Affimed - Q4 2022
March 23, 2023
Transcript
Operator (participant)
Good day, ladies and gentlemen. Thank you for standing by. Welcome to today's Full Year and Fourth Quarter Earnings and Business Update Conference Call by Affimed N.V. 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, Alex Fudukidis, Director of Investor Relations at Affimed. Please go ahead.
Alex Fudukidis (Director and Head of Investor Relations)
Thank you, Olivia, 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 Hoess, our Chief Executive Officer, Andreas Harstrick, our Chief Medical Officer, Arndt Schottelius, our Chief Scientific Officer, Wolfgang Fischer, our Chief Operating Officer, Denise Mueller, our Chief Business Officer, and Angus Smith, our Chief Financial Officer. The team will be 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 forward-looking statements publicly or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statement, even if new information becomes available in the future. These forward-looking statements are subject to risks and uncertainties, 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 that we issued today and filed with the SEC. With that, I'll turn the call over to Adi. Adi?
Adi Hoess (CEO)
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 pipeline. Let's jump to slide four of the presentation. Importantly, in 2022, we generated highly compelling results with AFM13 in combination with natural killer cells. We did sign a partnership with Artiva now that gives us access to a commercially viable co-product, the right natural killer cell, and we advanced our other clinical programs, AFM24, and now most recently AFM28.
From the data we reported, there are a number of key findings about our innate cell engagers and their specific mode of action, which we believe are differentiating features versus other NK and engager approaches, as well as engineered NK cells, including CAR-NK. The unique mode of action of our innate cell engagers generated from the ROCK platform has always included the ability to engage different innate immune effector cells such as NK cells and macrophages. This effective engagement of the innate immune system has proven now to trigger an adaptive immune response, leading to a full immune response during T-cells. We believe that this feature is unique to our innate cell engager. As we show on slide five, this differentiating feature of our innate cell engager molecules was demonstrated through our work in our AFM24 monotherapy study.
Since the last year, we presented data on AFM24 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 inhibitor, which allow now these T-cells to attack the tumors in the tumor zone. The well-established safety profile of our innate cell engager molecule enables these combinations to deliver additional clinically meaningful benefit to cancer patients that indeed remain underserved. This potential success of this combination approach was most recently observed in our AFM24 combination study with atezolizumab, where a gastric pain patient who had disfiguring skin lesions and failed to respond to any previous treatment, including a checkpoint inhibitor, had her skin lesions nearly fully eliminated with a substantial reduction in her primary gut GI tumor. Let's jump to AFM13.
With the completion of our phase II-B REDIRECT study, we demonstrated that AFM13 has single agent efficacy and the phase and well tolerable for patients. REDIRECT each showed good efficacy in a very difficult to treat patient population that currently only has very limited treatment options, in particular, once relapse refractory. As of the end of 2022, we have treated overall approximately 200 patients across all our AFM13 programs and saw a very consistent and manageable safety profile. Now, even though we saw efficacy for monotherapy, we made the decision to pursue the treatment based on the combination therapy of AFM13 with natural killer cells. 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 our work on AFM13 with NK cells, strongly now suggests that we can deliver more benefit to CD30-positive lymphoma patients with this approach, including Hodgkin lymphoma and T-cell lymphoma patients. Treating 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. Let me jump to slide six, which shows here our priorities for 2022. Our number one this year is the execution of the AFM13 AB-101 clinical development plan. We call the program AFM13-203. We're looking forward to submitting the IND 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 50, 54-year-old woman who was being sent to hospice after five lines of therapy that included combination chemo, brentuximab vedotin, and an anti-PD-1 antibody. This patient had a complete response with the AFM13 NK cell combination. This is the type of patient outcome is why we come to work every day. We believe Artiva's cells has the key features that will allow for similar clinical results as those we saw with the MD Anderson cell, and very importantly, meet critical commercial requirements.
