Q2 2021 MacroGenics Inc Earnings Call
Good afternoon, we will begin the Macrogenics 2021 second quarter corporate progress and financial results Conference call in 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 this point I will turn the call over to Chris.
Operator: We will begin the Macrogenics 2021 second 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 Chris James, Vice President of Investor Relations and Corporate Communications at Macrogenics.
Chris James Vice President of Investor Relations and corporate communications of Macrogenics.
Chris James: Thank you, operator. Good afternoon, and welcome to the Macrogenics Conference Call.
Chris James: call to discuss our second quarter 2021 financial and operational results.
Thank you operator, good afternoon, and welcome to Macrogenics conference call to discuss our second quarter 2021.
Regional results for anyone who has not had a chance to review. These results we issued a press release.
Chris James: 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. 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. I would like to alert listeners that today's discussion will include statements about companies' future expectations, plans, and prospects that constitute forward-looking statements for purposes of the State Harbor provision under the Private Securities Litigation Reform Act of 1995.
This afternoon.
On today's announcements, which is available under the investors tab on our website at Macrogenics Dot com.
You May also listen to this conference call via webcast on our website, where it will be archived for 30 days beginning approximately 2 hours after the call is completed.
I would like to alert listeners that todays discussion will include statements about the company's future.
Your expectations plans and prospects that constitute forward looking statements for purposes of the safe Harbor provision under the private Securities Litigation Reform Act of 1095 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 risk factors section of our annual.
Chris James: Actuals may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our annual, quarterly, and current reports filed with the SEC. 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.
Quarterly and current reports filed with the SEC.
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 and now I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of Macrogenics.
Scott Koenig: And now, I'd like to turn the call over to Dr. Scott Koenig, President and Chief Executive Officer of MapRajette. Thank you, Chris. I'd like to welcome everyone participating via conference call and webcast today. For those who have not yet met Chris James, he recently joined Microgenics as our VP of Investor Relations and Corporate Communications. We are delighted to have him on board.
Thank you Chris I'd like to welcome everyone participating via conference call on webcast today for those who have not yet met Chris James He.
He recently joined Macrogenics as our VP of Investor Relations and corporate Communications, we are delighted to have him on board.
Scott Koenig: This afternoon, I will provide key highlights from our clinical programs. But before I do so, we first turn the call to Jim Carrels, our chief financial officer, who will review our financial results for the second call. border. Thank you, Scott, and welcome Chris.
This afternoon, I will provide key highlights for our clinical programs, but before I do so let me first turn the call to Jim Carroll, Our Chief Financial Officer, who will review our financials.
Actual results for the second quarter.
Thank you Scott and welcome Chris.
This afternoon Macrogenics reported financial results for the quarter ended June 32021, which highlight our financial position as well as our recent progress.
James Karrels: This afternoon, MacroGemus recorded financial results for the quarter ended June 30, 2021, which highlight our financial position as well as our recent progress. As described in a release this afternoon, macrogenic total revenue, consisting primarily of revenue from collaborative agreements, was $30.8 million for the quarter ended June 30, 2021, including 3.2 million net sales of Margenza, which launched in mid-March. The 30.8 million compared to total revenue of 20.3 million for the quarter ending June 30, 2020.
As described on or at least this afternoon Macrogenics total revenue consisting primarily of revenue.
Elaborative agreements was $38 million for quarter ended June 32021, including $3.2 million net sales of March Enzo.
Which launched in mid March.
For $38 million compared to total revenue of $20.3 million for the quarter ended June 32020 revenue recognized during the quarter ended June 32.
James Karrels: Revenue recognized during the quarter ending June 30, 20201, included 14.4 million from ZyLab related to the recent June 2021 collaboration announcement and a $5 million milestone related to the development progress of Reda Family Map under our exclusive global collaboration and license agreement with insight. Our research and development expenses were $55.8 million for the quarter ending June 30, 2020, compared to $57.4 million for the quarter ending June 30, 2020. Selling general and administrative expenses were $15.2 million for the quarter ending June 30, 2021, compared to $10.2 million for the quarter ending June 30, 2020.
From 21 included $14.4 million for XI lab related to the recent June 2021 collaboration announcement and a $5 million milestone related to the development progress of credit file amount under our exclusive global collaboration and license agreement with insight our research and development expenses were $55.8 million for the quarter.
Ended June 32021, compared to $57.4 million for the quarter ended June 32020.
Selling general and administrative expenses were $15.2 million for the quarter ended June 32021, compared to $10.2 million for the quarter ended June 32020. This increase was primarily due to macrogenics.
60% share of sales and marketing costs related to margin to launch activities as per our agreement with Arizona Macrogenics net loss was $39.9 million for the quarter ended June 32021, compared to a net loss of $46.9 million for the quarter ended June 32020.
James Karrels: This increase was primarily due to Macrogensics' 50% share of sales and marketing costs related to Margenza launch activities, as per our agreement with Eversana. Macrogenics' net loss was $39.9 million for the quarter ending June 30, 2021, compared to a net loss of $46.9 million for the quarter ending June 30, 2020. Our cash, cash equivalence, and Markable Securities Balance as of June 30, 2021, with $297.3 million compared to $272.5 million as of December 31, 2020. Our June 30, 2020 cash position did not include $55 million received from Xyleab in July related to our broad
Our cash cash equivalents in marketable.
<unk> Securities balance as of June 32021 was $297.3 million compared to $272.5 million as of December 31, 2020, Our June 32021 cash position did.
It did not include $55 million received XI lab in July related to our broad strategic collaborations.
<unk> to develop and commercialize preclinical bispecific antibodies in oncology. This collaboration was announced on June 16, 2000, $21 million to $55 million consisted of a $25 million upfront payment and a $30 million equity investment as consideration for the execution of the collaboration agreement.
Finally in.
In terms of our cash runway, we anticipate that our cash cash equivalents and marketable securities as of June 32021, combined with funds. Subsequently received in addition to anticipated and potential collaboration payments should enable us to fund our operations operations through 2023, assuming the company's programs.
James Karrels: related to our broad strategic collaboration to develop and commercialize preclinical, bi-specific antibodies in oncology. This collaboration was announced on June 16, 2021. The $55 million consisted of a $25 million upfront payment and a $30 million equity investment as consideration for the execution of the collaboration agreement. Finally, in terms of our cash runway, we anticipate that our cash, cash equivalence, and marketable securities as at June 30, 2021, combined with funds subsequently received in addition to anticipated and potential collaboration payments should enable us to fund our operations through 2023, assuming the company's programs and collaborations advance as And now, I'll turn to call back to Scott.
Collaborations advance as currently contemplated and now I'll turn the call back to Scott.
Thank you Jim we are excited by our continued progress towards our goal of providing multiple potentially life changing therapeutics to patients with cancer in March we launched margin for the treatment of her 2 positive.
<unk> in metastatic breast cancer more recently at <unk>, we presented encouraging preliminary clinical data from our phase 1 study of <unk>, our anti <unk> 2 antibody drug conjugates.
Plan to present updated clinical data from the <unk> phase 1 study as.
On the module a mahogany study of margin talks a mab in gastric cancer at ESMO in September.
With that backdrop, let me use this time to walk you through the update on our portfolio of clinical molecules when.
Scott Koenig: Thank you, Jim. We are excited by our continued progress towards our goal of providing multiple, potentially life-changing therapeutics to patients with cancer. In March, we launched Margenza for the treatment of Hurtu positive metastatic breast cancer. More recently, at ASCO, we presented encouraging preliminary clinical data from a Phase 1 study of MGCO-18, our anti-B7803 antibody drug concept. We plan to present updated clinical data from the MGCO-18 phase one study, as well as Module A of the mahogany study of Margotoximab in gastric cancer, at ESMO in September.
