Q1 2021 Agenus Inc Earnings Call
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Thank you for holding your conference will begin shortly thank you for your patience. Once again your conference will begin shortly thank you for your patience.
Operator: will begin shortly. Thank you for your patience. Once again, your conference will begin shortly. Thank you for your patience.
Yeah.
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Operator: Thank you. Thank you.
Operator: Good morning, ladies and gentlemen. Thank you for standing by, and welcome to Jenna's first quarter, 2021, conference call and webcast. At this time, all participants are in a listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, please press the star, then one.
Operator: Please note that this event is being recorded and may be used in future Agenis promotional material. I would now like to turn the conference over to John Medina, Director of Investor Relations. John, please go ahead.
Please note that this event is being recorded and may be used in future a janice promotional material I would now like to turn the conference over to John Medina Director of Investor Relations. John. Please go ahead.
John Medina: Thank you, Rebecca, and thank you all for joining us today. Today's call is being webcast and will be available on our website or as a replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory, and commercial plans and timelines, as well as timelines for data release and partnership opportunities. These statements are subject to risks and uncertainties, and we refer you to our SEC filings for more details on these risks. As a reminder, this call is being recorded for audio broadcast.
Thank you Rebecca and thank you all for joining US today today's call is being webcast and will be available on our website for replay.
I'd like to remind you that this call will include forward looking statements, including statements regarding our clinical development regulatory and commercial plan and Taiwan as well as timelines for day to release in partnership opportunities. These.
These statements are subject to risks and uncertainties and it would be for you to our SEC filings for more details on these risks as a reminder, this call is being recorded for audio broadcast joining me today or Doctor Garo, Armen, Chairman and Chief Executive Officer, Dr Agenda per Buil, President and Chief operating Officer, Dr. Stephen Though day hour.
John Medina: Joining me today are Dr. Garrow Armin, Chairman and Chief Executive Officer, Dr. Jennifer Buell, President and Chief Operating Officer, Dr. Stephen O'Day, our Chief Medical Officer, and Christine Claskin, Vice President of Finance. Now I'll turn the call over to Garrow to highlight our progress during 2021 so far. Good morning, everybody, and thank you, John.
<unk> Medical officer, and Christine Corsican, Vice President of Finance now I'll turn the call over to Garo to highlight our progress during 2021, so far.
Good morning, everybody and thank you drive thank you all for your participation and interest and agendas.
Garo H. Armen: Thank you all for your participation and interest in Egenesis. In the past seven and a half weeks since our last call, we have continued to make progress on our key programs and milestones. These include additional clinical trial data, Advancing our INKT programs in COVID and cancer, earning two presentation slots at ASCO, filing our first VLA, defining our strategy for 1181, and being on track for cash accretive corporate transactions for this year with a start in the current quarter.
In the past seven and a half weeks.
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These include additional clinical trial data.
Advancing R I N K T programs, and COVID-19 and cancer.
Earning two presentation's slots at <unk>.
Firing our first BLA.
Defining our strategy for 11 81.
And being on track for cash accretive corporate transactions for this year.
Start in the current quarter.
Garo H. Armen: Firstly, we announced that we submitted our postulamab, BLA, to the FDA for the treatment of recurrent or metastatic cervical cancer under the accelerated approval pathway. Second, regarding our next generation CTLA-4 inhibitor, Agen 1181. At the ACR annual meeting in April, we disclosed new clinical responses for this antibody. There have been steady and impressive results, continuing the trend we had previously disclosed.
Firstly, we announced that we submitted our while still <unk> BLA to the FDA for the treatment of recurrent or metastatic cervical cancer under the accelerated approval pathway.
Second <unk>.
Regarding our next generation CLA for inhibitor Adrienne 11 81.
Garo H. Armen: Additional data and clinical responses will be presented at upcoming conferences. Third, regarding our INKT program, as we indicated in our last call in March, we extended our INKT clinical development program to cancer. While we continue to advance INKT cells in patients with acute respiratory distress syndrome secondary to COVID-19, we have recently announced the initiation and dosing of our first patient with cancer, and we will soon initiate our cell therapy combinations with checkpoint antibodies in solid tumor cancer. Turning to Tidget, we have advanced our efforts to expect to file an IND for our lead anti-tigid program, Agent 1-377, by specific during this current quarter. Next, regarding corporate transactions.
Garo H. Armen: We continue to expect cash accretive corporate transactions this year, starting in the current quarter. While there has been tremendous upheaval around the world over the last 12 months, A Genesis's core mission is unchanged, and we are on track with the delivery of our objectives. Feed and quality of our innovations are and will continue to be the core to our strategy. We will continue to marshal the best people and the resources that are paramount to achieve success for us. I would like to now turn the call over to our President and Chief Operating Officer, Dr. Jennifer Buell. Dr. Buell
We will continue to be the core to our strategy.