Today, we can share with you that the data Artiva has seen so far from the AB-101 rituximab combination study looks quite encouraging, particularly given that several patients are relapsed or refractory to prior CAR-T therapy. Artiva expects to provide an update on this clinical trial later in the year. Moving on to AFM24. 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 this year. This will allow us to analyze where we are seeing the most promising activity, thereby enabling our decision on where to focus further investments. Our third asset in clinical development is AFM28. Key activities for the monotherapy trial in Europe are underway with multiple CTAs in place. Four approved sites and enrollment initiated at our lead site in Spain.
Our goal in the phase I study is to confirm the safety profile and understand potential cytotoxic activity. Once we begin to understand the monotherapy profile, we intend to swiftly advance into a combination study with an NK cell, as we believe the science supports this approach as a compelling differentiated therapy. With that, let me turn the call over to Andreas, who will provide additional insight on our clinical pipeline. Andreas?
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Thank you, Adi, warm welcome to everybody on the call. 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 AFM13, on slide nine, you can see that we are making progress in our AFM13 program. As we show on slide 10, at ASH in December 2022, we reported data from the phase I/II study of AFM13 combined with cord blood-derived NK 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 treated at the recommended phase II 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 II dose were Hodgkin lymphoma patients. In this subgroup, the overall response rate was 97%, and the complete response rate was 77%. In the four non-Hodgkin lymphoma patients that were treated, the antitumor 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. In this cohort of four patients, all four patients also achieved a complete response. We are also encouraged by the durability of the responses observed so far.
Specifically, 63% of the 24 patients treated as a recommended phase II 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 study at a scientific conference towards the end of the year. 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. In addition to chemotherapy, all patients had received brentuximab vedotin, and all Hodgkin lymphoma patients had also been pre-treated 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 pre-treatment are the individual patient's 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 this 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 lymphodepleting 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 natural 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 AFM13-203 trial in collaboration with Artiva. In this study, we will combine AFM13 with Artiva's NK cell product AB-101. As previously reported, we have been closely working with FDA in the pre-IND process on the design of this study, and here we can reiterate our guidance that we will submit an IND in first half of this year and initiate the clinical study in the later course of this year. As you know, AB-101 is an allogeneic cryopreserved cord blood-derived NK cell 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 goods structures. The new co-administered combination therapy of AFM13 with AB101 is designed to treat patients with relapsed refractory Hodgkin 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 pre-treated patients with peripheral T-cell lymphomas and is well-tolerated.
We look forward to share more information from this study with the scientific community. Let's now move to AFM24. As you will see on slide 11, we have made progress with our solid tumor ICE candidate. 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 I-A to phase I/II-A combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab. From the AFM24 combination study with autologous NK cells.
The company expects to report data from the dose escalation phases of both studies. In the AFM24 monotherapy trial, we are continuing to enroll patients in the expansion phase at the recommended phase II dose of 480 mg weekly. As you know, these expansion cohorts includes patients with renal cell carcinoma, non-small cell lung cancers who are EGFR mutant and colorectal cancer KRAS wild type. New qualitative science data that we published at SITC 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. We believe this is a significant new finding as we are observing the activation of cytotoxic T-cells in the periphery and in tumor biopsies, pointing to the activation of the adaptive immune system in addition to engagement of NK cells and macrophages.
NK cells and cytotoxic T-cells increased in biopsies of AFM24-treated patients who received doses of 160 mg and above, indicating that cytotoxic T-cell function of both NK 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 with checkpoint inhibitors, as we are doing with AFM24-102. On slide 12, we are shown the initial data from the study that's presented at SITC last year. Here we show a gastric cancer patients that had 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, that was followed by progression while still receiving PD-1. Thus, it represents a patient in whom a response to PD-1 re-challenge is very unlikely. The second patient in the study, a patient with pancreatic adenocarcinoma, exhibited clinically meaningful stable disease on the combination of AFM24 with atezolizumab after showing progression on three different chemotherapy regimens prior of being enrolled into the AFM24-102 study. The second combination of AFM24 is investigating the combination of AFM24 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, squamous cell carcinoma of the head and neck, and colorectal cancer. In this study, we are currently confirming the recommended phase II dose of 480 mg on three additional patients. Let's move to AFM28, and on slide 13, we show the progress of this ICE designed to bring a new immunotherapeutic approach to patients with CD123 positive myeloid malignancies, including AML and myelodysplastic syndrome. AFM28 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 ASH 2022 showed that AFM28 induces NK cell-mediated lysis of CD123 positive tumor cells with high efficiency and potency. ADCC activity in vitro was not affected by high mutational status or low 123 expression. In contrast to FC enhanced monoclonal antibodies, activity is also unaffected by CD64 expression. AFM24 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. AFM24 has exhibited potent antitumor activity in murine AML models. In the meantime, we have received clinical trial application approvals in four European countries, including Belgium, France, Denmark, and Spain. As Adi mentioned, the study is open for patient enrollment now.
