Q3 2020 ALX Oncology Holdings Inc Earnings Call
Ladies and gentlemen, and thank you for standing by and welcome to the L. ex oncology conference call.
At this time all participants are in listen only mode. After the speaker presentation. There will be a question and answer session to ask the question. During the session you will need to press star one on your telephone please.
Please be advised of today's conference maybe recorded true to require any further assistance. Please press star zero on.
And I like the hand, the conference over to your host Chief business Officer, L. ex oncology Gi need you.
Good afternoon, and Jimmy Choo, Chief business Officer of Alex oncology.
On behalf of the L. ex team I'd like to thank you for joining us on todays conference call to discuss new clinical data from asked and one on phase one of the study and gastric cancer, combining and Alex one for eight.
That's true and Matt on the.
Sure and that and Paclitaxel the.
This data was presented last week at the society for immunotherapy of cancer, we should see virtual meeting.
The flight deck for this webcast is available on our website and electoral college of Dot Com and your news and events and the Investor section also a press release detailed and the phase when the data was issued on November nine and the poster and can be found under publications on the of corporate website.
Today, we're joined by renowned gastric and colleges Dr. Yang and you bought professor the Meritas of Seoul National University Hospital he's.
He is the leading investigator and gastric cancer, among others to my Histologies and.
And the key investigator and Alex its first in human trials, the Alex one freight.
Dr. BAAM has also been the principal investigator and number of clinical trials, including toga.
Tick Shine and go.
To kick off our call today Dr. John the upon the CEO of Alex oncology will provide an overview of Alex one for Mike and its differentiation from the other C. D 47 blockers.
Dr. Banca Lee the phase one b gastric cancer combination study and doctors the fear Red Dog Electro College as Chief Medical Officer will provide a summary of our clinical development plan for Alex One for me.
At the end of our presentation, well open up the call for questions.
Before beginning let me remind you that today's presentation will include forward looking statements are based on management's current expectations and beliefs.
Such statements represent our judgment as of today and involve substantial risks and uncertainties that may cause actual results to differ materially from the results discussed in the forward looking statements.
Please refer to our filings with the FCC on the website.
With that I'd like to turn over the cost of Dr., John the upon the CEO of Alex oncology Djalma.
The next oncology the sudden immuno oncology company focused on.
On to see books and by the way.
They see the purpose of both ways, so true sorry, the beaches being made on it that the immune system.
And what lead candidate PL S will put the eight.
Like the sound block on.
And I was designed to be used in combination.
In the commodity.
The money and showed that they need but I'd be simplifies the process and people.
Could be as high at boosting and you stay out of those the.
Yes indeed.
Oh Syndicate of me the CIC bet I think I see.
Well, let me ask and he got the concept.
Well, it's getting on the logic of I'm, sorry to Mike how.
Oh, the initial well see some and B S M and I'm sorry, the motion.
And like.
Mechanistically she put the seven you said of protein expressed on kind of sense and that's a lot of my sense that you could actually within the sector.
I think the express Americas gauges, and all that of me like <unk>.
And that actually and you say maybe thought the production that we call I'd on it and the signal.
Mendicants at age and.
I got the guys kind of people these on the chemotherapy.
And you can be seen though that's kind of thought of it got success of destruction.
Hi, Jeff and I have to go sit on people on this but.
Right and PC Oems on GAAP themselves I.
And we did actually with the C. With the second would be actually got a lot of sets of somebody just the bite that youd and they seem to.
The situation.
And so I, probably see book yourself on the provide I don't if the thing, though the venting deflect PDP open maybe at the constant lesions.
Looking back the do you have to block C book of settled with the molecule and next couple of P. Eight.
And then on these the people that show up on the Asia.
And it's important and that's the kind of sound the body.
We have decided to design the molecule that's on the block 67, and that's not in that I think that's the got most of them.
One of the companies have decided to make molecules that would the board.
And that we buy and see seven and.
Instead of you got to pick up on the sector, and thereby providing a positive signal and.
On the leasing and they get the signal at the same time.
Yes, I'd say that would be good day.
And he put the seven when only express and that the steps Betsy.