We will continue to marshal the best people and the resources that are paramount to achieve success for us.
I would like to now turn the call for our President and Chief operating Officer.
There's Jennifer Buell.
Jennifer Buell: Thank you, Garrow. As Garrow described, we made great progress during the opening months of 2021, advancing each major program efficiently towards our major objective. He also mentioned that speed of innovation remains our imperative. The industry standard for timelines and drug development, from ideation to the clinic, is four years. But in that same time, we've actually delivered 15 new discoveries. This is, in part, attributable to our technology integration. This is realized in our vision platform, short for virtual systems for immunoancology.
That could be.
Thank you Kyle.
As Gary described we made great progress during the opening months of 2021 advancing each major program efficiently towards our major objective.
He also mentioned that speed of innovation remains our imperatives the industry standard for timelines in drug development.
From ideation to the clinic.
For years.
But in that same time, we've actually delivered 15 new discoveries.
This is in part attributable to our technology integration.
This is realized in our vision platform short for virtual systems for immuno oncology.
Jennifer Buell: What is vision's purpose? The purpose of vision is to generate superior I.O. assets in less time by quickly defining why and how immunotherapy works to control tumors. Vision enables quicker validation of drug targets. It empowers faster optimized molecule design.
What his vision purpose. The purpose the vision is to generate superior I O assets and less time by quickly defining why and how immunotherapies work to control tumors.
Jennifer Buell: Faster Drug Candidate Selection. It defines biomarker signatures that predict which patients will respond to therapy, and Vision offers ways to customize those treatments to expand patient benefits. What is Vision?
Jennifer Buell: Vision is a virtual drug discovery system that mimics or recapitulates a patient's tumor microenvironment and their immune system. It uses artificial intelligence and predictive algorithms to explore a much broader range of drug biology interactions than any human capability. It generates data and provides feedback in real time to enable better drug discovery decision-making. More importantly, this vision has helped give rise to our pipeline of differentiated molecules. This includes balsstilam, our PD1 inhibitor, which we believe is showing differentiated activities preclinically and clinically. This also includes HN 2373.
Hello for the Doctor, Stephen Though day, our Chief Medical Officer to provide Higgins day. His insight on 11 81, including the differentiated activity. We just closed at this year's ACR annual meeting day.
Jennifer Buell: That's our CD-137 antibodies. Both antibodies will be featured in an upcoming Virtual ASCO annual meeting in early June. And of course, this also includes Agent 1181, our anti-CTLA-4 antibody, which we believe is showing the potential to have best-in-class activity in the clinic. And with that said, I'll turn the call over to Dr. Stephen O'Day, our chief medical officer, to provide his insight on 1181, including the differentiated activity we disclosed at this year's AACR annual meeting. Steven?
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Both German Garo discussed we've made additional progress with age 11 81.
The evolving clinical data strongly supports the preclinical flock bindings and continues to show the strength of the engineering behind this antibody.
We anticipate additional HMO 11, 81 clinical data disclosure at upcoming clinical conferences.
As the data matures, we continue to see responses and cold tumors traditionally a very difficult set of tumors to treat with Io therapy.
These cold tumors are typically low and tumor mutational burden they were microsatellites stable and they have lower negative PDL what expression.
This is in contrast to warm or hot tumors that typically have higher tumor mutational burdens. They can be high microsatellite tumors and they have higher levels of PDL. One expression. These warm or hot tumors are typically related cancers to environmental exposure.
Steven J. ODay: Thank you, Jen. As Jen and Garrow discussed, we've made additional progress with Agen 1181. The evolving clinical data strongly supports the preclinical fluk findings and continues to show the strengths of the engineering behind this antibody. We anticipate additional HN 1181 clinical data disclosure at upcoming clinical conferences. As the data matures, we continue to see responses in cold tumors, traditionally a very difficult set of tumors to treat with IOT therapy. These cold tumors are typically low in tumor mutational burden, they are microsatellite stable, and they have low or negative PDL1 expression.
Yours like tobacco alcohol or viral free.
Tumors.
In addition, we have noted responses and patience with the low affinity CD 16, illegal which day to suggest would be expected to have an inferior responds to first generation <unk> for antibiotics.
The clinical trial to date has been dominated by traditional cold Io tumors due to referral patterns to phase one Io trials.
Recently, we have treated our first patient with melanoma Ah Hot Io tumor with single agent 11, 81 with a rapid objective response.
This patient was PD, one refractory and importantly had seedy 16 low affinity allele.
Regarding adverse events no immune mediated hypothesised us pneumonitis or hepatitis have been reported to date, which is encouraging and favorable compared to patients treated with your board based Io regiments.
Steven J. ODay: This is in contrast to warmer, hot tumors that typically have higher tumor mutational burdens, they can be high-microsatellite tumors, and they have higher levels of PDL1 expression. These warm or hot tumors are typically related to environmental exposures like tobacco, alcohol, or viral pre-tumers.
