Q1 2021 MacroGenics Inc Earnings Call
Good afternoon, we will begin the Macrogenics 2021 first quarter corporate progress and financial results Conference call and just a moment all participants are in a listen only mode at the moment and we will conduct a question and answer session at the conclusion of the call at the.
Operator: Good afternoon. We will begin the MacroGenics 2021 First Quarter Corporate Progress and Financial Results Conference call in just a moment. All participants are in a listen-only mode at this point, 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 Jim Karrels, Senior Vice President, Chief Financial Officer, at MacroGeneral. Thank you, operator.
The point I will turn the call over to Jim Carroll, Senior Vice President and Chief Financial Officer of Macrogenics.
Thank you operator, good afternoon, and welcome to Macrogenics conference call to discuss our first quarter 2021 financial and operational results for anyone who has not had the chance to review. These results we used and the press released this afternoon outlining todays announcements, which is available under the investors tab on our website at Macrogenics Dot com.
James Karrels: Good afternoon, and welcome to MacroGenics' conference call to discuss our first quarter 2021 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 also 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.
You May you May also 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.
James Karrels: I would like to alert listeners that today's discussion will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of the Safe Harbor Provision, under the Private Securities Litigation Reform Act of 1995.
Like to alert listeners that todays discussion will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of the safe Harbor provision under.
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 and the risk factors section of our annual and quarterly and current reports filed with the us.
James Karrels: Actual results may differ materially from those indicated by these four linking statements as a result of various important factors, including those discussed in the risk factors section of our annual, quarterly, and current report filed with the SBA. 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 extent required by applicable law. Now, I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of MacroGenics.
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 and the future. We specifically disclaim any obligation to do so even if our views change except to the extent required by applicable law and now I'd like to turn.
The call over to Dr. Scott Koenig, President and Chief Executive Officer of Macrogenics.
Scott Koenig: Thank you, Jim. I'd like to welcome everyone participating via conference call and webcast today. This afternoon, I will provide key highlights from our clinical program. But before I do so, let me first turn the call back to Jim, who will review our financial results for the first quarter.
Thank you Jim 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 back to Jim who will review our financial results for the first quarter.
Thank you Scott does the afternoon Macrogenics reported financial results for the quarter ended March 31, 2021, which highlight our financial position as well as our recent progress.
James Karrels: Thank you, Scott. This afternoon, MacroGenics reported financial results for the quarter ended March 31st, 2021, which highlight our financial position as well as our recent progress. As described in our release this afternoon, MacroGenics total revenue, consisting primarily of revenue from collaborative agreements, was $16.9 million for the quarter-ended March 31, 2021, including $0.9 million net sales of Margenza, which launched in mid-March, compared to total revenue of $13.7 million for the quarter-ended March 31, 2020.
And as described and are released this afternoon Macrogenics total revenue consisting primarily of revenue from collaborative agreements was $16 $9 million for the quarter ended March 31, 2021, including 0.9 million net sales of more gender, which launched in mid March compared to total revenue of $13 7 million for the.
Quarter ended March 31, 2020 revenue recognized during the quarter ended March 31, 'twenty 'twenty. One included a $10 million milestone related to the development progress of Red a fan the mab outside the U S under our exclusive global collaboration and license agreement with insight.
James Karrels: Revenue recognized during the quarter-ended March 31, 2021 included a $10 million milestone related to the development progress of Retifamilamab outside the U.S. under our exclusive global collaboration and license agreement with Insight. Our research and development expenses were $53.1 million for the quarter ended March 31, 2021, compared to $48.9 million for the quarter ended March 31, 2020. This increase was primarily due to higher expenses related to Fleta-Tuzumab, MGCO-18, MGD-019, and preclinical projects, partially offset by a decrease in development and manufacturing costs for retifamlimab.
Our research and development expenses were $53 $1 million for the quarter ended March 31, 2020, one compared to $48 9 million for the quarter ended March 31, 2020. This increase was primarily due to higher expenses related to flood of twos Mab M. G. C. O M. G D O 19 and preclinical.
<unk>, partially offset by a decrease and development and manufacturing costs from our read of family Man.
Our selling general and administrative expenses were $15 million for the quarter ended March 31, 2021, compared to $10 2 million from the quarter ended March 31, 2020. This increase was primarily due to macrogenics, 50% share of sales and marketing costs related to margins of prelaunch and launch activities.
James Karrels: Our selling, general, and administrative expenses were $15 million for the quarter-ended March 31, 2021, compared to $10.2 million for the quarter-ended March 31, 2020. This increase was primarily due to MacroGenics' 50% share of sales and marketing costs related to Margenza pre-launch and launch activities, as per our agreement with IRISANA.
As per our agreement with Arizona.
Our net loss was $51 $3 million for the quarter ended March 31, 2021 compared to a net loss of $44 7 million for the quarter ended March 31 2020.
Our cash cash equivalents in marketable securities balance as of March 31, 'twenty, 'twenty, one with $343 $2 million compared to $272 $5 million as of December 31, 2020.
James Karrels: Our net loss was $51.3 million for the quarter ended March 31, 2021, compared to a net loss of $44.7 million for the quarter ended March 31, 2020. Our cash, cash equivalents, and marketable securities balance as of March 31, 2021 was $343.2 million compared to $272.5 million as of December 31, 2020. During the quarter ended March 31, 2021, we sold 3.62 million shares through our at the market or ATM facility at an average price per share of $27.60, raising net proceeds of $98.2 million.
During the quarter ended March 31, 2021 we sold 362 million shares through our aftermarket or ATM facility and an average price per share of $27.60 raising net proceeds of $98 $2 million and it's fully completed our previously filed $100 million ATM facility.
And today, we refreshed the ATM by filing a $200 million prospectus supplement to our shelf registration statement.
Finally in terms of our cash runway I will remind listeners that there are to produce the target action dates scheduled for July of this year relating to BLA for bus and the fan the map and to close the map.
For cash budgeting purposes, we continue to just kind of both milestones as we have no control over them, even with the discounting we anticipate that our cash cash equivalents and marketable securities as of March 31, 2021 combined with anticipated and potential collaboration payments should enable us to fund our operations through 2020.
James Karrels: As this fully depleted our previously filed $100 million ATM facility, today we refresh the ATM by filing a $200 million prospective supplement to our shelf registration statement. Finally, in terms of our cash runway, I will remind listeners that there are two PDUFA target action dates scheduled for July of this year relating to BLAs for both methamlamab and teplizumab. For cash budgeting purposes, we continue to discount both milestones as we have no control over them.
Three assuming the company's programs and collaborations advance as currently contemplated and now I'll turn the call back to Scott.
Thank you Jim with the recent launch and commercialization of March and we are delivering on our vision to provide potentially life changing therapeutics to patients with cancer. We are well positioned to advance. This mission is the growing body of data emerges from our deep pipeline of clinical and preclinical product candidates.
James Karrels: Even with this discounting, we anticipate that our cash, cash equivalents, and marketable securities as of March 31, 2021, combined with anticipated and potential collaboration payments, should enable us to fund our operations through 2023, assuming the company's programs and collaborations advance as currently contemplated. Now, I'll turn the call back to Scott.
We are particularly excited about the multiple ongoing registrational or potentially registration, enabling studies, including for the two the math and AML and margin talks of moving gastric cancer.
