Affimed at Leerink’s Conference: Clinical and Strategic Insights

On Tuesday, 11 March 2025, Affimed NV (NASDAQ: AFMD) presented at Leerink’s Global Healthcare Conference 2025. The discussion, led by CEO Sean Nilan, highlighted both the promise and challenges of its clinical programs and financial strategies. While Affimed’s innovative therapies show potential, the company faces hurdles in financing and strategic partnerships.

Key Takeaways

• Affimed is prioritizing its pipeline based on investor interest and clinical data, focusing on AFM24 and AFM28.
• The partnership with Artiva Biotherapeutics presents challenges, impacting the commercial strategy for Acitamig.
• Promising clinical data for AFM24 in NSCLC and AFM28 in AML could attract investors and partners.
• Affimed is exploring higher dosing strategies to enhance the efficacy of AFM24.

Pipeline and Clinical Updates

AFM24 - EGFR/CD16A Innate Cell Engager:

• Monotherapy in EGFR mutant NSCLC showed a 7% overall response rate (ORR).
• Combination therapy with atezolizumab in EGFR wild-type patients showed a 21% ORR and a preliminary progression-free survival (PFS) of 5.6 months.
• A higher dose cohort (720mg) will be enrolled to potentially improve efficacy, targeting an ORR > 30% and median PFS > 7 months.

AFM28 - CD123 for AML:

• At the 300mg dose level, a 40% composite complete remission (CR) rate was observed in 11 patients.
• Affimed plans to escalate to dose level seven, with data updates expected in 6-9 months.

Acitamig in Hodgkin’s Lymphoma:

• The collaboration with Artiva involves combining Acitamig with allogeneic NK cells, showing a CR rate above 50% and an overall response rate above 80%.

Financial and Strategic Considerations

• Affimed’s pipeline prioritization is driven by investor interest and commercial potential, given its limited cash runway.
• Investor discussions focus on AFM24 and AFM28 due to promising data and high unmet needs.
• The partnership with Artiva poses business challenges, complicating the commercial viability of Acitamig.

Future Outlook

• Affimed is open to exploring partnerships with different anti-PD-1/L1 agents, despite the current benefits of its Roche collaboration.
• The company aims to navigate its financial and clinical strategy carefully to maximize its pipeline’s potential.

Q&A Highlights

• Roche provides atezolizumab for free in combination studies.
• Affimed is not considering bunched up dosing for NK cells to increase AUC.

In conclusion, Affimed’s strategic focus on its clinical assets and partnerships was evident at the conference. For more details, readers are encouraged to refer to the full transcript.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Dana Grabosch, Senior Analyst, Lyric Partners: Okay. Welcome, everybody. My name is Dana Grabosch. I’m the, a senior analyst here at Lyric Partners. I cover mostly immuno oncology.

And, since the beginning of my time at Lyric, I’ve covered Afimed. And I’m happy to have their CEO, Sean, here with me today. Thanks for joining. Yes. Thanks for

Sean Nilan, CEO, AffiMed: having us.

Dana Grabosch, Senior Analyst, Lyric Partners: We can jump right in. I only have thirty minutes and about, you know, 50 questions to get through. I have a hard hitting one to start. But before that, maybe I’ll just ask to introduce yourself because you’re a new CEO at EpiMed. Sure.

Everybody knows, you and where you’re coming from.

Sean Nilan, CEO, AffiMed: Yeah. So, Sean Nilan. I’m a pharm d by training. I’ve been in the industry for about seventeen years. I joined AffiMed in September of last year.

Prior to that, I was a CEO for a private company called Forbio. Helped them raise a 75,000,000 series d financing in August of twenty three, and also brought their lead program into a phase two study with registrational intent. Prior to that, I was founder and CEO for Elevation Oncology, helped the company raise over 200,000,000 worth of capital, took the company public in just two years’ time, brought their lead program into a phase two study with registrational intent, and did a variety of other strategic transactions while there, including in licensing of their Claudine eighteen point two ADC, which is now their lead program. Prior to that, I’ve held mostly head of business development roles. I had started my career at Eli Lilly.