Steven J. ODay: In addition, we have noted responses in patients with the low-affinity CD-16 allele, which data suggest would be expected to have an inferior response to first-generation CTLA-4 antibodies. However, the clinical trial to date has been dominated by traditional cold I.O. tumors due to referral patterns to phase one I.O. trials.
Steven J. ODay: Recently, we treated our first patient with melanoma, a hot IOT tumor, with single agent 1181 with a rapid objective response. This patient was PD1 refractory, and importantly, had a CD16 low affinity allele. Regarding adverse events, no immune-mediated hypophysitis, pneumonitis, or hepatitis have been reported to date, which is encouraging and favorable compared to patients treated with urvoy-based I.O. Regiment.
Dollars compared to a net loss for the same period in 2020 or $45 million for 31 cents per share, which includes non-cash expenses of $3 million.
Steven J. ODay: As of our latest disclosure at AACR's annual meeting in April, we've observed a total of seven objectives, including two responses in endometrial cancer, two responses in colorectal cancer, two responses in ovarian cancer, and one response in melanoma. We believe we have tremendous flexibility with the clinical development of HN1181 and the potential regulatory path. Studies are continuing as monotherapy with 1181 and in combination with our PD1 inhibitor balstilament. We plan to develop Agent 1181 in indications that represent large market opportunities. This strategy is exemplified in our ongoing face-to-expansion cohort of MS-stable colorectal patients in our current trial, which is actively accruing patients.
We recognize revenue of 12 million $15 million for the quarters ended March 31, 2021, and 2020, respectively, which includes revenue related to non-cash royalties earned and revenue recognized under our collaboration agreements.
I now turn the call back together.
Thank you very much Christine.
Okay. Thank you all again for your interest in the address and for joining US This morning.
The progress of Genesis, making so far this year is positioning us for a strong peer 21.
Moving into the current quarter and beyond we expect to achieve value of driving events.
With clinical and preclinical Cup pipeline.
And this includes an extensive list of important items starting with.
This year, we expect a further detail or BLA strategy for the combination of box per map and zone through a map.
To having filed our first VLA continuing to work with the FDA for our first product that's cool.
Three.
Preparing for commercial launch for a second line cervical cancer for.
Or <unk>.
Continue with our face for development for a general revenue 81, plus plus the other map.
With a strategy for transition of these studies to Registrational trials.
Christine M. Klaskin: Our initial registration plan targets indications for rapid launch by seeking approval through the accelerated approval pathway, as monotherapy 1181, or on top of our PD1, balstilamab, or any approved PD1, including patients with unmet needs. I'd like to now turn the call over to Christine Claskin to discuss our financial. Thank you, Stephen. We ended our first quarter of 2021 with a cash balance of $119 million as compared to $100 million at December 31st, 2020.
Five additional day or presentation for our own pipeline of agents and partners progress six.
Advancing are Adrienne one triple seven digits program into and through the clinic.
Seven.
Completing enrollment of the phase one iron Casey study and integrated COVID-19 Patriots.
Extending in generating clinical data from our recently initiate the day and Casey cancer trials.
Nine progressing with our commercial manufacturing facility for antibodies.
Then.
Progressing with our sustainable supply of <unk> 21.
911, progressing and delivering on our cash accretive corporate transactions.
For you again for your attention now we will open for the call to questions.
Thank you.
We will now begin the question and answer session. If you have a question. Please press star than one on your Touchtone phone.
Christine M. Klaskin: Cash used in operations for the three months ended March 31st, 2021, was $43 million compared to $35 million for the quarter ended March 31st, 2020. The net loss for the quarter ended March 31st, 2021, was $54 million or 27 cents per share, which included non-cash expenses of $12 million, compared to a net loss for the same period in 2020 of $45 million or $31 per share, which included non-cash expenses of $3 million.
If you wish to be removed from the queue. Please press the pound sign or the husky, if you're using a speaker phone you may need to pick up the handset first before pressing the numbers. Once again, if you have a question. Please press Star then one.
And our first question is from my young from be Riley's Securities. Your line is open.
Good morning day, and thanks for taking other questions and comes out from the progress. So if I may ask quickly on the 1181 to 10 or Dr for a day.
In terms of patients that you're moving to treat could you provide more color.
You said melanoma, but what sort of patients do you anticipate having update this year and specifically the gardens comment on what could allow you to transition do a dissertation trial and then just a follow up to that you know there was a or dark I'm gonna be meeting on checkpoint.
Christine M. Klaskin: We recognized revenue of $12 million and $15 million for the quarters ended March 31st, 2021, and 2020, respectively, which includes revenue related to non-cash royalties earned and revenue recognized under our collaboration agreement. I now turn the call back to go. Thank you very much, Christine. And thank you all again for your interest in the genus and for joining us this morning. The progress that Genesis is making so far this year is positioning us for a strong 2021.