These are in addition to two per due for outcomes related to the Blizzard of Mad and read a fan of the Mab and July.
And finally, we know many of you are eagerly awaiting clinical data from multiple dose expansion or proof of concept studies, including from the M. D. C. O 18, Tebo telematics and M. G. D. O 19 with that backdrop, let me use this time to walk you through updates on our portfolio of the eight political.
Scott Koenig: Thank you, Jim. With the recent launch and commercialization of Margenza, we are delivering on our vision to provide potentially life-changing therapeutics to patients with cancer. We are well positioned to advance this mission as a growing body of data emerges from our deep pipeline of clinical and preclinical product candidates. We are particularly excited about the multiple ongoing registrational or potentially registration-enabling studies, including flotatuzumab and AML, and margituximab in gastric cancer. These are in addition to two PDUFA outcomes related to teplizumab and retifanilamab published in July.
Molecules.
First let me provide and update on margin and that as Jim and I, Both mentioned and more gender was launched in mid March and coordination with our commercial partner episodic.
As a reminder of our agenda is approved in combination with chemotherapy for the treatment of adult patients with metastatic <unk> positive breast cancer, who have received two or more prior anti her two regimens at least one of which was for metastatic disease.
Our agenda was recently included and the NCC and guidelines.
Scott Koenig: And finally, we know many of you are eagerly awaiting clinical data from multiple-dose expansion or proof-of-concept studies, including from MGC018, Tebotelumab, and MGD019. With that in mind, let me use this time to walk you through updates on our portfolio of eight clinical molecules. First, let me provide an update on Margituximab. As Jim and I both mentioned, Margenza was launched in mid-March in coordination with our commercial partner, Evasana. As a reminder, Margenza is approved in combination with chemotherapy for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Margenza has recently been included in NCCN guidelines.
As I mentioned on our last quarterly call we of modest expectations from our agenda sales given competitive realities that have taken place and the her two positive breast cancer market, including multiple new approvals, which is great for patients.
And do these recent changes and the market and the abbreviated sales history, we don't expect to provide more Genesis sales guidance until later this year when we have a better sense of uptake by oncologists.
Finally, with regard to margin talks of map and metastatic breast cancer as you may recall, the phase III Sophia trial is still ongoing for overall survival.
Based on the current accrual rate of Oss events, and the ongoing phase III, Sophie and metastatic breast cancer study that supported our approval by the FDA. We now anticipate completing the final analysis of O S data based on the accrual of the 380 <unk> test O S event by the end of the third quarter.
Beyond breast cancer, we are evaluating margin talks of map and the phase two and three mahogany study and patients with advanced gastric and gastroesophageal junction cancer.
Scott Koenig: As I mentioned on our last quarterly call, we have modest expectations for Magenta sales, given the competitive realities that have taken place in the HER2-positive breast cancer market, including multiple new approvals, which is great for patients. Owing to these recent changes in the market and the abbreviated sales history, we don't expect to provide Margenza sales guidance until later this year when we have a better sense of uptake by oncologists. Finally, with regard to Margitoximab and metastatic breast cancer, as you may recall, the Phase III SOFIA trial is still ongoing for overall survival.
This trial consists of two modules designed to evaluate margin talks of map as an investigational agent in combination with the checkpoint inhibitor with or without chemotherapy as the potential first line treatment for patients with advanced or metastatic her two positive gastric or gastroesophageal junction cancer.
As previously indicated we submitted a placeholder abstract of margin talks of NAV in gastric cancer and mid February for our first half medical meeting the <unk>.
Many of the abstract included the initial safety and efficacy data relating to 'twenty four resist the valuable mahogany module eight patients who were treated with the combination of red of family Mab and investigational anti PD, one antibody and margin talks of map.
Scott Koenig: Based on the current accrual rate of OS events in the ongoing Phase 3 SOFIA metastatic breast cancer study that supported approval by the FDA, we now anticipate completing the final analysis of OS data based on accrual of the 385th OS event by the end of the third quarter. Beyond breast cancer, we are evaluating margituximab in the Phase 2-3 mahogany study in patients with advanced gastric and gastroesophageal junction cancer. This trial consists of two modules designed to evaluate modutoximab as an investigational agent in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer.
And the abstract was accepted by ask though however, and in consultation with the study's lead investigator, whose preferences to present updated results. When most of the 40 enrolled patients will have been evaluated radio graphically by Central review, we and the lead investigator withdrew the apps <unk> abstract and we will.
Submit an updated one to ESMO.
Module, B, which is evaluating March rituxan, and <unk> plus either of two of Macrogenics checkpoint inhibitor molecules and combination with chemotherapy compared to standard of care therapy of Trastuzumab with chemotherapy and patients with her two positive tumors irrespective of PDL one expression.
Is currently ongoing enrollment and coordination with our regional partner and Greater China XI lab.
Scott Koenig: As previously indicated, we submitted a placeholder abstract on margituximab and gastric cancer in mid-February for our first half medical meeting. The submitted abstract included initial safety and efficacy data relating to 24 Resist-Evaluable Mahogany Module A patients who were treated with a combination of retofamilamab, an investigational anti-PD-1 antibody, and margituximab. The abstract was accepted by ASCO. However, in consultation with the study's lead investigator, whose preference is to present updated results when most of the 40 enrolled patients will have been evaluated radiographically by central review, we and the lead investigator withdrew the ASCO abstract, and we will submit an updated one to ESMO.
Module B is expected to continue enrollment through 2020 one.
Next let me discuss floated to the map our investigational by specific C. D. One twenty-three by CD three dart molecule. We continue to enroll the single arm Registrational clinical study to evaluate flood of Tuesday night of and up to 200 patients with primary induction failure or early relapse AML.
We anticipate providing further updates on the clinical development of Florida to the Nab and late 2021 and completing full enrollment of the study in 2020 two.
I'll next discuss M. D. C O 18, our investigational antibody drug conjugate designed to deliver of DNA alkylating do akamai as the inside of the toxic payload to cells that express <unk> seven and eight three.
As you saw and ask those release of abstract titles yesterday, we plan to provide and update on M. D. C of O 18 phase one clinical data at the upcoming conference the a poster presentation.
Scott Koenig: Module B, which is evaluating Marchituximab plus either of two MacroGenics checkpoint inhibitor molecules in combination with chemotherapy, compared to standard of care therapy of Trastuzumab with chemotherapy in patients with HER2 positive tumors, irrespective of PD-L1 expression, is currently ongoing enrollment in coordination with our regional partner in Greater China, Xi Lab. Module B is expected to continue enrollment through 2021.
And when they ask all of abstract comes out in mid May you will see that as of January of 'twenty. One 2021 data cut off ahead of the February 17th submission deadline, we had enrolled the four make per Kid cohort, which included three melanoma patients.
Based on preliminary data from these patients we added of melanoma of expansion cohorts of the phase one study.
Scott Koenig: Next, let me discuss flotatuzumab, our investigational biospecific CD123 by CD3DART molecule. We continue to enroll the single-arm registrational clinical study to evaluate flotatuzumab in up to 200 patients with primary induction failure or early relapsed AML. We anticipate providing further updates on the clinical development of flotatuzumab in late 2021 and completing full enrollment of the study in 2022. I'll next discuss MGCO-18, our investigational antibody drug conjugate designed to deliver a DNA-alkylating duochromycin cytotoxic payload to cells that express B7H3.