When we first discussed M D C O 18, our investigational antibody drug conjugate.
Well is going to deliver a DNA alkylating door for mice and cytotoxic payloads to cells that express <unk> 3.
Macrogenics presented an update of clinical data from the ongoing phase 1 study of <unk> in patients with advanced solid tumors at <unk> in June of this year and held a conference call on webcast.
Designed with external guest presenters to discuss the results.
As a day may 3.2021 data cut off the study demonstrated antitumor activity in all 3 melanoma patients from the 4 Meg per kg dose escalation cohort were enrolled subsequent to the Twenty-twenty ESCO poster presentation, Inc.
Clothing, 1 with.
As current partial response.
As presented preliminary results in the metastatic castration resistant prostate cancer cohort expansion as demonstrated 11 of 22 or 50% of the patients had a PSA reduction of 50% or greater anti tumor activity was observed in for a 7.
7 of these patients with measurable disease, who had their first 9 week imaging results available, including 1 unconfirmed partial response.
The adverse events continue to be manageable and include hematologic and skin toxicities as well as plural in pericardial effusions overall, we are encouraged by the data presented.
Scott Koenig: With that backdrop, let me use this time to walk you through the updates on our portfolio of clinical molecules. When we first discuss MGCO18, our investigational antibody drug conjugate designed to deliver a DNA-alkalating duercomycin cytotoxic payload to cells that express B7H3.
The current fate the poster presentation of this study is available under the investors tab on our website.
M D. C. O 18 trial cohorts are ongoing for metastatic castration resistant prostate cancer melanoma, non small cell lung cancer squamous cell carcinoma of the head and neck.
And triple negative breast cancer.
Finally, we submitted a placeholder abstract to ESMO based on the same may 3rd 2021 data cut presented at <unk> and it was accepted for poster presentation. We anticipate that the data to be presented at ESMO will be based on a data cut closer to the actual.
Scott Koenig: Macrogens presented an update of clinical data from the ongoing phase one study of MGCO-18 in patients with advanced solid tumors at ASCO in June of this year and held a conference call via webcast with external guest presenters to discuss the results. As of the May 3, 2021 data cutoff, the study demonstrated antitumor activity in all three melanoma patients from the 4-Mig-per-Kig dose escalation cohort who were enrolled subsequent to the 2020 ASCO Post to present date, including one with a confirmed partial response. As presented, preliminary results in the metastatic castration-resistant prostate cancer cohort expansion demonstrated that 11 of 22, or 50% of the patients had a PSA reduction of 50% or greater.
Meeting date in September.
Another of our investigational molecules exploiting the overexpression of <unk> III in solid tumors as a novel to the map an FC engineered antibody created using our FC optimization platform.
In March we initiated a combination study of a novel twos, a mab in a chemo therapy.
Therapy free regimen in frontline squamous cell carcinoma of the head and neck with either Tebo tell him there for patients who are PD lone negative with Red are found on the mab in patients who are PD lone positive.
Although enrollment at this time is proceeding slowly we're taking steps to accelerate recruitment and recently expanded efforts to enroll.
For this study in Europe.
Next let me discuss further to the Nab our investigational by specific CD 123 by CD 3 dart molecule, we continuing to enroll that single arm registration, enabling clinical study to evaluate for the to the map and up to 200 patients with primary induction phase.
Failure or early relapse AML, we anticipate providing further updates on the clinical development of Florida to the Mab in late 2021.
Scott Koenig: Antitumor activity was observed in four of seven of these patients with measurable disease who had their first nine-week imaging results available, including one unconfirmed partial response. The adverse events continue to be manageable and include hematologic and skin toxicities, as well as plural and paracardiofusion. Overall, we are encouraged by the data presented to date.
We expect to submit the investigational new drug application for M. G. D. O 20 for our next generation CD 123 by CD 3 dart molecule.
Patients in the fourth quarter of this year. This molecule incorporates a CD 3 component designed to minimize cytokine release syndrome, while maintaining antitumor side of lytic activity, along with an FC domain to permit intermittent dosing through a longer half life.
Scott Koenig: The poster of presentation of the study is available under the Investors tab on our website. MGCO-18 trial cohorts are ongoing for metastatic castration-resistant prostate cancer, melanoma, non-small cell lung cancer, squamous cell carcinoma of the head and neck, and triple negative breast cancer. Finally, we submitted a placeholder abstract to ESMO based on the same May 3rd, 2021 data cut presented at ASCO, and it was accepted for post of presentation. We anticipate that the data to be presented at ESMO will be based on a data cut closer to the actual meeting date in September.
Next up let me walk you through our PD 1.
<unk> assets Tebo telematic <unk>, our investigational Bispecific PD, 1 by lag 3 dart molecule.
We are currently evaluating Cabo telemedicine patients as both monotherapy as well as in combination with other agents.
<unk> lab, our partner in greater China is evaluating tebo Telemark as monotherapy in patients with.
Cellular carcinoma, and melanoma as well as in combination with Niraparib in a variety of advanced or metastatic solid tumors.
At <unk>, we were pleased to see Bristol Myers Phase III relativity, O 47 data, which validated the combined targeting of both PD, 1 and lag 3.
This is a potentially good news for patients and provides further support for evaluating a bi specific molecule against these 2 targets. We expect to provide an update on plans for the next stage of development for tableau tell them that in the coming months.
Next M. G. D O 19 is our investigational bispecific.
Scott Koenig: Another of our investigational molecules exploiting the overexpression of B7H3 in solid tumors is Novituzumab, an FC-engineered antibody created using our FC optimization platform. In March, we initiated a combination study of Obituzaab and a chemotherapy-free regimen and front-line squamous cell carcinoma of the head and neck with either Tebotelemaab for patients who are PDL-1 negative or with reti Although enrollment at this time is proceeding slowly, we are taking steps to accelerate recruitment and have recently expanded efforts to enroll patients for this study in Europe.
Specific checkpoint dart molecule that targets PD, 1 on Cte life for we are conducting a phase 1 dose expansion studying in cohorts of patients with microsatellite stable colorectal cancer checkpoint naive non small cell lung cancer, metastatic castration resistant prostate cancer and melanoma.
Yeah.
Let me next turn to read Osama Mad the investigational anti PD, 1 antibody that we licensed to insight as I N C. M. G. A 0012.
Last Friday after the close inside announced that the FDA had issued a complete response letter or C. R. L.
Regarding its BLA for Red are found on that for the treatment of patients with locally advanced or metastatic squamous cell carcinoma of the anal canal insights announcement indicated that the FDA determined that additional data are needed to demonstrate the clinical benefit of red a phantom NAV for the submitted indication and that insight is reviewing the CRM.
Omar will discuss next steps with the FDA.
Scott Koenig: Next, let me discuss Flotutuzimab, our investigational bispecific CD123 by CD3 DART molecule. We continue to enroll the single-arm registration-enabling clinical study to evaluate Flotutuzumab in up to 200 patients with primary induction failure or early relapse AML. We anticipate providing further updates on the clinical development of Flotutuzumab in late 2021. Additionally, we expect to submit the investigational new drug application for MGD-O24, our next generation CD-123 by CD3 DART molecule, in the fourth quarter of this year.
Beyond anal cancer inside as stated it is exploring development of Red Phan Le Mab as monotherapy and potentially registration, enabling studies in patients with MSI high endometrial cancer Merkel cell carcinoma in lung cancer. In addition, they are value.
