scott Koenig: Moving on to MGC018, our investigational antibody drug conjugate designed to deliver a DNA-acetylating stuartomycin cytotoxic payload to cells that express B7H3. Initial dose escalation data from the ongoing Phase I study was very well received at the ASCO Virtual Annual Meeting. Of particular interest was the early evidence of clinical activity observed in patients with metastatic castration-resistant prostate cancer, or MCRPC. Reductions in BSA levels of 50% or more were observed in five of seven patients, including one with substantial regression abundance.
Reductions it be I'd say levels at 50%. So more were observed in five of seven patients.
Moving one with substantial regression about disease.
The safety profile with M.D.C.O. 18, which includes even logic and skin toxicity expected that's been basketball.
The patients with prostate cancer reported so were enrolled at the to make her kids or dream Big for kids dose cohorts.
Since Oh, we have completed the planned dose escalation up to four makes for kids and selected three makes for keurig as the recommended dose for expansion based on pharmacokinetic analysis.
Scott Koenig: Safety Profile of MGCOH, which includes hemologic and skin toxicities as expected and has been manageable. The patients with prostate cancer reported at ASCO were enrolled in the 2 mg per kg or 3 mg per kg dose cohort. Since ASCO, we have completed the planned dose escalation up to four migs per kig and selected three migs per kig as the recommended dose for expansion based on pharmacokinetic analysis. In the third quarter, we expect to begin dose expansion in patients with metastatic CRPC with a target enrollment of up to 40 patients. Next, I would like to turn to initial data related to MgD-013, our investigational biospecific PD-1 bilact-3-DART molecule also presented at ASCO, in the ongoing phase one dosis expansion study. The data presented showed anti-tumor activity of MgDO13 as monotherapy across several tumor types evaluated.
In the third quarter, we expect to be getting dose expansion in patients with metastatic CRP see with a target enrollment of up to 40 patients.
Next I would like to turn to initial data related to energy older gene our investigational Biospecific PD one buybacks, we dart molecule also presented at ASCO.
And the ongoing phase one dose expansion study.
The data presented showed anti tumor activity of NGL 13, as monotherapy across several tumor types evaluate.
Initial translational studies and indicated that response and you feel 13 monotherapy with associated with black free expression and that gamma interferon gene signature and tumor samples taken a baseline.
Finally, we are investigating further.
We have previously observed that lack three expression or on a mutants effector cells is enhanced by margin talks about our investigational S. The engineered my hope conaway antibody targeting hurt too.
Therefore, we included an expansion cohort of patients with advanced her two positive tumors treated with a combination of MTO 30 and margin talks about.
Scott Koenig: Initial translational studies have indicated that a response to NGTO13 monotherapy was associated with lac3 expression and a gamma interferon gene signature in tumor samples taken at baseline, a finding that we are investigating further. We have previously observed that lac3 expression on immune effector cells is enhanced by margituximab, our investigational ST engine monoclonal antibody targeting HER2. Therefore, we included an expansion cohort of patients with advanced herd-to-positive tumors treated with a combination of MgdO13 and Marchetoximab. Of the 14 evaluable patients treated with this combination, we observed confirmed and unconfirmed objective responses in 6 or 43% of patients. In contrast to the monotherapy finding presented at ASCO, in the combination cohort, the majority of respondents whose baseline tumors were evaluated were either negative four or expressed low levels of LAG3 or PD-L1.
14 about patients treated with this combination we observe confirmed our confirmed objective responses in six well 30, 43% of patients.
In contrast to the monotherapy farming presented at ASCO and the combination cohort. The majority of responses baseball tumors were evaluated worried there negative four or express low levels of last three or PDL one.
Given the strong but early efficacy signal and it's an acceptable safety profile. We're prioritizing the combination of NGL 13 Tomorrow, just talked about what further development.
We are rolling three subgroups of patients with her two positive tumors.
I would guess trickle gastroesophageal junction cancer, one with breast cancer and finally, a basket of all other her two positive cancer types.
We are initially targeting 30 patients in each group, we believe that combining fcr scaring a checkpoint blockade has the potential to engage both innate and adaptive immune responses against a broad range of tumors with dairy tumor microenvironments.
With regard to March talks about the deal. It's a margin talks NAV in combination with chemotherapy as a treatment for patients with metastatic hertwo positive breast cancer, but do for target action date December 18, 2020 <unk>.
Scott Koenig: Given this strong but early efficacy signal and an acceptable safety profile, we are prioritizing the combination of MgDO13 and Margeret's Huximab for further development. We are enrolling three subgroups of patients with HER2-positive tumors, one with gastric or gastroesophageal junction cancer, one with breast cancer, and finally a basket of all other HER2 positive cancer types. We are initially targeting 30 patients in each group. We believe that combining FC engineering and checkpoint blockade has the potential to engage both innate and adaptive immune responses against a broad range of tumors with varied tumor microenvironments. With regard to margituximab, the BLA for margituximab in combination with chemotherapy as a treatment for patients with metastatic HER2 positive breast cancer, the PDUFA target action date is December 18, 2020. As previously announced, during the mid-cycle communication with the U.S. FDA, they notified us they no longer plan to hold an ODAC meeting to discuss the BLA. The Ombudsman.
As previously announced during the mid cycle communication with the rest of D.A.. They notified us they no longer planned to hold and ODAC meeting to discuss the B.L.A.
Beyond breast cancer assays to three mahogany studies evaluating merger talks about and checkpoint blockade the frontline treatment for advanced gastric Gastroesophageal junction cancer.
Module away the single arm part of the mahogany study of March talks about and run afoul about an investigational anti PD. One antibody is enrolling and we expect to submit initial data for presentation and assigned to the conference the first quarter 2021.
Module will be the randomized component of mahogany is currently planned to start the fourth quarter 2020.
Let me next discuss MTV, all 19, our investigational by specific PD, one by CTO like for Dart molecule.