In addition, although we did not enroll and he squamous cell carcinoma of the head and neck patients in dose escalation based on preclinical Pdx mouse model data presented at ACR and other available data. We also added of squamous cell carcinoma of head and neck dose expansion cohort with both.
The melanoma and squamous cell carcinoma of the head and neck patients to be dose of three megs per kit.
We expect the fully enrolled the 40 of.
Of metastatic castration resistant prostate cancer patients as well as the 20 non small cell lung cancer patients by midyear and the 'twenty triple negative breast cancer patients later this year with regard to the metastatic castration resistant prostate cancer expansion cohort as of today, we have enrolled more than.
20 patients all but two of them remain on therapy, and we are encouraged by the PSA data we've seen to date again with appropriate caveats. Here. This is early preliminary data we have too few scans from any of the cohort expansion patients at this time to draw any conclusions.
Scott Koenig: As you saw in ASCO's release of abstract titles yesterday, we plan to provide an update on MGC 018 Phase 1 clinical data at the upcoming conference via poster presentation. When the ASCO abstract comes out in mid-May, you will see that as of January 21, 2021, data cut off ahead of the February 17th submission deadline, we had enrolled the four MIG per kid cohort, which included three melanoma patients. Based on preliminary data from these patients, we added a melanoma expansion cohort to the Phase I study.
We look forward to presenting the M. D C of O 18 day that ask though.
Another of our investigation of molecules exploiting the overexpression of <unk>, seven and eight three and solid tumors is and over to the Mab and FC engineered antibody created using our FC optimization platform.
And March we initiated a combination study of the novel to the map and the chemotherapy free regimen in frontline squamous cell carcinoma of the head and neck with either of Tebo tell them that for patients who of PDL, one negative or the red a fan of the mad and patients who of PDL one positive.
Scott Koenig: In addition, although we did not enroll any squamous cell carcinoma of the head and neck patients in dose escalation, based on preclinical PDX mouse model data presented at AACR and other available data, we also added a squamous cell carcinoma of the head and neck dose expansion cohort with both melanoma and squamous cell carcinoma of the head and neck patients to be dosed at three mixes per We expect to fully enroll the 40 metastatic castration-resistant prostate cancer patients, as well as the 20 non-small cell lung cancer patients by mid-year, and the 20 triple negative breast cancer patients later this year.
Next up Tebo tell them that is our investigational bispecific PD one by lag three dart molecule. We are evaluating type of telematics and the phase one dose is expansion study as both monotherapy and several tumor types as well as and combination study with margin took the map.
We expect to provide updates on the next stage of development for type of Telematic. Later this year our partners XI lab has the right to develop and commercialize type of telematics and mainland China, Hong Kong, Macau, and Taiwan, and currently has multiple ongoing monotherapy and combination studies of Teva tell them at.
Let me next discuss Mgd of 19, our investigational by specific checkpoint dart molecule that targets PD, one and CTO of <unk> for our phase one dose expansion study is initially evaluating patients with microsatellite stable colorectal cancer and checkpoint naive non.
Scott Koenig: With regard to the Metastatic Castration-Resistant Prostate Cancer Expansion Cohort, as of today, we have enrolled more than 20 patients, all but two of them remain on therapy, and we are encouraged by the PSA data we've seen to date. Again, with appropriate caveats here, this is early preliminary data.
Small cell lung cancer at the recommended phase II dose of six Migs per kit, we are and the process of adding expansion cohorts with metastatic castration resistant prostate cancer patients and with melanoma patients.
Scott Koenig: We have too few scans from any of the cohort expansion patients at this time to draw any conclusions. We look forward to presenting the MGC 018 data at ASCO. Another of our investigational molecules exploiting the overexpression of B7H3 in solid tumors is enoblatuzumab, an Fc-engineered antibody created using our Fc Optimization Platform. In March, we initiated a combination study of anoblatuzumab in a chemotherapy-free regimen for front-line squamous cell carcinoma of the head and neck with either tebotelumab for patients who are PD-L1 negative or redofanilumab for patients who are PD-L1 positive.
And the next turn to read a fan of the Mab the investigational anti PD one antibody that we license to insight is I N C. M. G. A 0012.
The FDA accepted for priority review insides BLA for Red a fan of the mab as the potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal, who have progressed on all of her who are intolerant of platinum based chemotherapy.
According to inside statements. The <unk> target action date for Red a fan of Mab is July of 'twenty to 2021.
In addition to anal cancer insight has stated is pursuing development of red of Sandler math, as monotherapy and potentially registration, enabling studies and patients with MSI high endometrial cancer Merkel cell carcinoma and lung cancer. In addition, they are evaluating and the molecule in combination with other assets.
And the immuno oncology portfolio.
And finally, our second investigational ADC I M. G. C O 93, six which targets and I'm nine is being advanced under our co development agreement with Immunogen.
Scott Koenig: Next up, Tebotelumab is our investigational bispecific PD-1 bilag-3-DAR molecule. We are evaluating Tebotelumab in a phase 1 dose expansion study as monotherapy in several tumor types, as well as in a combination study with margituximab. We expect to provide updates on the next stage of development for Tebotelumab later this year. Our partner, Xi Lab, has the right to develop and commercialize Tebotelumab in Mainland China, Hong Kong, Macau, and Taiwan and currently has multiple ongoing monotherapy and combination studies of Tebotelumab.
Under a 50 50 collaboration Immunogen is leading clinical development and they have indicated they expect to complete dose escalation and move to expansion cohorts and the phase one study with initial data anticipated by early 2020 two.
We look forward to continuing to build momentum and advance our pipeline of innovative product candidates in 2020. One we would be happy now to open the call for questions operator.
Thank you and reminded to ask the question.
Scott Koenig: Let me next discuss MgD019, our investigational bispecific checkpoint DART molecule that targets PD-1 and CTLA-4. Our Phase 1 Dose Expansion Study is initially evaluating patients with microsatellite-stable colorectal cancer and checkpoint IV non-small cell lung cancer at the recommended Phase 2 dose of 6 mg per kg. We are in the process of adding expansion cohorts with metastatic castration-resistant prostate cancer patients and with melanoma patients. Let me next turn to retifanilamab, the investigational anti-PD-1 antibody that we licensed to Insight is INCMGA0012.
Yes, you will have the press star one on your telephone and till they draw. Your question. Please press the pound key.
Please stand by while we compile the Q&A roster.
Our first question will come from the line of Jonathan Chang from SVP Leerink you may begin.
Hi, guys. Thanks for taking my questions.
First question can you provide your latest thoughts and help set expectations as it pertains to the upcoming M. G. C 018 update I'd ask all of.
And you provided some color on the process of expansion current and maybe.
Scott Koenig: The FDA accepted for priority review an Insight BLA for retifanlamab as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on or who are intolerant of platinum-based chemotherapy. According to Insight Statements, the BDUFA target action date for retifanlamab is July 25, 2021.
The fall up and that should we expect to see any lung cancer expansion cohort data and Africa.
Jonathan and thanks very much for your question at this point, we're not expecting updates on the on the lung cohort given the very early nature of that study and the as.
The indicated previously of patients did not start enrolling in that study until after the beginning of this year.
We haven't actually looked at the full data set available we are of devising the of the poster very shortly but as of now I don't expect the the lung cancer patients to be included and the update.