I’ve been at Ariad Pharmaceuticals, Argos Therapeutics, and Verastem Oncology.

Dana Grabosch, Senior Analyst, Lyric Partners: Awesome. Thank you. Okay. So AfiMed has three, what I think are promising clinical assets, but the next meaningful readouts are just at or beyond your cash cash runway. Yep.

And I think that’s essentially maybe the hardest question I have for you today. So what are your plans for getting the financing to take those programs forward?

Sean Nilan, CEO, AffiMed: Yeah. I mean, I think more and more in this day and age where you’re in a challenging market, I mean, pipeline prioritization is top of mind for everyone. It’s not an easy task in the situation of Afimed because as you’ve mentioned, I mean, all three of these programs have clinical proof of concept, right? So it’s not necessarily easy to kill one of those programs. At the end of the day, I think the pipeline prioritization will be dictated by the investors that come into, you know, this next financing round.

So I mean, I think that will be the key driver. I mean, I think as you look at the portfolio of assets, you know, with all three programs having clinical proof of concept, there’s different commercial potential associated with those three assets and programs. You know, I think, you know, the one with the smallest commercial potential happens to be, you know, the asymptomatic program. So as you think about, like, if you have to make some tough choices, you know, is that the program that ends up getting deprioritized just because it’s got the smallest commercial potential? You know, I think that that’s these are the things that we will have to think about.

But every investor that I’ve spoken with has their favorite kind of two programs, and you’ll get different responses from all of those investors. So it’s again, it’s not an easy decision to make from that regard. But I think, you know, the vast majority of our investor discussions as well as partnering discussions have, you know, really focused on AFM24. I mean, I think that data has been extremely encouraging. I think folks are really looking forward to seeing kind of how that data evolves, especially at the higher dose of seven twenty milligrams given the post hoc analysis.

So that’s really kind of been the core focus. And there’s also been a lot of interest in AFM twenty eight. I mean, obviously, AML is a huge unmet medical need. So the clinical proof of concept and data we’ve shown in dose escalation there has been extremely promising as well.

Dana Grabosch, Senior Analyst, Lyric Partners: Can you talk about some of the conversations, I guess, with partners versus investors? Are there any differences? And are are they holding up any milestones or thresholds?

Sean Nilan, CEO, AffiMed: Yeah. I think I think, honestly, the partner and investor feedback is quite similar. I don’t think that there’s a ton of disconnect between, like, what the partners want to see and what investors want to see. You know, I mean, I think, you know, kind of going through program by program, you know, you have you know, there are companies that are focused in, you know, hematologic malignancies, for example, that are looking for late phase bolt on programs where a program like Asymptomatic makes a lot of sense. Right?

So, you know, there are folks that want to meet and talk about Asymptomig, because it’s a late phase development program, it’s got compelling differentiated clinical data, and you know, we have an agreed upon path to registration there with the regulators. So that program comes up in partnering discussions. Obviously, AFM 24 comes up in a number of partnering discussions as well just because of the significant commercial opportunity, the unmet medical need that exists in kind of second, third line and beyond non small cell lung cancer. So that is a hot topic of discussion. And for the same reasons, you know, CD123 is obviously a well validated target in AML, but has been very difficult to pursue because of the narrow therapeutic index.

And because of our unique approach with the NK cell engagers, you know, and being able to thread that therapeutic index, there’s also been a lot of interest, given the updates we’ve had around the, AFM twenty eight program.

Dana Grabosch, Senior Analyst, Lyric Partners: Actually, on, one one follow-up on acitamig. You’re partnered there with, an NK cell therapy company, Artiva. How does that complicate the partnering conversations or add to it?

