Q4 2022 Affimed NV Earnings Call
Speaker 1: Music
Speaker 2: to today's full year and fourth quarter earnings and business update conference call by AppeMed NV. As a reminder, all participants are in listen-only mode. A question and answer session will follow the formal presentation. Please note this conference call is being recorded. I would now like to hand the call over to your host for today.
Speaker 2: Alex Puducatis, Director of Investment Relations at App InMed. Please go ahead.
Speaker 3: Thank you, Livia, and thank you all for joining us today for our full year 2022 update call. Before we begin, I'd like to remind everyone that we issued the relevant press release earlier today, which can be found on the investor relations section of our website. On the call today, we have the members of our management team, including Adi Hirsch, carb wire central maintenance team, and our number of trustedulin us to do fact dates in the?", we have been shared the reason you all saw me in this video and be certain
Speaker 3: available for the Q&A session after the prepared remarks. Before we start, I'd like to remind you that today's presentation contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this call, except as required by law, we assume no obligation to update these...
Speaker 3: and actual results may differ materially from those expressed or implied in these statements due to various factors including but not limited to those identified under the section entitled risk factors in our filings with the SEC and those identified under the section entitled forward-looking statements in the press release.
Speaker 3: that we issued today and filed with the SEC. With that, I'll turn the call over to Ari. Ari?
Speaker 4: Thank you, Alex. Good day, everyone, and thank you for joining us for our 2022 year-end results and operational update call. I'd like to begin by reviewing the key highlights of 2022 during which we made exciting progress across all our pipelines.
Speaker 4: Let's jump to slide four of the presentation. And importantly, in 2022, we generated highly compelling results with AFM13 in combination with natural killer cells.
Speaker 4: We did sign a partnership with Ateiva now that gives us access to a commercially viable CoBlaT-derived natural killer cell and we advanced our other clinical programs, AFM24 and almost recently AFM28.
Speaker 4: From the data we reported, there are a number of key findings about our inner cell engagement.
Speaker 4: and their specific mode of action, which we believe are differentiating features versus other NK-s and engaged approaches, as well as engineered NK cells, including core NK.
Speaker 4: The unique mode of action of our innards and engagers generated from the ROC platform has always included the ability to unable Section 3 of Our
Speaker 4: to engage different innate immune effect results, such as NK cells and macrophages.
Speaker 4: And this effective engagement of the immune system has proven now to trigger an adaptive immune response.
leading to a full immune response during T-cell.
We believe that this feature is unique to our Inertel Engager.
At least I want to slide five. This differentiating feature of our entertaining agent molecules was demonstrated through our work in our ASM24 monotherapy study.
And since the last year, we presented data on ASM24 monotherapy.
showing this read-through to the adaptive immune system, the activation and migration of cytotoxic T-cells into the tumor.
We can further strengthen the full immune response through combinations with PD-1 or PD-L1 checkpoint inhibitors.
which allow now these T-cells to attack the tumors in the tumor cell.
The well established safety profile of our in-amp training gator molecule
enables these combinations to deliver additional clinically meaningful benefits to cancer patients that indeed remain underserved.
This potential success of this combination approach was most recently observed in our AFM24 combination study with abysmalizumab, where a gastric pain patient...
who had disfiguring skin lesions and failed to respond to any previous treatment, including a checkpoint inhibitor that has skin lesions nearly fully eliminated with a substantial reduction in her primary gut GI tumor.
Now let's jump to AFM 13. With the completion of our phase to be a redirect study, we demonstrated that AFM 13 has single agent efficacy.
and the safe and well-tolerable for patients.
Redirected each cell's good efficacy in a very difficult to treat patient population.
that currently only has very limited treatment options, in particular one relapse refractory.
As of the end of 2022, we have treated overall approximately 200 patients across all our AEM 13 programs and saw a very consistent and manageable safety profile.
Now, even though we saw a efficacy from monotherapy,
We made the decision to pursue the treatment based on the accumbation therapy of AFM13 with natriculazole. We made the decision to pursue the treatment based on the accumbation therapy of AFM13
The much stronger efficacy seen with this type of treatment
and the ability to address a much larger patient population led us to the decision to move forward with this combination.