We're excited to have data from the phase one dose escalation study of NGL 19 selected for an oral presentation at the ESMO virtual Congress in September.
The study is ongoing it in all covered population with advanced cancers, we have not restricted the study to tumor types that are known to respond to checkpoint inhibitors.
Dose cohorts ranged from 0.03 to 10 rigs for kick.
Additional patients have been a role more recently at three nights for kids, six Vicksburg gig and tenant expert keurig dose levels of which we observed initial clinical activity.
Scott Koenig: Phase II-III Mahogany Stem
Scott Koenig: Tuxomab, and Checkpoint Blockade as a frontline treatment for advanced gastric and gastroesophageal junction cancer. Module 8, the single-armed part of the mahogany study of March tuximab and retifalumab, an investigational anti-PD-1 antibody, is enrolling, and we expect to submit initial data for presentation at a scientific conference in the first quarter of 2021. Module B, the randomized component of mahogany, is currently planned to start in the fourth quarter of 2020.
The data continues to mature with some patients early in their treatment course.
That's why was the data cut off date for the presentation at ESMO, we anticipate up to a total of 30 patients will be a valuable for response.
We had a we used to one on treatment scan.
No that this number includes patients enrolled and treated at all doses with approximately 18 enroll a three mix for gig and Bob.
Let me next turn to read the SAP about previously known as M.G.A., Okay, well be investigational anti PD, one antibody that we licensed insight.
At ESMO data are scheduled to be presented from inside ongoing podium to over one study redness, Alabama monotherapy in patients with Merkel cell carcinoma.
Those data are in addition to the data expected in the second half a year from podium too old to insights potentially registration, enabling studies in patients with anal cancer, which is fully enrolled.
Scott Koenig: Let me next discuss MGD-019, our investigational bi-specific PD-1 bi-CTLA-4 DART molecule. We are excited to have data from the Phase I Dose Escalation Study of MGD-019 selected for an oral presentation at the ESMO Virtual Congress in September. The study is ongoing in an elderly population with advanced cancer. We have not restricted the study to tumor types that are known to respond to checkpoint inhibitors.
Furthermore, we expect inside to initiate two phase three studies in 2020 podiums three or four in patients with metastatic non small cell lung cancer and podium three or three in patients with NATO cancer, both in combination with chemotherapy.
No. There are probably six registration directed clinical studies ongoing or planned 2025, new macrogenics or insight across a broad range of tumor types.
Scott Koenig: Those cohorts range from 0.03 to 10 Migs per Kg. Additional patients have been enrolled more recently at 3 mix per kig, 6 mix per kig, and 10 mix per kig, dose levels at which we observed initial clinical activity. The data continues to mature with some patients early in their treatment course. By the time of the data cut-off date for the presentation at ESMO,
Last but not least we're pleased that our second antibody drug conjugate is expected to enter clinical testing this year.
We recently received FDA clearance at the investigational new drug variety application, Brian GC 936, and.
And they see targeting I don't know line that is being advanced under a co development agreement within minutes.
Under those 50 50 collaboration imaging will be leading clinical development and they expect to initiate a phase one dose escalation study in patients with select advanced solid tumors in the fourth quarter 2020.
Scott Koenig: We anticipate up to a total of 30 patients will be available for response, having had at least one on-treatment scan. Note that this number includes patients enrolled and treated at all doses, with approximately 18 enrolled at 3 mgs per kg and above.
For background I don't nine cents, a grid and Mattel protein kinase domain containing protein going is the cell surface antigen does over expressed a very solid tumor types and it's been shown to correlate with core.
Doses in several cancers.
This regulation about nine that's been implicated in tumor progression to metastasis as well as pathological neovascularization.
Scott Koenig: Let me next turn to retifanilamab, previously known as MGA-012, the investigational anti-PD-1 antibody that we licensed to Insight. At ESMO, data are scheduled to be presented from INSIGHT's ongoing Podium 201 study of retifalobab monotherapy in patients with Merkel cell carcinoma. Those data are in addition to the data expected in the second half of the year from Podium 202, an potentially registration-enabling study in patients with anal cancer, which is fully enrolled.
Andy I'm going to antibodies are officially internalize integrated.
I'm diamonds expressing tumors, making it an attractive babies to target for delivering inside of toxic halo.
I am GC Nok 36 is comprised of humanized antibody engineered by Macrogenics cards, you gave the site specific manner to a D. R 21, a next generation winter payload designed by imminent.
This molecule combined some attach Lloyd microtubule disrupting payload.
Peptide wayfair is designed to convey greater stability and bystander activity and other de EMM platform.
The drug anybody ratio award a door is too.
Scott Koenig: Furthermore, we expect Insight to initiate two phase three studies in 2020, podium 304 in patients with metastatic non-small cell lung cancer and podium 303 in patients with anal cancer, both in combination with chemotherapy. In all, there are currently six registration-directed clinical studies ongoing or planned in 2020 by either MacroGenics or Insight across a broad range of tumor types. Last but not least, we are pleased that our second antibody drug conjugate is expected to enter clinical testing this year. We recently received FDA clearance for the Investigational New Drug, or IMD, application for IMGC 936, and an ADC targeting ADAM9 that is being advanced under a co-development agreement with Immunogen. Under this 50-50 collaboration, Immunogen will be leading clinical development, and they expect to initiate a phase one dose escalation study in patients with select advanced solid tumors in the fourth quarter of 2020.
As you can see we continue to build momentum and advancing our pipeline of innovative product candidates. We would now be happy to open the call for questions.
Operator.
Thank you.
Asked the question you only need the press Star then one on your telephone to withdraw your question. Please press the pound King.
My first question comes on the line of Debjit Chattopadhyay with H.C. Wainwright. Your line is now open.
Hey, good afternoon, Scott than non Jim Thanks for taking my questions.