Sean Nilan, CEO, AffiMed: Yes. I mean, I think it’s, it’s one of those things where there’s clear synergy, right? I mean, obviously, we’ve tested, you know, Symptomag as a monotherapy, and I think you see encouraging response rates, but the durability piece seems to be lacking with the monotherapy approach. So I think for Symptomig, the combination is necessary and has dramatically improved not only the overall response rate, but also the durability piece. So I think it’s an inherent necessity.

I think where the partnership with Artiva becomes more complicated is the business relationship that exists, right? I mean, we own two thirds of the economics. They double refractory Hodgkin’s lymphoma that’s two thousand five hundred to three thousand five hundred patients a year, you know, that’s that becomes challenging when you have an economic split like that to make it work from a business perspective. So I mean, I think in order for someone to be interested, it’s very important to be able to expand and show, you know, clinical proof of concept in in relapsed refractory PTCL, which would essentially triple that commercial opportunity.

Dana Grabosch, Senior Analyst, Lyric Partners: Are you enrolling PTCL to that trial?

Sean Nilan, CEO, AffiMed: So we have not started enrolling PTCL, but that would be a clear next step for that program because that is what will truly unlock the commercial potential for that program. Obviously, we’ve shown, in some monotherapy, clinical proof of concept. So we know that there’s activity of the symptom, again, if you look at the precedence of, you know, other CD30 targeted therapies like ADCETRIS, I mean, I think we feel highly confident that it’s going to work in relapsed refractory PTCL, but, you know, obviously, we’re in a world and an environment where it’s a show me story. So Got

Dana Grabosch, Senior Analyst, Lyric Partners: it. Let’s talk about AFM twenty four. So your eGFR CD 16 a innate cell engager.

Sean Nilan, CEO, AffiMed: Yep.

Dana Grabosch, Senior Analyst, Lyric Partners: You’re focused on lung cancer

Sean Nilan, CEO, AffiMed: Yes.

Dana Grabosch, Senior Analyst, Lyric Partners: Even though you’ve seen activity in some other tumors Yes. But starting that prioritization there. Can you describe the activity you’ve observed there, in mono and in combination with Roche’s atezolizumab?

Sean Nilan, CEO, AffiMed: Yeah. So we’ve seen both monotherapy as well as combination activity. As a monotherapy and non small cell lung cancer, the development was focused on EGFR mutant non small cell lung cancer. So as a monotherapy, we have not tested that program in eGFR wild type. There were thirteen patients with, eGFR mutations that were enrolled.

These were refractory patients. One out of those thirteen patients had a response, so about seven percent overall response rate. On that patient population, you know, there was about a third of patient, a little bit over a third of patients, that had tumor shrinkage, and there was about six out of those thirteen patients that were on treatment for six months or longer. So we did see benefit in patients and some of those benefits that we saw were durable. Where I think the data gets much more exciting is when you’re leveraging both the innate and adaptive immune system with this combination with atezolizumab or you could really use any you know, checkpoint inhibitor.

We have also shown, really good additivity synergy with Pembrolizumab with the combination of asymptomatic and Pembrolizumab as well. So we think that this, you know, additivity synergy isn’t specific to just atezolizumab for example, we think we can see this with any CPI. In the Phase two combination study with atezolizumab, we have two cohorts. One cohort is patients with eGFR wild type. The other is patients with eGFR mutations.

All of these patients have seen standard of care chemotherapy plus anti PD-one and all of these patients have documented progression on anti PD-one as well.

Dana Grabosch, Senior Analyst, Lyric Partners: Wait, not the mutant patients,

Sean Nilan, CEO, AffiMed: if indicated they Yes, if indicated. Yeah. And in the wild type patient population, we’ve released data on thirty three patients, twenty one percent overall response rate there. Preliminary PFS is at five point six months. So I think that’s quite encouraging.