Our commercial analysis.
as well as insights from Albracon A13 with Incaizels, strongly now suggests that we can deliver more benefit to CDSR depositors to inform our patients with this approach.
including Hodgkin lymphoma and T-cell lymphoma patients.
Tweaking patients with a combination therapy is expected to deliver better and more durable efficacy. It is the right thing to do for patients and it's also the most efficient use of company resources.
Now, let me jump to slide six, which shows you our priorities for 2020.
Thank you.
I will number one this year.
is the execution of the AFM 13 AB 101 Kennedy Development Plan.
We call the program AFM 13203.
We are looking forward to submitting the ID and getting this important study up and running.
We know from the data and our work with our partners at MD Anderson.
that the combination of AFM13 with NK cells can deliver meaningful therapy to patients with significant medical need.
Let me just give you an example. A patient that always comes to my mind is a young 54 year old woman.
Who was being sent to hospice after five lines of therapy that included combination chemo, brain toxin building and principle Pitt Dominic <expletive> ondidn e one antibody At wave
Now this patient had a complete response with the AFM13 NK zone combination. This is the type of patient outcome is why we come to work every. We believe our team as so.
as the key features that will allow for similar clear-making results.
as those with OBTMD endosom cell and very importantly meet critical commercial requirements.
Today, we can share with you the data Ateba has seen so far.
From the AB101 retuximab combination study, looks quite encouraging, particularly given that several patients are relapsed or refractory to prior cardiotherapy.
Akiva, expect to provide an update on this clinical trial later in the year.
Moving on to April 24.
We're generating data that will inform critical decisions on the future development path. As Andreas will discuss, we expect to have data from all three studies listed here.
This will allow us to analyze where we are seeing the most promising activity, thereby enabling our decision on where to focus for the investments.
Our third asset in clinical development is AFM28. Key activities for the monotherapy trial in Europe are underway with multiple CAAs in place. Transcending process inMI testing diet
4 approved sites and enrolment initiated at our lead site in Spain.
Our goal in the phase 1 study is to confirm the safety profile and understand potential phytotoxic activity.
Once we begin to understand the monotherapy profile, we intend to swiftly advance into a combination study with an NK zone, as we believe the science supports this approach as a compelling, differentiated therapy.
Now with that, let me turn the call over to Andreas, who will provide additional insights on our Carnegie pipeline.
Address.
Yeah, thank you Adi and a warm welcome to everybody on the phone.
It's my pleasure now to give you an overview of our three clinical programs and the progress we are making. Let's turn to AFM 13 and on slide 9, you can see that we are making progress in our AFM 13 program. We are making progress in our AFM 13 program.
As we show on slide 10.
at ASH in December 2022. We reported data from the phase 1-2 study of AFM13 combined with cold blood derived in K cells.
that we are conducting in collaboration with investigators at MD Anderson, in patients with relapsed and refractory CD30 positive lymphomas.
In the 35 patients are treated at the recommended phase two dose.
We saw a very high overall response rate of 94%
and a complete response rate of 71%.
Important, 31 out of the 35 patients that were treated at the recommended phase 2 dose were Hodgkin and former patients.
In this subgroup, the overall response rate was 97%.
and the complete response rate was 77%.
In the four non-hot skin lymphoma patients that were treated...
The anti-tumor activity was also encouraging with an overall response rate of 75%.
The anti-tumor activity was also encouraging with an overall response rate of 75% and a complete response rate of 25%.
Another important finding was that four patients with Hodgkin lymphoma in this cohort had been previously treated with CD30 targeting CAR T cell approaches and had either not responded or immediately relapsed after CAR T cells.
of the 24 patients treated as a recommended phase 2 dose.
and who had at least six months of follow-up at the data analysis.
remained in complete response for six months.
We, together with our colleagues from MD Anderson, expect to provide additional data from the University at a scientific conference towards the end of the year.
I think it is also important to put things into perspective. This study was done in a very heavily pre-treated patient population.
The median line of prior therapies that patients received prior to enrollment into the study was seven. The median line of prior therapies that patients received prior to enrollment into the study
In addition to chemotherapy, all patients had received ritoximab, Vidodine,
And all Hodgkin lymphoma patients had also been pretreated with PD-1-containing regimens.
A high proportion of patients, 78%, had also previously received a stem cell transplant.