Betsy book of seven you snuck, one of the experiment that the steps.
Yes, that's the express the many accessing the Bobby I believe most out of something body sort.
For example, it gets better you kind of explain summed up the upsells and that's what people are complete.
And for most of the double block of see pockets and by the way, but at the same time through by the big signal and.
And they have to have not the sector.
And you can go south of destruction.
And the clinic those molecules have shown the second opinion and like I mean, yes, you put the me out sort of numbers of the opinion.
So we decided to do whats the create the molecule that's on of the block C of up to seven and the second the quite interesting, though we've come from another money put exemption and not the kind of send people lucky that we specifically kind of get on the kinds of steps.
It's like seven.
Our molecule intellectual property.
Price is what the call I guess the piece of the buffer.
<unk> expenses on the main sort of thought so the.
The receptor the books, so you put the seven.
That's been the P.P. mature two banks he put the seven we speak of Lucky and <unk>.
And that's really do a bundle of the types of the bus stop by and shape of the seven within a few p. or perhaps the none of them on the two why much on one of them.
So we feel the soundness of coal fired I see the perceived hope you said the that'd be my true obviously the puzzle.
I woke up use of that the completely back to me to pick see that piece not able to interact with ex he got most of those.
And he said of for not able to book the need macrophages.
However, this ex he does provide the same sounds like the time Peabody.
So we have 50 basis like on the study state that that's the piece the gig weekly.
And then one of the mud weight the like 48, you stop of the antibody.
So we have twice the number of much of it was good I'm talking.
So tell me sort of keep hoping index will put the use of the people that affected me sort of keep well find people on the impacts of binding site.
Oh, so there's much of this most size of.
The likes of put the eight may provide bit of smoking attrition and the.
Doubling of PDP I'm sorry, the most.
The manufacturing facility that will put the eight he's completely and people understand the.
We've been kind of you.
More comfortable on the lead the you got two thoughts on that.
And then you said you have the U.S. look of stability and support ticket east of the liquid formulation.
He piece of Betty was the case.
Thank you gentlemen, I'd like to introduce Dr., you and you bomb Professor Emeritus of Seoul National University Hospital, Dr., Bob and his distinguished Oncologists, who is co author of close to 500 papers, including papers and the New England Journal of Medicine and much of it. He's also a key investigating the elecsys phase one b.
Gastric cancer trial, we're privileged to have him with us and Seoul Korea Dr. bomb.
Dan Skinny.
Good morning.
Do you have any of my colleagues.
But its my great on all of two pretty can't at the if input on the mid Ken.
Today I'm going to speak on.
Eight ex the 148 for advanced Heart Taposh, Keith Cozza cancer.
'cause it kind of shot each one of the most common cancers and.
And it's the saw the leading cause of job tens of das globally.
Each of you just don't the rate each of high used in eastern Asia.
Tens of the force the rights that IP patient threed or the vans part the part two of cuts of <unk> East.
Across the map loss to most of the Pea.
<unk>, Oh floral piece of meat and platinum.
And second line therapy, saboteur, H. and I'd be used.
However, the combination of Roman sort of <unk> and property types. There was no I'm pair each.
Oh, sorry, the the best outcome and kind of start the regulatory is tend of care.
For the other line well subsequent set of P. Three flow the deed and keep the Russian walk you know Nick could ease of use.
For the PDL, one part of two patients.
The reason map block the boardroom and can be used.
Next the slide is slide 14.
Risk pretty broad Smith did on con on you antibody drug conjugate, what's the test kit for southern right instead of Oh heart the past you've got the Kennesaw you know randomized phase two study.
The primary endpoint was what was the active response rate wall Art art.
The study was Huskies you the how you all are and longer sell by bar.
Keith age and really become does tend to kill.
Well first of all the rights that IP all the her two positive got the cancer.
However, please note that crossing of tariff cut was on associate we'd see any client or the board you balance.
My and lots of personal of common.
51% of patient head grades three well, how you neutropenia and 5% head fevered aren't you true opinion.
In addition component of patient had interest yard long the gige potentially challenging you use in or do you have line of a set of P.
Next slide 17.
