Autolus Therapeutics plc (NASDAQ:AUTL) Q4 2022 Earnings Call Transcript

But I think this gives you a very good penetration and ability to reach the ALL population with this profile, as we see basically demonstrated through Blincyto already.

James Shin: Thank you.

Operator: Thank you. One moment. Our next question comes from the line of Sebastiaan van der Schoot with Van Lanschot Kempen. Your line is open.

Sebastiaan van der Schoot: Hi, good morning and good afternoon, everyone. It’s Sebastiaan van der Schoot from Van Lanschot Kempen, but–no worries. Congrats on the progress. I was just wondering at the opportunity of obe-cel in other indications beyond ALL. Will there be additional updates on the ALLCAR study for the other indications with additional patients, and are there any of these indications that you believe would allow for accelerated approval pathway if the additional data can show the same level of efficacy as last year? Then you also spoke a little bit about the life cycle management of AUTO122. Can you expand on your thinking on the possibility to continue development of AUTO122 beyond the pediatric indication into adult indications? Thank you.

Christian Itin: Thanks Sebastiaan and thanks for joining. When we look at the opportunity that we see with obe-cel, obviously what the product has a remarkable profile in is to basically remove the B cell compartment both on malignant cells as well as healthy cells, and do that with a very good safety profile, so that’s the basic property of the product. Where that is suitable obviously is in leukemia, it is in non-Hodgkin’s lymphoma, which is what we’re evaluating what we’re evaluating as part of the ALLCAR19 study, and then as Kelly was pointing out, there is also certain applications in the autoimmune space where that might become quite interesting and some of the lead data would indicate that we might even be transformational in those settings.

This is sort of the range, I think you have in terms of opportunity, significant on the oncology side but also one that starts to build up also on the autoimmune side, so that’s the range. Now it’s a question of choice. What we’re seeing in our ALLCAR19 study is really that we’re having a very high level of clinical activity across the entire range of these indications, and that gives us also more confidence in terms of the overall property of the product. In terms of the individual indications, obviously you have opportunities looking at , as an example, where we see very high levels of complete remissions that are sustained. We haven’t seen any relapses to date in that cohort, which is quite remarkable. There are obviously very interesting data in mantle cell as well as in that we now see.

Now, all those indications are opportunities to develop these segments of the indication which allows it to move relatively quickly and with an accelerated path, and then depending on the indication you look at, you also may then want to sort of go for a last line we’ll want to actually start looking at an earlier line study as well, which typically be a randomized control study in that earlier line. I would want to move on that reasonably–in a reasonable sort of time relation to your last line setting. So that’s sort of the opportunity and we’re looking at these, and obviously the data from the ALLCAR study does give us, I think, a very nice basis just to develop the right options for the investment. You then also asked about how in that conversation, how AUTO122 fits, and as we indicated, we obviously do know that with AUTO122 that we have a very active program.