Scott Koenig: In addition to anal cancer, Insight has stated it is pursuing the development of retifanilamab as monotherapy in potentially registration-enabling studies in patients with MSI-high endometrial cancer, Merkel cell carcinoma, and lung cancer. In addition, they are evaluating the molecule in combination with other assets in their immuno-oncology portfolio. And finally, our second investigational ADC, IMGC0936, which targets ADAM9, is being advanced under a co-development agreement with Immunogen. Under our 50-50 collaboration, Immunogen is leading clinical development, and they have indicated they expect to complete dose escalation and move to expansion cohorts in the Phase I study, with initial data anticipated by early 2022. We look forward to continuing to build momentum and advance our pipeline of innovative product candidates in 2021. We would be happy now to open the call to questions. Operator?
Got it. Thank you and one clarifying question I think I heard desperate and I just wanted to double check and all.
Our both the N G C 018 expansion cohorts and head and neck cancer and melanoma and evaluating the same three make per kg dose level and regimen and the other ongoing expansion cohorts.
That's correct, the new expansion cohorts and head and neck and melanoma at twin mixed per kit Q.
Q3 weekly.
Got it and just one final question from me and.
What are your latest thoughts and potential 018 updates beyond ask of this year.
So we intend to provide updates at future scientific meetings. This year we are.
And considering a submission to ESMO, obviously, the date has not come up yet, but that is and the planning stage.
Yes.
Got it thanks for taking the questions.
Operator: Thank you. As a reminder, to ask a question...
Our next question comes from the line of Peter Lawson from Barclays. You may begin.
Operator: I'm reminded to ask a question. You will have to press star 1 on your telephone, and to withdraw your question, please press the pound key.
Hey, Thanks for taking my questions just the other.
Operator: Please stand by while we compile the Q&A roster. Our first question will come from Jonathan Chang from SVB Larynx. You may begin. Hi guys, thanks for taking the time to answer my question. First question, can you provide your latest thoughts and help set expectations as it pertains to the upcoming MGC018 update at ASCO? You provided some color on the prostate expansion cohort, maybe a follow-up on that, should we expect to see any lung cancer expansion cohort data at ASCO?
As we think about them as good data for piece of a page three.
And I guess two parts really.
Kind of how much prostate data should we expect to see would we see any of the indications.
The breast cancer and then.
The other any of data.
Thanks, Thanks, Peter So with regards to the quantity as I said, we're doing a cutoff.
This this past week in terms of the data update and I haven't seen the actual data at the.
Yet as we devised the poster and my expectation is that you'll have the and the new expansion cohort of the of.
Scott Koenig: Jonathan, thanks very much for your question. At this point, we're not expecting an update on the lung cohort given the very early nature of that study. As I have indicated previously, patients did not start enrolling in that study until after the beginning of this year. Hence, we haven't actually looked at the full data set available. We are preparing the poster very shortly, but as of now, I don't expect the lung cancer patients to be included in the update.
Prostate patients they'll be it the double digit number of patients included as.
As I said on the call today.
And we have treated over 20 patients. So given that we are looking at PSA result on the Q3 weekly basis and looking at of scans on the on every nine a week basis.
It is possible that we'll have significant number of patients having a lease some initial of PSA evaluations and that prostate cohort with regard to the triple negative breast as I indicated that is enrolling slower than the.
Scott Koenig: Got it. Thank you. And one clarifying question. I think I heard this, but I just want to double check. Are both the MGC018 expansion cohorts in head and neck cancer and melanoma evaluating the same 3 mg per kg dose level and regimen as the other ongoing expansion cohorts?
And the prostate and lung cancer patients and don't expect the completed enrollment of the 20 patients of that cohort until the second half of this year. So we will not include debt at the Astro meeting.
However.
As we have indicated today.
We have data from the form make per keg of.
Scott Koenig: That's correct. The new expansion cohorts in head and neck and melanoma at
Q3 week dosing in the dose expansion, which of them as I noted today on the call.
Scott Koenig: Head and Neck and Melanoma at 3 mixes per kit.
We will include the three melanoma patients and we had historically said we had two prostate patients and there will be another patient within other indications included in the study.
Scott Koenig: Got it. And just one final question for me. What are your latest thoughts and potential 018 updates beyond ASCO this year?
Scott Koenig: So we intend to provide updates at future scientific meetings this year. We are considering a submission to ESMO. Obviously, the date has not come up yet, but that is in the planning stage.
And then.
And to add it.
Was that influenced by Daiichi is trial or just the pdx model.
Scott Koenig: Got it. Thanks for taking the call. Our next question will come from the line of Peter Lawson from Barclays. You may begin. Hey, thanks for taking my questions. Just the, as we think about the ASCO data, H3. I guess there are two parts, really.
You know as our as and when we can.
Some of the today of the ladder with regard to the Pdx model was obviously very reassuring, but even before we had the pdx model data as you recall, two and a half years ago and presented very compelling data of the nobu twos and that combined with Pembina and late line head and neck patients.
With the.
33%.
Overall response rate with a lot of durability of those responses.
Scott Koenig: How much prostate data should we expect to see? Would we see any other indications? Breast Cancer
As you know of frontline head and neck cancer.
Scott Koenig: Thanks, Peter. So with regard to the quantity, as I said, we're doing a cutoff this past week in terms of the data update. I haven't seen the actual data as yet as we devised the poster, but my expectation is that in the new expansion cohort of prostate patients, there will be a double-digit number of patients included. As I said on the call today, we have treated over 20 patients. So given that we are looking at PSA results on a Q3 weekly basis and looking at scans on every nine-week basis, it is possible that we'll have a significant number of patients having at least some initial PSA evaluations in that prostate cohort.
The treatment is <unk> plus chemotherapy, so the ability now of.
Potentially treating a frontline population.
With two.
Two different checkpoints based on PDL, one status of <unk>.
And the two the Mab was very encouraging to us and we thought that was very natural then to add and M. D. C. O 18, and late line patients as well.
Okay.
Final question would be get durability data in the abstract and we have to wait for the for the presentation.
With regard to the abstract again as <unk> discussed today. The cutoff date was January the.
And the abstract was due on February 17th so very little data, but for the comments.
Scott Koenig: With regard to triple-negative breast cancer, as I indicated, that is enrolling slower than the prostate and lung cancer patients and don't expect to complete enrollment of the 20 patients in that cohort until the second half of this year. So we will not include that at the ASCO meeting. However, as we have indicated today, we have data from the four McPig Q3 week doses in the dose expansion, which, as I noted today on the call, will include three melanoma patients. We had historically said we had two prostate patients, and there will be another patient with another indication included in the study.
The comments on the formic per Kid of cohort group.
And is included and that abstract.
Having said that as I have noted on earlier calls and the past months I know, there's at least one of the.
Four of them make per kick patients that's still on therapy. So.
Again the.
We'll have to wait for the apps the actual data.
And to hear the update.
Yes.
Thank you. Our next question comes from the line of Jonathan Miller from Evercore ISI. Your line is open.
Yeah. Thanks for taking the questions guys I think let's start with maybe one more about the Astro data.
Or are we expecting to see any color at all on those other cohorts in.
Scott Koenig: And the reason to add the head and neck, was that influenced by Daichi's trial or just the PDX model?
Non profit cohorts mid year or should we have to wait to ask where do you see anything on the activity side from from those cohorts.