Probably even more important than this extensive pretreatment are the individual patients' characteristics. Important to note that none of the patients treated in the study had shown a response to their most recent previous line of therapy.
indicating that the expected response rate that you could achieve in the specific patient population with available treatment is zero. The treatment was also very well tolerated in the larger patient population.
with minimal side effects beyond the expected myelosuppression that results from a lympho-depleting chemotherapy.
Important to note, no instances of cytokine release syndrome were observed.
No immune effector cell associated neurotoxicity and no graft versus host disease were encountered.
In summary, the data from the study demonstrate that the combination of AFM13 with national killer cells is highly effective and well tolerated for patients who have limited or no other treatment options.
This makes the next step in the development for us even more important, which is trying to bring the combination therapy to more patients in need. As Adi has already mentioned, the next step is now to initiate our AFM13203 trial.
in collaboration with Ateiva.
In this study, we will combine AFM13 with Artivas and K-cell product AB101. As previously reported, we have been closely working with FDA in the pre-IND process on the design of the study.
And here we can reiterate our guidance that we will submit an IND in the first half of this year and initiate the clinical study in the later course of this year. As you know, AB101 is an allogeneic cryopreserved, cold blood derived, and case of product, and it is already in clinical development.
This off-the-shelf product offers a consistent and high CD16A expression.
is produced at a GMP-grade manufacturing site with the right scale for larger clinical trials and future commercialization at a viable cost of good structures.
The new co-administered combination therapy of AFM13 with AB101 is designed to treat patients with relapsed refractory Hodgkin's lymphoma.
The planned study will also have a separate exploratory cohort to evaluate the combination in relapsed refractory CD30 positive non-Hodgkin lymphomas.
Let's switch to the AFM13 monotherapy study, our redirect trial.
As we announced last week, we will present detailed data from this study in an oral presentation at AACR 2023.
At our company event during ASH, we already presented top-line data showing that AFM13 is active as a single agent in pretreated patients with peripheral T cell lymphomas and is well tolerated.
Now we look forward to share more information from this study with the scientific community.
Let's now move to IESM 24. As you will see on slide 11, we have made progress with our solid tumor ICE candidates.
Important to note, we expect to report data from all three AFM24 studies at scientific conferences in the second or third quarter of 2023.
For the monotherapy study AFM24-101,
The company expects to present data from approximately 15 patients.
from the non-small cell lung cancer and the colorectal cancer cohort.
In the Phase 1 to A Combination Study of AFM24 with the NTPDL1 Checkpoint Inhibitor Atisodizumab,
And from the AFM24 combination study with autologous adk cells.
The company expects to report data from the dose escalation phases of Pulsadis.
In the AFM24 monotherapy trial, we are continuing to enroll patients in the expansion phase at the recommended phase 2 dose of 480 mg weekly.
As you know, these expansion cohorts include patients with renal cell carcinoma, non-small lung cancers who are ETF are mutant.
and a colorectal cancer, KRAS-Y type. New qualitative science data that we published at CITSE last year demonstrate that AFM24 effectively activates the innate immune system and also triggers the adaptive immune system in the periphery and in the tumor.
NK cells and cytotoxic T cells increased in biopsies of AFM24 treated patients.
who received doses of 160 milligrams and above.
indicating that cytotoxic cell function of both MK cells and T cells are increasing.
We believe this finding provides strong evidence for the cross activation of the adaptive immune system as an additional mechanism of action of our innate cell engagers.
We believe that this data strongly supports the combination of checkpoint inhibitors as we are doing with IFM24-102.
On slide 12...
We are showing the initial data from the study as presented at CITSI last year. Here we show gastric cancer patients that have already been pretreated with pembrolizumab and chemotherapy combination in first line.
followed by three lines of various chemotherapies before being included in the study. This patient showed a partial response, including noticeable reductions of the skin metastasis, which had not responded to any of the prior treatment lines.
It's important to note that this patient had a short lasting response with previous treatment of a combination of chemotherapy and PD-1.
which was followed by progression while still receiving PD-1.
and thus it represents a patient in whom a response to PD-1 week challenge is very unlikely. The second patient in the study, a patient with pancreatic adenocarcinoma exhibited clinically meaningful stable disease on the combination of IFM24 with Atesolizumab.
with SNK01. The ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech.
both given weekly to patients with non-small cell lung cancer.