Valley waiting the molecule in combination with other assets in their immuno oncology portfolio.
Our second investigational ADC I M. G C O 936, which targets Adam 9 is being advanced under our co development agreement with Immunogen under a 50.50 collaboration immunogen is leading.
Leading clinical development and they have indicated they anticipate disclosing initial data in early 2022.
Last but not least I will provide an update on margin tax of map. We are evaluating margin types of Nab in the phase II 3 mahogany study in patients with advanced gastric and gastroesophageal junction cancer.
This trial consists of 2 modules designed to evaluate margin toxin that is 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 her 2 positive gastric cancer Gastro esophageal junction cancer.
Scott Koenig: This molecule incorporates a CD3 component designed to minimize cytokine release syndrome while maintaining antitumor cytolytic activity, along with an FC domain to permit intermittent dosing through a longer half-life. Next up, I will walk you through our PD1-based assets.
At the ESMO meeting in September we expect to report initial safety and efficacy data relating to the approximately 14 resist the valuable mahogany module a patients who were treated with a combination of red are found on mab and margin toxin map.
Scott Koenig: Tebowelamab is our investigational bi-specific PD1-Belag3 dart molecule. We are currently evaluating Temotelemav in patients as monotherapy as well as in combination with other agents. Zylaab, our partner in Greater China, is evaluating Tabletelamab as monotherapy in patients with epithelial carcinoma and melanoma, as well as in combination with naraparip in a variety of advanced or metastatic solid tumors. At ASCO, we are pleased to see Bristol-Myers Phase 3 Relativity 047 data, which validated the combined targeting of both PD1 and Lag 3.
With regard to margin talks on that in metastatic breast.
So as a reminder, more agenda was launched in mid March in coordination with our commercial partner ever Sona.
My agenda is approved in combination with chemotherapy for the treatment of adult patients with metastatic <unk> positive breast cancer, who have received 2 or more anti heard 2 regimens at least 1 of which.
Was for metastatic disease.
We are pleased that margin is in the market and that patients are being treated and it may benefit from the therapy as reported margins on net sales were $3.2 million for the quarter. After a few months on the market.
As I mentioned in prior earnings calls we have.
Scott Koenig: There's potentially good news for patients and provides further support for evaluating a bi-specific molecule against these two targets. We expect to provide an update on plans for the next stage of development for Tabletalab in the coming month. Next, MGD-019 is our investigational bispecific checkpoint dart molecule that targets PD1 and CTLA4. We are conducting a phase one dose expansion study in cohorts of patients with microsatellite-stable colorectal cancer, checkpoint naive non-small cell lung cancer, metastatic castration-resistant prostate cancer, and melanoma.
S Kansas expectations for margins as sales given competitive realities that have taken place in the her 2 positive breast cancer market, including multiple new approvals, we expect to provide more genesis sales guidance. After the therapy has been marketed for at least a year.
Finally, as you may recall, the phase III for Sofia.
Motto is still ongoing for overall survival based on the accrued overall survival events in the Sofia metastatic breast cancer Phase III study, we expect to complete in share top line results for the final analysis of overall survival data based on 385 of OS events.
By the end of the third quarter of 2021.
We look forward to continuing to build momentum and advanced our pipeline of innovative products in 2020.1 we.
We are now happy to open the call for questions operator.
Thank you Anna sorry to ask a question simply press Star 1.
The trial telephone to withdraw your question press, the pound or hash key.
Scott Koenig: Let me next turn to Redofanlamab, the investigational anti-PD antibody that we licensed to Insight as INCMGA 0012. Last Friday, after the close, Insight announced that the FDA had issued a complete response letter or CRL regarding its BLA feretophanlamab for the treatment of patients with locally advanced or metastatic squamous cell carcinoma of the anal canal. The Insight announcement indicated that the FDA determined that additional data are needed to demonstrate the clinical benefit of retifanlamab for the submitted indication, and that Insight is reviewing the CRL and will discuss next steps with the FDA.
And we have a question from the line of Yigal knock on mortgage with Citi. Your line is.
On on your plan.
Great Hi. This is currently on for Yigal. Thank you so much for taking our question.
Our net.
M D. C. O 18 can you comment at all on on it.
The antitumor activity observed in for.
For out of southern prostate cancer patients, who had measurable disease is deepening over time.
And Relatedly if the 1 unconfirmed PR has since been confirmed and then similarly for it for the melanoma dose escalation patients have you seen any evidence of anti tumor activity deepening overtime. There. Thank you.
Scott Koenig: Beyond anal cancer, Insight has stated, it is exploring the development of retifanlamab as monotherapy and potentially registration-enabling studies in patients with MSI-high and ametrial cancer, Merkel cell carcinoma, and lung cancer. In addition, they are evaluating the molecule in combination with other assets in their immunoncology portfolio. Our second investigational ADC, IMGC, 0936, which targets Adam 9, is being advanced under a co-development agreement with Immunogen.
It all Carly thanks for the question this is Jim Carol.
I think Scott.
We have a thunderstorm here I think Scott line in the office dropped so you're going to have to repeat that question.
On a moment you're on Okay. I have I have my thoughts on the we had a thunderstorm here in it.
Okay.
Okay.
But you might get Scott did you hear the question if not maybe currently non repeating it.
Scott Koenig: Under our 50-50 collaboration, Immunogen is leading clinical development, and they have indicated they anticipate disclosing initial data in early 2022. Last but not least, I will provide an update on Margetyxinab. We are evaluating Marchetoxymeb in the Phase 2-3 Mahogany Study in patients with advanced gastric and gastroasophageal cancer. This trial consists of two modules designed to evaluate margitoximab 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 gastrocancer or gastroesophageal junction cancer.
Okay. Okay sure I can repeat it yeah I was just asking about sort of an update to what you had shown it as go if you've seen any evidence of antitumor activity deepening over time and look.
Cut off.
It can't get patients with an eye drop on fees.
And whether that 1 unconfirmed PR income.
And if you had any similar comments on it.
Non nomad dose escalation cohort and tankage.
That's tomorrow.
That would be really helpful.
Thank you very much for the question, obviously, we're very excited.
For providing updates at the upcoming ESMO meeting and so we don't want to.
Scott Koenig: At the ESMO meeting in September, we expect to report initial safety and efficacy data relating to the approximately 40 resist-a-vali Malagony Module A patients who are treated with a combination of retifanlamab and margituximab. With regard to Margetyxumab and metastatic breast cancer, as a reminder, Margenza was launched in mid-March in coordination with our commercial partner, Ever Margenza is approved in combination with chemotherapy for the treatment of adult patients with metastatic hertipositive breast cancer who have received two or more anti-herd-2 regimens, at least one of which was for metastatic disease.
[laughter] previewed it ahead of that meeting.
As we've said on the call today, we're going to try to provide.
On a update.
Of the data as latest policy.
For the babble and still meet the obligations of the poster session.
My expectation is that we will have at least 3 months of additional data. So that will include.
Following the original 22 patients we discussed with regard to PSA 50 reduction and then additional patients.
In this study.
In that regard we have recently completed the full enrollment of the castration resistant prostate cohort, which was consisted of 40 patients. In addition, we had completed enrollment of.
Scott Koenig: We are pleased that Margenza is in the market and that patients are being treated and may benefit from the therapy. As reported, Margenza net sales were $3.2 million for the quarter after a few months on the market. As I mentioned in prior earnings calls, we have modest expectations for Margenza sales, given the competitive realities that have taken place in the her2 positive breast cancer market, including multiple new approvals. We expect to provide Margenza sales guidance after the therapy has been marketed for at least one year.
Of the 20 patients in the metastatic lung.