No I'm going to the PK do any share data read and ex 148.
She do 47 block off in combination read trusting that you do walk we do our two most of the P. inpatient we'd heard Taposh people got the kennesaw on the F. O I spent the one investigators.
In the study and its the 148 each be tested inpatient threed got the Kansas and head and neck cancer and easier to do towards the Gente. The at the end you and me well, it's like you see on November Elevens.
In Ottawa and that's the 148 was the Cascade as a monotherapy.
Maximum tolerated dose or MTD, what's the not Ritchie.
And that's the <unk> or the my niece told the Ddos well Index 148 was 10 me do it on <unk> LTV was so do you mean, you mean paki average adobe.
In pots to patient read hard parts. The biggest kind of saw well I had then the cancer received and if the 148 can walk 15 me do it and keep everybody in combination we crossed Smith pembrolizumab and cash.
Most of the Pea.
Patient has had the most of it or at least nine rump of young and the <unk>, probably <unk> exposure to on and key cdforty stable and what sort of our age on.
Next the slight east like the nine King.
Sure I'll describe the parts of the patient the core.
They shouldn't read so the walk rate the line hurt the PUC, you've got to kind of saw who had.
The problem is on standard of forthright and Richmond is encouraging and hard to sort of P. Deceived index of 148 in combination we crossed MEP profit Rempac wall.
Beat profit Smith.
The primary endpoint of gift study is safety.
And well the Jack to response rate is the important secondary endpoint.
The data cut off date was October 1st to solve the try and key.
Next the like eat slide 21.
These papers summarized the baseline characteristics of the study for patients.
In the old into east portion of of the study.
The study enrolled patients the from the United States and South Korea, we the more patients and not in the study.
The majority of patient had on <unk> GAAP School was.
We the two quota of patient with guts Kennesaw well.
But one patient and each will have the two most debt force on price and keep hurt the sort of P.
And like the rest and hop in the eight ex 148 Cross the trust them of course.
Had the too much debt had the protest of pod, two or more price and <unk> agent and you. It is probably a checkpoint inhibitor therapy.
Well the group had the seeking the could well done all of the GE, we'd be sort of the metastatic disease.
Hey, there's the 148 was well tolerated in combination of Reed thrush, Matt we do on the dark rent per share.
The most come on treatment of related or the boat event.
The across both the regiment was low grade for the key Dominion born and raised you walk right. The other was the beds.
We have previously should and ask the early debt you and when she's tend to read it ex the one for the Ace of molecular the Jain there was no east Pooja Cytopenias and relationship.
Well the jolt in approximately 94 patients read the Baird your sort of your tumors recede and if the 148 and the single agent <unk> income nation read Pembrolizumab, Watrous, MEP and dose ranging from 10 million and key to the sorry.
Some of your key.
Keith you should the data suggest that.
Eight ex of 148 babies seem pretty well do you mean, the stood we'd have to most of the container richman reaches.
Which is important to you know the two continue to develop the component in earlier lines of of cancer therapy.
Next slide he writes history.
Here in the first Taber, we summarize the initial anti cancer cubic Oh, and EPS of 148 in combination we'd crossed the MEP and Empire.
In the fourth temptation to walk right. The right part of the parts of the that's kind of saw what was the active response rate was 64.3%.
I'd like to remind you what would you have to be supports the rate to be the ramp pad and second line therapy in Rainbow study was 28 plus and.
Well do the simple site at these types of the smaller <unk> any share data is quite the promising.
Several of the night patients should be the peers on foamed.
It's all of the data cut off and.
And Reed both five points the most media on funded Oh.
In the second table and be somewhat on the uptake of the Korean TV the data with eight EPS of 148 last <unk>.
Chemo free regimen.
Well you have to be response rate was 21.1%.
And media and traditional <unk> response was 8.7 months.
D C C class.
Yes.
And if the 148, it's not designed to have one of the sort of keep the tea and.
On top of the mic each node and nothing to chemotherapy and second 9.2 parts of the <unk> cancer, whose tumors have laid the pros on probably a trust them of treatment in <unk> and <unk>.
Randomize patients the study.