Disclaim the Cercosinomorphs, the head and neck, and colorectal cancer.
In this study, we are currently confirming the recommended phase 2 dose of 480 mg on three additional patients.
Now let's move to ASM 28. And on slide 13, we show the progress of this ACE designed to bring a new immunotherapeutic approach to patients with CD 123 positive myeloid malignancies. And then we show the progress of the new immunotherapeutic approach to patients with CD 123 positive myeloid malignancies.
including AML and myelodysplastic syndrome.
AFN28 engages cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity, even at low CD123 expression levels.
Given the aggressive nature of the disease and need for viable treatment options, we are working hard to bring this treatment option to refractory and relapsed AML patients as quickly as possible.
As a reminder, the most recent poster presented at F2022 showed that AFM28 induces NK cell-mediated lysis of CD123-positive tumor cells with high efficiency and potency.
ADCC activity in vivo was not affected by high mutational status or low 123 expression.
And in contrast to Fc-enhanced monocline antibodies, activity is also unaffected by CD64 expression.
AFM28 demonstrates that ex vivo AML and MDS patients bone marrow samples efficiently can be depleted of both 123 positive leukemic cells and importantly also of leukemic stem cells. And ASM24 has exhibitedhh
for patient enrollment now. With this, I will turn over the call to Angus to update you on our quarterly financial numbers.
With this, I will turn over the call to Angus to update you on our quarterly financial numbers. Angus, please. Hi, everyone.
Thank you, Andreas. Balance sheet and income statement highlights are shown on slides 15 and 16 of the presentation.
APIMEDS consolidated financial statements have been prepared in accordance with IFRS issued by the International Accounting Standard Board or IASB.
The consolidated financial statements are prepared in euros, which is the company's functional and presentation currency. Therefore, all financials that I will present in the call today, unless otherwise noted, will be in euros. We ended 2022 with cash and cash equivalents of 190.3 million euros compared to 197.6 million euros on December 31st, 2021.
Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into 2025. Net cash used in operating activities for the year ended December 31, 2022 with 104.9 million euros compared to 86.6 million euros in 2021.
So, revenue for the year ended December 31st, 2022 was 41.4M euros. Compared with 40.4M euros for the year ended December 31st. 2021 sound bites
As a reminder, revenue predominantly relates to the Genentech and ROYVANT collaborations.
Research and development expenses for 2022 increased by 21% from 81.5 million euros in 2021 to 98.8 million euros in 2022.
The increase was primarily driven by higher expenses associated with the development of AFM 24 and AFM 28, a result of an increase in manufacturing of clinical trial material and costs for the preparation of the filing of an IND application, an increase in costs associated with other early programs and infrastructure, and an increase in share-based payments.
General and administrative expenses increased 32% from €24.2 million in 2021 to €32.1 million in 2022. The increase predominantly relates to higher personnel and share-based payment expenses and an increase in insurance premiums and higher consulting costs. Net finance income for the year decreased from €6.5 million to €7.5 million in 2021 to €7.5 million in 2021. The increase in insurance premiums increased from €7.5 million to €7.5 million in 2021 to €7.5 million in 2021. Net finance income for the year decreased from €7.5 million to €7.5 million in
2022 was 86 million euros or 60 cents per common share, compared with a loss of 57.5 million euros or 48 cents per common share for the year ended December 31st, 2021. The weighted number of common shares outstanding for the year ended December 31st, 2022 was 142.4 million.
Finally, we encourage shareholders to also review our 20 filing for the year, which will be filed with the later today.
I will now turn the call back to Adi for closing remarks. Adi.
Thanks Angus. Yeah, thanks Angus. Thank you for making progress across all our pipeline projects.
And I believe we are putting the right pieces in place for a series of milestones now during 2023 and even beyond.
Our part is further enhanced through the initiation of the phase 1 study of AFIN28 in AML, more education, transparency and Eachnar Jacobsen and for more depth talk, we look forward
We continue to make progress with our ongoing partnerships. In the case of Genentech, we have handed over several programs to them for further pre-genity development.
Now, a second collaboration, AfriOne Sciences, a Royal company, submitted two pertangiologists abstracts which have been accepted for poster presentation at the ASDR Annual Meeting this year.
Appybandt expects there's a bit 90 for ADT 2101, formerly AECM 32, in the first half of 2020.