Lung cancer cohort. So we're very happy with the strong interest of investigators and patients to participate in the study.
We should be able to provide them obviously updates.
The data.
With regard to both PSA as well as the scans on the original for or actually the original 13 patients.
Scott Koenig: Finally, as you may recall, the Phase 3 Sophia trial is still ongoing for overall survival. Based on the accrued overall survival events in the Sophia Metastatic Breast Cancer Phase 3 study, we expect to complete and share top-line results from the final analysis of overall survival data based on 385 OS events by the end of the third quarter of 2021. We look forward to continuing to build momentum and advance our pipeline of innovative products in 2021. We are now happy to open the call to questions. Operator? Thank you. And as a reminder, to ask a question, simply press Start.
That we had identified that had at least 1 scan at the time.
I'll ask though.
For the follow ups on those patients.
Additional patients that have come in over the last few months.
While we will not have a full data set on all 40 patients. My expectation is is that we should have approximately 30 or so patients included in that dataset of which we expect probably around half of those pace.
<unk>.
Be ah ones with measurable disease based on the disease within the this ROE lymph nodes.
Operator: Thank you, and as a reminder, to ask a question, simply press Star 1 on your telephone. To withdraw your question, press the pound or hash key. And we have a question from the line of Gigal Nokomovits about a city. Your line is open. Great, hi, this is Carly on Freehagall.
With regards to the melanoma patients as you recall in the for Mig per Kid cohort, we had 3 patients with a significant reduction in tumor size.
We noted on the call that 1 of those patients had a partial response, which was confirmed on them.
Carly: Thank you so much for taking our questions. On MGC-O-18, can you comment at all on whether the antitumor activity observed in four out of seven prostate cancer patients who had measurable disease is deepening over time, and relatedly, if the one unconfirmed PR has since been confirmed? And then similarly, for the melanoma dose escalation patients, have you seen any evidence of antitumoractivity? positiv
Pleased to say that patient.
<unk> continues as of last week as I know.
Of the lab cuts of data.
We continue on this study and.
<unk> continued to do well so again, we're very encouraged by that we should also note debt we have enrolled some patients in the new.
James Karrels: Carly, thanks for the question. This is Jim Carroll.
[noise] identified melanoma cohort.
James Karrels: I think Scott, we have a thunderstorm here, and I think Scott's line in the office dropped. So you're going to have to repeat that question in just one moment. You're on? Okay. I have my stuff on the, we had a thunderstorm here, and it's cut off. Carly, would you mind? Scott, did you hear the question? If not, maybe Carly, would you mind repeating it?
And hope to continue our progress to the planned 20 patients over the course.
Well this year and maybe into early next year.
Thank you. Our next question is from Jonathan Chang with <unk> Leerink.
Hi, guys. Thanks for taking my questions.
Carly: Okay, okay, sure, I can repeat it. Yeah, I was just asking about sort of an update to what you had shown at ASCO, if you've seen any evidence of anti-tumor activity deepening over time in the four out of seven prostate cancer patients with measurable disease and whether that one unconfirmed PR has been confirmed.
First question it looks like there'll be data from a competing b 7 H.
3 ADC program coming up at ESMO, how are you thinking about the competitive landscape for zero when they and what are the key things that you'll be looking to learn from the competitor datasets.
Scott Koenig: And if you had any similar comments on the melanoma dose escalation cohort in terms of, you know, deepening of tumor responses over time, that would be really helpful.
Thank you Jonathan.
No we are aware of them competing data from.
E G are being presented at ESMO I'm, obviously, we're very encouraged.
Scott Koenig: Yep, thank you very much for the question. Obviously, we're very excited about providing updates at the upcoming ESMO meeting, and so we don't want to preview this ahead of that meeting. As we said on the call today, we're going to try to provide an update of the data as late as possible and still meet the obligations of the poster session. My expectation is that we will have at least three months of additional data.
By the fact that they at least anecdotally.
Anecdotally reported that they've seen responses in a couple of tumor types for which we have yet to enroll in our study.
That's very encouraging debt in terms of having an outside.
Organization validated target and the approach obviously, they're using a different antibody drug conjugate going forward overall we.
Scott Koenig: So that will include following the original 22 patients we discussed with regard to PSA 50 reduction, and then additional patients in the study. In that regard, we have recently completed the full enrollment of the castration-resistant prostate cohort, which consisted of 40 patients. In addition, we have completed enrollment of 20 patients in the metastatic lung cancer cohort. So we're very happy with the strong interest of investigators and patients to participate in the study.
We feel that it's again always in the best interest for patients that have opportunities.
With the different mechanisms of action.
And look forward to reviewing their data, but we're very encouraged as I say with the data we've seen to date and we intend to continue to expand.
Our plans for this program.
Got it. Thank you and second question, what do you view as the appropriate efficacy benchmarks for zero on 8 in non small cell lung cancer.
In prostate I assume.
Oh in law in lung and prostate or just.
Scott Koenig: We should be able to provide, obviously, updates on the data with regard to both PSA, as well as the scans on the original four or actually the original 13 patients that we had identified, that had at least one scan at the time of ASCO, further follow-ups on those patients, plus additional patients that have come in over the last few months. While we will not have a full data set on all 40 patients, my expectation is that we should have approximately 30 or so patients included in that data set, of which we expect probably around half of those patients to be ones with measurable disease based on disease within the visceral lymph nodes.
On.
Jonathan.
He asked about loans.
For lung okay.
Well.
The answer is it's too early to see what's the appropriate response rate.
I mean, the only thing that I can comment on from a quick.
Mechanisms of action.
At Ash go as I am aware I'm sure they'll be reported results in non small cell lung cancer on late stage patients with response rates of approximately 25%.
But clearly we.
We would like to see the best response.
On response, there and.
Given that this will be a a early cut of data what we present, we will continue to follow these patients through the course of the year. So it's just too early to.
Scott Koenig: With regard to the melanoma patients, as you recall, in the 4-mic-per-kid cohort, we had three patients with a significant reduction in tumor size. We noted on the call that one of those patients had a partial response, which was confirmed. I'm pleased to say that the patient continues, as of last week, as I know, of the last data to continue on this study and continue to do well. So, again, we're very encouraged by that.
Our benchmark the responses at this time.
Understood. Thank you.
<unk>.
Our next question is from Jonathan Miller with Evercore ISI.
Hi, guys. Thanks, so much for taking my question.
First I guess the the Kols on your ask a webinar talked about pleural effusion and hand foot syndrome is potentially concerning for the O&M and prostate data.
Scott Koenig: We should also note that we have enrolled some patients in the new identified melanoma cohort and hope to continue progress to the planned 20 patients over the course of this year and maybe into early next year.
But it seemed like you had a different take there with a little more follow up how are those signals evolving that worried us kols at the time, you also mentioned optionality on dosing and schedule and I would love to check in on how those efforts at this point are evolving and how you balance the need to advance the molecule with a desire to fully explore the dosing space.
Jonathan Chang: Thank you. The next question is from Jonathan Chang with SVB.
Jonathan Chang: Hi guys, thanks for taking my questions. The first question is,
Scott Koenig: It looks like there will be data from a competing B7H3 ADC program coming up at ESMO. What are you thinking about the
Jonathan.
Thank you very much for the question Hum as though we have noted consistently we have found on the side effect profile, which as we stated today, including.
Scott Koenig: The competitive landscape
Scott Koenig: For 018, and what are the key things that you'll be looking to learn from the competitor data system?
The skin toxicities, which include hand foot syndrome, and pleural effusions as noted to be manageable and we don't.
Scott Koenig: The competitor data set.
