Iovance Biotherapeutics, Inc. (NASDAQ:IOVA) Q1 2024 Earnings Call Transcript

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Dr. Fred Vogt: And then on the Type D question, is Raj available? Raj, can you take that question? We may be a little, we may have a breakdown here, Reni, in the audio, I will take it for you. We have to have regulatory meetings with the FDA for each indication for potency assays right now. Now ultimately, we may be able to take a platform approach. I’m sure you’ve seen Peter, Marks talking lately about platforms and this kind of thing. But as of today, what we’re doing is we’re going to the FDA with each of our indications and talking to them about the specifics of the potency assay for that indication and that’s what we successfully did recently for non-small cell lung, which is a very important step in getting towards a BLA submission for non-small cell lung cancer with lifileucel.

Reni Benjamin: And as we think about timing, Fred, like can we at least assume that since you it took pretty a decent amount of time to get that discussion lead and for everyone to be on the same page. We say that that’s kind of 80%, 90% there already with non-small cell lung cancer and so things should go by a lot quicker or are we kind of back to the drawing board with each indication?

Dr. Fred Vogt: No, no, we’re definitely not back to the drawing board. What we’re doing now is we’re doing it what we think is the right way. We’re getting in front of the FDA at the right point in our clinical development program for non-small cell lung. You can see we’re still enrolling for that study. We’ve got enough data now from enough patients that we can actually show them what we think is a viable potency matrix proposal with data from the actual pivotal patients which is very important. While we’re early enough in the study to be able to make adjustments should they have questions or have things they want to change. As opposed to what we did the last time with melanoma, it was effectively do that all after the fact or largely after the fact if the study was already complete.

So what we’re doing now we think is the right way to develop polyclonal T cell therapies and this should actually accelerate our process, so that when we finish non-small cell lung, we go straight to a pre BLA meeting and straight to a submission.

Operator: And our last questioner coming from the line Ben Burnett with Stifel. Your line is open.

Ben Burnett: I was wondering if you could maybe just talk about the patient flow within the hospital. Are you seeing any bottlenecks popping up, like for example, are there any, have there been any learnings that have needed to happen sort of efficiently coordinate with the surgeon or anything like that?

Dr. Fred Vogt: Yes. Actually, I would say the opposite. We’ve really seen a tremendous enthusiasm from the surgeon all the way through the cell therapists and the nurses that treat these patients. We’ve seen a hospital bend over backwards to find operator in time, space in the hospital. We really haven’t experienced any of the potential bottlenecking even as we increase. Most of the things that we encounter are really just sort of small questions on details, but not the big issues like having a time or place to treat a patient.

Ben Burnett: And if you could also just comment on just the quality of tumor sample coming in for manufacturing, I guess, how is like kind of the specifications around those tumor samples compared to like what you saw in clinical trials?

Dr. Fred Vogt: I can take that or Igor if you would like.

Dr. Igor Bilinsky: I’d be happy to. Good question. So far, the experience has been very consistent with our clinical experience, including the quality and the size and the quality of the tumor samples for manufacturing.

Operator: Thank you. And ladies and gentlemen, that’s all the time we have for our Q&A session. I will now turn the call back over to Dr. Fred Vogt for any closing remarks.

Dr. Fred Vogt: Thank you again for joining the Iovance Biotherapeutics’ First Quarter 2024 Financial Results and Corporate Update Conference Call. As we’ve shared on this call, we are very pleased with the strength of the Amtagvi launch and excited to see accelerated growth throughout the rest of 2024. Thank you to those in the patient, healthcare and advocacy communities, our partners and our exceptional Iovance team. I would also like to thank our shareholders and covering analysts for their support. We look forward to presenting data at ASCO and lifileucel and frontline melanoma and we’ll host an Analyst and Investor event on May 31st. Please feel free to reach out to our Investor Relations team for follow-up. Thank you.

Operator: Ladies and gentlemen, that does not conference call for today. Thank you for your participation. You may now disconnect.

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