Yeah, and keep you up with the double that and the second well create the right instead of you provide.
Robot the rational on for Ed you on to the quarter on ramp path tend to carry on.
<unk> effort to improve upon the and key parts of <unk> in the phase three Rainbow study.
Next slide is slide 24.
This is the what top four plot inpatient the recede being and if plus cross MEP lumped pack.
The Companys centre and assessed her to of course from a high bar samples of present keyed on an ex ex U.S.
Oh of course, Mpos may have been biopsied from before or after probably a hard to target the setup.
In the part of the fraud and tens of typically was well the Joe's we the initial did you eat assessment and eight weeks.
Continued the shrinkage both major tumor regions appeared to keep putting all the time.
Slides 25 <unk>.
Here, we show the what to put plot and support of the plot inpatient the T to be eight ex the 148 Clos Cross Smith.
Slide 26.
On the figure shows the concentration time profiles of eight ex 148.
Oh, the share of chemotherapy to eight ex plus trust the map Wap <unk> had no impact on an ex the 148, you spoke to the revenues and.
And it's the one for eight income <unk> Reed.
Matt demonstrate keyed linear PK, and 10, and 15 media and public kicked to the revenues.
The estimate keyed pay the state how price Fob and ex the 148 and people give me the ramp up key.
Could be it's about 30 days.
Slide 27.
Your complete C. D 47 receptor occupancy what of the job.
Of course, the Georgia into bar in the pita pit abroad, or or patient, we'd cut the catch the or I didnt kind.
And so we see being regimens containing eight of 148 profit chemotherapy.
In conclusion.
It ex the 148.
Hi, Hi, affinity city of 47 myeloid checkpoint EBITDA.
We don't inactive EFI she'd come not domain and feed about popularity of profile demonstrates.
Compelling objective of response in combination we crossed map you do and reduction most of the P. inpatient read second or create the line lots of cancer.
Two hour and salaries D C. <unk> on you see the 47, how did the agent and a pretty neat.
It has shown good payback of Kb tea in the slowly to my second.
Preliminary data suggests that and ex the 148 can be safe pretty combined we didnt know maximum tolerated dose of retreat and a maximum of the may start to do the Oh peeped immediate on pulp key dolphin and weak.
In combination we talked about net profit Rempac regimen study.
And if the 148 demonstrate a promising 64% objective response rate and patient read second of all great Top line, what the positive cash 10. So in combination read profit map Rama sort of debt and public text and.
<unk> compared varied the historical data.
Updated data from patient read second on greater line, what part of the biggest concern.
The deceived it if the 148 in combination with profit Smith.
So just the clinic and QB key beyond the debt expected from the 11th the historical contours.
Then true for your attention.
Thanks, Dr., Bob we appreciate your share and your valuable perspective on the phase one b gastric cancer data from our asking one trial.
Now I'd like to turn the call over the doctors to feel Randall Chief Medical officer of election called the G to discuss our near term clinical development plans for Alex 148, and solid tumors and Hematological malignancies Sofia.
Thanks, Denise and.
As Dr. Boeing has discussed our compelling results in her two positive gastric cancer provide the rationale for us to continue development and the phase two setting and further supports our fast track designation and that was previously granted by U.S. ft based.
Based upon the clinical activity seen we plan to initiate Aspen six the phase two study evaluating ale ex 148 in combination with tries to the mab surrounds the and Paclitaxel in patients with second line or greater her two positive gastric.
Yes, the carcinoma or gastroesophageal junction cancer that has progressed on prior anti her two directed therapy approximately 60 patients will receive the combination and will be evaluated for objective response, that's the primary study and point.
On slide 31 here, we summarize an overview of our Alex 148 clinical development program with the focus on the solid and hematologic malignancies.
On the solid tumor side, we continue to evaluate Alex 148 in patients with head and neck squamous cell carcinoma and.
The combination with keytruda with and without chemotherapy and while we will.
The be collaborating with Merck on this program. We have also received fast track designation by the FDA for this indication.
