BioLineRx Ltd. (NASDAQ:BLRX) Q3 2023 Earnings Call Transcript

Of course, I’m not ruling out us potentially taking this forward ourselves depending on the situation. but it’s likely in a very significant indication like this. And when we’re talking about PDAC, we’re not only talking about PDAC. We look at this as sort of as a proof of concept for other solid tumors as well. And so obviously, that would speak to a larger company conducting many studies, many Phase III studies across the board in order to get broad approval in a number of indications. So I hope that answered your question. I think that we’re looking at this as a potential launch launching pad, so to speak, for business development with larger companies in this particular area of solid tumors.

Joe Pantginis: It certainly answer the question. I appreciate the color and as usual what I’m hearing personally is that you continue to have a lot of optionality going forward. Thanks a lot guys.

Phil Serlin: Thank you.

Holly May: Thank you.

Operator: The next question is from John Vandermosten of Zacks. Please go ahead.

John Vandermosten: All right. Thank you and hello, Phil, Holly and Mali. As the previous — as Joe mentioned, APHEXDA was added to the NCCN guidelines, how quickly is a change like that incorporated into practice?

Phil Serlin: Holly, do you want to take that?

Holly May: Sure. I mean from a market access perspective, that’s what many of these payers will mean on it for decisions about the reimbursability, et cetera. So from an NCCN perspective, pretty much immediately.

John Vandermosten: That’s great. And then looking at gene therapy, I mean, personally, I think that’s one of the greater options that you guys have out there. You’ve got quite a few. But there was recently a sickle cell disease drug approved Vertex, I think, in the UK. And I think they’re also applied in the EU and the U.S. as well. Is that what are the bottlenecks there in terms of gene therapy for sickle cell disease is stem cell mobilization part of the bottleneck there. Is that approval and potentially two others and somewhere where you can get into as well? I mean you’re doing work there. Maybe you can help me understand kind of how that drug that just got approved in the UK might be something that you could take advantage of.

Phil Serlin: Holly, do you want to take that? I mean…

Holly May: Why don’t I begin and then you can add on if I set some gap. And I may be a good one to ask just because it’s a world I came from. So prior to this, I was the Chief Commercial Officer at a gene therapy company. So I certainly understand the challenges — we also know that both Vertex and Bluebird are looking at PDUFA dates in December here in the U.S., so that could be significant. I think that the thing that is that gene therapy company to these ex-vivo gene therapy customers are always looking to solve for is that entire patient journey and what kind of improvements can be made. And that can happen on several different fronts conditioning with one area that, of course, they’re always looking at, but also [indiscernible] is another area.

And I think this is especially true with sickle cell disease because the standard for mobilization. We see it with our multiple myeloma indication is G-CSF plus a mobilizer such as APHEXDA and with that, we know that sickle stop patients are unable to be unable to use G-CSF in sickle cell patients. So I think it produces a an appendage situation in sickle cell. That’s not to say that symptom mobilization isn’t also something that’s looked at for some of these other applications. And in the future as these come to market. We will — we could also be looking at those. But right now, of course, our efforts are focused on the high unmet need in sickle cell. And as has been announced, we do have the study at Wash, which is looking at some of that.

So did I forget into, was there anything you wanted to add to that?

Phil Serlin: I think I might want to add. I think we’ve mentioned this previously, but we look at this area as something that we can really, really find a real place for it. There is an unmet need. There’s a huge amount of cells that are required to be mobilized in — for gene therapy. We’re talking about 15 million to 20 million CD34+ positive cells per kilogram. And just for example, in multiple myeloma, our phase III, we’re talking about 6 million cells per kilogram. And so a significantly higher number of cells need to be mobilized in order to move forward in gene therapy. And in addition, as Holly mentioned, these patients cannot receive G-CSF and therefore, it’s that much more difficult to mobilize. So the current mobilization regimen require these patients to go through multiple cycles of after recessions and mobilization and collection with usually a 30-day period between each cycle.