Scott Koenig: As we commented today, the latter with regard to the PDX model was obviously very reassuring, but even before we had the PDX model data, as you recall, two and a half years ago, we presented very compelling data of anoblatuzumab combined with Pembro in late-line head and neck patients with a 33% overall response rate and a lot of durability of those responses. As you know, for front-line head and neck cancer, treatment is Pemperilismet plus chemotherapy.
And secondly, you said you I thought I heard that you said the PSA response as you were happy with PSA responses and the MCR of P. C cohort.
Is that it might be and I hear you correctly is it fair to say that those rates are holding in.
And then maybe switching gears a little bit.
Scott Koenig: So the ability now to potentially treat a frontline population with two different checkpoints based on PDL1 status plus an obo-tuzumab was very encouraging to us, and we thought it was very natural then to add an MGC-O-18 in late-line patients as well.
And let me hear the questions first before I introduce you.
Yes, thanks, John So with regard to the other cohorts and the timing and all I can project right. Now is obviously, what we can do at ESCO.
We typically like to present these data at scientific meetings and time it appropriately so.
Scott Koenig: Okay, just a final question. Would we get durability data in the abstract? We have to wait for the presentation.
And my sense is is that is most likely to be presented at one of them more scientific meetings and the second half of the year with regard to the the PSA and the expansion cohorts.
Scott Koenig: With regard to the abstract, again, as discussed today, the cutoff date was January. The abstract was due on February 17th, so very little data but for the comments on the 4 McPerKig cohort group is included in that abstract. Having said that, as I have noted on earlier calls for MIG-PRKG patients who are still on therapy. So, again, you'll have to wait for the actual data to hear the update.
Just keep the general that the biological activity is trending favorably and the day to day looked at literally a week ago.
And I.
I won't say more than that obviously, we will have.
Some additional.
Numbers come in this week.
But.
No from what I've seen so far I'm very pleased of what I'm seeing with regard to bioactivity.
The safety profile, we've described historically.
Scott Koenig: Thank you. Our next question will come from the line of Jonathan Miller from Evercore ISI. Your line is open.
And with the new patients and then.
And.
Additional of data that we're getting from the four Mig per kit.
Scott Koenig: Thanks for taking the questions, guys. I think we should start with maybe one more about the ASCO data. Are we expecting to see any color at all on those other cohorts in non-PASI cohorts mid-year, or should we have to wait to see anything on the activity side from those cohorts? Secondly, you said you were happy with PSA responses in the MCRPC cohort. Is that – did I hear you correctly? Is it fair to say that those rates are holding in? And then maybe switch gears a little bit.
Expansion cohort.
Thanks, and I guess now we can switch gears, maybe I noticed the new CD, one and 23 CD three.
And the moving forward there should we how should we think about that in the context of the potentially registrational cohort for flow to the Nab.
And your plans for updates on that dataset.
Totally independent of the.
The other.
The enrollment of the registration study of Florida to the Madden and the type of reductions failure early relapse patients is continuing and we.
Scott Koenig: Let me hear those questions first before I inundate you. Thanks.
The PE providing updates.
By the end of the year on that study.
Scott Koenig: Yes, thanks, John. So, with regard to the other cohorts and the timing, all I can project right now is obviously what we're going to do at ASCO. We typically like to present these data at scientific meetings and time them appropriately. So, my sense is that it's most likely to be presented at one or more scientific meetings in the second half of the year. With regard to the PSA in the expansion cohorts, I'll just keep it general that the biological activity is trending favorably in the data that I looked at literally a week ago.
As I've highlighted before we're very excited about the prospects of of.
Advancing our platform technologies.
So with regard to the season, one and 23 by CD three and.
And this contains a slightly off the CD three molecule that should dramatically reduce the cytokine release, but the preserves the antitumor effects, we have seen with one of the two the mab plus the ability of having.
The intermittent dosing of those patients based on the incorporation of the an FC domain. So and we're very excited as this is one of several molecules and our preclinical portfolio that's emerging on this.
Scott Koenig: And, you know, I won't say more than that. Obviously, we'll have some additional numbers come in this week. But, you know, from what I've seen so far, I'm very pleased with what I'm seeing with regard to bioactivity, the safety profile we've described historically, and with the new patients, and then additional data that we're getting from the formic per kick expansion cohort.
The advanced and our platform technology.
Makes sense and just one last one on the new expansion cohorts for MTGE 019.
And what's giving you confidence and in prostate I think of melanoma makes sense for this the sorts of targets across day, there's a little bit different can you talk a little bit about what's driving you into that of the game.
So there are a couple of things that's driving up obviously with a strong interest and prostate cancer, we're looking at opportunities.
Scott Koenig: Thanks. I guess now we can switch gears, maybe. I noticed the new CD123-CD3 moving forward there. How should we think about that in the context of the potentially registrational cohort for fluid eczema and your plans for updates on that data set?
And to advance multiple molecules and that indication as you probably remember from one of the patients that had and.
Objective response in fact, the complete response.
Scott Koenig: Totally independent. The enrollment of the registration study of flotatuzumab in the primary induction failure early relapse patient is continuing. We anticipate providing updates on that study by the end of the year. As I've highlighted before, we're very excited about the prospect of advancing our platform technologies. So with regard to this CD123 by CD3, this contains a slightly altered CD3 molecule that should dramatically reduce cytokine release but preserve the antitumor effects we have seen with flotatuzumab, plus the ability to have intermittent dosing of those patients based on the incorporation of an FC domain. So we're very excited as this is one of several molecules in our preclinical portfolio that's emerging from this advance in our platform technologies.
And our dose escalation study was a patient with castration resistant prostate cancer, which again.
Was the quite remarkable and that patient.
It's still in remission and.
And I think that's coming on close to two years now I know, it's the least a year and a half.
So we're very pleased about that also as you know I'm stuck.
The studies that were conducted with it being Evo and <unk>.
The state cancer showed our responses.
That were quite favorable although they did not meet the objectives of the study for approval.
The idea here of being able to use a safer and potentially.
Potentially safer and a very active molecule like M. G. D. O 19 gives us a lot of enthusiasm and then finally as you know one of our missions and our company is the combined ability of our molecules and.
And so as we develop these molecules the individually and of particular indication, we look for the opportunity to combine them.
The mechanism that AR and mechanisms that are orthogonal to each other to get too and even better response, our preclinical data for instance, combining M. G. C. O 18, and checkpoint molecules has been shown to be quite favorable and so do not be surprised and as future studies of <unk>.
Scott Koenig: and our platform technology.
Scott Koenig: And just one last one, on the new expansion cohorts for MGD019, what's giving you confidence in prostate? I think melanoma makes sense for these sorts of targets, but prostate is a little bit different. Can you talk a little bit about what's driving you into that?
The design to ask those questions and indications that we're pursuing as monotherapy.
Scott Koenig: So there are a couple of things that are driving, obviously, with our strong interest in prostate cancer, we're looking at opportunities to advance multiple molecules in that indication. As you probably remember, one of the patients that had an objective response, in fact, a complete response, in our dose escalation study was a patient with castration-resistant prostate cancer, which was again quite remarkable. And that patient is still in remission, and I think that's coming on close to two years now. I know it's at least a year and a half.
The next question will come from the line of Stephen Willey from Stifel. You may begin.
Yeah, good afternoon, and thanks for taking the question and.