And patience with second line or greater her two positive gastric and G.E.J. cancer. We are studying a Alex one for it in combination with trust to the map with or without Cyramza. Paclitaxel. This program also has received fast track designation by the FDA and then in collaboration with volume works. We are excited to also start.
Evaluating a novel combination of L. ex 148, and then a debt to nap in patients with her two positive breast cancer.
On the hematologic side, we are currently evaluating Alex on freight and combination with society, Dean and patients with higher risk Mds and plan to evaluate Alex as well in combination with Venetoclax and they society and patients with first line and now who are not candidates for induction chemotherapy.
Alex and combination with for talks and that has also been studied in this program and patients with B cell on non Hodgkin's lymphoma.
And slide 32, we show an overview of the Lx one for its initial activity and the combination setting dr. Bonnie has summarized the initial activity seen and patients with gastric cancer and we have also presented initial activity and patients with first line had the next wave muscle car.
The Noma I'm actually see this year with three out of the first four patients having and objective response, including one confirmed response in combination with Keytruda and chemotherapy.
In the second line checkpoint naive head and neck population Weve also showing the 40% objective response rate well above the historical benchmarks and.
The similar population from keynote 40.
Together these results support our randomized phase two program in patients with first line checkpoint and naive disease and.
The waiting ale ex 148, and Pembrolizumab with and without chemotherapy. Our initial data in non Hodgkin's lymphoma with the 55% objective response rate is also compelling and this will be updated at ash and another month.
On Slide 33, you can see a timeline of our upcoming studies shown here with our Mds phase one study, having already initiated and updates from our gastric carcinoma and head and neck program that we presented on at Citi.
As well as non Hodgkin's lymphoma updates, which will be presented at ash in December of this year we.
We are still on track to initiate our phase two head and neck program and the first half of 2021, and our gastric and and all programs in the second half of 2021.
At the end of the year the phase one portion of the Mds study is anticipated to read out and we will then seamlessly move into the phase two portion of this program. So it's a busy year for Alex oncology, but with consistent anti cancer activity demonstrated and the solid tumor setting.
On the as well as the lymphoma setting I think we have an ambitious program to expand upon the signal.
In our phase two development.
Thanks Sophia.
Operator could you open up the line for questions.
[laughter].
As a reminder to ask the question you will need to press star one on your Touchtone telephone to withdraw your question press the pound key once again Thats star one and you touched on the telephone to ask the question. Please stand by while we compile the Q and a roster.
Our first question comes from the line of Michael Yee of Jefferies. Your question. Please.
Hi, Thank you very much I had two questions for the Doctor I'm. The maybe in the gastric you could talk a little bit about the idea that I believe a PD one pembro and also very potent there should maybe just talk a little bit about.
Where that the Chen I presume, that's first line and and and really your combination is really focused on the second line. So maybe just talk a little bit about the evolution of first and second line.
And and you are and your trial and how that fits and the to the future and then I guess for the company same question for head and neck, because as I understand PD, one calm, but you're also very potent and head and neck and first line shall I see the you're running two phase two studies, but maybe just talk a lot of it about how.
The one shakes up in head and neck, and how youre programs like that thank you.
Oh, the sees the dockets on skin.
And actually you on right.
At this time.
Well, the forthright and set up the all the POC and stuff kind of saw.
No profit cost net profit pembro being cascade <unk>, the forthright setting.
So yeah, you're right so actually.
And I see the need.
<unk>.
The ever use so you did take <unk> I guess.
The.
One of the breach and why I left so.
To go for the second line I see.
Yeah. The appeal, we do the yeah, yeah, and other thinks Dr., Bob and thanks for the question I'm absolutely agree I think the first line studies that are ongoing based off of very again, the compelling smaller studies.
Looking at Pembrolizumab in combination with tries to use the bad and that chemotherapy and the first line setting it'll be really interesting to see how those pan out over the course of the next several years, regardless and the second line setting.
I think that the.
The advantage of that Alex has the is Ah that we certainly are showing activity in patients who have already received prior tries to the mab therapy and the first line setting. So it's still I think is a very relevant population when they go on to progress and the first line into the second line.