Could you talk to the ability to get to higher doses with M.T.D. Zito. One nine is it an engineered lower affinity for C.D., therefore, or do you need engagement to both PD one on C.D. the for on the T cells, which allows you to kind of circumvent the G.I. docs.
So that's it thanks, thanks for the question.
The the molecule was a was designed very specifically to get.
Maximum engagement.
A PD one antibodies, but this was a tetravalent bispecific molecule and so the answer that he is.
Scott Koenig: For background, ADAM9, a disintegrin and metalloproteinase domain-containing protein 9, is a cell surface antigen that is overexpressed on various solid tumor types and has been shown to correlate with poor prognosis in several cancers. Furthermore, disregulation of NM9 has been implicated in tumor progression and metastasis, as well as pathological neovascularization. Anti-ADAM9 antibodies are efficiently internalized and degraded by ADAM9-expressing tumors, making it an attractive ABC target for delivering a cytotoxic payload. IMGC-936 is comprised of a humanized antibody engineered by MacroGenics conjugated in a site-specific manner to DM21, a next-generation linker payload designed by Immunogen. This molecule combines a metansinoid microtubule disrupting payload with a peptide linker that is designed to convey greater stability and bystander activity than other DM platforms. The drug-antibody ratio, or DAR, is 2.
The increase.
When you get an initial engagement with.
And because there are two finding so let's see like for you get a busy advantage well then finding the TCOS seem to like fore sight. So in essence, we are getting optimum recognition.
Now, let me Express Oh receptor you also see obviously finding themselves that express PD, one PD, one alone and occasionally ones that.
Only see feel anymore, but it was really designed as a way to enhance the engagement.
Colin spreads so.
Could we go higher than 10 Megs per kilo Oh, yes, it's certainly caused Oh, we found that says we will discuss at the as both a presentation is I've learned a very optimal range, we're seeing clinical.
This across multiple doses.
As reported seeing responses between three and hadn't makes for a good number one and secondly, we saw.
Scott Koenig: As you can see, we continue to build momentum and advance our pipeline of innovative product candidates. We would now be happy to open the call for questions. Operator
The nation markers associated with this third responses, so we see no need to.
And the treatment above 10 makes for care.
Operator: Thank you. To ask a question, you will need to press star then 1 on your telephone. To withdraw your question, please press the pound key. Our first question comes from the line of Deb J. Chattopadhyay with H.C. Wainwright. Your line is now open. Hey, good afternoon, Scott and Jim. Thank you for taking my questions.
Great just one follow up then since you're collecting the biomarker data are you seeing any differential evolution in either the C. D to C D for effector T cell compartment.
Compared to monotherapy PD, one and CDN afford.
In the patients.
Yeah, and the responder spoke for example versus say the non responders.
I can't I can't really address that with regard to the sub populations at this time, but it's a question we can look.
Subsequent analysis.
Scott Koenig: Could you talk about the ability to get to higher doses with MGT019? Is it an engineered lower affinity for CTLF4? Or do you need engagement of both PD-1 and CTLF4 on the T-cells, which allows you to kind of circumvent the GI tox?
Just one last follow up on me. Thanks, the M.T.D. Sito didn't plus margin have all the six response has been confirmed since it's been a few more.
More than a few weeks since I spoke thank you so much.
The Ob confirmed responses of nobody can and we've had additional patients enrolled in the trial that you. Just described we expect that we will provide.
Scott Koenig: Thanks for the question. The molecule was designed very specifically to get maximum engagement of PD-1. As you remember, this was a tetravalent bispecific molecule, and so the affinity is slightly increased on PD-1. You get initial engagement with that, and because there are two binding sites for CTLA-4, you get an affinity advantage for then binding the CTLA-4 site. So, in essence, we are getting optimum recognition of cells that express both receptors. But you also see, obviously, binding to cells that express PD-1 alone and occasionally ones that have only CTLA-4.
An update on this combination trial assigned to the conference later this year.
Thank you so much and good luck.
Thank you.
Thank you. Our next question comes on the line its third the rule with Guggenheim Securities. Your line is now open.
Hey, this is Paul on threats are I think sort of taking my question I want to ask about mahogany I understand I know, we're expecting data for module eight of the trial next year I was wondering have you measured lag three expression in the monthly patients.
Scott Koenig: But it was really designed as a way to enhance the engagement of these co-expressing cell types. Could we go higher than 10 mixes per kick? It certainly could, but we found, as we will discuss at the ESMO presentation, that we're in a very optimal range. We're seeing clinical responsiveness across multiple doses. What we have previously reported is seeing responses between 3 and 10 mixes per kick, number one. And secondly, we saw activation markers associated with these therapeutic responses. So we see no need to expand the treatment above 10 mixes per kick.
As a potential economy it for what the patient make up in muscle P. might look like.
And so what did you observed I'm also wondering about weather library expression might inform your plan for potentially accelerating in the March plus I wonder, although and study. Thanks.
Thank you for that question.
On a where I'm actually looking at those patients at this at this point, so I can't comment on where three into my module a.
Clearly, we will continue to look in Poland Biomarkers in module will be as we go forward and certainly as we get more data.
Scott Koenig: Great. Just one follow-up question, then, since you're collecting the biomarker data, are you seeing any differential evolution in either the CD8 or CD4-affected T-cell compartment compared to monotherapy PD-1 and CD8F4?
From the MGT 13, monotherapy study along in terms of determining whats Biomarkers, Oh, that's predictable responsiveness and that could be expanded beyond the last three PDL, one oh and other activation markers. So I'm still too early to comment on that.
Scott Koenig: in a patient
Scott Koenig: Yeah, and the responders, for example, versus, say, the non-responders.
Scott Koenig: I can't really address that with regard to the subpopulations at this time, but it's a question we could look at in subsequent analysis.
Okay, Great and then just one more follow up on what it isn't that I'm, just a little bit on the timing could you give it some update about whether or not the trial with PD. One U.S. phase one two study that was partly because it has not started up again.