I'm going to ask you a couple here one of your questions. If you don't mind, but.
I guess, there seems to be a lot of the emphasis around this notion of.
And whether or not we're going to see I guess, some resist the valuable prostate cancer patients and ask them. Even though this is I believe the minority of the most refractory prostate cancer patients.
Scott Koenig: So we're very pleased about that. Also, as you know, studies that were conducted with ipinevo in prostate cancer showed responses that were quite favorable, although they did not meet the objectives of the study for approval. The idea here of being able to use a safer, and potentially safer, and a very active molecule like MGT019 gives us a lot of enthusiasm. And then, finally, as you know, one of our missions in our company is the combinability of our molecules.
Is there anything that you can say.
And just with respect to I guess, the double digit patients that may be included in the presentation of.
And of what proportion of those.
Do you think we may actually be able to see some wishes David.
Thanks, Steve.
So with regard to the expansion cohort with regard to resist the dial patients.
And I haven't looked over the.
Scott Koenig: And so as we develop these molecules individually in a particular indication, we look for the opportunity to combine them in mechanisms that are orthogonal to each other to get to an even better response. In our preclinical data, for instance, combining MGT018 and checkpoint molecules has been shown to be quite favorable. And so do not be surprised if future studies may be designed to ask those questions in indications that we are pursuing as monotherapies.
The latest list of patients with regard to whether they had measurable disease, what ive noted on previous looks they.
And they seem to be following the.
The the normal composition of patients that of bony only disease, which a little bit more than 50% and then the patients that have either lymph node or of visceral disease that is measurable what's it a little less than 50%.
Scott Koenig: The next question will come from the line of Stephen Willey from Stifel. You may begin. Yeah, good afternoon. Thanks for taking the time to ask the question. And I'm going to ask you a couple of questions, if you don't mind. But, um, I guess there seems to be a lot of emphasis around this notion of whether or not we're going to see some resistant prostate cancer patients at ASCO, even though this is, I believe, the minority of most refractory prostate cancer patients.
So I'm, assuming that we have a pretty normal distribution.
The issue becomes is.
Whether we have any evaluable scans at the time, because as I said most of these patients came in in 2021, and we're only getting scans every nine weeks. So if we don't have anything that's a valuable by ask though we certainly will have and a valuable and the second half of the <unk>.
Yeah. So you know it's not that we're holding back anything we just you know the patients have to.
Have to be evaluated.
Got it that's very helpful and.
And in the literature right. There's the suggestion that the correlation between PSA 50 response and and resist responses.
Scott Koenig: Is there anything that you can say just with respect to, I guess, the double-digit patients that may be included in the presentation and what proportion of those do you think we may actually be able to see some RSSIS data?
Hi.
Scott Koenig: Thanks, Steve. So, with regard to the expansion cohort, with regard to Resist the Valuable Patients, I haven't looked over the latest list of patients with regard to whether they have measurable disease. What I've noted on previous looks is that they seem to be following the normal composition of patients that have bone-only disease, which is a little bit more than 50%, and then patients that have either lymph node or visceral disease that is measurable, which is a little less than 50%.
Do you think that correlation differs Anna.
On the target by target basis in terms of just modality of therapy or do you think that that's just the correlation that broadly holds across the treatment landscape.
You know I think.
The full answer is not in yet I think that the recent data suggests a pretty good correlation and as you know many of the agents that are approved for treatment.
Scott Koenig: So, I'm assuming that we have a pretty normal distribution. I think that the issue becomes whether we have any valuable scans at the time because, as I said, most of these patients came in in 2021, and we're only getting scans every nine weeks. So, if we don't have anything that's valuable by ASCO, we certainly will have it by the second half of this year. So, you know, it's not that we're holding back anything. We just, you know, the patients have to have time to be evaluated.
And are part of the E R inhibitor family and so I suspect that the effects on PSA and then ultimately prediction there may be different than.
Say and ADC molecule cytotoxic effects I think will just needs of more time to evaluate this I think that.
It is.
And the case here, where you're using and ADC and the.
Scott Koenig: Got it. That's very helpful. And I know in the literature, right, that the correlation between, you know, a PSA-50 response and a resist response is pretty high. But do you think that correlation differs on a target-by-target basis in terms of just modality of therapy, or do you think that that's just a correlation that broadly holds across the treatment landscape?
The only thing that I can truly is ascribe to the reduction of PSA is actually a reduction in tumor. That's the only mechanism that I can see here either by direct cytotoxic effects or possibly by secondary immunological mechanisms.
So you.
Scott Koenig: You know, I think the full answer is not in yet. I think that the recent data suggests a pretty good correlation. As you know, many of the agents that are approved for treatment are part of the AR inhibitor family. And so I suspect that the effects on PSA and then ultrapol prediction there may be different than, say, an ADC molecule with cytotoxic effects. I think we'll just need more time to evaluate this.
We'll have to seems the weather that correlation of I should also note that for patients that particularly of late stage patients that have continually rising Psa and the ability to.
The shutdown of that doubling time is also it should be also seen as quite favorable because ultimately we're not curing late stage patients. We're looking at both improving the morbidity and mortality of.
Scott Koenig: I think that, you know, in the case here where you're using an ADC, the only thing that I can truly ascribe to the reduction in PSA is actually a reduction in tumor. That's the only mechanism that I can see here, either by direct cytotoxic effects or possibly by secondary immunological mechanisms.
Of these patients and prolonging their lives. So I think again, we're going to need more time to ultimately come out with the conclusions here, but as I said.
I was very we were very excited the last year by the initial data we continue to.
Scott Koenig: So you know, we'll have to see whether that correlation holds. I should also note that for patients that, particularly late-stage patients that have continually rising PSAs, the ability to shut that off, that doubling time, should also be seen as quite favorable because, ultimately, we're not curing late-stage patients. We're looking at both improving the morbidity and mortality of these patients and prolonging their lives. So I think, again, we're going to need more time to ultimately come up with the conclusions here. But as I said, you know, we were very excited last year by the initial data, and we continue to see the current data in a positive light.
See the current data in a positive light.
That's helpful and and just lastly, Scott you mentioned.
The.
And the possibility of combining <unk> with a PD, one inhibitor and I know that the.
Protocol for the M. D C O N E O and <unk> trial calls for.
I guess with or without a read of Allomap.
Have you started dose escalation with right of a fan of a lab and and I guess.
Does the.
So some of the PD, one plus chemo data that we've seen and the refractory David and the refractory setting kind of ex.
Scott Koenig: That's helpful. And just lastly, Scott, you mentioned the possibility of combining ONA with PD-1 inhibitors. I know that the protocol for the MGC-ONA trial calls for, I guess, with or without retifamilumab. Have you started dose escalation with retifamilumab? And I guess..., does the... Does some of the PD-1 plus chemo data that we've seen in the refractory data in the refractory setting kind of accelerate that? It's not, you know, as you've said, Aldana, I don't recommend that they do this. Thanks.
Accelerate debt.
Those development timelines and especially now that you've settled on them on a recommended phase two dose.
Excellent question, Steve. So you know when we were starting the dose escalation and we expect it to quickly go over and flipped to the combo study with the router family of Mab, However, and we were obviously.
Pleasantly surprised with the robustness of data, we saw with the PSA reduction and so rather than continue on with that part of the protocol as you know, we didnt even finish out the dose escalation and we went to the expansion.