And of our drug should still be active and and then in terms of development on Guy would be interesting given our synergies that we're seeing in combination with pembrolizumab in the head and neck side of our program and it'll be interesting to see what sort of future on Intel's four of our drug and moving up in line.
Therapy with gastric and so you know very I think of it.
Astute comment on.
In terms of the second question around I'm, the head and Adam.
And our plans and in head and neck, and so absolutely I mean, the data that weve shown that we should it succeed today Oh excuse me of earlier this week or so is the combination of both the second line setting and the first line setting.
On the second line setting was from the earlier point in time and from our trial when I Pembrolizumab was actually and not yet approved in the first line setting so the value of our second line head and neck of population and is really around the fact that those patients.
Who were checkpoint naive showed us that our drug in combination with Pembro was meaningful on in that sub population now when you look at where do the checkpoint naive patients reside they all reside in first line. So the current on.
Standards of care for head and neck and the first line setting on.
Our either Keytruda alone.
For Keytruda plus five of USIS plot, so our development plans and head and neck on add on to those two standards of care.
Yeah, and based off of the keynote 48 studies the will be initiating two phase two studies and the first line head and neck, Alex plus Pembro hail ex plus pembro five of the spot.
Right show and address the semis and gastric of PD, one and moving up but you're out of a very good line of sight as the.
And that quadruple combo and second line and head and neck Keytruda is there and do you have an opportunity to look at any combination the need to first line or second line up and ask that as that of all of the yeah with the exception that I think got pember lives and that in the second line setting well in head and neck will be.
Decreased didn't use because it's all the items right first line yeah. So that's one of the.
Yeah, you're doing on top of that on top of <unk> of chemo stuff. Okay. Thank you.
Thank you. Our next question comes on the line of Marty Oscar of Credit Suisse. Your line is open.
Hey, guys. Thanks for taking the question and and Oh, great job running through 33 slides on behalf of those those.
It was pretty fish and I was wondering could you guys frame the duration of response and you're seeing so far and gastric relative to what you'd kind of expect the seeds and stuck and third line standard of care and kind of how how meaningful this is going forward. Thanks.
So and and maybe I can start and then the Doctor Boeing if you want to and I'm.
I'm sure they will they'll be very interested in your opinion as well.
For the second line and gastric cancer on first off when we look at our data in combination with tries to the mab surrounds the and Paclitaxel, our media and follow up time has only been about five months so trying to understand.
And duration of response and that population, it's a little too early at this point in time.
But then Dr., Bob and I'm sure can speak to what one would expect in terms of the benchmarking there in the second line.
Gastric population, where our drug was only used as a doublet in combination with.
In combination with Herceptin and.
On the.
There we saw a median duration of response that was reported at it sits in 19 patients of 8.7 months.
But remember that this isn't a chemo free regimen.
And in patients who are second line or greater therapy, So, but dr., Bob do you want to maybe speak to the on what the benchmarks of duration of response would be out of range, though.
Yes, that's true actually.
The response rate <unk> was at all and.
28% and the second line.
And he's the best debt to response rate for the second line treatment of across the country. So and you know we're doing smart <unk> simple side. The small the response rate the C and D studies.
Obviously like the leap.
For some of the rights that are you on the we expect the.
We expect the response rate on <unk>.
And Paul said.
Kind of like to conclude can reach the man and as you know we've been lucky though.
And the Sunrise and the responsibilities and rest and 5% so.
No.
And and I do know in PD and one positive that's the kind of stuff. It's the southern line Pember reason that produced around the 16% the disciplined study the.
Sure.
64% and in the study quite the probably the.
And that's up here and they want the commenting that hit the Maxwell, sometimes especially on the phone.
[noise] right so for so far our head and neck population and in the in the first and the second line checkpoint naive population.
And when we looked at our drug in combination of.
And with Pembrolizumab on our median duration of response was about 4.3 months.
And Ah and when we look at our objective.
A response rate was about 40% on which compares very well.
With the standard of care keynote 40, and the second line checkpoint and <unk> population, where you're a objective response rate of somewhere around 15% and even in the first line setting when you combine with with the Pembro monotherapy, you're still on the looking at a response rate of about 17 on per se.