If you look at the PD-one retreatment historical numbers, the overall response rates that you would expect in that patient population is about five percent to ten percent and the PFS is at two point five months. So I think what we’re seeing is quite encouraging standard of care there in this setting would be docetaxel, which produces an overall response rate of about ten percent, and a median PFS that’s around four months. So in the wild type, we seem to be seeing both NORR as well as PFS signal. In the patients with eGFR mutations, in our last data release there were seventeen evaluable patients. There we’re seeing a twenty four percent overall response rate.

In the median PFS there is also coincidentally five point six months. There is interestingly still about a third of patients that remain on treatment and all of those patients have been on treatment for eight months or longer. So there seems to be a very clear tail of the curve effect, which is what you would hope and want and expect to see, with an immuno oncology product.

Dana Grabosch, Senior Analyst, Lyric Partners: You’re currently, and you alluded to earlier, enrolling a higher dose cohort

Sean Nilan, CEO, AffiMed: Yes.

Dana Grabosch, Senior Analyst, Lyric Partners: Seven twenty mgs. Is there just first, is there an efficacy threshold that you’re looking to hit in this this new cohort?

Sean Nilan, CEO, AffiMed: Yeah. Yeah. So we just for clarity, we haven’t started enrolling the cohort yet. We’re still waiting for the amendment to to be approved to start enrolling patients at the seven twenty milligram dose. You know, the decision to move to the seven twenty milligram dose was driven by a post hoc analysis, which showed a very strong correlation between higher exposure and not only response rate, but also PFS and overall survival.

And not only did we see this trend in non small cell lung cancer, but as you alluded to Dana, we also saw the same trend in the other tumor types that were enrolled. And we’ve seen the same trend across our portfolio of NK cell engagers where there’s this clear correlation between higher doses and a response. So in terms of the threshold that we’re looking to see, I mean I think as you look at the competitive landscape for non small cell lung cancer, I would say both in eGFR wild type as well as eGFR mutant patients, the overall response rates that we’ve been seeing are kind of in that twenty percent to thirty percent range. And PFS numbers are right around kind of that five to six month range. So I think what we’re showing currently at the four eighty milligram weekly dose, I think is competitive with what others have shown.

The question is, is how can you be differentiated, right? What do people really want to see to get excited about this program? So I mean, I think internally and what we’ve heard from investors, what we’ve heard from partners is they want to see north of a 30% ORR and they want to see ideally north of a seven month median PFS. So those I would say are kind of the benchmarks of what folks are hoping to see. I think we’ve seen others produce that 20% to 30% ORR and that median PFS in the five to six months range and then they go and spend $100,000,000 to $150,000,000 on a Phase three registrational trial to go head to head dose versus docetaxel, and they end up falling short.

Dana Grabosch, Senior Analyst, Lyric Partners: Are you still enrolling all patients for post chemo and PD one? Did you consider allowing just post PD one? Is that might be a nice

Sean Nilan, CEO, AffiMed: you know,

Dana Grabosch, Senior Analyst, Lyric Partners: maybe just get you a little bit easier Yeah.

Sean Nilan, CEO, AffiMed: I mean, the the the study the cohorts have enrolled quite rapidly. Right? I mean, now that we have kind of all the sites up and running and active, you know, enrollment has not been an an issue or a challenge from that perspective. So I mean, and when you think about kind of standard of care for these patients, I mean, the vast majority of patients are still seeing both chemo and anti PD-one. I mean, maybe you have some elderly patients that are not suitable for chemotherapy where they would just get anti PD-one, but I don’t think we’re losing a ton of patients by, like, the inclusion criteria that we have.

Dana Grabosch, Senior Analyst, Lyric Partners: I was just thinking, maybe you could gain some patients that are not chemo refractory. Would you see a different kind of signal? Yeah. I mean,

Sean Nilan, CEO, AffiMed: I think it’s a relevant question. Right? I mean, especially given the, you know, the the prior taxing analysis that we’ve done. Right? So I mean, you know, as part of the post hoc analysis, not only did we see the correlation between higher exposure and better efficacy from an ORR, PFS and OS standpoint, but we also looked and did an analysis to look at the impact of prior taxane exposure and patients that did not see a prior taxing had a median PFS of 7.4 months versus those that did have prior taxing exposure had a median PFS of 4.4 months.