Scott Koenig: Excellent question, Steve. So, you know, when we were starting the dose escalation, we expected to quickly go over and switch to the combo study with retafamilamab. However, we were obviously pleasantly surprised with the robustness of data we saw with the PSA reduction. And so rather than continue with that part of the protocol, as you know, we didn't even finish the dose escalation. We went to the expansion. Now that we have so much more data with both tebotelumab, PD-1 Lag-3, and with MGD-019, PD-1 CTLA-4, in addition to retafamilamab, we have a lot of different opportunities now and don't necessarily have to resort to just using retafamilamab. And so we're right now in discussions of next steps and designing those combination studies. And so I wouldn't necessarily assume that it's going to be retafamilamab.
Now that we have so much more data with both the tebo tell them out of the PD, one lag three and with M. G. D. O 19, PD one <unk> four in addition to read a fan of the map we have a lot of different opportunities now and don't necessarily have to resort to just using red of family Mab and so we're right now and.
The discussions of next steps and designing those combination studies and so I wouldn't necessarily assume that it's going to be rid of family members.
<unk>.
Yeah.
Our next question will come from the line of you're going to come of it just from Citigroup you may begin.
Hi, Scott and Jim Thank you for taking the question.
And you just clarify why you're combining and novelties and add with people to the Nab and the PDL, one negative and net patients given the pivotal and the targets PD one.
Yeah. So.
All of this goes back to the observations, we made and described last year and asked with regard to our FC engineering.
Scott Koenig: Our next question will come from the line of Yigal Nochomovitz from Citigroup. You may begin. All right, Scott and Jim, thank you for taking the questions. Could you just clarify why you're combining Inoblituzumab with Tivitilumab in PD-L1 negative head and neck patients given that Tivitilumab targets PD-1?
And the combination with Tebo telematics as you recall, we presented the <unk>.
Very exciting data of margin talks of Mab.
With tebo tell them that and patients that were her two positive and late line patients who of the majority of many of these had very low checkpoint the.
Scott Koenig: Yeah, so Yigal, this goes back to the observations we made and described last year at ASCO with regard to RFC engineering and the combination with tebotelomab. As you recall, we presented very exciting data of margituximab with tebotelomab in patients that were HER2 positive in lane-line patients where the majority, or many of these, had very low checkpoint ligand So very low PD-L1, very low lag-3; in fact, many of the patients were PD-L1-0. At the same time, we were conducting preclinical studies with that combination.
Log and expression, so very low PD L. One.
The very low lag three and in fact, many of the patients were PD L. One zero at the same time, we were conducting the preclinical studies with that combination. We are also conducting and know the Tucson lab and combination studies with Tebo telematics and demonstrated as we have discussed before.
And the ability to drive up and Nate and specific immunity.
Scott Koenig: We were also conducting inoblituzumab in combination studies with tebotelomab and demonstrated, as we have discussed before, the ability to drive up innate and specific immunity as a result of treating with FC engineered inoblituzumab. And by upregulating both lag-3 and PD-L1, we see that as an opportunity to now get a much more dramatic therapeutic effect when added to te So again, this is a phase one study in inoblintuzumab and PD-L1-0, but our assumption is the same FC engineering that's in MARG, where we see positive clinical results, would translate the same way for PD-L1-0 patients when given this FC engineering plus tebotelomab.
As a result of treating with the U.
FC engineered and know the twos of map and by up regulating.
Both lag three and <unk> and PD L. One of them.
And we see that as an opportunity of now getting a much more dramatic therapeutic effect when added to tebo tell them and so again. This is a phase one study.
In the notebook to the mountain PDL, one negative, but our assumption is the same that's the engineering, that's and in March where we saw positive clinical results would translate the same way for the PDL one negative patients.
When given the subsea engineering, plus tebo telematics and as you know the historical data of from Merck with Pembroke or from Bristol with Nemo in head and neck with PDL. One negative was very poor so any way of to increase the expression here, we think will be have salutary.
Scott Koenig: And as you know, the historical data from MARG with PEMBRO or from Bristol with NEBO in head and neck with PD-L1-0 were very poor, so any way to increase the expression here we think will have salutary effects.
Sex.
Okay got it.
Scott Koenig: Okay, got it. And then, could you just comment on the rationale for expanding the Phase I MGC-018 study into melanoma? I'm just wondering if you also had mouse PDX data for melanoma as you did for head and neck.
And then could you just comment on the rationale for expanding the things one M. D. C of one eight study and to melanoma and just wondering if you also had mouse pdx data from melanoma as you did for head and neck.
Okay, so well.
Scott Koenig: Okay, so without revealing specific data, as you noted on our call today, we had, at the four-mic per kick, three patients with melanoma. That's all I'll say about those patients and wait until the ASCO presentation.
And without revealing specific data as you noted on our call today, we had at the formic per kit three patients.
With melanoma, that's all I'll say about those patients and wait till till the.
Scott presentation, but I also should put this in the in the context of our historical experience and melanoma, where the noble to the math as the single agent and we had objective responses or the tumor reduction in late stage melanoma patients and the same thing was also observed.
Scott Koenig: But I also should put this in the context of our historical experience in melanoma. Given oblituzumab as a single agent, we had objective responses or tumor reduction in late-stage melanoma patients. And the same thing was also observed in patients who were treated with our bispecific MGD-009, which was the CD3 by B7H3. So we have many avenues at this point that suggest melanoma would be a good population to continue to evaluate. And, of course, we also have done immunohistochemistry studies with tissue specimens from melanoma patients showing high expression of B7H3.
And in patients who are treated with our bi specific M. G. D O nine which was the C D. Three.
Hum buy a piece of an H three so we have many avenues at this point that suggest a melanoma.
And would be a good.
Population to continue to evaluate and of course, we also have done.
Immunohistochemistry studies with tissue specimens from melanoma patients showing high expression of <unk> seven and eight three.
Great. Thank you very much Scott.
Scott Koenig: Great. Thank you very much, Scott. Our next question will come from the line of Brad Canino from Credit Suisse. You may begin. Great. Thank you for having me on the call.
Our next question comes from the line of.
And can you know from credit Suisse may begin.
Great. Thank you for having me on the call I'll, just ask one and not about data expectations, but I do have a question on the product market fit for the gastric cancer module, a that youre going to be reporting at ESMO, because they understand the rationale of the chemo free regimen and to reduce toxicity.
Scott Koenig: I'll just ask one, and not about data expectations, but I do have a question on the product market fit for the gastric cancer module A that you're gonna be reporting at Edmo, because I understand the rationale of a chemo-free regimen to reduce toxicity. But you know, these patients present with pretty debilitating symptoms from the tumor, are likely struggling to eat, and I would think they would want a fast response, which is what chemo would provide. So how important is the chemo-free regimen? Is this just a niche opportunity relative to your chemo triple that you'll have later? Or do you think there's really a demand for them here? Thank you.
And these patients present with pretty debilitating symptoms from the tumor or likely struggling to eat and I would think they would want a fast response, which is what the chemo would provide.
So how important is the chemo free regimen is this just the niche opportunity relative to your chemo triple that you'll have later or do you think theres really of demand here. Thank you.
Scott Koenig: That's an excellent question, Brad. Nice to meet you via phone.
That's an excellent question, Brad and nice to meet you via phone.
So.