With this, I will turn over the call to Angus to update you on our quarterly financial numbers. Angus, please.
Angus Smith (CFO)
Thank you, Andreas. Balance sheet and income statement highlights are shown on slides 15 and 16 of the presentation. Affimed's consolidated financial statements have been prepared in accordance with IFRS, as issued by the International Accounting Standards Board or IASB. The consolidated financial statements are prepared in euros, which is the company's functional and presentation currency. 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 EUR 190.3 million compared to EUR 197.6 million 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 31st, 2022 was EUR 104.9 million compared to EUR 86.6 million in 2021. Total revenue for the year ended December 31st, 2022 was EUR 41.4 million, compared with EUR 40.4 million for the year ended December 31st, 2021. As a reminder, revenue predominantly relates to the Genentech and Roivant collaborations. Research and development expenses for 2022 increased by 21% from EUR 81.5 million in 2021 to EUR 98.8 million in 2022.
The increase was primarily driven by higher expenses associated with the development of AFM24 and AFM28, 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 EUR 24.2 million in 2021 to EUR 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 EUR 6.5 million for 2021 to EUR 2.1 million in 2022.
Net finance income is largely due to foreign exchange gains related to assets denominated in US dollars as a result of currency fluctuations between the U.S. dollar and the euro during the year. Net loss for the year ended December 31st, 2022, was EUR 86 million or EUR 0.60 per common share, compared with a loss of EUR 57.5 million or EUR 0.48 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. We encourage shareholders to also review our 20-F filing for the year, which will be filed with the SEC later today. I will now turn the call back to Adi for closing remarks. Adi?
Adi Hoess (CEO)
Yeah. Thanks, Angus. As you've heard, we make progress across all our pipeline projects, and I believe we're putting the right pieces in place for a series of milestones, now during 2023 and even beyond. Our pipeline is further enhanced through the initiation of the phase I study of AFM28 in AML. More to come. 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-clinical development. A second collaboration, Affivant Sciences, a Roivant company, submitted two pre-clinical abstracts, which have been accepted for poster presentation at the AACR Annual Meeting this year. Affivant expects to submit an IND for AVT-2101, formerly AFM32, in the first half of 2023.
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 U.S. and Europe who are passionately dedicated to our efforts to bring life-saving medications to cancer patients. We're now ready to take your questions. Thank you. Operator?
Operator (participant)
Thank you. Ladies and gentlemen, to ask a question, you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, press star one one again. Please stand by while we compile the Q&A roster. Our first question coming from the line of Daina Graybosch from SVB Securities, your line is open.
Daina Graybosch (Managing Director and Senior Biotechnology Analyst)
Hi, guys. Thank you for the question. I have a couple-part question on the AFM24 data. First one on the timing. You say Q2 or Q3. Is that because, you know, you're submitting abstracts already, you have data in-hand, and it's a matter of which conference, or you're still gathering data and haven't decided which conference to submit to yet? The second question, also on AFM24. I wonder if you could give us some context of the type of patients to expect in the lung cancer and CRC monotherapy cohorts. For instance, in lung cancer, all presumably will be post an EGFR TKI. Should we also expect them to have been exposed to amivantamab, for instance, and for CRC exposed to cetuximab? Thank you very much.