With this, I'd like to thank you for all your continued support for the patients and their families and for our employees in the US and Europe . We're passionately dedicated to our efforts to bring life-saving medications to cancer patients.
We're now ready to take your questions. Thank you. Thank you, Rachel.
Thank you. Ladies and gentlemen, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced.
To withdraw your question, press star 1-1 again. Please send by while we compile the Q&A roster.
And our first question coming from the line of Taina great push from SBB security. The line is open
Hi, guys. Thank you for the question. I have a couple-part question on the ASM24 data. You say, first one on the timing, you say 2.2 or 2.3. Is that because you're submitting abstracts already, you have data in hand, and it's a matter of which conference, but you're still gathering data and haven't used that?
in lung cancer all presumably will be post an EGFR TKI. Will they, should we also expect them to have been exposed to amivansimab for instance, and for CRC exposed to cetuximab? Thank you very much.
Thanks, Dana. I'll hand over to Andreas. Andreas, can you take the question?
Yeah, sure. Hi Dana. So let's start first with the timing and you're absolutely right.
We are targeting a couple of conferences in the second third quarter of 2023. For some of those we have submitted abstracts, for some of those we will be submitting abstracts with updated data.
Now we are waiting for feedback from these conferences.
Important to note, at the time of the conference we will always provide the most updated
that probably will include more patients or longer follow-ups than even reported in the abstract.
So this explains a little bit why we have this guidance Q2, Q3.
Now, in terms of patient populations, specifically for the 101 study,
Let's start with colorectal. For this specific colorectal cohort we expect that patients will have in the majority
two to three lines of chemotherapy, at least two lines of chemotherapy. They will all have been exposed to the standard drugs like Afloroperamidine, Oxalipletin, Irenotecum, and in various permutations. They can have additional drugs and they will all be also be exposed to Erbitex.
or another eGFR targeting medication. In terms of our non-small cell lung cancer cohort, again, this is restricted to patients with activating eGFR mutations.
The requirement here is that all patients have exhausted targeting therapy. So this could either be the Ozymertinib as a starting therapy or a sequence of a first or second generation TKI followed by Ozymertinib. Patients can have also additional chemotherapy on top of CT-TI.
But this is not an absolute requirement, so we probably have a mixed population of patients who have exhausted all TKI options and also some patients who have TKI and chemotherapy and then go on the trial. And you know if there's amabantamabic...
Great. Thank you.
Thank you. One moment before next question.
And our next question coming from the line up, Zikripa Devapakonda from Truis, your line is open.
Hey guys, thank you so much for taking my questions.
I've got a couple of questions on AFM 13. So for the CONVOS study, I think you said in a recent investor call that you expect to find IND in the first half and start treating patients in the second half. Can you help frame timelines for, you know, from IND acceptance to when you will start treating patients?
what sort of work you can do in terms of getting sites up and running before the IND acceptance.
you can do in terms of getting sites up and running before the IND acceptance.
And then for ASM24, you have both, with ASM14 you have a partnership with
cord leg derived cells and then with FM24 you have autologous based on the IND process that you are going through with both of them.
Do you see one being easier than the other? Maybe it's too early, but just wondering if you have any thought process into that going out into the future. Thank you. Yeah, let's start with 24 first. Andreas, can you go ahead with the 24 answer? And then we'll jump back to the regulatory question.
Yeah, okay, for 24, I tried to remember all the different aspects. So, one question was relating to the different NK cell sources, right? So, whether autologous or allogeneic NK cells are more or less difficult. So, one question was relating to the different aspects.
We cannot finally say it because before AFN24 and the NKGen autologous cells, obviously, we have completed our IND process and already have an open study. I can say that FDA was extremely collaborative on this IND.
And, yeah, so this was a rather smooth process. Again, also for the allogeneic process with AFM30, we have very collaborative interactions with FDA. We have not completed the R&D process yet, so it's hard to compare these two processes.
But again, the attitude and the discussions with FDA have been very constructive in those cases. Fantastic. And now your second part of the question was? Yes, I'm 13. So once you have the IND acceptance, I was just wondering how long it would take for you to start treating your first patient and what work you can do to help them.
FDA. Now we are already looking to feasibility studies at sites. We have identified our primary lead investigator. We are now working with key opinion leaders in the field to smooth the setup process of sites as good as we can. We have identified
or CRO that will support us in our study conduct.
