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| Matsui at Johns Hopkins, and it's been one debate that's been going on for a while in the field, but we believe also with the data that we see now in SLE, there's a good chance that that actually has an ability to potentially give us sort of a deeper form of remission and also more sustained presence of the cells that is driven through the CD19 side |
| I think we're at an excellent spot in terms of the time and dose, which is a highly competitive position |
| And we can show very high level of clinical activity that gives us a good level of sustained activity, as well as an excellent safety profile |
| obe-cel has shown an excellent profile in adult patients with relapsed/refractory acute lymphoblastic leukemia |
| So, we believe actually having seen a replication of the cellular properties in our FELIX study tracking what we have seen in the ALLCAR study gives us a high degree of confidence that we're on the right track in terms of a longer-term follow-up as well |
| Critical for the successful outcome of the FELIX study was our robust product delivery platform with high manufacturing success rate, short vein to delivery time, and high percentage of patients dosed with obe-cel |
| But also, it will help to further improve the already very, very attractive safety profile of the program, and should also allow us to consider at least patients with low disease burden and patients who are in relatively good shape to consider actually dosing patients, ultimately in a hospitalized patient setting as well, which I think will further, I think, support access and facilitate access to obe-cel as a therapy |
| In non-Hodgkin's lymphoma, in our ALLCAR19 study, we demonstrated very high levels of metabolic complete remission rates in patients across B non-Hodgkin's lymphoma indications, with an attractive high level of sustained CRS in DLBCL patients |
| We believe the excellent safety and efficacy profile we have seen for O obe-cel in ALL and on Hodgkin's lymphoma patients will translate well into B-cell-mediated autoimmune diseases, and together with our established commercial manufacturing and delivery base, plus attractive COGS, will drive a well-differentiated expansion of the obe-cel opportunity |
| Looking into obe-cel lifecycle, the pediatric ALLCARPALL study with AUTO1/22 was updated at the EBMT meeting in the second quarter, and continues to show an impressive level of clinical activity and a very favorable safety profile |
| And obviously, we're looking forward to really driving this program through that process and hopefully onto the market with, I think, a very strong belief that the product has an ability to be transformational for a very challenging indication |
| Moving to the summary on slide 16, obviously we're very excited with the outcome that we have seen in this study |
| And to see the outcome, both on efficacy, as well as on safety to be so consistent with what we've seen before, gives us a lot of confidence in the property of the product, but also with our ability - in our ability to deliver the product reliably at high level of quality and in time for these patients, which is really critical |
| But as they're cycling back into action again, they not only actually continue in a serial killing mode, which actually is at much, much lower level of toxicity overall, they also actually give a very strong signal to proliferate |
| If you look at the half-life, very nicely matching our prior experience |
| And also what we're seeing is good levels of persistence |
| We expect to get started early next year in dosing patients, and we're really excited, obviously about the opportunity here |
| We also have a commercial manufacturing base, and we have an ability to deliver these products reliably and at attractive cost of goods |
| We believe we're actually extremely well positioned with our product because we obviously do have, as far as we can tell, based on our data today, is that we have the safest and probably the most active CD19 CAR in the business |
| The safety has been excellent in all of these indications, and we believe that the safety profile should allow obe-cel to actually be used in outpatient settings in those respective indications as well |
| So, the outcome was very remarkable, very different from I think anything we've seen in the field based on monoclonal antibodies |
| We looked obviously specifically for cytokine release syndrome and neurological toxicities as measured by ICANS, and I think it's remarkable when you see overall that we have a remarkably safe product |
| So, an exciting time, very intense, but also I think very rewarding because we're feeling that we're working with a product that has a very unusual profile, and I think that promise to really have a big impact on patients' lives going forward |
| So, it's been a very successful operations that we had |
| And that ultimately will translate, not only in robustness, but also in increased efficiency, and with that, continued ability to decrease cost of goods over time, as well as reduce turnaround time |
| So, to summarize, and we're moving to Slide 36, we think we have an exciting time ahead of us |
| Moving to Slide 37, we believe we're at very attractive and interesting point with the company |
| Very interesting, obviously what we're seeing in DLBCL where we actually see sustained responses and have no relapses so far, which is quite remarkable |
| And in fact, we have now two of those patients that have crossed one year, and that starts to give us a lot of confidence in the clinical effect and benefit that we can actually induce with the seratherapy |
| The safety profile, which was remarkable with low levels of high-grade cytokine release syndrome in ICANS, and the data tracked very well on persistent and duration of response with our prior ALLCAR19 study where we have seen 35% of treated patients and long-term remissions without any need for additional anti-leukemia therapies |
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| And that creates a lot of problems, a lot of disappointment, and it's something that is really important to get right |
| What I'd like to point out, as indicated before, patients that have Extramedullary disease, tend to have a poor outcome, as are patients that have very high levels of disease in the marrow |
| And that's been one of the critical issues that we've seen in the spaces that the capacity available at launch was completely outstripped by the demand |
| So, what you see on the right hand side is actually a capacity challenge we conducted in the second quarter where you see literally every one of the Prodigy machines running in parallel at that point in time in the facility, which obviously leads us to maximal use - maximal amount of people in the room, maximal flow, pressure on flow, et cetera, of materials, good, et cetera, through the facility, and really gives you the ability to pressure test, identify where you have issues or stress in the system, and then actually address that and keep improving from there |
| The first is, when you are dealing with patients with acute leukemia, you actually start with a very challenging starting material, because many of these patients do not only have disease in their bone marrow, but also actually have disease that actually gets into the blood and basically leads to very high tumor burden also in the blood |
| So, it's clearly an aspect you look at, and I think the shorter vein to delivery time overall helps, also because a lot of these patients are very immune -suppressed and there's always a risk that the patients could actually pick up an infection, which would then actually could delay the dosing because that infection needs de first be taken care of before you could dose the type therapy |
| And at the same time, there is obviously not insignificant amount of risk, particularly if it's a second transplant, that you have complications related to the second transplant, including treatment-related mortality |
| So, from a confidence interval, not clearly differentiated |
| It was a very unusual project |
| You also don't want to actually over-engineer or over-design the capacity, because if you go too high, you have too much excess capacity |
| What we’ve seen at ASCO is obviously just scratching the surface of the data that we've collected |
| And the longer experience with the product is that while the first patient on the ALLCAR study received a stem cell transplant, actually that user transplant decreased quite a bit after that |
| We've taken a significant amount of risk out of the program with the successful data presentations for the FELIX study at ASCO and EHA |
| I think what I'd like to point out that at the bottom is obviously the patients did have high levels of tumor burden in their marrow, and also we had a significant proportion of patients that had Extramedullary disease, which are known to be very difficult to treat and to manage |
| I think it's also worthwhile pointing out and not a surprise that obviously if you have patients that had a very significant number of prior lines of therapy, they tend to do less well than patients that had been less exposed to therapy before |
| And as you can imagine, that's an incredibly difficult starting material because you have to first get rid of those cells before you can even think about manufacturing, and which means that your manufacturing process has to be able to handle a wide range of very complex and challenging starting materials |
| That's not a good idea |
| We were not able to go onto the sites |
| Now, people are critical here and I think we shouldn’t underestimate the importance of the piece that you have to build here, and the people you have to train |
| If you're below 20%, you have a very low probability of experience to high-grade ICANS |
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