And so our second line data is compelling not only if you look at second line standards of care, but even as you look at first line monotherapy a temporal loosen up.
Great. Thanks for the answers.
Thank you and next question comes from Alethia Young the of Cantor. Your line is open.
Hey, guys. Thanks for taking my questions and congrats on Lake Congrats on the data its lets see I guess a couple from me one.
Can you just talk a little bit about your kind of and creates conviction as youve added more agents and combination and see relatively low rates and the name yet still and how that's differentiated and combination use versus other and I see the 47 and then I'm. Just also can you just talk a little bit about on the dose response at 10 and 15, Meg and then just give us a little bit flavor on the as I'm sure they'll you and.
And this evening just kind of you know why you thought they weren't interesting you know asset partner the from kind of the partner with the the still things.
Sure. So in terms of the in terms of the safety profile I think that at this point on whether we're looking at our drug as a single agent our drug in combination with a checkpoint inhibitor or in combination with anti cancer specific antibodies and even with the multi agent chemotherapy.
On the hour a safety profile has been rock solid. So we continue to have a single digit grade three and above talks and the and and have had no problems combining and this is with the flat dosing no need for priming no need for moving with flat dosing, we've had a very good safety profile.
And many of our patients actually the the and particularly on these the head and neck population, who have been on for quite some time Weve had patients who are now passing their two year mark of receiving our drive and which is just really wonderful with ongoing objective response from some of the earlier earlier cohort.
Particularly the doublet cohort for head and neck. So.
So this isn't the agent that it's important for its development so not only for the individual patients because yes, you can always transfuse the patient with some risk of talks but from a development standpoint. This is the drug that can be combined with the cytotoxic agent and the.
All tie, but multi agent regimens and so that's that's the one important point on.
In terms of the Designworks question.
So there.
Yes. The this is an exciting collaboration on where we will be combining with their second generation her to buy specific her to agent and one of the nice things about ale ex <unk> is that as long as that combination partner has an active F.C. than theirs.
The biologic rationale for EPS to be combining with sat down with that partner and using its anti cancer specific honing in on the direct that innate immune response to the cancer cell itself and in the presence of the myeloid checkpoint inhibitor aspect of CD 47, So it's a.
It's a really nice I think proof of principle that now that we have shown on this this encouraging data with with tries to the map.
And now we look at some second generation on her to agents and zone. It out and that is one of them and so we'll be looking at her two positive breast cancer, both high and low her to and Ah and the other non.
Breast her two positive of patient populations I don't know Ginny, if you want to say anything more.
Well John.
No I think the physically just cosic without a lot of.
Hi deal of five.
Spending.
Each one of these trials into new indications with new combinations that are now that the the tell on beat the today.
Because of some of you said with the second part and for combining with the absence of molecules and all the indications.
[music].
Yeah, and the other thing that I would add is that this is an opportunity for us to pursue breast cancer, where there's a high unmet medical need. So this was an opportunity for us to expand into new indications.
And then the 10, Meg and the 15 and the gastric and does the song.
Right. So in the 10, Meg and the 15th so for the it's a little harder to be able to I think suss out dose response, and the gastric because we only had three patients and the combination with chemotherapy on at the tent make per kid as opposed to the 11.
But from from the AFE well see from Yeah last year, when we get in the valuation in the non Hodgkin's lymphoma population and where we had a bit more in terms of numbers of patients and we were able to show that a numeric improvement.
In the objective responses. When we went from 10 makes particular week up to 15 makes particular week, suggesting that there could be a dose response of exposure response on analysis, we will be updating that data at ash coming up and I think it's very clear to us.
That the 15 make her keurig.
The two week exposure level is the way to go and Ah, that's and exposure that we will be applying programmatically, whether it's 30 every other week 45, Q3 weeks or 60, Q4 weeks and our Mds program and we'll be looking for that studies the exposure.
Levels that are associated with that type of the Baptists.
Great. Thank you.
Thank you. Our next question comes on Chris Raymond of Piper Sandler Your question. Please.
Thank you and just a couple of gastric questions, maybe first Sofia I just.
With respect to the the the quadruple therapy, what understanding of the better the the her two scoring the sweet.
