N4 Pharma plc (LON:N4P) Chief Executive Officer Nigel Theobald caught up with DirectorsTalk to discuss the Material Transfer Agreements, collaborating with more partners, the in vivo studies, how the work done under the MTA may negate the need for the Company to do its own proof of concept work and what investors can expect in the coming months.
Q1: First off, congratulations on a well-received operations update. Can you explain what is involved in the Material Transfer Agreements (MTA) that N4 Pharma has announced?
A1: I think the first thing is this shows that the data we’re actually putting together is now becoming more relevant to potential partners so it’s great that we’ve managed to get a couple of Material Transfer Agreements signed.
As you say, the MTA is a quick and inexpensive way really for us of engaging with potential collaboration licensing partners. So, what we do, under the MTA, they will send us their material, we will do a series of tests on that material so how well does it load, how well it disperses and transfects.
They would do any in vivo testing, we would just do some simple in vitro testing so if there’s expensive in vivo testing to do then we would send the material back to them or the protocols for them to test it.
So, predominantly, we were doing vitro testing, we might test a particular dose that they’re interested in, a particular combination of plasmids so it depends on what the partner is looking to achieve in working with Nuvec.
What it does do is it gives our partner or potential partner a much greater competence that Nuvec is going to fit with their program and it’s worth investing in.
Q2: Are the agreements exclusive or are you looking to collaborate with more partners?
A2: Not they’re non-exclusive, we’re very much hopeful that they will lead to licensing and they’ll probably be exclusive licenses for particular areas, depending on how well the tests go and how well the fit is with their program as a result of the MTA.
We are looking to do more, and we can do more, and that’s something, as I say, that is a great way of engaging with potential partners. Our goal is not to do lots of MTA’s, our goal is to actually convert these into licensed collaborations.
Q3: The in vivo studies, they look very positive but can you tell us more about them and what it actually means for the business?
A3: We’ve been doing a lot of work on how we can improve and disperse the formulations of Nuvec and we previously announced on a lot of that progress and that fact that we can now disperse Nuvec very well.
So, this is the first time we’ve been able to attest an improved formulation of Albumin and it’s in a pilot in vivo study and it’s given us fantastic results. What it’s showing is that a lower dose of say 10 micrograms of Albumin, when it’s fully monodispersed in formulation, gives actually a better response than the higher 50 microgram dose in our original Nuvec formulation, which we have seen was more agglomerated. That very much fits our theory as to what was causing some of the variation.
So Nuvec has always worked, we’ve never had a problem with Nuvec working, in previous tests we’ve seen some variation and we felt it was caused by the agglomeration and what this is sort of hinting is that when we were getting 50 micrograms loaded, not all of it was fully engaging with the particle, so we were only getting a fraction of that working.
So, the fact that we can get 10 micrograms fully dispersed, you’d expect the performance to drop off but it doesn’t, it improves because we’re getting a more consistent amount loaded per particle, and that all leads to a better, more positive test.
What collaborators really want to see is lower doses and good consistent results and that’s exactly what we’re beginning to get but it is a pilot. We going to test it again, making sure consistency and also to make sure that Evotech, our other CRO, and the potential collaborators under the MTA’s, that they’re using the exact same protocol that we’ve seen in this fully monodispersed formulation for any testing that they do.
Q4: Can you explain for us how the work done under the MTA, and subsequent relationships, may negate the need for the company to do its own proof of concept work with an off the shelf COVID-19 plasmid?
A4: We’ve always said, the work that we’re doing on COVID is, again, delivering proof of concept work using a COVID plasmid rather than just using Albumin, we’re not developing our own product for selling on the market and that’s very important.
If we’re now testing Nuvec with a potential partner and we’re testing their actual plasmid DNA for COVID and if that work is positive, then that pretty much removes the need for us to do a lot of our own proof of concept work because we’d have proven it was their plasma. So, it doesn’t make sense to spend lots and lots of money doing proof of concept when we’ve actually got our collaborators in real live plasmid DNA that we can work with.
The other thing it does is it allows us to just review the work because since we started working on the COVID proof of concept, there’s many more companies now that are offering off the shelf plasmids. Some of them, when we look at them, seem much better than the NIH one that we acquired back a year ago now, so we’re also going to review which plasmid is the right one to use for any work that we might need to seemingly still need to do something depending on the outcome of the work they’re doing under MTA.
So, it gives us a chance to sort of just step back a bit from our own proof of concept because we’re doing the proof of concept with someone else’s actual plasmid.
Q5: What can investors expect from N4 Pharma in the coming months?
A5: I hope much more of the same. We’re looking to do, as I said earlier, more MTA’s and because that’s a great way of engaging with potential licensees, we’re also making sure that there is a view to licensing as a result of those MTA’s.
The new Postdoctoral employee that we’ve got at the Medicines Catapult is going to allow us to do a lot more work, both for our own formulation testing and also, doing this simple, inexpensive MTA collaboration.
We’ll also be looking to do further testing of the improved monodispersed formulations, maybe looking at different doses etc. and hopefully we’ll have further country patent grants coming through. We’ve already notified of the intention to grand the UQ patent in Europe and Australia and we’re hoping for others soon.
So, that all means lots of good, strong, steady progress and this is very much what we hope is good news for our long-term shareholders.