So perhaps maybe you could further enrich, you know, by just allowing for patients who had anti You

Dana Grabosch, Senior Analyst, Lyric Partners: are excluding piritaxine now though, right? So in

Sean Nilan, CEO, AffiMed: the next cohort, in the seven twenty milligram cohort, the plan is to exclude patients that had piritaxines. Got it. Yeah. I mean, I think anything you can do to enrich for, you know, the the PFS north of seven months, then clearly, that’s a signal that would allow us to do so.

Dana Grabosch, Senior Analyst, Lyric Partners: Let’s talk more about this dose. I mean, I like I said, I covered Afimid for a long time. And one, there’s always worry that you’re seeing a post hoc signal because it’s small, so there’s chance that it’s not right. But also, there was a lot of work on picking the dose. Yep.

It took a long time.

Sean Nilan, CEO, AffiMed: Yes. There

Dana Grabosch, Senior Analyst, Lyric Partners: was a lot of pharmacokinetics, pharmacodynamics, like, we’re these beautiful posters showing that you’re fully saturating receptor occupancy, I believe on the NK cell side, at the four eighty. So why did all that modeling work fall short?

Sean Nilan, CEO, AffiMed: Yes. So I mean, your PD marker is only as good as the assay and, you know, a lot of this is dependent upon, like, where you’re measuring those corresponding markers, right. So the assay that was run-in this scenario that you’re describing for the PD marker is a NK cell based assay in terms of receptor occupancy, but it’s in the peripheral blood, right. So it doesn’t highlight how much drug is getting into the tumor microenvironment, it doesn’t highlight, probably even more importantly, how much drug is actually getting into the tumor itself. So even though we were reaching full saturation on the peripheral blood NK cell occupancy assay, you know, I think the concern here with this postdoc analysis was that that’s not necessarily indicative of how much is getting into the microenvironment and how much is getting into the tumor, because the post hoc analysis that we’ve done, you know, albeit with the character, like the caveats associated with the post hoc analysis, it is a very robust analysis and it’s over 100 patients worth of data.

So I think we feel quite confident in all of that data, you know, trends towards this suggestion that like higher exposure correlates with the improved efficacy and again it’s across all efficacy parameters, it’s ORR, PFS, NOS. You said over 100 patients? Yes.

Dana Grabosch, Senior Analyst, Lyric Partners: That’s because you’re pulling in all the other tumor types?

Sean Nilan, CEO, AffiMed: Correct. Yeah. You didn’t share all that, right? No. So this this, data was shared in the as part of the post hoc analysis.

Okay. So we did pool not only just the non small cell lung cancer patients, but we also pooled the analysis around other solid tumors, and it includes both monotherapy as well as combination. So that’s where you get to, like, over a hundred patients’ worth of data for the analysis.

Dana Grabosch, Senior Analyst, Lyric Partners: I know it’s early, and and it’s this is you have to get to the next step.

Sean Nilan, CEO, AffiMed: Yes.

Dana Grabosch, Senior Analyst, Lyric Partners: But how are you considering registration paths here, in this setting, going to frontline? Is there a front front runner option here?

Sean Nilan, CEO, AffiMed: Yeah. So, I mean, I think in terms of, the registrational path, I mean, I think the registrational path and second, third line non small cell lung cancer really hasn’t changed a lot in probably the past, like, you know, decade, if not close to two decades at this point, right? I mean, it’s a, you know, you will be required to run a Phase three randomized study, and that comparator is docetaxel, today. I mean, it has not changed. I think people are optimistic that maybe TRO2 ADC would overcome docetaxel, but it was obviously unable to do so.

So that would be the registrational path, and that would be true in either, you know, the eGFR wild type or the eGFR mutant patient population.