Scott Koenig: Thank you, Jonathan. As you know, we are aware of competing data from Daichi being presented at ESMO. Obviously, we're very encouraged by the fact that they, at least anecdotally, have reported that they've seen responses in a couple of tumor types, which we have yet to enroll in our study. That's very encouraging. In terms of having an outside organization validate the target and the approach, obviously, they're using a different, generic drug conjugate going forward.
R&D day anything from that that observation patients are continuing on.
On studies.
Even in many of these patients who have experienced these side effects as we have pointed out.
We have included in the study design.
On the ability to hold doses of reduced us doses going forward.
As some of the side effect profiles emerge.
As we have taken.
<unk> taken our strategy forward, we felt it was more important to get a larger patient sales experience.
Scott Koenig: Overall, we feel that it's, again, always in the best interest of patients to have opportunities with different mechanisms of action and look forward to reviewing their data. But we're very encouraged, as I say, by the data we've seen today, and we intend to continue to expand our plans for this program.
It's a 3.
As for kids.
Every 3 weeks and then make the operations during the study to then do an evaluation when the 40 patients in the.
Prostate study are completed we will then be able to come up with a decision moving forward.
<unk> made the appropriate dose based on both the safety profile and the efficacy we observed as.
Jonathan Chang: Got it, thank you. And second question: what do you view as the appropriate efficacy benchmarks for 018 in non-small?
As we have noted before some of the things under consideration would be to increase or decrease the frequency of giving the drug we feel that most of the side effects are an area under the curve is.
Jonathan Chang: for 018 and non-smotile lung cancer, in the prostate, I assume. Oh, in the lung and prostate or just the lung? Jonathan.
Scott Koenig: He asked about my lung. For lung, okay. Well, you know, the answer is it's too early to deem what's the appropriate response rate. I mean, the only thing that I can comment on from equivalent mechanisms of action, at ASCO, as I am aware, Trudelby reported results in non-small cell lung cancer and late-stage patients with response rates approximately 25%. But clearly, you know, we would like to see the best response there. And given that this will be an early cut of data, what we present, we will continue to follow these patients through the course of the year. So it's just too early to benchmark responses at this time.
What are the fact and so the longer exposure to the drug we think will be more beneficial for the patient the other alternatives are.
This would reduce doses going forward and in some other operations, we have not come up for the conclusion, but all I can say is debt.
Based on enrollment between them.
CAGR dime right now I think things are going going as planned.
I think some of it I guess a second question.
The insight TRL, obviously setback that program and I recognized that they are leading the development for it for all of that but.
And does this impact your ability to use this molecule as a backbone.
1 for combos is it impact your does delay any of your combo plans or your expectations for milestone associated with that advance and how relevant those are for your cash runway.
Jonathan Miller: Okay. Thank you. Our next question is from Jonathan Miller with Evercore Island.
Jonathan Miller: Hi guys, thanks so much for taking my question. First, I think the KOLs in your ASCO webinar talked about Plural Fusion and Hand-N-Foot syndrome being potentially concerning for the 018 prostate data, but it seemed like you had a different take there. We have a little more follow-up. How are those signals evolving that were those KOLs? At the time, you also mentioned optionality on dosing and schedule, and I would love to check in on how those efforts are evolving at this point and how you balance the need to advance the molecule with the desire to fully explore the dosing.
So with regard to the use of Red Oak's Allomap in any of our studies.
No effect at all in.
Her ongoing studies or other studies, we might want to use this or in fact any partnership that we developed and which we wanted to include right of time on that as part of the opportunity to combine this with a other.
Other parties.
Our molecule. So all of that is the same with regard to the.
Either cash runway again, we are risk adjusted.
The opportunity for milestones from this payment.
Scott Koenig: Jonathan, thank you very much for the question. As we have noted consistently, we have found the side effect profile, which, as we stated today, including the skin toxicities, which include hand-foot syndrome, and the fluorifusions, as noted, to be manageable. We aren't deviating from that observation. Patients are continuing in studies, even many of these patients who have experienced these side effects. As we have pointed out, we have included in the study design the ability to hold doses or reduce doses going forward as some of these side effects emerge.
As.
As noted on today, there is no change in projected.
Cash runway even in.
No and.
Anticipated milestones coming from an approval.
Due to the C. R L.
Okay. Thank you very much.
Yes.
Our next question is from Tom Shrader with at B P. I G.
Hi, This is carey on for Tom Thanks for taking our questions and thanks for the update.
My and my first question is for the module a mahogany study has the bar for on a go no go decision changed for this study after the data release from the keynote <unk> 811 trial.
Scott Koenig: As we have taken our strategy forward, we felt it was more important to get a larger patient-based experience at the 3 mix per KIG every three weeks and then make the alterations during the study to then do an evaluation when the 40 patients in the prostate study are completed. We will then be able to come up with a... decision moving forward about what is the appropriate dose based on both the safety profile and the efficacy we observed. As we have noted before, some of the things under consideration would be to increase or decrease the frequency of giving the drug.
That's a very good question. Thank you very much for for asking it.
As many of you know.
<unk> announced and the FDA approved on an accelerated basis in frontline gastric cancer the use of herceptin.
Plus chemotherapy.
Airplanes, plus temporal iliza mab in patients with newly diagnosed gastric or gastroesophageal cancer.
Scott Koenig: We feel that most of the side effects are an area under the curve associated effect, and so the longer exposure to the drug, we think will be more beneficial to the patient. The other alternatives are our initial doses with reduced doses going forward and some other alterations. We have not come up with a conclusion, but all I can say is that based on enrollment in the treatment paradigm right now, I think things are going as planned.
In that study.
There was a controlled study they saw a.
In the control population approximately a 54% overall response rate in it.
The treated population with Pembina as a mab.
Was a 71%.
And noted historically as we've pointed out.
Jonathan Miller: Thanks so much. I guess second
Jonathan Miller: and the Intite CRL obviously sets back that program, and I recognize that they're leading the development of Ritofalumab, but does this impact your ability to use this molecule as a backbone for COMP?
The baseline data prior to this study.
It was about a 47% overall response rate.
Based on the previous.
Previous approval of chemotherapy in <unk> and herceptin in the syndication. So what we have always indicated while not giving the specific number that we hope to exceed it was greater than 50%.
Scott Koenig: Does it impact your delay any of your combo plans or your expectations for milestones associated with that advance and how relevant those are for your cash runway? So with regard to the use of retifanlamab in any of our studies, it has no effect at all on either ongoing studies or other studies we might want to use this, or in fact, any partnership that we develop in which we want to include retifanlamab as part of the opportunity to combine this with another party's molecule.
Just on conversations that we had.
With the F D. A I think the question that.
We need to decide.
Decide is if we do not achieve 70, 471% of greater response.
Can this drug will be used in a chemo free setting in this popular.
Scott Koenig: So all that is the same. With regard to the cash runway, again, we risk adjusted the opportunity for milestones from this payment. And as noted today, there is no change in projected cash runway, even with no anticipated milestones coming from an approval due to the CRO.
Population.
Somewhere between 50, and 71% and that's something we we don't have the day to yet because the data will be analyzed in the coming months.
Jonathan Miller: Okay, thank you very much.
By with results from Central review.
Tom Freed: Our next question is from Tom Freed with a B-T-I-D.
Of the study.
Kavari: Hi, this is Kavari for Tom. Thanks for taking our questions and thanks for the update.
And if the.
If that does occur.
We will certainly think about what are the appropriate next steps are and we will certainly seek advice from the FDA on what is the appropriate way.
Kavari: And my first question is about the Modulae Mahobany study. Has the bar for a...