Adi Hoess (CEO)
Yeah. Thanks, Daina. I'll hand over to Andreas. Andreas, can you take the questions?
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Yeah, sure. Hi, Daina. Let's start first with the timing, and you're absolutely right. We are targeting a couple of conferences in the second quarter of 2023. For some of those, we have submitted abstracts. For some of those, we will be submitting abstracts with updated data. And now we are, yeah, waiting feedback from these conferences. Important to note, at the time of the conference, we will always provide the most updated data that probably will include more patients on longer follow-ups than even reported in the abstracts. This explains a little bit why we have this guidance Q2, Q3. In terms of patient populations, specifically for the 101 study, let's start with colorectal cancer.
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 fluoropyrimidine, oxaliplatin, irinotecan in various permutations. They can have additional drugs, and they will all also be exposed to Erbitux 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 an osimertinib as a starting therapy or a sequence of a first, second generation TKI followed by osimertinib.
Patients can have also additional chemotherapy on top of TKI treatment. This is not an absolute requirement. 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.
Daina Graybosch (Managing Director and Senior Biotechnology Analyst)
Do you know if there's amivantamab exposure in the cohort?
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
We have not specifically looked for that yet. It would be permittable to have it, but it was not a requirement prior to going onto this trial.
Daina Graybosch (Managing Director and Senior Biotechnology Analyst)
Great. Thank you.
Operator (participant)
Thank you. One moment please for our next question. Our next question coming from the line of Srikripa Devarakonda from Truist your line is open.
Srikripa Devarakonda (VP of Biotechnology Equity Research)
Hey, guys. Thank you so much for taking my question. A couple of questions on AFM13. For the combo study, I think you said on a recent investor call that you expect to file IND in first half and start treating patients in second half. Can you help frame timeline for 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? For AFM24, you have both, or with AFM13, you have a partnership with cord blood-derived cells, and then with AFM24, you have autologous. Based on the IND process that you've going through with both of them, do you see one being easier than the other?
Maybe it's too early, but just was wondering if you have any thought process into that going out into the future. Thank you.
Adi Hoess (CEO)
Let's start with 24 first. Andreas, can you go with the 24 answer, and then we'll jump back to the regulatory question.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Yeah. Okay, for 24, I try to remember all the different aspects. One question was relating to the different NK cell sources, right?
Srikripa Devarakonda (VP of Biotechnology Equity Research)
Yes.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Whether autologous or allogeneic NK cells are more or less difficult. We cannot finally say because for AFM24 and the NKGen autologous cells, obviously we have completed our IND process, already have an open study. I can say that FDA was extremely collaborative on this IND. Yeah, this was a rather smooth process. Again, also for the allogeneic process with AFM13, we have very collaborative interactions with FDA. We have not completed the IND process yet, it's hard to compare these two processes. Again, the attitude and the discussions with FDA have been very constructive in both cases.
Srikripa Devarakonda (VP of Biotechnology Equity Research)
Okay. Fantastic.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Now your second part of the question was?
Srikripa Devarakonda (VP of Biotechnology Equity Research)
For AFM13. 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 ahead of time to get the centers up and running.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Yeah, I think
Adi Hoess (CEO)
Andreas, do you want to continue with this?
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Yeah. We can give, of course, only detailed guidance, once we have the protocol finalized and the final blessing, if you will, by FDA. We are already looking, doing feasibility studies at sites. We have identified our primary lead investigator. We are now working with key opinion leaders in the field, to smoothen the setup process of sites as good as we can. We have identified a CRO that will support us in our study conduct. Again, final timelines can only be given after we have a final protocol.
Srikripa Devarakonda (VP of Biotechnology Equity Research)
Great. Thank you so much for taking my question.
Operator (participant)
Thank you. Our next question coming from the line of Maury Raycroft with Jefferies. Your line is now open.
Maury Raycroft (Equity Research Analyst)
Hi, thanks for taking my questions. I was gonna ask one on the AFM13 combo as well. Wondering when you plan to update the street on trial design, 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 AB-101 cell combo?