Scott Koenig: Great. Just one last follow-up for me, thank you. The MGD 013 plus Marge, have all the six responses been confirmed since it's been more than a few weeks since ASCO? Thank you so much.
Scott Koenig: The unconfirmed responses have now been confirmed, and we've had additional patients that have been enrolled in the trial as we've just described. We expect that we will provide an update on this combination trial at a scientific conference later this year.
So what we have decided to do given that has to go ahead. Just talk is registration study with monotherapy and given the form it's about portfolio.
Scott Koenig: Thank you so much and good luck!
Sorry, not to start up on the combination study. So later time, we're still very interested because we do see a and enhance signal in preclinical and as you know.
Scott Koenig: Thank you.
Operator: Thank you. Our next question comes from the line of Etzer Darout with Guggenheim Securities. Your line is now open. Hey, this is Paul on behalf of Etzer. Thanks for taking our questions. I wanted to ask about mahogany.
In a few patients initially, but because of the Cobas 19 situation. It was the hot it was difficult to enroll patients, but that's more likely to sort out sometime next year.
Scott Koenig: I understand, I know we're expecting data from Module A of the trial next year. I was wondering, have you measured lag-3 expression in the Module A patients as a potential kind of hint for what the patient makeup in Module B might look like? And if so, what have you observed? I'm also wondering about whether lag-3 expression might inform your plans for potentially accelerating the merge plus a 1-3 combo in the study. Thanks.
Got it thanks, so much.
Thank you. Our next question comes on the line of Jonathan Miller with Evercore ISI. Your line is now open.
Hi, guys. Thanks, so much for taking the question I.
I guess a couple here first the cancellation of the AD come from our took some at a is that a sign of the ft is thinking on the approvability of that drug you read take that as a direct read through to the likelihood of success there.
Scott Koenig: Thank you for that question. I'm not aware of actually looking at those patients at this point, so I can't comment on Lab 3 in Module A. Clearly, we will continue to look at and follow biomarkers in Module B as we go forward, and certainly as we get more data from the MGD-013 monotherapy study alone, in terms of determining which biomarkers are best predictive for responsiveness, and that could be expanded beyond Lab 3, PD-L1, and other activation markers. So it's still too early to comment on that.
And secondly, when do we have any color on when that Registrational cohorts for included choose the Matt when that when that decision cohort could get started a and it's so when you might expect data from them.
Thank you. So that's one of the for the question so with regard to the outcome of its very difficult to interpret.
What's the thinking is up from the F.D.A. I would say that given this was mid cycle review.
Many months before or whatever the time.
We perceive this has a very favorable response, but I can't speak for the F.D.A. in that context, and some always the questions that we had gone that that's fine and subsequently.
Scott Koenig: Okay, great, and then just one more follow-up on the Florida Tuesday map. Just a little bit on the timing. Could you give us an update about whether or not the trial with PD-1, the ex-US Phase I-II study that was positive for COVID, had started up again?
Suggests that they continue to have interest in evaluating this evaluating his board approval, but again, it's in the hands in the up the I can comment on that with regard to the registration study.
For uploaded to them.
Scott Koenig: So what we have decided to do, given that we've had the go-ahead to start this registration study with monotherapy and given the broadness of our portfolio, we decided not to start up the combination study until a later time. We're still very interested because we do see an enhanced signal in preclinical studies and, as you know, we treated a few patients initially because of the COVID-19 situation. It was difficult to enroll patients, but that's more likely to start up sometime next year.
As I had previous reported.
We have made modifications on phase one too.
Program and so we have not stopped enrollment.
In that trial and including the.
Patients with this specific pre treatment regimens.
That we've aligned with the FDA.
And so that is it's it's that ongoing right now.
Our expectation right now is that we will.
I have some update on data from patients treated from the previous Ash meeting last December.
Scott Koenig: Got it. Thanks so much.
Operator: Thank you. Our next question comes from the line of Jonathan Miller with Evercore ISI. Your line is now open. Hi guys, thanks so much for taking the question. I guess there are a couple here. First, the cancellation of ADCOM from artituximab; is that a sign of the FDA's thinking on the approvability of that drug? Do you take that as a direct read-through to the likelihood of success there? And secondly, do we have any color on when that registrational cohort for clotatuzumab, when that two-in-a-patient cohort could get started, and if so, when you might expect data from them?
Hopefully.
Our abstract is accepted at the Ash meeting this year, so we'll be able to provide interim update on some additional data oh patients being treated and that our hope is to complete enrollment.
Ladies and then the end of next year assuming that the.
Enrollment.
Yeah.
Great. Thank you very much I guess, the one of the thing that I want to ask about is when you discussed your cash runway now being extended into 23, you mentioned that that is relying on payment of certain future milestones and I guess, you probably won't tell us which milestones exactly you're assuming are going to hit but can you can you tell.
How much money is or how much milestone based money is a assumed in that run with new run my God.
So hi, Jonathan Carol Thanks for your question. So we can't Unfortunately can't answer that question, specifically, but we will remind you another listeners that under our agreement with insight.
Scott Koenig: Thanks, Jonathan, for the question. So with regard to the outcome, it's very difficult to interpret what the thinking is from the FDA. I would say that given this was at mid-cycle review many months before or whatever the time outcome, we perceive this as a very favorable response, but I can't speak for the FDA in that context. And similarly, the questions that we had gotten at that time and subsequently suggest that they're continuing to have an interest in evaluating this and evaluating it for approval. But again, it's in the hands of the FDA.
We have the ability to collect up to $405 million and clinical and regulatory milestones as well 330 million in commercial milestones and then aside from that regarding to put them out, which we life, we actually sold.
To prevention bio we have the ability to to receive a $60 million milestone upon BLE approval of about asset, which the BLE process of being submitted now on a rolling basis, and we anticipate a likely PDUFA date of that sometime middle of next year, We handicap all the.
Milestones.