Scott Koenig: Has the bar for a go-no-go decision changed for this study after the data released from the Keynote 811 trial?
To.
Continue with this study to get it available for patients.
Scott Koenig: That's a very good question. Thank you very much for asking it. As many of you know, Merck announced and the FDA approved on an accelerated basis in front-line gastric cancer the use of Herceptin plus chemotherapy plus Pembralizumab in patients with newly diagnosed gastric gastrogylopageal cancer. In that study, that was a controlled study. They saw, in the control population, approximately a 54% overall response rate. In the treated population with Pemberlizumab, it was 71%.
I'm still yet.
And to be determined.
Got it and for the module will be of mahogany study youre evaluating combination for led both PD, 1 and PD 1 lag 3 do you expect to screen patients for a luxury level sales on the emerging data.
So at this point.
It's not that would obviously be a huge impediments on getting enrollment of a trial of that of that size.
Scott Koenig: As noted historically, as we pointed out, the baseline data prior to this study was about 47%, and the overall response rate based on the previous approval of chemotherapy and herceptin in this indication. So what we have always indicated, while not giving the specific number that we hope to exceed, it was greater than 50% based on conversations that we had with the FDA. I think the question that we need to decide is, if we do not achieve 71% of greater response, can this drug still be used in a chemo-free setting in this population, meaning somewhere between 50% and 71%.
Yeah.
As you know from the relativity O for 7 study there was no difference in terms of responsiveness of patients based.
We aren't lag 3 hum and so we still do believe based on our own results, particularly in solid tumor population. There is potentially a role for screening patients are based on lag 3 but at this point, we have not changed plans are going forward with.
Based on our 2.
Screening and we would then do this retrospectively analyzed.
Scott Koenig: And that's something we don't have data on yet because the data will be analyzed in the coming month with results from a central review of the data. of the study. And if that does occur, we will certainly think about what the appropriate next steps are, and we will certainly seek advice from the FDA on what the appropriate way to continue with this study is to get it available for patients. But it is still yet to be determined.
Based on clinical results as well as biomarker expression pattern.
Thank you. Our next question is on Stephen Willey with Stifel.
Yeah. Good afternoon, thanks for taking the question.
Can you, maybe just provide a little bit more granularity around when you completed enrollment into the prostate and lung expansion cohorts and then I guess.
Scott Koenig: Got it. And for module B of the Mahogany study, you're evaluating combinations with both PD1 and PD1 lag 3. Do you expect to screen patients for lag three levels based on the emerging data?
How should we be thinking about.
Any potential disclosure coming out of a triple negative cohort.
This is for M. G D M D C.
Scott Koenig: So at this point, we are not. That would obviously be a huge impediment to getting enrollment in a trial of that size rapidly. As you know, from the Relativity 047 study, there was no difference in terms of responsiveness of patients based on Lag 3. And so we still do believe, based on our own results, particularly in the solid tumor population, there is potentially a role for screening patients based on lag three, but at this point, we have not changed plans going forward with regard to screening, and we would then do this retrospectively and analyze it based on clinical results as well as biomarker expression patterns.
Zero.
And just whether or not there's an opportunity to maybe.
Either sneak out into ESMO or maybe.
More likely into a into a San Antonio presentation.
Thanks, Steve for the question.
Both the assets as you recall.
Quite vividly.
The guidance has always been to have both cohorts enrolled by mid year, prostate and lung and that was achieved and that was achieved quite recently so.
While you know are.
Enrollment of prostate began late in.
Last year.
But all the patients got enrolled.
Hum since February on prostate and since March on lung.
Stephen Douglas Willey: Thank you. Our next question is from Stephen Willie with Steeffel.
Stephen Douglas Willey: Yeah, good afternoon. Thanks for taking the questions. Can you maybe just provide a little bit more granularity?
So as you can imagine on some of these patients came in quite recently and therefore would not have have day to so.
Scott Koenig: completed enrollment into the prostate and lung extension cohorts. And then I guess how should we be thinking about any potential disclosure coming out of a triple negative cohort? This is for MGC 018. And just whether or not there's an opportunity to maybe, either sneak that into ESMO or maybe, more likely, into a San Antonio presentation.
Again to reiterate.
Right My guidance, what I, what I said is it likely we should have on.
For ESMO by then the next data cut 30, or so patients in prostate to be able to describe in some with regard to PSA and some of the scans that will continue obviously as Ah patients.
Scott Koenig: Thanks, Steve, for the questions. Both, as you recall quite vividly, the guidance has always been to have both cohorts enrolled by mid-year for prostate and lung cancer, and that was achieved, and that was achieved quite recently. So while, you know, enrollment for prostate cancer began late last year, almost all the patients got enrolled since February on prostate cancer and since March on lung.
Continue on treatment and on lung, we're hoping took for provide updates on about half those patients, but by the end of the air. We certainly will have a lot more data on the full cohort of both those groups with regard to triple negative breast.
We're continuing to enroll as I've indicated that will should complete.
Scott Koenig: So, as you can imagine, some of these patients came in quite recently and therefore would not have data. So, again, to reiterate my guidance, what I said is that, likely, we should have 30 or so patients and prostate cancer to be able to describe in some with regard to to PSA and some of the scans that will continue, obviously, as patients continue on treatment, and on lung, we're hoping to provide updates on about half those patients.
In the second half for this year.
But I can't give you a specific commitment of time of update of that data.
Okay, that's helpful and.
Maybe you can just speak a little bit with respect to.
Where you are.
With <unk> 019 dose escalation.
Complete spin.
Specifically.
We're not dose escalation with dose expansion and I guess, specifically within the prostate cohort.
Scott Koenig: But by the end of the year, we certainly will have a lot more data on the full cohorts of both those groups. With regard to triple negative breasts, we're continuing to enroll, as I've indicated, that will, should complete in the second half of this year. But I can't give you specific commitments of time for updates on that data.
If I remember correctly you achieve.
Let's get it was a PR or CR within dose escalation in prostate and I'm just kind of wondering.
That.
Spansion data within prostate is going to serve as kind of the.
Scott Koenig: Okay, that's helpful. Maybe you can just speak a little bit with respect to where you are with MGD 019 dose escalation and, I guess specifically, or not dose escalation but dose expansion. And I guess, specifically within the prostate cohort, I think, if I remember correctly, you had seen a
The decision.
The decision, making point for whether or not you pursue oh on 8 combo with that asset.
Other than say something like credit of Allomap.
Steve Thanks, very much for both the suggestions in the crash [laughter] with regard.
Scott Koenig: I forget if it was a PR or CR within dose escalation and prostate cancer.
Scott Koenig: and I'm just kind of wondering if that expansion data within prostate is going to serve as kind of the decision-making point for whether or not you pursue a 018.
To the dose expansion.
Scott Koenig: pursue a 018 combo with that asset rather than say something like RedaFans. Steve, thanks very much for both the suggestions and the questions.
If you recall, we initially started with.
Colorectal and are stable.
Colorectal and lung.
Scott Koenig: With regard to the dose expansion, if you recall, we initially started with colorectal and stable colorectal tumors and with lung, particularly lung, that proceeded slowly because of our interest in the enrolling patients who were naive to anti-PD-1 therapies. So that has picked up lately, mostly obviously in Europe from those patients. The new prostate and the new melanoma cohorts for 019 were only recently added, and while we have had some patients enrolled, there are very few at this point.
Particularly long debt proceed slowly because of.
Our.
Interest in enrolling patients who are naive to anti PD 1 therapies. So that has picked up for lately, mostly obviously in.
In Europe from those patients.
