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

Christian Itin: Yes, very good question. What you’re referring to is the AUTO8 program that we’re working on with our colleagues on the academic side. We’re currently running a Phase I clinical trial to evaluate the activity of AUTO8 in relapsed refractory multiple myeloma patients. I think we’re at an interesting spot with regards to the CAR T therapies in multiple myeloma. We have obviously seen very nice levels of activity with the two approved products in the space, but there is also a very high unmet need and, at this point, still a remarkable inability to meet the demand in this indication, and that is likely going to continue for quite some time. With regards to what we’re looking to see with the program, we obviously want to see a very high level of complete remissions in these patients combined with deep molecular remissions, and at the same obviously we’re looking at the safety profile.

We clearly want to see a very significant level of clinical activity in these patients as a basis to consider taking the program forward, and if we’re at that point, clearly we’d anticipate that this would make sense to do in a partnership. Thank you Gil.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Mara Goldstein with Mizuho Group. Your line is open.

Mara Goldstein: Great. Thanks so much for taking my question. First of all on the multiple myeloma data that you do anticipate having this year, can you just give us some element of scope of that, number of patients and what exactly we should be prepared to be looking at? Then I also wanted to ask on obe-cel and thinking forward from a competitive perspective, is the competitive go-to-market strategy versus Blincyto or Tecartus, can you help us understand how you plan to position obe-cel?

Christian Itin: Yes, hi Mara. Thanks a lot for the two questions. The first question was related to the AUTO8 study. The AUTO8 study is a small Phase I clinical study, so we’re looking at around 10 patients as the initial experience and then we’ll take it from there, so it’s going to be an initial look at that, at the profile of the product in that initial set of patients. Now with regards to obe-cel, what we’re expecting to go for is obviously a positioning of the product in the relapsed refractory setting whether patients have had already received Blincyto or are post-Blincyto. I think that is obviously what the current study actually is evaluating, is patients that have very advanced disease and with a portion having had Blincyto and inotuzumab, or in a portion who didn’t, so you’re looking to position the product both in parallel or after Blincyto therapy.

Tecartus obviously is positioned in that exact same way, so it would be the same type of positioning that we would expect for the program.

Mara Goldstein: Okay, thank you.

Christian Itin: Thanks Mara.

Operator: Thank you. One moment for our next question. Our next question comes from the line of Matthew Phipps with William Blair. Your line is now open.

Matthew Phipps : Hi Christian, thanks for taking my questions. At the recent European CAR T meeting, Kite’s, or Gilead presented some long term follow-up from ZUMA-3 with Tecartus, and it shows very few patients really remaining in CR even beyond two years, so it’s a pretty big contrast to the data you presented at ASH from follow-up with ALLCAR19 – it shows, I don’t know, 35, 40% of patients still on CR at three years. Do you expect the FELIX data to recapitulate the ALLCAR19 durability given you’ve talked about a little bit tougher to treat patient populations with extra-medullary disease and such? I guess how do you get that durability message across to physicians in your education process?