Scott Koenig: on that. With regard to the registrar.
No.
It extends makes pop it makes sense and then that's what we budget. So we tend to we tend to to value this fairly conservatively.
Scott Koenig: As I previously reported, we made modifications to the Phase 1-2 program, and so we have not stopped enrollments in that trial, including patients with the specific pre-treatment regimens that we have aligned with the FDA. And so that is, in fact, ongoing right now. Our expectation right now is that we will have some update on data from patients that we have treated from the previous ASH meeting last December, and hopefully, if our abstract is accepted at the ASH meeting this year, we'll be able to provide an interim update on some additional data from patients being treated. And then our hope is to complete enrollment not later than the end of next year, assuming that the enrollment goes as planned.
Yeah, I think obviously, but that.
Alright makes sense. Thank you very much guys driven.
Thank you. My next question comes on the line of Jonathan Chang with S., we'd be Leerink. Your line is not open.
Hi, guys. Thanks for taking my questions.
First question on N. cheese fees, there when Keith.
Can you elaborate on your decision to before it was the street make protect dose.
Oh, yes pleasure Jonathan has I had.
On the last call we ever seen responses.
Okay, even if we make.
Okay range.
As I've noted.
Sensible.
Toxicity profile.
We had a form fone kinetic analysis.
Scott Koenig: Great, thank you very much. I guess one of the things that I wanted to ask about is when you discussed your cash runway now being extended into 2023, you mentioned that that is relying on payment of certain future milestones. I guess you probably won't tell us which milestones exactly you're assuming are going to be hit, but can you tell us how much money is, how much milestone-based money is assumed in that new runway guidance?
Since our last call and we found that.
As predicted that we would see suitable PK.
Between two and three mix for tech.
I would be though would be acceptable to move things forward. So we selected the three Nick <unk> dose.
And.
Yes protocol is being amended right now and we expect to a patients are starting to enroll later in this quarter.
Karl: Hi Jonathan, this is Karl. Thanks for your question. Unfortunately, we can't answer that question specifically, but we will remind you and other listeners that under our agreement with Insight... We have the ability to collect up to $405 million in clinical and regulatory milestones, as well as $330 million in commercial milestones. And then, aside from that, regarding Teplizumab, which we actually sold. To Prevention Bio, we have the ability to receive a $60 million milestone upon BLA approval of that asset, which the BLA is in the process of being submitted now on a rolling basis, and we anticipate a likely PDUFA date of sometime in the middle of next year. We handicap all of these milestones to the extent it makes sense, and that's what we budget. So we tend to value this fairly conservatively. Yeah, I think I'll just leave it at that.
Got it when could we expect the next day to day on the 018 program.
So we were thinking about what's the most appropriate form for this going forward because we like some additional data from some of these new patients that would be in role.
So given that the let's say the cut on the phase one study was very recent in May.
We believe that is most likely that we would.
Presenting a very early in.
2021.
Scientific meeting.
Acceptance of an abstract.
Got it and just one last question to follow up on a previous question.
Earlier in the Air you spoke about prioritizing your pipeline I can't talk about your current thoughts on that as it relates to your cash position and runway.
I'm, sorry pardon nationwide.
Operator: All right, that makes sense. Thank you very much, guys. Thank you. Our next question comes from the line of Jonathan Chang with SVB LaRinc. Your line is now open. Hi guys, thanks for taking my question. First question on MGC018, can you elaborate on your decision to move forward with a 3 mg per kick dose?
Oh pipeline.
Likewise.
I you know I. If you look at so we didn't want announced today is I think its winding up quite nicely, obviously ongoing support for more for the for the B.L.A. opponents using that registration study.
The studies on MGT 13 in combination in particular.
Scott Koenig: Oh, yes, pleasure, Jonathan. As I had commented on the last call, we were seeing responses at the two mcg per kg and a three mcg per kg range with, as I've noted, acceptable toxicity profiles. We have performed follow-up kinetic analysis since our last call, and we found that, in fact, what I had predicted, that we would see suitable pK at between two and three mcg per kg would be acceptable to move things forward. So we selected the three mcg per kg dose, and that protocol is being amended right now, and we expect to have patients starting to enroll later in this quarter.
Spansion there we are.
Moving forward, obviously in the new program without a nine with Immunogen and then clearly additional data from 19 wouldn't would likely come next year would follow up on the current Asia. So it's obviously what.
I just described.
Coordinating so I think this is sitting in quite nicely with or without plans going forward and the additional cash I'm, giving us additional runway I think very robust pipeline to be able to report new data and the next six months.
With these.
In patients.
Scott Koenig: Got it. When can we expect the next data update on the 018 program?
Got it thanks for taking the questions.
Thank you. Our next question comes on the line of Stephen Willey with Stifel. Your line is now open.
Scott Koenig: So we were thinking about what the most appropriate form for this going forward because we'd like some additional data from some of these new patients that would be enrolled. So, given that the last data cut for the phase one study was very recent in May, we believe that it's most likely that we would present data very early in 2021 at an appropriate scientific meeting with the acceptance of an abstract.
Yeah, good afternoon extra taking the questions.
Scott on the on a on the flow Tuesday night Registrational trial can you remind us if if you're going to be enrolling both transplant eligible and eligible patients and I guess as he was sets for durability of response.
Are you gonna be able to allow.
Oh for any censoring of patients, who who subsequently our bridge to transplant.
Scott Koenig: Got it. And just one last question to follow up on a previous question. Earlier in the year, you spoke about prioritizing your pipeline. Can you talk about your current thoughts on that as it relates to your cash position and runway?
Yeah. So we also allow calls eligible in ineligible patients in fact.
You know our hope is even patients who are initially that ineligible may become eligible through the course of therapy, we've actually observe that in some of the patients.
In the earlier phase one studies. So this is very much in the hope that if we can get.
Scott Koenig: I'm sorry, prioritization of what? A pipeline of the pipeline.