But again, final timelines can only be given after we have a final protocol.
Thank you so much for getting the question. Thank you. And our next question coming from the line up, Mari Raycroft with Jeffrey, is now open.
Hi, thanks for taking my questions. I was going to ask one on the AFM 13 combo as well. Wondering when you plan to update the street on additional trial design details and what are your latest thoughts on what the FDA wants in terms of bridging or dose lead-in for the AV1.
We have a good understanding, a very good understanding how that should look like. I think in the past we have said that we intend to give the NK cell in combination with AFM13 as a weak installment over roughly three weeks and then we follow...
with three weekly doses of AFM 13, or this is procedure for lympho depletion. And then roughly after eight weeks of basic care from start of treatment, you've got to do your re-spaging and then you include a short break before you go to the second part and third part.
So in general, we have already explained what the study design is going to look like. So based on the feedback with FDA, we have made the respective adaptations.
And as soon as we have the final I&T, we can update you on the further details.
And as soon as we have the final INT, we can update you on the further details. I hope this helps.
Yes, that's helpful. I also wanted to ask about the monotherapy AFM24 update. For the approximate 15 patients in CRC, non-small cell lung cancer, what's the internal bar for success there in terms of a go or no-go decision? Will that decision be made in the second quarter or third quarter update?
I'll hand over to Andrea.
As you know, clinical data always have multiple aspects. So we have some ideas about response rates that we want to see. We also have some ideas about the duration of responses we want to see.
We have not communicated those and it will always be a composite of these two parameters in addition to patient characteristics, how refractory are these patients, what's the pre-treatment pattern. You will hear a lot about this, but you need one you mean so far.
Our intention clearly is to make go-no-go decisions based on this data. As this data is maturing, we will have better discussions or more detailed guidance once we have disclosed this data. Okay, that makes sense. Thanks for taking my question. Thank you.
And our next question coming from the line up. Lee Watsak from Cancer. Your line is open. Hey, thank you for your questions. Maybe with just one on AFM13, maybe clarify if you had additional interactions with FDA regarding your R&D.
filing since your pre-antibate meeting and what are the remaining steps that you have to go through to have it filed.
Volkan, you want to take this question? Yes, I can take that question. Thank you. So first of all, we had the pre-IND right which we got feedback early in January . And because of constructive feedback, we had one or two clarifying questions.
for the FDA and we got responses. And with this constructive feedback, we are currently working on the documents to submit the IND, as we said in the first half of this year. And as Andreas already mentioned before, the feedback has been very positive and constructive.
So we're looking into and we didn't see any roadblock and now we are preparing to submit. Okay and then maybe a question on AFM 28. Since now you have been declaring for European countries and have been rolling you know...
here.
Andathy Tool backstory
Yes, we said we have CTA clearance. The study is open for enrollment, so we are just starting enrollment. Of course, we cannot.
say anything about what we have seen so far. And then we have not given clear or detailed guidance about the data releases. This will come once we see the initial enrollment of these patients.
anything about what we have seen so far. And then we have not given clear or detailed guidance about the data releases. This will come once we see the initial enrollment of these patients. Okay, thank you.
Thank you one moment please for our next question. And our next question coming from the line of yellow Jen from laid love your line of self in.
Good morning and thank you for taking the question.
Again, on AFM 13203 study, just like to know what, how many sites you are planning at this time, and what would be the overall goal in terms of just bridging the earlier study.
or you anticipate more in terms of potential status, for example, phases of the study, whether that will lead into a more advanced trials. And then they have a follow up, thanks.
Wolfgang, do you want to take that? Yeah, I can take that. Thank you. So number of sites, we are working with the general sites. I do not have the exact number on top of my head. But it's about 12 to 15, if I recall that correctly.
And the objective of our trial is to confirm what we have seen in the MD Anderson trial. This is, we are convinced and we see that the AV101 cell is a good cell which works very well with AFM13. We have seen that in all our preclinical studies demonstrating that.
is to confirm what we have seen with MDM. OK, great. Maybe the follow-up here is that in terms of AFM-1D8, and you're prepared to say may indicate that subsequently you will use added to a NK combo study. I'm just curious in this case, would that be
AB 101 or you have other options or has not been determined. And thanks. Yeah, exactly. So we have not announced it, let's put it this way. And in the moment where following how 1820 is doing at 28 is now performing.