The price the new prostate and the new melanoma cohorts for own 19 were only recently added and while we have had some patients enrolled there are very few at this point.
Scott Koenig: With regard to future combinations of checkpoints, as I indicated on our call at ASCO, we are very encouraged by our pre-clinical data that combining checkpoints does increase the antitumor effects of 018, and so certainly 019 would be one of those under consideration to combine. And as you pointed out, especially with the fact that we saw a CR in the original dose escalation study of a patient with late-stage prostate cancer, we're very encouraged as that as one of the leading candidates. Okay, and maybe just one quick little thing.
With regard to our future.
<unk> combinations of checkpoint as I indicated on our call.
Call. It as though we are very encouraged our preclinical data that combining checkpoint does increase the antitumor effect of OE team and.
And so certainly 119 would be.
1 of those under consideration to combine and as you pointed out, especially with the fact that we saw a C. R.
In the.
Original dose escalation study of a patient with late stage prostate cancer, we're very encouraged as 1 of the as that is 1 of the leading candidates.
Okay, and maybe just 1 quick logistical question for Jim.
James Karrels: Okay, and maybe just one quick logistical question for Jim. Are the outgoing payments to Eversana realized in real time, i.e., the quarter in which they happen, or is there a look back or a true payment that's made at some point towards the end of the year? It's not the end of the year; it's on a quarterly basis.
On the outgoing payments to ever Sona are those realized in real time, I E. The quarter in which they happen or is there a look back or a true up payment. That's made at some point towards the end of the year.
It's not the end of the year, it's on a it's on a quarterly basis.
Okay.
Thank you for taking the questions.
Etzer Darout: Our next question is from Edser Daruth with Goodenheim Security.
Our next question is from at Sir that route with Guggenheim Securities.
Etzer Darout: Great, thanks for taking the question. Just, you know, wanted to get a sense from you, Scott.
Great. Thanks for taking the question just wanted to get a sense from you Scott if you have any updates on the number 1 for evaluable patients we may see.
Scott Koenig: If you have any updates on the number of evaluable patients we may see for lung cancer with ONAE, and then the follow-up, I guess, to the earlier question, just around sort of the benchmark question, you know, we think back to sort of the Trope 2 ADC from Daichi in the 21 to 25 percent response. We saw in lung and monotherapy, I guess, and sort of a, you know, second line plus setting. Is that kind of a fair benchmark, if you will, in terms of what we would consider as encouraging results?
Oh for lung cancer with on 8 and then the follow up I guess to earlier question just.
Around sort of the benchmark question.
Back to sort of good trop, 2 ADC from Daiichi and the 21% to 25% response, we saw on lung monotherapy I guess on sort of.
Second.
Plus setting is that kind of a fair benchmark. If you will in terms of what we would consider as encouraging results. We know different mechanism, but just wanted to kind of get a sense of your.
Scott Koenig: You know, we know different mechanisms, but just kind of get a sense of your sense, I guess, of the landscape, given those data sets. Thank you. Yeah, thanks. You may have missed my comments and some questions. Both these came up.
Since I guess on the landscape given those those datasets.
Yeah, I think that you may have missed my comments on some questions on both.
Both of these came up what I said with regard to the lung. We recently completed the enrollment of the 20th lung patients. Obviously some of them came in more recently, we're going to do the data cut likely sometime in August.
Scott Koenig: What I said with regard to the lung patients, we've recently completed enrollment in the 20 lung patients. Obviously, some of them came in more recently. We're going to do the data cut likely sometime in August, so given these scans are done every nine weeks, while I can't give you the exact number of patients we'll report on the lung, I think it'll be about 10 of the 20. Don't hold me to a specific number, but we'll obviously try to include as many as possible.
So given these scans are done every 9 weeks.
I think.
Second word.
While I can't give you the exact number of patients will report on the lung I think it'll be about 10 of the 20.
Don't hold me to the specific number but we'll obviously try to include as many as possible with regard to the benchmark.
On the.
Scott Koenig: With regard to the benchmark with regard to the reported at ASCO on Trudelevy of 25%, I commented before, obviously higher is better, but I noted the same observation. So, you know, certainly it would be nice to be in that 20 to 30% range and then potentially higher. But, you know, I have no sense right now exactly what it's going to be. And certainly, this will be just a cut of data, and we're going to be continuing to follow many of these patients for the rest of the year. So given that they presented the data of a completed study, we are going to be presenting the data of an ongoing study.
Regard to reported at ESMO on Fidelity of 25% I commented before obviously higher is better but I noticed the same observation. So you know certainly it would be nice to be in that 20% to 30% range and then potentially higher.
But I have no.
Since right now exactly what it's going to be and certainly this will be just a cut of data.
And we're gonna be continuing to follow the many.
Many of these patients through the rest of the year. So given that they presented the data for completed study, we're going to be presenting data of the ongoing study.
Great. Thank you.
Our next question is from boring speaker with a collar on.
Bori Speaker: Our next question is from Bori Speaker with a callon. Hi, this is Cynthia on behalf of Boris. Thinking through MGDO-24, how do you think about the development of that dart alongside plutotusinab? And then just thinking, I guess, preclinically, how do those two dart molecules stack up with Garcese safety and anti-tumor activity?
Hi, This is cynthia on for for S. I'm thinking for N. G. D O..2 for how you think about that development of that dark alongside for it as an AD and then just thinking I guess pre clinically.
How do those 2 dart molecule stack up with regards to safety and anti tumor activity.
So thank you very much or with regard to your questions on our C. D 120 for ICD 3 programs with regard to <unk> 'twenty 'twenty for obviously, we're going to enter into this as.
Scott Koenig: So thank you very much with regard to the questions on our CD123 by CD3 programs. With regard to 024, obviously, we're going to enter into this as a dose escalation study, and, you know, we expect that I&D to be filed in the fourth quarter, as noted. Clearly, the initial patients that would be incorporated would be late-line patients who have progressed on other AML treatments initially, whether we expand this into other CD-123 bearing indications. We have not determined that as of now, we will focus initially on AML.
Dose escalation study.
And we expect that I N D to be filed in the fourth quarter as noted on.
Clearly I'm in.
Initial ah patients that would be incorporated.
Would be on late late line patients who have.
There's 8 on on.
Other AML treatments initially whether we expand this into other CD 123 bearing indications we have not determined that as of now will focus initially on AML given that the way. This drug is designed both in terms of a dramatic.
Scott Koenig: Given the way this drug is designed, both in terms of a dramatic, reduced cytokine release profile based on preclinical studies, as well as the FC engineering, which allows us to give the drug intermittently and still achieve CMAX binding to the tumor, we are looking forward to developing this in much earlier lines of therapy than floatidusimab. We have data both with floatidusimab and with MGD-O24 that we can combine with HMA inhibitors, the Netoclacs, and other molecules.
Dramatically reduced cytokine release profile based on preclinical studies as well as the FC engineering with all which allows us to give the drug intimately and still achieve a C. Max binding to the tumor.
We.
Looking.
Progress forward to.
Developing this in much earlier lines of therapy than then floated to the map we have data both looks relative to the Madman M. G. D. O 20 for that we can combine this with HMA inhibitors are the net of class.
And other molecules.
Looking so I think this would be a very.
Scott Koenig: So I think this would be a very nice addition, potentially, based on the preclinical data, to add to the arsenal for treating AML and other diseases that express CD-123. With regard to the safety and antitumor responses that we've seen in xenograph models. While the actual dose required for MGDO-24 is higher, we achieve the maximum killing effect and achieve equivalent amounts of tumor control in xenograph model systems. And with regard to monkey studies, with regard to the elimination of circulating CD-123 monocytes and other granulocytes that would express CD-123. They were equivalent in terms of their efficiency.