Dana Grabosch, Senior Analyst, Lyric Partners: Do you need to show contribution in some ways, or have you talked to FDA about the PD-one?

Sean Nilan, CEO, AffiMed: Yeah. So I mean, I think you would rely on kind of the historical numbers with kind of the PD one rechallenge here. We haven’t had any discussion with the agency around the contribution of parts. So, you know, it it’s something that I would imagine will come up in a discussion with the agency, you know, once we are ready and prepared to to have that registrational phase three discussion with them.

Dana Grabosch, Senior Analyst, Lyric Partners: How do you disentangle your development from Atiso and move it to a more validated PD one antagonist? We can debate if Atiso is worse or not, but I think it adds risk. I’d rather be with pembroke, samlopumab, or tislelizumab.

Sean Nilan, CEO, AffiMed: Yeah. Any of them. Yeah. I mean, I think the the good thing here, and and I I think I mentioned this earlier. I mean, we have shown that this additive synergistic effect that we see between the innate immune system and the adaptive immune system is not just unique to atezolizumab, right?

We have shown this with other NK cell engagers, most notably with Asymptomig, in combination with pembrolizumab, and that work was done in Hodgkin’s lymphoma, you know, where we meaningfully improved the overall response rate and probably more importantly in that setting improved the CR rate as well. So I think we’re highly confident that we should see good additivity in synergy with any of the anti PD ones. You know, I think it’s also important to note, like, you know, at this time Roche is paying, and contributing atezolizumab for free. So I mean, I think, you know, we’re open to, you know, looking at other anti PD ones or l ones, in this setting, but I I don’t think the results will change regardless of which anti PD one or l one you use.

Dana Grabosch, Senior Analyst, Lyric Partners: So it’s different to say you’re open and that you’re out there. I guess you’re just you’re not willing to say you’re out there actively thinking about it. Okay. I had forgotten, Tyler, was preparing for this, session that there was a one dose, lead in with AFM twenty four

Sean Nilan, CEO, AffiMed: Yes.

Dana Grabosch, Senior Analyst, Lyric Partners: In the study before the combo. And you mentioned you had monotherapy activity alone. Did you look at anything? Is that enough time? Yeah.

Sean Nilan, CEO, AffiMed: I mean, I think as an expert in immuno oncology, you know these things take time to work, right? Yeah. So I mean, it’s nice to have, like, a one week monotherapy activity, but it’s just too short of a period to learn anything, like, at that stage.

Dana Grabosch, Senior Analyst, Lyric Partners: Let’s move on to AFM twenty eight, which is the CD123 for AML. I wonder if you could just summarize the activity you’ve seen thus far, and also yeah. Let’s start

Sean Nilan, CEO, AffiMed: with that. Yeah. So I mean, I think, the data has been quite quite encouraging. I mean, obviously, AML is a significant unmet medical need. You know, patients in the relapse refractory setting have a median overall survival expectation of about four months.

You know, we are currently dose escalating. We started to see signs of clinical activity at dose level five. So this was at the two hundred milligram dose level. You know, we’ve seen increased activity at the current dose level, which is three hundred milligrams. So at the three hundred milligram cohort, we had an oral presentation of our data at ASH.

There was 11 evaluable patients. At that point, what we’re seeing is a forty percent composite CR rate. So CR, CRI and patients, and those durations of response range anywhere from two point five to six point five months. When you think about recent regulatory precedents and how does that data stack up, you can look at the recent approval of the Syndax Menin inhibitor, which was approved in patients with KMT2A translocations. That was approved based upon a 20% composite CR rate in a median duration of response of six months.

So even though we’re currently continuing to dose escalate, I think we’re seeing very encouraging signs of activity with that 40% composite CR rate, and durations that range anywhere from two point five to six point five months, which obviously stack up quite nicely against that recent regulatory precedence.