Thank you. And our next question coming from the line up.
Brad Canino from Stiefel, Jelena Felpen. Hey, this is Bijan, welcome to Brad Canino. Thanks for taking our question. For the ASM24 combination studies, how many patients should we expect to see in the upcoming data, and will there be enough efficacy for us to determine the contribution of parts?
This is a John or practically no thanks for taking our question for the ASM 24 combination studies. How many patients should we expect to see in the upcoming data? And will there be enough efficacy for us to determine the contribution of parts? And if so, how many patients should we expect to see in the upcoming data?
As we said, the focus for the two combination studies will mainly be on...
safety and the definition of the individual recommended doses that we are using in these combinations. dying
For 102, the combination study with Atisolizumab, we have recently opened expansion cohorts.
So we will see some patients, but again, the frequency data to expect it more towards the end of the year or early next year. So we will see some focus here.
on recommended phase 2 dose, same probably for 103. Got you. That's clear. Okay, thanks. And then one on AFM13. What should we learn to expect from the AHR presentation that could be helpful for the NK cell combo study? Okay, no joke.
You mean the AFM13 monocerapeutic?
study that we are discussing in detail. This will be mainly detailed description of the activity of monotherapy of AFM13 in PTCL.
looking at the safety profile, looking at activity in individual subgroups, providing further data in terms of follow-up.
I think there is.
there is not.
very much to learn for the specific combination study. As you know, the primary target population of the combination study is Hodgkin's lymphoma, where we intend to generate through the 203 study a dataset that would be able to support an accelerated approval.
Now the data that we showed at ASCO will be on PTCL, peripheral T cell lymphomas, with different...
Here we also have an exploratory cohort in our 203 study, which will provide us further guidance on the next steps with NK cells and AF-inserting also on PTCL. Andreas, you said AF-s, but you meant AACR. So the presentation on AF-inserting monotherapy will be at AACR.
Sorry, ACR of course. Thank you.
Thank you. One moment please for our next question.
And our next question coming from the line up. So I am Pakhula Ramakhan from AC Wind Radio Line is open. Thank you. Adi, I apologize. Another question on AFM 13. This is on the 203 program. Just trying to understand the rationale behind
CD13 positive, the Exploretic cohort, which you're looking at, CD13 positive relapsed refractory NHL.
Yeah, so, yeah, this study is open for CD30 positive lymphomas, as was the MD Anderson study. It basically has two parts. So the larger part…
and where we are focusing on our registration intent is for patients with Hodgkin lymphoma. I think here the MD-endosome data have provided clear proof of concepts. As Arund and others have elucidated, we believe that the AB101 cell has the activity and the type of
of biology that should enable us to replicate these data with a very high response rate, was a good duration of responses. So this is the main part of the study.
As we have also shown, we have seen good responses also in non-Hodgkin lymphoma in the MD-ANDA study. However, this is only four patients so far. So, the 203 study has a separate cohort that enrolls peripheral T cell lymphoma patients, tries to or is looking for…
The response rate also in peripheral T cell lymphoma patients. And once we have seen this data, we will have a further decision how to proceed also in peripheral T cell lymphoma. Based on the limited data that we have seen in these four patients at MD Anderson, we believe that also peripheral T cell lymphoma is an indication that will benefit from the combination of NK cells and AFM13.
Thank you very much, Andres. Thank you. I'm showing no additional questions at this time. I'll turn back to the speakers if there's any closing remarks. Thank you.
Thank you very much for listening in. This finishes our year-end update call of the year 2022. And as we've just mentioned, we have a lot of milestones coming up, in particular for AIM 13 with initiation of the registration directed study based on a filing.
and feedback from FDA are putting to come soon. And then we have AFM24 with multiple data readouts starting in Q2, but basically going into Q3 and Q4 this year and last but not least, AFM28 is open for recruitment.
So again, that should lead to a pull from initial data that will keep you updated as usual, at least on the earnings calls. And we will also move forward when we have some reasonable data to submit further abstract. With that, I conclude the call and thank you for listening in.
Ladies and gentlemen, that's all for today. Thank you for your participation. You may now disconnect.
you
Subjected scenario