I never get number these patients transplant, our experience to date that they live save lives a much longer lives and there's always the possibility of George. So this is obviously a very upbeat objective for the study.
Scott Koenig: You know, if you look at what we've announced today, I think it's lining up quite nicely. Obviously, ongoing support for MARCH, for the BLA, the Flotatuzumab registration study, the studies on MGD13 in combination, and in particular, the expansion there. We are... Moving forward, obviously, in the new program with ADAM9 and the immunogen, and then clearly additional data from 19 would likely come next year with follow-up on the current patient. So it's all, obviously, what I just described with expansion cohorts on 18. So I think this is fitting in quite nicely with our plans going forward and the additional cash giving us additional runway. I think we'll have a very robust pipeline to be able to report new data in the next six months to nine months with these added patients.
Okay, and just on MGC 018.
There anything that you can say about the experience you had with patients.
<unk> perky dose level and.
Maybe the number of patients that you would rolled into that and I'm just any observations you might be able to share.
You know probably you know what that that's the ongoing it's very few patients as a 3.3 design, so really nothing more than.
That I could have tried to.
What we've seen in the other parts of the study and.
The detail I don't that's something on patient, but there's nothing really outstanding doesn't make any conclusions about.
Okay and then just finally, maybe for Jim another cash guidance question can you.
Scott Koenig: Got it. Thanks for taking the question. Thank you. Our next question comes from the line of Stephen Willey with Stiefel. Your line is now open. Yeah, good afternoon.
Maybe speak to what extent that guidance runway contemplates any kind of merger talks and the commercialization activities.
Operator: Thanks for taking the questions. Scott, on the Flotatuzumab registrational trial, can you remind us if you're going to be enrolling both transplant-eligible and ineligible patients? And I guess, as you assess for durability of response... are you going to be able to allow any censoring of patients who subsequently are bridged to transplant?
Thanks for that question, Steve So baked into our budget, we have de minimis spend on commercial commercialization.
You know as Scott has indicated in the past our our intent here is to his department the opportunity.
So we have a bare minimum of commercial spend too.
It's sort of deliver that asset to a place where you know a partner could be.
And.
Over the finish line in terms of commercializing.
Got it very helpful. Thanks for taking my questions.
Scott Koenig: Yeah, so we are going to allow both eligible and ineligible patients. In fact, you know, our hope is that even patients who are initially ineligible may become eligible through the course of therapy. We've actually observed that in some of the patients in the earlier phase one study. So this is very much in the hope that if we can get a significant number of these patients to transplant, our experience today is that they live much longer lives, and there's always the possibility of cure. So this is obviously a very big objective for the study.
Thank you. Our next question comes on the line of your Gal.
No, which all of which.
[laughter] Citi. Your line is now open.
Hi, Sanjay, mostly Samantha Bee a call. Thanks very much for taking my question.
First question on mahogany modular a that state inox sections first quarter I, just wondering can set expectations that the number of patients we should expect ads.
The degree of durability, and whether or not that this patient that will be sufficient for years to oh look for accelerated approval.
Scott Koenig: Okay, and just on MGC 018. Is there anything that you can say about the experience you had with patients at the 4 mg per kg dose level and, you know, maybe the number of patients that you enrolled into that and just any observations you might be able to share?
Thanks, so much Samantha so.
Got it previously were targeting to have a 40 patients enrolled by the ended the year you know as again.
Scott Koenig: You know what? We'll probably, you know, that is still ongoing, it's very few patients, it's a 3 plus 3 design, so really nothing more than I can ascribe to what we've seen in the other parts of the study, and we'll provide the details at our next update on patients, but there's nothing really outstanding there to make any conclusions about.
A significant portion of those patients even if we hit the 40 would not be a valuable because they would come later in the year. So a lot of this will be timing of when those patients come in.
No I'm pleased that despite the.
<unk> 19, we've been able to enroll additional patients in the U.S.
Scott Koenig: Okay, and then just finally, maybe for Jim, another cash guidance question: can you maybe speak to what extent that that guidance runway contemplates any kind of Margituximab commercialization activities?
Now we have a 11 sites open in Korea, and so we're hoping that.
They greater insights and patients coming into the trial.
Those Korean sites.
To get to the 40 by the end of the here.
Jim Carroll: Thanks for that question, Steve. So, baked into our budget, we have de minimis spend on commercialization. You know, as Scott has indicated in the past, our intent here is to partner the opportunity. So we have a bare minimum of commercial spend to sort of deliver that asset to a place where, you know, a partner could be helpful in taking it over to the finish line in terms of commercialization. Got it.
If we have.
Sufficiently early enough in 2020, then it's likely we would be able to report this out early in 2021 and make some decisions about how to further accelerate this trial to get an ROE, but you know provide updates.
In the course of the year on how that's going.
Got it thank you.
And then just on that mgo industry and merger talks not on by enrolling gastric cancer patients. There I think Joe the lap, perhaps that what I hopped on a module fee.
Scott Koenig: Very helpful. Thanks for taking the questions. Thank you. Our next question comes from the line of Yigal Novochomovitz.
That is a chemo are well I guess, what's your rationale for having both of those combinations and how do you eat I'm sitting in the landscape.
Operator: If you are in the city, your line is now open. Hi, Scott and Jim. This is Samantha on behalf of Yigal.
Excellent question on again, the or the fact that very late stage patients.
Scott Koenig: Thanks very much for taking our questions. The first question is on Mahogany Module A, data not expected in the first quarter. I'm just wondering if you can help set expectations there and the number of patients we should expect, the degree of durability, and whether or not this patient set will be sufficient for you to look for accelerated approval.
Even in the phase one study in combination we're responding was.
A very exciting.
For the patients and for us and so we would like to understand how robust that signal is by using digital agencies justification and that's in that combination study for the 13.