Adi Hoess (CEO)
Yes, Maury. Thank you. As we've said in the past, we've had clarifying interactions with FDA, and we have been basically bringing this together into the study design. Obviously, we have a good understanding and 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 weekly installments over roughly three weeks. We follow with three weekly doses of AFM13 or this is preceded by lymphodepletion. Roughly after eight weeks of basically from start of treatment, you're gonna do your restaging, and then you include a short break before you go to the second cycle and third cycle.
In general, we have already explained what the study design is gonna look like. Based on the feedback with FDA, we have made the respective adaptations. As soon as we have the final IND, we can update you on the further details. I hope this helps you.
Daina Graybosch (Managing Director and Senior Biotechnology Analyst)
Yes. Yeah, that's helpful. 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?
Adi Hoess (CEO)
I'll hand over to Andreas.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
As you know, clinical data always have multiple aspects. 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. Our intention clearly is to make go, no-go decisions based on these data. As these data are maturing, we will have, I think, better discussions or more detailed guidance once we have disclosed this data.
Daina Graybosch (Managing Director and Senior Biotechnology Analyst)
Okay. Makes sense. Thanks for taking my questions.
Operator (participant)
Thank you. Our next question coming from the line of Li Watsek from Cantor. Your line is open.
Li Wang Watsek (VP of Biotech Equity Research)
Hey, thank you for taking our questions. Maybe with just one on AFM13, maybe clarify if you had additional interactions with FDA regarding your R&D filing since your pre-R&D meeting, and what are the remaining steps that you have to go through to have it filed?
Adi Hoess (CEO)
Wolfgang, you wanna take this question?
Wolfgang Fischer (COO)
Yes, I can take that question. Thank you. First of all, we had the pre-IND, right, where we got feedback early in January. We got constructive feedback. We had one or two clarifying questions for the FDA, and we got responses. With this constructive feedback, right, we are currently working on the documents to submit the IND, as we said, in the first half of this year. As Andreas already mentioned before, the feedback has been very positive and constructive, so we're looking into... We didn't see any roadblock, and now we are preparing them to submit.
Li Wang Watsek (VP of Biotech Equity Research)
Okay. Maybe a question on AFM28. Since now you have R&D clearing for European countries and have been enrolling, you know, patients, maybe just update us on maybe how the enrollment is ongoing. It seems like you can make a pretty quick read on maybe the response rate in CR in AML patients. Any chance that we might see some data this year?
Adi Hoess (CEO)
Andreas?
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
As we said, we have CTA clearance. The study is open for enrollment. We are just starting enrollment. Therefore, of course, we cannot say anything about what we have seen so far. We have not given clear or detailed guidance about the data releases. This will come once we see the initial enrollment of these patients.
Li Wang Watsek (VP of Biotech Equity Research)
Okay. Thank you.
Operator (participant)
Thank you. One moment, please, for our next question. Our next question coming from the line of Yale Jen from Laidlaw. Your line is open.
Yale Jen (Senior Managing Director and Senior Biotech Analyst)
Good morning, thanks for taking the question. Again, on AFM13-203 study, just like to know how many sites you are planning at this point, what will 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, you know, leading to a more advanced, trials. I have a follow-up. Thanks.
Adi Hoess (CEO)
Wolfgang. Do you want to take that?
Wolfgang Fischer (COO)
Yeah, I can take that. Thank you. Number of sites we are working with several sites. I do not have the exact number on top of my head, but it's about 12-15, if I recall that correctly. The objective of our trial is to confirm what we have seen in the MD Anderson trial. We are convinced, and we see that the AB-101 cell is a good cell which works very well with AFM13. We have seen that in all our preclinical studies demonstrating that. It's to confirm what we have seen with MD Anderson.
Yale Jen (Senior Managing Director and Senior Biotech Analyst)
Okay, great. Maybe the follow-up here is that in terms of AFM28 and your prepared statement indicate that subsequently you will use added to NK combo study. I'm just curious, in this case, would that be AB-101 or you have other options or it has not been determined? Thanks.
