Nick Talamantes 0:00
John, thank you so much for joining me at LSI Europe.
John von Benecke 0:03
Great to be here.
Nick Talamantes 0:03
Tell me a little bit about Locate Bio.
John von Benecke 0:05
So we are a spin out from University of Nottingham. Interestingly, from the School of Pharmacy, we are definitely focused on sort of bringing combination products to market. And I think that heritage coming from leaving school of pharmacy in the UK gives us a great capability to bio converge between pharmaceutical skill sets and med tech skill sets, which is our other core competency.
Nick Talamantes 0:26
Talk a little bit more about the two core competencies at the heart of Locate Bio.
John von Benecke 0:31
Yeah, so on the one hand programmed to drug release, which is really better aligning known molecules with their bioavailability relative to the biological need. And the other core competencies, material engineering, so building instructive tissue scaffolds, so that's building scaffolds that have features about them, that can actually guide cell fate towards a particular tissue type.
Nick Talamantes 0:54
Programmed drug delivery sounds incredibly interesting, what how do you program a drug to be delivered?
John von Benecke 1:01
Yeah, so we've got a couple of different technologies that we use. Some are biodegradable polymers. So we have a, our lead product is called LD Graft. It's a lower dose controlled release BMP two. So BMP two is a highly effective therapeutic protein used to grow bone and we control it's released, because we, in case that protein within this biodegradable polymer, and these little polymer pellets, as they start to degrade, release fresh BMP into the microphone, so so that's one of the ways that we control and extend the release of drugs. The other is using, I suppose you would call it a nano medicine type technology. It's it's very early stage for us, but we're seeing some incredible results with that as well. So we're using that to deliver anti biotic for bone and joint infections, and again, having a really extended release profile, which helps for those particular drugs that are time dependent, rather than dose dependent. So some of the antibiotics that you use to clear biofilm infections require very long release off off the antibiotic. And we're able to achieve that with this material.
Nick Talamantes 2:12
The ortho biologics market is a pretty large one, if I'm not mistaken, what sort of the unmet need today that your company is addressing.
John von Benecke 2:21
So it is a super big market. You know, I think there's something like 1.7 billion people around the globe who suffer with some form of muscular skeletal disease, the actual bone grafting segment, is valued at just over $3 billion a year. And there's maybe 300 Odd products that are approved, and they go from fairly simple for non-contentious types of healing that are required all the way up through to powerful therapeutic products. And what we see our unique skill sets being able to bring is optimizing the bioavailability of those powerful molecules in the context of a three dimensional tissue scaffold. So we're able to locate the release of the drug exactly where we want it, and control it over a long period of time. And I think that gives us the opportunity to enhance healing, quicker healing, lower side effects will be the aim of the products that we're developing as well.
Nick Talamantes 3:20
Fascinating. You mentioned the market opportunity, what's sort of the indication that you're chasing after first year with the product
John von Benecke 3:28
So our initial indication is going to be for lumbar fusion. So low back pain is something pretty much everyone has had at some point in their life, it can be very painful, but often a loss lasts a short period of time. But for other patients, that's because they're suffering from something called degenerative disc disease or some other form of lower spinal instability. And the discs the, the shock absorbers of his spine. So as they start to age, they dehydrate slightly use a little bit disc height, and that can put pressure onto the facet joints of the back of the spine or the nerves coming out spine and it causes excruciating pain. So the treatment for those patients is your start and lifestyle changes that build up your core strength and you won't bend in same way. But then they will move on to very powerful painkillers, some of which are highly addictive, and so you can't take those for too long. So ultimately, some form of surgical intervention is required. And that's where really our product comes in, which is to for the people going and interbody fusion that that disease disc will be removed. They'll restore the disk height by putting a spacer or a cage and but you can't just leave it there, you've got to get burned to bear the weight. Otherwise, you'll be injuring the adjacent segments. So our product goes in and converts into bone over a number of months.
Nick Talamantes 4:45
Looking a bit further ahead, what's the sort of roadmap or pipeline for your technology?
John von Benecke 4:50
So LD graft, which is our lead program is just finishing its large animal study now so that those data are landing this month. The next month is really exciting time for us. We're pushing up products into human clinical studies next year. And that's an incredible milestone for any early stage company, our antibiotic product needs to go through a lot more preclinical testing. So this is the first time that that particular technology has been used in humans. So there's a lot of safety data we'll need to generate for that. We also have another product, which is just the instructive tissue scaffold on its own. And that's a simplified 10k regulatory process for us. So you know, again, we'll be pushing that forward towards submission towards the end of next year,
Nick Talamantes 5:28
Is your technology for instructive tissue scaffolding and program drug release. Is that only limited to bone regrowth? Or can it be used in other orthopedic indications,
John von Benecke 5:38
So it can be used in a lot of other areas. But as a small startup, we're kind of focused on musculoskeletal because we know it super well. You know, it's really where we focus. But as a drug delivery vehicle, both the technology we use, so the biodegradable polymer and the other technology for antibiotics that can be taken into a wide variety. So even if we wanted to stay just in muscular skeletal, there's other drugs that you may choose to deliver, whether those are for bone tumors, and you want a nice long extended release of a chemotherapy agent. But it can also be used in in pretty much any drug depo type, long acting release of small, small and large molecules, actually.
Nick Talamantes 6:20
So John, it's my understanding that you're currently raising money. Tell me a little bit about what you're trying to achieve with those funds and where it's going to take you.
John von Benecke 6:27
Yeah, so we've we've raised 18 and a half million pounds of money through our seed and series A rounds. And we're now going out for a series B, we really want to fund all the way through our first in human study for LD graft and bring our other product line products, you know, through their preclinical phases, that will give us our Series C as we see that to complete the clinical studies for the next phase for LD graphs. So there's two studies we're doing. The first is around 45 patients, and then we'll move into pivotal study. So Series B really gets us to the end of that pilot study, and pushes the preclinical work through for the other programs.
Nick Talamantes 7:07
Looking at territories. Are you looking at going to the EU first the US? What's the initial commercial strategy sort of look like for locate bio?
John von Benecke 7:17
Yeah, and again, you know, as a small company, where Absolutely, we have to focus, and it is absolutely focused on the US. So all of our regulatory regulatory interactions are, are geared at getting to a US approval first, the other territories will come, but they'll come later, you know, we're looking at US, UK, places like Australia. And hopefully by the time we're there, everything has settled down with the MDR transition in Europe. And therefore, you know, there's more clarity and how we can bring that product into Europe.
Nick Talamantes 7:50
So John, what brings you to LSI Europe,
John von Benecke 7:52
it's been a great event. I think it's fantastic opportunities to network with people and reconnect with people I've known over the years and the industry. Couple of really interesting meetings with service providers and with investors, and an opportunity really just to showcase the product.
Nick Talamantes 8:06
They had a lot of interesting meeting so far.
John von Benecke 8:09
Yeah, there will be an absolutely great and I think it's been really well run event and something that Europe's needed for a long time.
Nick Talamantes 8:15
It's been great getting to learn more about locate buy and what you guys are working on. Is there anything else you want to share with me about sort of maybe your mission?
John von Benecke 8:22
Yeah, you know, I think we are absolutely focused on on relieving suffering, improving quality of life and all those patients and I think we're doing that in a way that recognizes that health care costs can't just keep going up. So those are the call, go to market strategies for us, you know, how do we improve patient outcomes without increasing cost to the healthcare system? So that's, that's us on a on a napkin.
Nick Talamantes 8:46
It's great speaking with you.