Scott Koenig: Thanks so much, Samantha. As I have guided previously, we're targeting to have 40 patients enrolled by the end of the year. You know, and again, a significant portion of those patients, even if we hit the 40, would not be available because they would come later in the year. So a lot of this will be timing of when those patients come in. I'm pleased that despite COVID-19, we've been able to enroll additional patients in the U.S. Now we have 11 sites open in Korea, and so we're hoping that there will be a greater influx of patients coming into the trial from those Korean sites to get to 40 by the end of the year.
Trial.
Early in the mahogany be we're looking at.
Newly diagnosed patients.
The different population and in fact, as we get those combinations isolate one a therapy if that data is completely robots as you can gives us more impetus to accelerate.
The mahogany be remember, though the differences is that in my hobby.
So there will be differences irrespective of that and getting to understand what the effect of adding chemo.
I mean based therapies.
Got it and when you started rolling and mahogany be back we need be primarily I like are you starting rolling U.S. say wow in fourth quarter.
Scott Koenig: If we had that, and had it sufficiently early enough in 2020...
So.
I will take the lead they will start enrolling first and then we will follow up enrollment.
Scott Koenig: It's likely we will be able to report this out early in 2021 and make some decisions about how to further accelerate this trial to get it enrolled. But we'll provide updates during the course of the year on how that's going.
But the expectation is that they will enroll this year and we will start enrolling in the next year.
Okay, great. Thanks, so much for taking my question.
Thank you maam.
Thank you. Our next question comes on the line of Peter Lawson with Barclays. Your line is open.
Scott Koenig: Got it. Thank you. And then just on the MgDL-1-3 and margituximab combo, you're enrolling gastric cancer patients there, and it seems to overlap perhaps a bit with mahogany module B, even though that is a chemo arm as well. What's your rationale for having both of those combinations and how do you see them fitting into the landscape?
Thank you thanks, taking my questions on MGC 018.
What's the thought you think you need for for prostate what do you want to see in the next week.
Well that's a good question Peter obviously, you know looking at historical response rate in late stage.
I think cancers, they've been below 50% for most trials obviously in the.
Scott Koenig: Excellent question. Again, the fact that very late-stage patients, even in the phase one study and combination, were responding was very exciting for the patients and for us. And so we would like to understand how robust that signal is by getting additional late-stage gastric patients in that combination study in the 13 trial. Clearly, in mahogany B, we're looking at newly diagnosed patients, so it's a completely different population. And in fact, as we get those combination studies, the late-line therapy, if that data is completely robust, it even gives us more impetus to accelerate mahogany B. Remember, though, the difference is that in mahogany B, we're adding chemotherapy to that arm. So there will be differences irrespective of that and getting to understand the effect of adding chemo to those immune-based therapies.
50 recently that responds very I guess about 66%. So that's obviously a radio labeled drugs.
Our goal clearly is if we achieve responses comparable to what we've seen in the phase one study would be ideal.
But right now we haven't given specifics with regard to the range that ultimately with.
Determine how we would take us further I think that by enrolling.
The 40 patients as we just recently described we should get a good idea on how good is struggling.
What would you like to see for around jury duration of treatment.
Excellent questions well remember that historical data suggests on a PFS rate of currently approved drugs were talking about two to three months, where the survival.
Scott Koenig: Got it. And when you started enrolling in Mahogany Bee, was that going to be primarily the iLab, or will you start enrolling in U.S. sites as well in the fourth quarter?
This late stage population of around the year ending on study less or a little more.
Scott Koenig: So, I will take the lead, they will start enrolling first, and then we will follow up on enrollment. The expectation is that they will enroll this year, and we will start enrolling in B next year.
So obviously, if we see those parameters plus Oh, hey persistence.
Reduction appears to be a 50%.
Scott Koenig: Okay, great. Thanks so much for taking our question. Thank you. Our next question comes from the line of Peter Lawson with Barclays. Your line is now open. Thank you. And on MGC018, what's the bar you think you need for prostate cancer? What do you want to see in the next read?
Very early and for a long.
I think we'll be in.
Good shape.
Because of the drug.
I think that just finally around.
Just a PD 123, 50, Susan Matt just what should we expect to see by Q4.
It goes data.
So the plan is to present as at Ash, we submitted a number of different abstracts, obviously they have to go undergo review, but the expectation is to present, a double digit number of patients.
Operator: That's a good question, Peter. Obviously, you know, looking at historical response rates in late-stage prostate cancers, they've been below 50% for most trials. Obviously, in the lutetium trial recently, they had a response rate, I guess, of about 66%, but that's obviously a radiolabeled drug. You know, our goal, clearly, is if we could achieve responses comparable to what we've seen in the Phase I study, it would be ideal. But right now, we haven't given specifics with regard to the range that ultimately would determine how we would take this further. I think that by enrolling up to 40 patients, as we've just recently described, we should get a good idea of how good this drug is.
Since the last a ash meeting so they'll be a nice upsize.
The population to evaluate since our last.
The presentation.
Great. Thanks, much the sticking the questions.
Thank you. Our next question comes on the line of David Lebowitz with Morgan Stanley. Your line is now open.
Oh, Thank you for taking my question given the response, you've seen thus far with AMG easier one three and comedies.
Mark Smith.
Are there any other combinations, but you are thinking about trying.
With the PD one like free.
Scott Koenig: And what would you like to see around the duration of treatment?
Thanks, Dave for that question clearly 'em, we were very excited about the prospects of using NFC engineered a molecule.
Scott Koenig: Excellent question as well. Remember that, based on the PFS rate of currently approved drugs, we're talking about two to three months with a survival rate in this late stage population of around a year, depending on the study, a little less or a little more. So obviously, if we exceed those parameters, plus have a persistence of reduction of PSA of greater than 50%, very early and prolonged, I think we'll be in pretty good shape with regard to that.
The like margin talks about that we know it does as opposed to name specific community and what we have seen today that's up regulated.
Many of the activation markers, including last week.
And other checkpoint.