Adi Hoess (CEO)
Yes, exactly. We have not announced it, let's put it this way. In the moment we're following how AFM13 is doing and AFM28 is now performing in the clinic. In due course, we're gonna make the next decision on how that's all going and which cell we are using.
Yale Jen (Senior Managing Director and Senior Biotech Analyst)
Okay, great. Thanks a lot. I appreciate it.
Operator (participant)
Thank you. Our next question coming from the line of Brad Canino from Stifel. Your line is open.
Speaker 12
Hey, this is Bijan from Brad Canino. Thanks for taking our question. For the AFM24 combination studies, how many patients should we expect to see in the upcoming data? Will there be enough efficacy for us to determine the contribution of parts?
Adi Hoess (CEO)
Andreas?
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Yeah. 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. For 102, the combination study with atezolizumab, we have recently opened expansion cohorts, so we will see some patients. But again, efficacy data to expect it more towards the end of the year or early next year. Focus here on recommended phase II dose. Same probably for 103.
Speaker 12
Got you. That's clear. Okay, thanks. Then one on AFM13. What should we learn to expect from the AACR presentation that could be helpful for the NK cell combo study?
Adi Hoess (CEO)
Again, Andreas.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
You mean the AFM13 monotherapy study that we are discussing in detail? This will be mainly a 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 not very much to learn for the specific combination study. You know, the primary target population of the combination study is Hodgkin lymphoma, where we intend to generate through the 203 study a data set that would be able to support an accelerated approval. The data that we show at ASCO will be on PTCL, peripheral T-cell lymphoma, so different tumor type.
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 AFM13 also on PTCL.
Speaker 12
Andreas, you said ASCO, but you meant AACR.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Oh, yeah.
Speaker 12
AFM13 monotherapy will be at ACR.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Yeah. Sorry. ACR, of course.
Speaker 12
Thank you.
Operator (participant)
Thank you. One moment please for our next question. Our next question coming from the line of Swayampakula Ramakanth from HC Wainwright. Your line is open.
Ramakanth Swayampakula (Managing Director and Senior Equity Analyst)
Thank you. Adi, I apologize. Another question on AFM13. This is on the 203 program. Just trying to understand the rationale behind CD30 positive, the exploratory cohort, which you're looking at, the CD30 positive relapsed refractory NHL.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
Yeah.
Adi Hoess (CEO)
Andreas, can you-
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
So, um-
Adi Hoess (CEO)
Yeah. Thank you.
Andreas Harstrick (Chief Medical Officer and Member of Executive Management Board)
This, the study is open for CD30 positive lymphomas as was the MD Anderson study. It basically has two parts. The larger part, where we are focusing on our registration intent is for patients with Hodgkin lymphoma. I think here the MD Anderson data have provided clear proof of concept as Aarnt and others have elucidated. We believe that the AB-101 cell has the activity and type of biology that should enable us to replicate these data with a very high response rate, with a good duration of responses. 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 Anderson study, however, this is only four patients so far.
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. 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.
Ramakanth Swayampakula (Managing Director and Senior Equity Analyst)
Perfect. Thank you very much, Andreas.
Operator (participant)
Thank you. I'm showing no additional questions at this time. I'll turn back to the speakers if there's any closing remarks.
Adi Hoess (CEO)
Yes, thank you very much for listening in. This finishes our year end update call of the year 2022. As we've just mentioned, we have a lot of milestones coming up, in particular for AFM13 with initiation of the registration-directed study based on a filing and feedback from FDA, hopefully to come soon. Then we have AFM24 with multiple data readouts starting in Q2, but basically going into Q3 and Q4 of this year. Last but not least, the AFM28 is open for recruitment. Again, that should lead to hopefully some initial data, but we'll keep you updated as usual, at least on the earnings calls. 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.
Operator (participant)
Ladies and gentlemen, that does end our conference for today. Thank you for your participation. You may now disconnect.