Innovators very extensively over three days. So I was just curious broadly as you know you're one of the pioneers developing different approaches of check for and like what what did you think whether you implications for airports for Ya.
So maybe my and what I will do what we have publicly disclosed based on the data from Asia and 11 81.
As we have seen responses and stuff go day mentioned in tumor that our other way unresponsive immune therapies, those being microsatellite stable endometrial microsatellite stable colorectal ovarian and now also and two Mars considered hot or warm.
Being melanoma now that has been the extensive between publicly disclosed and so the data have been driving our decision on areas to pursue and which were eligible for fast to market opportunities like accelerated approval as well as very large mark opportunities such as Dr Day mentioned.
Garo H. Armen: Looking into the current quarter and beyond, we expect to achieve value-driving events with our clinical and preclinical pipeline. And this includes an extensive list of important items, starting with: This year, we expect to further detail our BLA strategy for the combination of busfillimab and xalphalumab. Two, having filed our first BLA, continuing to work with the FDA for our first product at Tuval, and preparing for commercial launch for second line cervical cancer.
And that being colorectal cancer MFL per.
Other rectal cancer. So I'll just ask that day to day, if he has any other feedback.
Thank you for the question I mean, what's exciting to us is but.
We have a designed next generation see Troy for that's showing activity in the current events, particularly in tumor types for traditionally Joan.
We're obviously experiment colorectal as we publicly disclosed and that's going well, we will continue to expand to other areas, where we're seeing signals and for science will follow us here as we expand these cohorts depending on the strength of the signal our goal as fast.
Garo H. Armen: Continuing with our phase two development for Agen 1181 plus postilomap, with a strategy to transition these studies to registrational trials. Five, additional data presentations for our own pipeline of agents and partner programs. Advancing our Agen 1-Triple-7 Tid program into and through the clinic. Completing enrollment in the Phase 1 INKT study in intubated COVID patients. 8, spending and generating clinical data from our recently initiated INKT cancer
A market and more not shying away from large markets because call tumors are traditionally large markets and we will pursue on other sites.
And my ankle related to the <unk> meeting this was.
You've seen predominantly focused on different product opportunities and I think consistent with what our expectations were from the meeting we.
We don't need them for received any negative impact to our portfolio of course products that show tremendous efficacy will continue to be fast chat and made available to patients and so those are the products that we're pursuing obviously.
So I think that the outcome was non.
Garo H. Armen: Nine, progressing with our commercial manufacturing facility for antibodies, progressing with our sustainable supply of QS21, and 11 progressing and delivering on our cash accretive corporate transaction. Thank you again for your attention. Now we will open the call to questions. Thank you.
Non impactful to us in any negative way.
Thank you and and maybe just a couple more.
Any incremental color on the C D. What thirty-seventh data coming up it goes out of you know how many patients you know.
<unk>, which is Mona therapy hardware says called humor any color on that and then maybe also if you have any update on the on the sustainable supply of use for anyone and and sort of value added with the synthetic manufacturing grocers. Thank you for thanks for other question obviously.
Operator: We will now begin the question and answer session. If you have a question, please press star, then one on your touch-tone phone. If you wish to be removed from the queue, please press the pound sign or the hash key. If you are using a speaker phone, you may need to pick up the handset first before pressing the numbers. Once again, if you have a question, please press star, then one. And our first question is from Maya Yang, from B. Riley Securities. Your line is open.
We'd have embargo data from ask us. So obviously I can't do you have any details rather except to say that as you would expect.
All phase one Iowa trials are with.
Tumor types that come into these trials are typically cold tumors.
And we're very pleased with how this trial is progressing and model therapy, and we anticipate we have not seen any major toxicity signals and we're looking forward to come do.
<unk> combination will approach is very soon so more to come from ASKO, where the detail of the of the trial to date will be summarised.
Pier, where it's on the molecule other differentiation design.
Maybe I'll just say that as a reminder for those new to this.
Product agent 23, 73 with design.
Assisted in anti city 137 Agonistes.
Mayank Mamtani: Good morning team, thanks for taking our questions and congratulations on the progress. So if I may ask quickly on the 1181, to Jen or Dr. O'Day, in terms of patients that you're continuing to treat, could you provide more color on, you know, you said melanoma, but what sort of patients do you anticipate having an update on this year and specifically to Gareth's comment on, you know, what could allow you to try Transition to a registration trial.
We know that these molecules and mechanism I really critical for bringing durable longterm immune response for patients for cancer the problem with.
Preceding molecules is that they have been toxic predominantly.
Lot of liver toxicity has been observed we designed our molecule to actually be.
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Not induce any liver toxicity, so essentially the molecule binds I'm only in the presence of the ligand. So effectively we call that conditionally active as a condition too. It's activity that we believe will be will support on more safer profile, our better tolerable profile. So.