Scott Koenig: So, again, if you recall, we conducted studies in second line with margituximab and pembrolizumab and actually saw, and these are patients who have progressed on Herceptin and chemotherapy, actually a very quick response in certainly a large number of those patients. And the additional value of that is that our overall survival in that population was dramatically better than the approved second line therapy, ramicirromab plus paclitaxel, and much better than first line therapy when compared across different studies.
Again, if you recall, we had conducted studies and second line cause the margin tuck the Mad and.
Timber iliza Mad and actually saw.
And these are patients who have progressed on herceptin and chemotherapy and saw and they're hard to three plus pause. The PDL one positive population actually a very quick response and is and certainly a large number of those patients and.
And the additional value of that is is that our overall survival of that population was dramatically better than the approved second line therapy reminiscent of them airports Paclitaxel and was even and much better than the first line therapy. When you when you compared of course of different studies.
Scott Koenig: And so that was the rationale. Also, the fact is that when you look at patients in the front line setting, their HER2 expression tends to be higher, and their PD-L1 expression tends to be higher. So, again, we are expecting, or had expected and hoped to be able to present the data later this year at a scientific conference addressing the question you have in terms of the rapidity of response and the durability of that response.
And so that was the rationale and also the fact is is that when you look at the patients and the frontline setting their her to hum expression tends to be higher and their PDL, one expression tends to be higher. So again, we are expecting or had.
Expected and hoped to be able to present the.
Data later this year at a of the scientific conference.
Addressing the question you had in terms of the rapidity of response and the durability of that response.
Scott Koenig: Great, thank you; look forward to Edmo. Our next question will come from the line of Boris Picker from Calin. You may begin. Boris, your line is open. And our next question will come from Etzer Darout from Guggenheim Securities.
Great. Thank you look forward.
Okay.
Our next question comes from the line of Boris Becker from Cowen and maybe you can.
Boris Your line is open.
And our next question will come.
Kind of absurd of Darrow from Guggenheim Securities you may begin.
Scott Koenig: Great, thanks for taking the questions. The first one is another sort of clarifying question from the introductory remarks. Just wanted to confirm that all but two patients in the sort of the prostate expansion arm remained on therapy, and then also on the pace of enrollment in melanoma and head and neck. And then I have a second question.
Great. Thanks for taking the question of the first of all I guess is another sort of clarifying question from the introductory remarks, just wanted to confirm that all but two patients and the sort of the policy of expansion.
And we meet on therapy, and and also on the pace of enrollment and melanoma and head and neck and then I have a second question.
Scott Koenig: So, based on the data that I had seen as of a couple of days ago, that is correct, so I can't tell you anything changed today, but as of a couple of days ago, that statement is correct. With regard to the speed in which we will enroll the head and neck and melanoma patients cohort, this is just opening up. The expectation is that we will enroll a significant number in the second half of this year, but again, we'll provide updates over the course of the year on how that's going.
So as the data that I had seen as of a couple of days ago debt was that is correct and tell you.
And change today, but as of a couple of days ago that that statement is correct.
With regard to the speed and which we will enroll the head and neck and melanoma patients cohort.
This is just opening up the expectation is as debt.
We would enroll them a significant number and the second half of this year, but again, we will provide updates over the course of the year, how that's going.
Great. Thank you and and one question on Mgd O two or I guess based on the preclinical evaluation you've done so far and how you're thinking about sort of maybe frequency of.
Scott Koenig: Great. Thank you.
Scott Koenig: And then one question on MGD-024. I guess based on the preclinical evaluation you've done so far, how are you thinking about sort of maybe frequency of administration as it kind of relates to sort of fluidity, you know, once every week, once every two weeks? Any thoughts around what that interval could be based on what you're seeing? Good question, Etzer.
Administration and that kind of relates to sort of alluded to the amount of interest you know once a week. Once every two weeks of any thoughts around and around what that interval could be.
And what you're seeing.
Scott Koenig: Good question, Etzer. Obviously, we'll have to see what happens in patients, but I think a Q2 weekly dosing regimen is certainly possible. It may reduce the Q1 or increase the Q3. We'll just have to see.
Good question and that's how we'll obviously, we'll have to see what happens and in patients, but I think.
Our Q2 weekly.
Dosing regimen is certainly possible and may reduce the Q1 or increase the Q3, we'll just we'll just have to see.
Great. Thank you.
Operator: Once again, as a reminder, that's star number one for questions, star number one. Our next question will come from the line of David Labowitz from the Moritz Family.
Once again as a reminder of the explorer one for question and Star one.
And our next question will come from the line of David Lebowitz from Morgan Stanley You may begin.
David Labowitz: You may begin, on the gastrointestinal trial. What is it? I mean, how many patients were originally expected to be presented at ASCO versus the 40? driving factor behind, I guess, the leading position wanting to postpone presenting the data at this point. What facts?
Thank you very much for taking my question.
On the.
Gastro and.
First of all trial.
Hey.
What is it I guess, how many patients were originally expected to be presented at ash versus the 40 that'll be presented later this year and.
And what I guess does it.
Is the driving factor behind the B.
And the.
The.
And I guess, the leading position and wanting to postpone.
Scott Koenig: Thanks, David. It was very simple.
Postpone presenting the data at this point and what what.
Factors or I guess, pushing wanting to just hold off until the complete data set is ready.
Scott Koenig: As you know, our decision to move forward is based on a central review of 40 patients, and we only had a little over 20 patients that had investigator review, so it was really an in-between presentation. And so, as I said, since there was no compelling decision and we're waiting until the full 40 patients get evaluated radiographically, we didn't see any harm in allowing the investigator to present this, hopefully, at ESMO. You know, given that it was only a partial study, it was going to be a poster session, and with a much fuller data set, there is obviously a potential for an oral presentation with this type of study.
Yeah. Thanks day that it was a very very simple as that.
As you know our decision to move forward based on the Central review of 40 patients and we only had.
About 20 of little over 20 patients.
And that had investigator review.
So it was really a and between.
The presentation and so of since there was no compelling decision and we're waiting till the full 40 patients.
Get evaluated radio graphically.
We didn't see any harm on Oh.
Allowing the investigator to present.
This.
And hopefully it at ESMO.
Given that it was only a partial study.
This was going to be of post recession and with a much more.
Fuller data set there is obviously of potential for an oral presentation.
With the with this type of study.
Scott Koenig: Have any of the patients in that original abstract undergone the, I guess, radiographic assessment to this point?
Have any of the patients and that original abstract.
Undergone the I guess radiographic and.
Assessment at this point.
So they have all the patients 20, some odd patients had investigator.
Scott Koenig: So they have all the patients, 20-some odd patients, have investigator evaluations. There have been some additional patients, but there's no full central review data set available at this point.
Evaluations and there's been some additional patients, but there is no full of central.
Central the review data set available at this point.
Okay.
Thanks for taking my question.
Scott.
Thank you and I'm not showing any further questions and the queue I'd like to turn the call back over to the speakers for any closing remarks.
Operator: Thank you. And I'm not showing any further questions in the queue. I'd like to turn the call back over to the speakers for any closing remarks.
Scott Koenig: Thank you, Operator, and thank you for your participation in the meeting today. We look forward to updating you on our programs in the not-too-distant future. Have a wonderful afternoon.
Thank you operator, and thank you for your participation and the meeting today and we look forward to updating you on our programs and the not too distant future have a wonderful afternoon.
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.
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