In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, explains which specific endpoints they'll be looking at in the Phase I trial to assess LP-284's potential efficacy and how the insights gained will be fed back into RADR®
While reaching the first-in-human stage is a significant achievement, what specific endpoints or biomarkers will you be looking at in the Phase I trial to assess LP-284's potential efficacy for non-Hodgkin’s lymphoma (NHL) and other targeted cancers?
All the phase I is mostly looking at safety and going for optimal dosing. This is our second phase one clinical trial in this class of drugs that we've launched. The first one is LP-184. This one is kind of a sister, drug sister therapy to 184 called LP-284 this one to us is particularly unique, because it doesn't work in solid tumors like when it for it really works and blood cancers. This is a drug that three years ago, we hadn't even made, we went from iron from a whiteboard, to a first in human clinical trial with this candidate and about three years at a cost of less than $3 million. And that's because we used AI, it's an unheard-of achievement in oncology drug achieve drug development. And the fact that we actually know what to look for mechanistically is also another great achievement. I've heard of many drugs that are going into phase I, where the CEOs of the CSOs will tell you point blank, 'we're not quite sure how this works, but we know it does something.' Unlike that we actually know what we're looking for, we think LP-284 was published multiple times, is a highly potent deplete er of B cells. And that's where a lot of NHL is arise is CD 19, and CD 20, B cells and T cells. And this drug seems to eat them up B cells in particular, so it's a potent depleted of B cells. And so that's one of the key things we're going to look for, we're going to look for the depletion of CD 19, and city 20, positive B cells and B cell populations in general.
But the other thing that we found with LP-284 is when there's any kind of DNA damage repair pathway deficiency, like ATM or ATR, it seems to be even more potent. So of course, we'll be looking for those Hallmark those biomarkers as well, mostly larger scale exploratory biomarkers around DNA damage repair pathways, which are not that common in NHLs. But if you look at the recurrent cases of NHLs, they tend to be enriched. So these tend to be more aggressive, more rapidly growing. So we're going to look at both sets of biomarkers, and that'll guide our next phase for LP 284. And like I said, this drug went from an idea on a whiteboard to the first human clinical trial in three years at a cost of about $3 million. And so we're pretty excited by that.
Your press release highlights the role of RADR® in identifying LP-284's potential. How will the insights gained from this Phase I trial be fed back into RADR® to further refine its capabilities for future drug discovery?
we'll have a lot of data from the pharmacokinetic work. In terms of drug availability, we'll have a lot of biomarker data around the B cell depletion from, you know, flow cytometry based assays and of course, will have transcriptomic and mutation data probably from the liquid biopsy samples we take. So all that data from that trial is anonymized and fed back into our platform along with outcomes. And we're going to have a range of outcomes as measured every few weeks. And so those criteria, as measured every few weeks, will be correlated with the biomarkers and will also floor correlate with the evolution of the biomarkers to see, where are we really seeing durable or more complete responses? And where if we find that unique signature even further refined, the patient population, you know, will then go into phase two, looking at a further selected patient population.
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