Nice addition, potentially based on the preclinical data to add to the armamentarium for treating AML and other diseases that express CD 123, with regard to the safety and antitumor responses that we've seen in.
In a xenograft model.
While the actual dose required for M. G. D. O 24 is higher we achieved the maximum killing effect and she and achieve equivalent amounts of tumor control in xenograft model systems and with regard to Monkey studies with regard to the.
The elimination of circulating PD $1.23 on.
Monocytes and other.
Granules types that would express CD 123, they were equivalent in terms of their efficiency.
Great. Thank you.
Our.
Question comes from Peter Lawson with Barclays.
Peter Richard Lawson: Our next question comes from Peter Lawson at Barclays.
Hey, Thanks for taking my questions. Thanks for the update so I may have missed this but for ooh and Ah when would we see the melanoma data Scott.
Peter Richard Lawson: Hey, thanks for taking my questions. Thanks for the updates. I may have missed this, but for 018, when would we see the melanoma?
Scott Koenig: I know Medita, Scott. Yeah, so, Peter, you know, as you know, that was one of the recent cohorts we added after we saw those four Mick per Kig responding patients. So it's very late to add this cohort, and a lot of the sites have just gone up recently. We're very encouraged that we have had a number of patients enrolled, and I think this cohort will enroll quickly. But to be realistic about this, this is a problem.
Yeah. So pier 1 as you know we that was 1 of the recent cohorts.
Our next Saturday after we saw those are forming for Kid responding patients. So it's very late added in a lot of the sites.
Have just gone up recently and we're very encouraged that we have had a number of patients enrolled.
And I think this cohort will enroll.
I'll quickly but to be realistic about this this is probably first half.
Scott Koenig: Probably first half, uh, 2022 update. Obviously, we'll try to get that data out as early as possible. But, uh, we are again, very encouraged by what we've seen today. And then just, I guess, holistically, Scott, just around B7H3, the EDC, are there particular
On a 2022 update obviously, we'll try to get that data out as early as possible but.
We are again very encouraged on what we've seen to date.
Good thing and then just.
Just I guess Holistically Scott just on around piece of an age 3 ADC.
On the other particular indications where you see you get.
Peter Richard Lawson: Are there particular indications where you think you get single agent activity sufficient for
Single agent activity sufficient for.
Pivotal trials.
But right now there's nothing to preclude us from.
Scott Koenig: Right now, there's nothing to preclude us from believing that, particularly in tumors where we're seeing very effective responses in late-line patients, especially ones that have no alternative therapy, that single agents would not be possible. But it's still too early to make that determination.
Believing that.
Particularly in tumors, where we're seeing.
Very effective responses in late line patients, especially ones that have no alternative therapy that single agents would not be possible. It is still too early to make that determination. We obviously.
Peter Richard Lawson: We obviously want the updated data on prostate cancer, but we want the updated data on melanoma and the other cohorts as well. But at this point, our strategy is going to be with a different intent; move as fast as possible with the monotherapy, particularly towards registration, if possible, if the data pans out in these phase one and two studies. But don't stop looking at combinations, particularly with agents that we are developing ourselves to get even a better higher response.
We want the updated data on prostate we want the updated data on on melanoma and the other other cohort, but at this point.
Our strategy is going to be.
In with different intense move.
Movers for SaaS that's past.
So with the monotherapy, particularly towards registration if possible if the data pans out in the in these phase 1.2 studies, but don't stop looking at combinations, particularly with agents. So we are developing ourselves to get it even a better higher response.
Peter Richard Lawson: We think in some of those cases, that may allow us to move further up quicker into earlier-line therapies, especially in tumors where, you know, for instance, checkpoint molecules are ineffective, or checkpoint molecules and chemo have not been approved. So we're analyzing this in terms of what's the fastest way to get new classes of drugs of this type to market.
We think in some of those cases that may allow us to move further up quicker into earlier line therapies, especially in.
In tumors that were you know for instance, checkpoint molecules are ineffective or checkpoint molecules.
And chemo.
They have not been approved so on where we're analyzing this in terms of what's the fastest way to get on.
New classes of drugs of this type 2 market.
Scott Koenig: Good, and just, if I could sneak in another question, just around the PD1-Lag3 update.
Thinking on another question just around the PD 1 lag 3 update.
Peter Richard Lawson: for this year.
For this year.
Scott Koenig: Are we going to see data, or is it going to be kind of a strategic update of directions you could go with?
What are we going to see data or.
It'd be kind of a strategic update of directions, you could go with that.
Peter Richard Lawson: You know, we have a little more data from the various studies, but it doesn't change what we have expressed at previous meetings. We are in discussions with various organizations and with key opinion leaders on what would be the fastest and best venue to develop this molecule towards registration. Because of ongoing discussions, it is possible that we're going to. we may provide data more likely to focus in on what the next steps with regard to particular tumor indications and how we intend to move this forward toward registration. Okay, perfect. Thank you so much.
We have a little more data from the bearing studies. It doesn't change what we has expressed at previous meetings, we are in discussions with various organizations.
And with our key opinion leaders.
On what would be the fastest and best venue.
To develop this molecule towards registration.
Ongoing discussions now is possible that we may provide data more likely for focusing on what's the next steps.
Or is it going to guard to particular tumor indications and how we are going to move.
Move this forward toward registration.
Okay perfect. Thanks, so much.
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David Levowitz: Thank you. And as a reminder, if you have a question, simply press Star 1 on your telephone. We have a question from David Levowitz of Morgan Stanley.
Thank you and as a reminder, if you have a question simply press star 1 on your telephone.
We have a question from day.
With lebowitz with Morgan Stanley.
Thank you very much for taking my question.
David Levowitz: Thank you very much for taking my question. In the upcoming ESMO update, will we be able to see, I guess, a breakdown of safety and tolerability data and patients on original doses versus those who've had dosing adjustments?
On the upcoming ESMO update on where we'd be able to see I guess a breakdown of.
Safety and Tolerability data in patients on original dosing versus those who had dosing adjustments.
Scott Koenig: David, thank you very much for that question. We have not obviously put this poster together yet and haven't even planned it out specifically. We want to get the cut of the data, but we do believe it's important to provide updates on safety, and how it's formatted with that regard. We obviously want to get as much data out as possible. So right now, I can't, you know, tell you how we're going to put it out, but we certainly will. and information regarding that.
So David Thank you very much for that question, we have not obviously put this poster together yet.
Haven't even planned it out specifically, we want to get the cut of the data, but we do believe it's important to provide updates on the safety how it's formatted with that regard we obviously.
I wanted to get as much stayed out of it as possible but.
So right now I can't.
Tell you, how we're going to put it out but we certainly will.
Information regarding that.
David Levowitz: Thank you for taking my question.
Thanks for taking my question.
You.
Operator: Thank you. And I'm not showing any further questions in the queue. I will pass this back to Scott.
Thank you and I'm not showing.
Further questions in the queue I will pass it back to Scott for final remarks.
Scott Koenig: For final remarks.
Scott Koenig: Yes, thank you very much for participating today. Sorry for the interruption to the Q&A session due to the weather, but we look forward to a further update during the course of the year. And with that.
Yes. Thank you very much for parts and say obtaining today sorry for the interruption on the Q&A session due to the weather, but we look forward.
2 a further update during the.
And any for the year end and have a nice evening.
And with that we conclude today's program. Thank you for your participation and you may now disconnect.
Operator: And with that, we conclude today's program. Thank you for your participation, and you may now disconnect.
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