ASH 2025 | Updated results from the iMMagine-1 trial of anito-cel in R/R multiple myeloma

Yeah, we got to present these updates at ASH 2025. And of course, this was our pivotal phase two study for patients with relapsed/refractory multiple myeloma. And patients had to have been triple-class exposed, so to a PI, IMiD, and anti-CD38. And the data cutoff for this presentation was October 7th, 2025. And so in general, or in total, there were 117 patients that actually got anito-cel infusion. And so the median follow-up for those patients was 15.9 months. 

And basically all the patients received anito-cel at 115 times 10 to the 6 CAR-positive T-cells. And here I’ll say that one of the differences between anito-cel and some of the other CAR-Ts that are already out there for lymphoma, myeloma, leukemia, is the SCFV. So the way that the CAR-T attaches to the target on the myeloma cell, it’s not a classical SCFV, and it’s actually something called a D domain. Basically, it’s a protein, a really small protein. And because of its size and the way it works, you can actually get a much better efficiency of CARs into the T-cells. And so, again, our target dose of cells is actually lower than most other CARs out there because most of the product is CAR-positive T-cells. There’s also a thought that maybe the way that protein works, it comes off the target quickly, like an off, you know, has a fast off-ramp time as well. And maybe that decreases inflammation as to why maybe there’s less side effects and a better toxicity profile for our patients. 

So, you know, in terms of the efficacy, we were able to show that there’s still a great response rate of 96%, but we’re seeing a deepening of that response, and so the CR and stringent CR rate was actually 74%, and the VGPR or better 88%. And then we were able to show a lot more MRD data, which is exciting. Because again, in CAR-T in general, we know that patients who get to MRD undetectable quickly tend to be the ones who get a really long-term PFS. And then more is the sustained MRD. And so for our data, there are 96 patients that we were able to get data for that were valuable, and 95% of them were actually MRD undetectable at 10 to the minus 5th. And then there are about 65 patients that had enough follow-up and repeat bone marrows that we were able to check six months or more later. And 83% of those patients were actually still MRD undetectable at 10 to the minus 5th, which is great to see. 

And then, of course, PFS. You know, we don’t have a completely calculated PFS yet. Our last patient that’s been treated, it was just about a year ago, but our 18-month PFS was 67.4%, and our 24-month PFS rate is 61.7%. So again, hoping that future data will show us that maybe we’re starting to have a plateau. We don’t know yet, but I hope that’s the case as it has been with a couple of our other CAR-Ts. And again, median PFS overall survival not reached. 

The other big, you know, update was the safety. And again, since our last discussion of this data at our last presentation in summer, no other toxicities, treatment-related, you know, serious adverse events or anything. And we haven’t seen any of the delayed non-ICANS neurotox, like Guillain-Barré or Parkinsonianism. And we haven’t seen cranial nerve palsies. And then we haven’t seen any of the IEC-colitis. And again, our last patient was about a year ago treated. So, you know, we would hope that if that was going to happen, we would have seen it now. But of course, we’re going to keep watching these patients. 

So again, just really great depth of response that we got to see the MRD, the calculated PFS, as well as the safety data that I think really helps us hopefully get more access to CAR-T for more of our patients. 8% of these patients, I forgot to mention, were actually outpatient. And I’m hoping with iMMagine-3, the phase three study that’s next, we’ll be able to do more outpatient now that we know a lot more about it, about the CAR-T. But this is what will, I think, really help with getting more access, you know, not just hospitals like us that can do CAR-T, but letting other hospitals be able to do it with the resources they have and to do it safely, I think is really important. And hopefully we’ll again increase the ability for our patients to get this great therapy.

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