More data will come out on the mechanism as well as what we're seeing in the clinic to the point that mechanism for.
Fair to say that covers green.
And he was 21.
Favorable cures for anyone as <unk> as you know.
Mayank Mamtani: And then just a follow-up to that, you know, there was an ODAC committee meeting on checkpoint inhibitors that was very extensive for three days. So I was just curious broadly as, you know, you are one of the pioneers developing different approaches to checkpoint inhibitors. Like what, what did you think were the implications for your potential?
So.
There is no ambiguity about the fact that <unk> 21.
Highly active perhaps one of the most if not be more active.
Now what does that mean.
That simply means bed.
Vaccines that have choice 21 is an adjuvant drive both huge one in th two components of the immune response those are very very important element.
Jennifer Buell: So maybe, Mayank, what I will do, what we have publicly disclosed based on the data from Agent 1181, is we have seen responses, as Dr. O'Day mentioned, in tumors that are otherwise unresponsive to immune therapies, those being microstolate-stallate-stable endometrial, microstolice-stallate-stable colorectal, ovarian, and now also in tumors considered hot or warm, Now, that has been the extent of what we've publicly disclosed, and so the data have been driving our decision on areas to pursue in which we're eligible for fast, go-to-market opportunities like accelerated approval, as well as very large market opportunities, such as Dr. O'Day mentioned, and that being colorectal cancer, MSS, colorectal cancer. So I'll just ask Dr. O'Day if he has any other feedback for him. Yeah, I mean, thank you for the question.
Now the problem is you know has been day.
In the past because we haven't had the kind of pandemic that we're experiencing right now.
Typical requirement for a vaccine has been such as for example, shingles vaccine in the tens of millions of doses per year it hasn't been in billions of those.
And now that we are confronted with this reality.
Because we don't know if the current pandemic is going to go away.
If it is going to continue we don't know for growth to be confronted with new pandemics that we're not even contemplating right now however.
However, what we know is that the world's state of mind has dramatically changed from one of his state of compliance or complacency brother to his state for heightened urgency could be ready for.
For Pandemics that requires that we need to be ready with a very highly effective adjuvant <unk> 21, there'll be able to produce enough of it to accommodate very large quantities of vaccine doses and in order to do that.
Steven J. ODay: I mean, what's exciting to us is that, as I've said, particularly in tumor types that traditionally and don't respond to traditional treatments. We're obviously expanding colorectal, as we publicly disclosed, and that's going well. We will continue to expand other areas where we're seeing signals, and the science will follow us here. As we expand these cohorts, depending on the strength of the signal, our goal is fast to market, and we're not shying away from large markets because cold tumors are traditionally large markets, and we will pursue the science.
The only way to do it in our opinion.
Is to try to replicate the raw material from it natural schorsch for.
Ah man made source and here, we're talking about making gate with cell lines, which we have started the prices. So right now as I've said earlier, it's a question of engineering not a question of Kansas be scientifically accomplished because we've done the science part with.
Sean it in small.
Scale quantities that we can make it and scaling up of course is a different kind of an effort and that's what we're in the process of doing and I'd say, we're probably a third of the way into it right now.
And that Scaleup prices.
Okay.
Question for you.
Yes. It does thank thank you for taking my questions.
And our next question.
Question is from Kelly from Jeffries Your line is open.
Steven J. ODay: And my, related to the ODAQ meeting, you know, this was, as you've seen, predominantly focused on different product opportunities, and I think consistent with what our expectations were from the meeting, we don't, we don't perceive any negative impact on our portfolio, of course. Products that show tremendous efficacy will continue to be fast-tracked and made available to patients. And so those are the products that we're pursuing, obviously. So I think that the outcome was not impactful on us in any negative way.
Hi, Good morning. This is Jason Bouvier on for Kelly. She thank you for taking our call.
We were wondering if you can discuss a little more how you're thinking about the development of the second June CTF law for antibody for example, how do you prioritize your price prioritize.
Prioritize the combination therapy with P D, one or the mono therapy, such as in the PD one refractory setting.
So let me make a general statement and then I'm going to read Steven and John.
Address it.
So our strategy for a bit.
Picture perspective is very simple.
And our strategies based on data that we have disclosed as well as data that we have in our possession that factors into our planning very important point, because we make decisions based on science.
Jennifer Buell: Thank you, and maybe just a couple more. Any incremental color on the CD-137 data coming up at ASCO, sort of, you know, how many patients, you know, combination versus monotherapy, heart versus cold tumor, any color on that, and then maybe also if you have any update on the sustainable supply of US 21 and sort of where you are with the synthetic manufacturing process. Thank you.
Now at one end of the spectrum.
Is Stevens said, we're seeing.
Very very.
Pronounced activity.
And tumors that are cold.