Dana Grabosch, Senior Analyst, Lyric Partners: So I think you’re currently, and tell me if I have this right, treating 12 patients at a higher dose, and five patients at the dose level six or we’re still ongoing treatment as of ASH? Yeah. So And is that right? And when will we see updated sort of outcomes from those cohorts? Yes.

Sean Nilan, CEO, AffiMed: So we continue to follow the patients at dose level six. So patients are still ongoing there. Next step will be, as you just mentioned, to dose escalate to dose level seven. We have not done that yet. That will be the clear next step is to go up to dose level seven and assess like, does the higher dose lead to deeper and more durable responses.

So in terms of timeframe as it relates to data updates, we haven’t provided any formal guidance, you know, but when you think about, like, how enrollment has gone and how quickly data has kind of come in thereafter, you know, I think once we start enrolling patients, to dose level seven, I would imagine you would have data kind of in that six to nine month time frame.

Dana Grabosch, Senior Analyst, Lyric Partners: What’s gaining the enrollment?

Sean Nilan, CEO, AffiMed: There’s nothing specific that’s gaining the enrollment. We’re just looking to make sure that we have a good sense of the durability at at dose level six before moving to the next dose level.

Dana Grabosch, Senior Analyst, Lyric Partners: Is that, like, for internal investment reasons or why?

Sean Nilan, CEO, AffiMed: Yes. Yes, yes. Yes. I mean, I think we want to make sure that not only are we seeing, good response rates, but I mean, I think making sure that you’re seeing durable responses is also like critical. I mean, I think as you think about, you know, having the three programs, you know, it’s important that we are good stewards of investor capital.

And I think making sure that we have as much information to make informed decisions is critical.

Dana Grabosch, Senior Analyst, Lyric Partners: So you mentioned earlier that a lot of CD123 directed approaches haven’t worked, including a monoclonal antibody from J and J and T cell engagers. Why is yours working? What’s different about it? And I guess we’ve also seen one working from Monet and Sanofi. Yes.

And is there what do we learn across those two programs? Yes. I mean,

Sean Nilan, CEO, AffiMed: I think what we’ve learned is that, you know, this this approach of using an NK cell engager is critical to navigate the narrow therapeutic index. You know, I think, you know, when you look at kind of those historical studies that you’ve mentioned that have pursued targeting CD123, you know, they’ve been TCEs, they’ve been CAR Ts, they’ve been ADCs, they’ve been monoclonal antibodies. And those therapeutic modalities don’t have the ability to differentiate that expression of normal healthy human tissue versus that on the tumor tissue, right? So in turn, you have collateral damage and that collateral damage with CD123 manifests as cytokine release syndrome, which is obviously a very challenging toxicity to deal with and manage. For an NK cell engager approach, what is unique and differentiated about this is that in the normal healthy human tissue, the NK cell engager will bind, but it will not attack and kill those normal healthy human cells because in that microenvironment, you have NK inhibitory factor that basically tells the engager that you’re in normal healthy human tissue and to not attack and kill those cells.

So that allows us to have a wider therapeutic index and I think that’s a key piece of the differentiation strategy. I mean we see the same effect with AFM24 in terms of pursuing eGFR for example. I mean if you look at you know, eGFR small molecule inhibitors, for example, or other therapeutic modalities against eGFR, you see that prototypical on target skin toxicity and mucosal toxicity. We don’t see that with AFM24. So that is a key component here of the differentiation.

And I think again Sanofi and N8 have seen the same thing. We seem to be showing slightly higher activity than what they have shown initially. But I think both of these approaches have validated that an NK cell engager approach could be optimal for pursuing a narrow therapeutic index target like CD123.

Dana Grabosch, Senior Analyst, Lyric Partners: So maybe the last question on acetaminig. You mentioned that maybe challenging commercial situation Yeah. Business situation with a partner and complexive NK cell. I guess for me, if I just think about it from a clinical perspective, you had proof of concept with the MD Anderson

Sean Nilan, CEO, AffiMed: Yeah.