Look at the.
That's a waterfall plot of looks like the you know you had about six I guess of 14 that were either not her two scored or words zero just can you confirm where those patients deemed her two positive at some point or what's the.
One of the threats that gets thrown into the into here to yeah. Yeah sure. So it's a little bit of a of a format and issue on the poster that we tried the correct with the flight deck associated with the with the Doctor Bongs discussion. So in the since the poster at the dashes for her to scoring I'm simply me and it was not.
And done so we have one patient who had a site determined excuse me and these are all centrally read excuse me. So had a on her to score that was centrally read the of zero on the others in terms of the archival samples that we of.
Okay and with this population I pretty much had her to scoring and again centrally read of the two plus or three plus on the dashes just meant that and in some cases, there was no archive of block available or archival block was available but that it was the insufficient for determining her to scoring.
From an eligibility standpoint on her to positivity was determined at the at the site level based on F.D.A. approved diagnostics and so it just so happens and this group in terms of the essentially review we had a few less.
Blocks to be able to reveal but all of these patients were considered her two positive from and eligibility standpoint based off of the site evaluation.
Okay, great. Thanks for that clarification, and and then maybe of for for Dr., Bob and I know you've had a few questions already on safety, but I guess, some as we were just sort of the eyeballing.
On the ceramic the label and gastric.
Yeah, and this is perhaps not apples to apples, but.
The experience. The you guys are reporting it looks like the safety is pretty much on par and in a quadruple therapy as say ramps of plus paclitaxel.
I guess a question for Dr. <unk> are you surprised by that or is that is that maybe your experience. Its it seems awfully up and I guess.
Yes.
Surely.
I think the it is consists of the read the mikes because the read the ramping got the kinds of so not so surprising to me and you know I I felt that actually execute the net add any sick and so on Pablo <unk> path and trust in the combination.
Good.
Thank you.
Good day.
Thank you again to ask the question. Please press star one and you touched on telephone. Our next question comes on the line of Adam ever It I'm, sorry, excuse me lifestyle of capital Your line is open.
Great and one for Dr., Bob on for the Air Whats going on for eight plus the trust to the map plus free on pack combination. In addition to the responders. There are a few patients with tumor reductions and stable disease, just curious how significant stable diseases and gastric cancer.
[laughter], yes.
We usually in general think debt if the is the long with density of all four months it is and medium for <unk>.
In general.
So the ratio of these import the.
[noise] God. This is Sofia all just I'm also add in for.
Some of these patients and I believe.
For a net.
Two of these patients with.
I had the best response of stable disease or actually on going and only had one one round of imaging. So to me, it's very encouraging that we're seeing tumor shrinkage and I think that's a hallmark of this drug that whether it's an objective response or disease control and we do see the.
See activity early even with the first round of imaging. So many of these patients go on to deepen and their response and so we're excited that the stable diseases or even shrinking and that they stay on the study we will continue to follow them.
Awesome and then real quick Sophia are you planning to enroll more patients and the cohort and maybe when could we see the durability of T.
Yes so.
See we have a few more patients that we are enrolling overall I believe weve already stated.
Externally that we anticipate about and 18 patients total and this and so you know definitely depending on how those the crew will be up providing additional updates on this over the course of next year as the as a phase one we can do that.
And what we we aren't intending at this point to enroll too many more patients into the gastric because we will be starting on phase two program.
By mid year, and and so you know in an effort to.
Yeah.
Conserve and patients and get the most information we can from this rare population you know, we don't want to be competing with ourselves for enrollment. So our phase two I'm looking at the same combination and the same pop in the same patient population slated to initiate and Didier.
Makes sense. Thanks, thanks for taking the questions.
Thank you and this time I'd like to turn the call back over to the XOMA ponds for any closing remarks Sir.
Thank you everyone.
Well, obviously the things high on behalf of the index team I would like to stand out with the appreciation to the of the bag for setting the effective today on the last couple of the eight.
The GAAP so.
Good day, and they say a you've got the you may now disconnect.
Ladies and.
And this concludes today's conference call you may disconnect your lines.
Thank you.
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