And represent very large markets because no immunotherapy indoors tumors has shown Rio R found activity, so far from one hand or strategies for sure that very very.
Additionally on the other hand, there are other cancers that our specialty cancer, so to speak where there may be a path for approval that is very rapid.
Jennifer Buell: Well, thanks for the question. Obviously, we have embargoed data from ASCO, so obviously, I can't give any details about it except to say that, as you would expect, all phase one I.O. Trials are with, you know, the tumor types that come into these trials are typically cold tumors, and we're very pleased with how this trial is progressing in monotherapy, and we anticipate we have not seen any major toxicity signals, and we're looking forward to doing combinational approaches very soon.
So we're looking get both of those strategies and Steven why don't you are operating yeah.
I understand people really wants from detail around the development plan I think what we've said is that there's going to be a lot of flexibility and options here and we simply need to see the strength of the signals as we expand from cohorts to know the path that's most.
To approval and it may be singled arm studies, if the strength of the signal is high enough. It may involve some comparative trials.
Each of the diseases, whether it's a cold or warm and hard tumor officers. You know is a very competitive landscape scape. What I can tell you is we're thinking through this very carefully and we're in parallel thinking about where are we want to go as the data evolves and we will be ready as soon as we have more data what we have been.
Jennifer Buell: So more to come from ASCO, where the details of the trial to date will be summarized in a few words and the molecule of the different designs. You know, my, maybe I'll just say, though, as a reminder for those new to this product, Agen 2373 was designed.
Able to do is to to reach.
Doses that we're comfortable with both in single agent in combination with a favorable toxicity profile and so we're ready now to expand these cohorts and see where the day to takes us.
Great. Thank you so much.
Once again, if you have a question. Please press Star then one.
Jennifer Buell: It's an anti-CD137 agonist. We know that these molecules and mechanisms are really critical for bringing durable, long-term immune responses for patients with cancer. The problem with preceding molecules is that they have been toxic, predominantly a lot of liver toxicity has been observed. We designed our molecule to actually not induce any liver toxicity. So, essentially, the molecule binds only in the presence of the ligand. So, effectively, we call that conditionally active.
And our next question is from <unk> from William Blair. Your line is open.
Good morning.
For Matt.
Just got down South cause I know you guys are having.
Ongoing conversations with the FDA was wondering if you could provide any color on.
Sort of the focus of those conversations.
And any alignment.
That needs to occur between you and the agency. There then I I believe you mentioned that you plan on presenting additional responses.
From the 11 81 trial.
Coming conferences.
I was just wondering if I heard that correctly.
And if so if you could provide any color on if those are in similar cancers for what you've seen responses before Joseph.
Jennifer Buell: There's a condition to its activity that we believe will support a safer profile or a better tolerated profile. So I think more data will... will come out on the mechanism as well as what we're seeing in the clinic to support that. Fair to say the color.
New indications.
I think our state previous statements hold there we are actively expanding these cohorts and we expect to present updated clinical and safety data.
Meetings this year.
And regarding their.
Jennifer Buell: It's fair to say the color is green.
Additional Colorado MTA conversations I think those are confidential then it would be appropriate for us for provider drove straight doing.
Garo H. Armen: QS21? Oh, QS21, like my own case, you know, so there's no ambiguity about the fact that QS21 is highly active, perhaps, one of the most, if not the most, active adjuvant. Now, what does that mean?
I think the one the line. Additionally, withstand bouncedown is that as you as you know and we've disclosed previously.
And the child has been enrolled for large trial over 150 patients.
Have concluded our follow up period. The median follow up period that was necessary and the data continue to look very strong. So this combination we believe it's a real potential opportunity for patients for cyclical cancer for them.
Garo H. Armen: That simply means that vaccines that have QS21 as an adjuvant drive both TH1 and TH2 components of the immune response. That's a very, very important element. Now, the problem, as you know, has been that in the past, because we haven't had the kind of pandemic that we're experiencing right now, the typical requirement for a vaccine has been, such as, for example, the Schingles vaccine, in the tens of millions of doses per year.
Alright tend to continuing to keep you updated.
Okay, Great and maybe one more real quick on the COVID-19 trial, I think last quarter, you had mentioned that you expected.
Relation to wrap up here in the first half of the year and now I think it's sort of shifted too.
Just general finishing in 2021, so I was wondering if you could provide any color on how.
How the enrollment is going in that trial.
Especially given that.
The the vaccination efforts that are ongoing in the U S.
So I will say just a couple of points on this but we have we are still on track to complete dose escalation. The first half of the here and then of course expand to your face tail and where we see a real opportunity here in patients who have sequela right.
Garo H. Armen: And now that we are confronted with this reality, because we don't know if the current pandemic is going to go away, if it's going to continue, we don't know if we're going to be confronted with new pandemics that we're not even contemplating right now. However, what we know is that the world's state of mind has dramatically changed from one of compliance, or complacency, rather, to a state of heightened urgency to be ready for pandemics.