Dana Grabosch, Senior Analyst, Lyric Partners: Investigator study, And you changed a lot of things

Sean Nilan, CEO, AffiMed: Yes.

Dana Grabosch, Senior Analyst, Lyric Partners: In the Artiva study by necessity

Sean Nilan, CEO, AffiMed: Yep.

Dana Grabosch, Senior Analyst, Lyric Partners: Versus what was done, you know, on a single site at MD Anderson.

Sean Nilan, CEO, AffiMed: Yeah.

Dana Grabosch, Senior Analyst, Lyric Partners: And I’d say for me, the updated data has a modest degradation in NK cell exposure, efficacy, and safety.

Sean Nilan, CEO, AffiMed: Yeah.

Dana Grabosch, Senior Analyst, Lyric Partners: So it’s still promising, but we saw a step down across the board. Is this luck or is this certain something about the new regimen that you would even consider testing as you have two dose arms Yep. In the registration study where you could test two different things?

Sean Nilan, CEO, AffiMed: Yeah. So I mean, I think I mean, we obviously tested a variety of different dose levels. On the most recent data release that came out at ASHRAE. We looked at two different doses of of Asymptomatic and two different doses of allogeneic and K cells. And, you know, small patient numbers, but I mean, there’s there’s no, you know, meaningful difference in the activity, you know, regardless of the dose of Asymptomatic or, regardless of the dose of of the allogeneic NK cells.

You know, I think it’s it’s important here to keep in mind, like, the unmet medical need that exists. Right? You know, patients with double refractory Hodgkin’s lymphoma have already been through chemo, they’ve been through ADCETRIS, they’ve been through anti PD one. Really, the only option for these patients is to get, additional chemotherapy, which in this double refractory setting would produce about a ten percent overall response rate and unlikely to produce, any CRs regardless of whether it’s kind of the MD Anderson regimen or the combination with Arteva’s allogeneic and K cells. I mean, we’re producing north of a fifty percent CR rate and an overall response rate that’s north of eighty percent in both of those settings.

So I don’t know if it’s necessarily fair to say that there’s like a modest degradation. I think the efficacy, safety, PK exposure are similar. So I mean, I think really the devil will be in the details. I think it’s important really to see how the durability piece plays out. So I mean, once we have that data in the second half of this year, you know, the PFS and durability, I think, will be the key components that folks will focus on.

Dana Grabosch, Senior Analyst, Lyric Partners: Okay. Didn’t ask me. We’re out of time, but I have to say.

Sean Nilan, CEO, AffiMed: Sure.

Dana Grabosch, Senior Analyst, Lyric Partners: If it were me, I would instead of testing the two higher NK cell doses as you do did, a lot of companies have shown you get better exposure with bunched up dosing. Sure. And in MD Anderson, they had the advantage of changing donors

Sean Nilan, CEO, AffiMed: Yeah.

Dana Grabosch, Senior Analyst, Lyric Partners: Which each dose. So I would try to do one where I punch the dosing up

Sean Nilan, CEO, AffiMed: Yeah.

Dana Grabosch, Senior Analyst, Lyric Partners: To try to give a better area under the curve. But are

Sean Nilan, CEO, AffiMed: you considering that at all? It’s not something we have considered. I mean, I think commercial viability is also a key component, which drove our decision to, I mean, you know, the MD Anderson cells were obviously not commercially viable. So like a big part of kind of the transition to partnering with Artiva was having access to, you know, commercially viable NK cells, you know, that could be accessible from a global standpoint. I mean, if it’s great that you could produce north of a 90% ORR and like a really high CR rate, but like if you can’t get that to centers, like that’s a problem.

Dana Grabosch, Senior Analyst, Lyric Partners: Yeah. Awesome. Well, thank you very much. Thanks, everybody, for your attention.

Sean Nilan, CEO, AffiMed: Sounds good. Thanks,

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