And so given that the F.C. engineered and old using that molecule, which is has the exact exact same.
Scott Koenig: Thank you. And then, just finally, around... CD123 Fertituzumab. Just what should we expect to see by Q4 as regards data?
I have seen modulation.
Mark.
I am also introduces the same up regulation.
Scott Koenig: So the plan is to present at ASH. We've submitted a number of different abstracts. Obviously, they have to undergo review. But the expectation is to present a double-digit number of patients since the last ASH meeting, so there'll be a nice-sized population to evaluate since our last formal presentation.
These markers and some of our in vitro studies.
We expect to.
A combination studies.
With.
With NGL 13 within all the season that and we will be updating later this year on the specific design and the start of those studies, which is likely to occur in 2021.
Operator: Great. Thanks very much. Thanks for taking the time to answer the question. Thank you. Our next question comes from the line of David Lebowitz with Morgan Stanley. Your line is now open. Thank you for taking my question. Given the response you've seen thus far with MGD-013 in common... Are there any other combinations? If you are thinking about trying... (inaudible)
Thanks for taking my question.
Thank you. Our next question comes on the line David Nierengarten with Wedbush. Your line is now open.
Hi.
Thanks for taking my question I think you have a couple of so they know what's with the harvest to pronounce names but.
Just a quick question on merger talks in Maryland, Oh 13 are you have you reported and are you planning to have you recorded one on cdsixteen mutations or polymorphisms in the patients already treated in the two are you planning to either stratify or screen.
Scott Koenig: Thanks David for that question. Clearly, we are very excited about the prospects of using an FC engineered molecule that, like margituximab, that we know induces both innate and specific immunity and what we have seen to date has upregulated many of the activation markers including LAG3, PD-L1, and other checkpoints. And so, given that the FC engineered enoblituzumab molecule, which has the exact same FC modulation as margituximab, and also induces the same upregulation of these markers in some of our in vitro studies, we expect to design combination studies with MGD013 with enoblituzumab and we will be updating later this year on the specific design and the start of those studies, which is likely to occur in 2021.
Either way or or just take a look at those patients going forward and the expansion cohorts of course is particularly impressed.
Yeah.
And the expansion cohorts going forward. Thanks.
David excellent question, we have I'm not planned to either select prospectively patients based on the Apple wheel variations.
Well, obviously analyze these retrospectively.
It is very possible.
Operator: Thank you. Our next question comes from the line of David Nierengarten with Wedbush. Your line is now open. Hey, thanks for taking my question. I think you have a list of analysts with the hardest to pronounce names.
With a combination therapy here.
With immune activation differences between the dip a little May go away. So this is another question that is very interesting to us and so we don't want was.
Scott Koenig: But, Just a quick question on marzituximab and O13. Have you, and are you planning to, reporting any CD16 mutations or polymorphisms in patients already treated? And then two, are you planning to either stratify or screen? Either way, or just take a look at those patients going forward in the expansion cohorts? Of course, I've been particularly impressed with the expansion cohorts going forward. Thanks.
Patients with different ILEC times.
Okay makes sense. Thanks.
Thank you. Our next question comes on the line of boys.
He there with.
Cowen and company. Your line is now open.
Hi, this isn't the on for Boris Thank you for taking your questions and I feel on that and you know Jan <unk> 0.36 molecule.
Can you put into context, what particular tumor types express Adam nine at a high level and perhaps what other programs are out there that may be targeting at nine.
Scott Koenig: David, excellent question. We have not planned to select prospectively patients based on the epithelial variations, but we'll obviously analyze these retrospectively. It is very possible that with the combination therapy here with immune activation, differences between the VF alleles may go away. So this is a question that is very interesting to us, and so we don't want to exclude patients with different allelic types. Okay, makes sense.
So thank you very much for that question I'm glad we got at least one question because we're very excited about the prospects and as Mark [laughter], you're welcome [laughter] no it's great.
Any other program that historically its been directed towards progress to out of nine so it's clearly a target that we are exporting.
This is an average isn't as high we over expressed on many different solid tumor types.
Operator: Okay, makes sense. Thanks. Thank you. Our next question comes from the line of Boris. Peter Wint, Cowan and Company, your line is now open. Hi, this is Cynthia Allen on behalf of Boris. Thank you for taking our questions. A few on the immunogen IMGC936 molecule. Can you put into context what particular tumor types express ADAM9 at a high level, and perhaps what other programs are out there that may be targeting
So included our non smoker, non small cell lung cancer pancreatic cancer gastric cancer triple negative breast cancer prostate cancer.
And others.
And so you know what we think that I'm presuming that.
We achieved good safety profile and evidence of efficacy that's has.
Sorry.
It's a very good opportunity to address lots of different cancer types.
Scott Koenig: So thank you very much for that question. I'm glad we've got at least one question because we're very excited about the prospects of this month. You're welcome.
Alright, Thank you for to your question.
Thank you.
This concludes today's question and answer session I would now like to turn the call back to Scott Wollney for closing remarks.
Thank you very much for joining our call today look forward to updating you in the near future about our programs have a good good afternoon.
Scott Koenig: Yeah, no, it's great. We don't know any other program that historically has been directed or is in progress to add a line. So it's clearly a target that we are exploiting.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
Scott Koenig: This is an antigen that is highly overexpressed in many different solid tumor types. So included are non-small cell lung cancer, pancreatic cancer, gastric cancer, triple negative breast cancer, prostate cancer, and others. And so, you know, we think that presuming that we achieve a good safety profile and evidence of efficacy, this has a very, it's a very good opportunity to address lots of different cancer types.
Right.
[noise].
Scott Koenig: Alright, thank you for taking our questions. Thank you. This concludes today's question and answer session. I would now like to turn the call back to Scott Koenig for closing remarks.
Scott Koenig: Thank you very much for joining our call today; we look forward to updating you in the near future about our programs. Have a good afternoon.
Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.
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