Acute respiratory distress syndrome secondary to COVID-19, and then we have a real opportunity to expand to bring potential benefit to those patients as well as beyond those suffering from a R. D S.
Independent of COVID-19 so.
So we see a number of opportunities for development of these cells and pulmonary disordered areas that are quite prevalent.
That will be.
Touched or be able to proceed independence of debt continued high prevalence of COVID-19, Although I will say despite the vaccine efforts we are still seeing.
The pandemic is Rob.
Ravaging certain community and it still remains a real problem.
Great. Thank you.
And we have another question from My Inc. Your line is open.
Thank you that you must value.
I was.
Garo H. Armen: That requires that we need to be ready with a very highly effective adjuvant by QS21 to be able to produce enough of it to accommodate very large quantities of vaccine doses. And in order to do that, the only way to do it, in our opinion, is to try to replicate the raw material from a natural source to a man-made source. And here we're talking about making it with plant cell lines, which we have started the process.
The the COVID-19 question Jen and also just the abbreviation of that and cancer.
Obviously these cell types the stores has to be also very scalable.
Lake How're, you sort of making choices what to get into a school big verses.
You are Gonzo study and then also in terms of the community that is average is your budget.
Considering doing trials and those that abilities.
The pain is greater.
Garo H. Armen: So right now, as I've said earlier, it's a question of engineering, not a question of whether this can be scientifically accomplished because we've done the science part. We've shown in small quantities that we can make it. And scaling up, of course, is a different kind of effort, and that's what we're in the process of doing. And I'd say we're probably a third of the way into it, right? in that scale-up process. Does that answer your question, ma'am? Yes, it does.
So I'll say mind with respect to scalability, they're real differentiation of adjourn test that it's based on a manufacturing prowess is that we actually has been able to address this isn't a biology promise an engineering problem. The scalability volume K T cells, and we have publicly presented data where we're seeing exponential.
Scalability with these cells and now producing nearly 10000.
This is for a patient at our current capability and then we're prepared to go far beyond that sales.
For adjourn test menu.
Manufacturing has been addressed and now scalability is very straightforward it for us. It's just a matter of the numbers and we don't need to scale far beyond what we have right now and he'll adjust that our current needs and the clinic and cancer as well as in COVID-19.
Mayank Mamtani: Yes, it does. Thank you for taking my question.
As far as the expansion of this child will provide more detail on the agenda says.
Operator: And our next question is from Kelly from Jeffries. Your line is open. Hi, good morning. This is Jason Bouvier on behalf of Kelly Shee.
And for the Iron Katie and COVID-19 and beyond.
And by the way this too for.
Address this.
Operator: Thank you for taking our call. We are wondering if you can discuss a little more how you're thinking about the development of the second-gen CTLA-4 antibody. For example, how do you prioritize? Do you prioritize combination therapy with PD1 or monotherapy, such as in the PD1 refractory setting? So let me make a general statement and then I'm going to let Steven and Jen address it. So our strategy, from a big picture perspective, is very simple.
Point very clearly.
God forbid.
Should.
Should the via a variance and vacations.
Keep ahead of our ability.
To develop vaccines that are going through.
Be able to confront the future challenges should that happen.
And should for example.
B a viable therapeutic approach silverado should here by if that were to happen.
Do not for see that manufacturing.
Garo H. Armen: And our strategy is based on data that we have disclosed, as well as data that we have in our position that factors into our planning. Very important point, because we make decisions based on science. Now, at one end of the spectrum, as Stephen said, we're seeing very, very pronounced activity in tumors that are cold and represent very large markets because no immunotherapy in those tumors has shown real profound activity. So on the one hand, our strategy is to pursue that very, very expeditiously.
Course of treatment will be an issue.
On a large scale.
On a large scale.
Okay. Thank you and maybe a follow up.
Do this is.
<unk> any update you could provide on what things you might be looking at going by yourself versus.
There could be a lot of support from external stakeholders public private.
Garo H. Armen: On the other hand, there are other cancers, that are specialty cancers, so to speak, where there may be a path for approval that is very rapid. So we're looking at both of those strategies. And Stephen, why don't you comment on this?
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Steven J. ODay: Yeah, I understand people really want some detail around the development plan. I think what we've said is that there will be a lot of flexibility in options here, and we simply need to see the strengths of the signals as we expand some cohorts to know the path that's most rapid to approval. And it may be single-on-rength studies if the strength of the signal is high enough, it may involve some comparative trials, and each of the diseases, whether it's a cold or warm and hot tumor, as you know, it's a very competitive landscape.
Steven J. ODay: What I can tell you is we're thinking through this very carefully, and we're in parallel thinking about where we want to go as the data evolves, and we will be ready as soon as we have more data. What we have been able to do is to reach doses that we're comfortable with, both in single agent and in combination, with a favorable toxicity profile.
Steven J. ODay: And so we're ready now to expand these cohorts and see where the data takes us. Great. Thank you so much. Once again, if you have a question, please press star, then one. And our next question is from Matt Phillips, from William Blair. Your line is open.
Operator: Hey, good morning, guys. This is the Hunter on for Matt.
Operator: Just on the thousand south convoy, I know you guys are having ongoing conversations with the FDA. I was wondering if you could provide any color on, you know, sort of the focus of those conversations and any alignment that needs to occur between you and the agency there. Then I believe you mentioned that you plan on presenting additional responses from the 1181 trial at upcoming conferences. I was just wondering if I heard that correctly, and if so, if you could provide any color on whether those are in similar cancers to what you've seen responses before, or those new indications.
Steven J. ODay: Yeah, I think our previous statements hold there. We are actively expanding these cohorts, and we expect to present updated clinical and safety data at meetings this year. And regarding the additional color on FDA conversations, I think those are confidential, and it would be an appropriate time to talk about it or sprit it. I think the one addition I would say on Val-Salle is that, as you know, and we've disclosed previously, the trial has been enrolled, the large trial with over 150 patients.
Steven J. ODay: We've concluded our follow-up period, the median follow-up period that was necessary, and the data continue to look very strong. So this combination, we believe, is a real potential opportunity for patients with cervical cancer. We'll look forward to continuing to keep you updated.
Steven J. ODay: Okay, great. And maybe one more real quick.
Operator: On the COVID trial, I think last quarter you had mentioned that you expected the dose escalation to wrap up here in the first half of the year, and now I think it's sort of shifted to just general finishing in 2021. So I was wondering if you could provide any color on how the enrollment is going in that trial, especially given that, you know, the vaccination efforts that are ongoing in the U.S. So I'll say just a couple of points about that, but we have
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Jennifer Buell: So I'll say just a couple of points on this, but we are still on track to complete dose escalation in the first half of this year and then, of course, expand to phase two. And that's where we see a real opportunity here in patients who have sequela, right? So it's acute respiratory distress syndrome secondary to COVID, and we have a real opportunity to expand to bring potential benefit to those patients, as well as beyond those suffering from ARDS, independent of COVID.
Jennifer Buell: So we see a number of opportunities for the development of these cells in pulmonary disorders that are quite prevalent that will be untouched or be able to proceed independent of the continued high prevalence of COVID. But I will say, despite the vaccine efforts, we are still seeing that the pandemic is ravaging certain communities, and this still remains a real problem. Great, thank you. We have another question from Myank. Your line is open.
Mayank Mamtani: Thank you for taking my follow-up. I would want to ask the COVID question, Jen, and also just the implication of that in cancer. As obviously these cell types, you know, the source has to be also very scalable. Like, how are you sort of making choices about what to go towards COVID versus, you know, your cancer study? And also, in terms of the communities that are ravaged to your point, Jen. And are you considering doing trials in those territories where, you know, the pain is greater? So I'll say my opinion with respect to
Jennifer Buell: So I'll say my uncle, with respect to scalability, the real differentiation of a gen test, and this is based on our manufacturing prowess, is that we actually have been able to address, this isn't a biology problem, it's an engineering problem, the scalability of INKT cells, and we have publicly presented data where we're seeing exponential scalability with these cells. I'm now producing nearly 10,000 doses for patients at our current capability, and then we're We're prepared to go far beyond that.
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Jennifer Buell: So for Agentes, manufacturing has been addressed, and now scalability is very straightforward for us. It's just a matter of the numbers, and we don't need to scale far beyond what we have right now. It'll address our current needs in the clinic in cancer as well as in COVID. As far as the expansion of this trial is concerned, it will provide more detail on Agentis' plan for INKT and COVID and beyond. And by the way, just to address this point very clearly, God forbid should the viral variance and invocation keep ahead of our abilities to develop vaccines that are going to be able to confront future challenges.
Jennifer Buell: Should that happen? And should, for example, INKTs be a viable therapeutic approach? There are a lot of shoulds here. But if that were to happen, we do not foresee that manufacturing or costs of treatment will be an issue on a large scale.
Jennifer Buell: Okay, thank you. And maybe a follow-up, uh, to this is how any update you could provide on what things you might be looking at, you know, going by yourself versus, you know, there could be a lot of support from external stakeholders, public and private, towards some of these activities. So any color you could provide from a timeline standpoint, you know, when we could expect some of the strategic discussions you might be having.
Garo H. Armen: All of these prospects are being actively pursued.
Mayank Mamtani: Okay, thanks for taking my follow.
Operator: And we have no other questions at this time.
Operator: Great, thank you everyone for joining us. We'll talk to you soon.
Operator: Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.
Operator: and and and and and Thank you You Thank you Bhopin. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you, and so on.
Operator: Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you. Thank you.