Van de CC na de kwartaalcijfers (27 augustus)
This is Pam Barendt, on for Chris Shibutani. We're really looking forward to the initial clinical trial readouts toward the end of this year, for 343 in particular. Could you help frame for us how we should be thinking about the results? Remind us what kind of results for key endpoints you're trying to achieve? And what endpoints, in particular, will be most important for informing your plans for next steps?
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Stephen S. Yoder, Pieris Pharmaceuticals, Inc. - CEO, President & Director [15]
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Okay. Thanks for the question. I think we'll, again, let Lou start with this answer, given the scientific nature here.
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Louis A. Matis, Pieris Pharmaceuticals, Inc. - Senior VP & Chief Development Officer [16]
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Yes, thanks, Steve. So with respect to PRS-343, as I mentioned earlier, as we move forward through the cohorts and the trial is recruiting extraordinarily well. There's a lot of excitement from all of our investigators. As you know, obviously, it's a multiple dose-escalation trial. And so we want to be able to establish the PK safety, immunogenicity of the drug, how well tolerated it is. So obviously, that's -- those are the primary endpoints of a Phase I dose-escalation trial in these patients. In addition, we have serial biopsies, and what we can say is that all of our sites are complying beautifully with that. And we're getting very high frequency of patients getting the pre and post biopsies that we've asked for. So we intend to be mining a considerable amount of data from that. And that data will include, as you might expect, evidence of immunologic activity within the tumor microenvironment; increases or not in CD8-positive T-cells as well as CD8 T-cell Treg ratios, which is another emerging biomarker in pre- and post-treatment studies in immuno-oncology drugs as evidence of likely clinical response. We're also doing RNA analysis and looking for what would be known as an inflammatory signature that develops with the drug. And so clearly, we'll be reporting on that. And then we'll also be reporting on evidence for objective responses in the patients with respect to tumor shrinkage. So with respect to PRS-060, we'd be reporting the Phase I study. And in that study, obviously, we'll be looking at -- and that was in healthy volunteers. So we'll be talking about the drug's -- [both] pharmacology, how well tolerated it is, lack of immunogenicity. And in addition, we may have some assays to demonstrate drug activity against the target, even in the healthy volunteers. This being said, we're now moving with the -- a multi-dose escalation in patients with mild asthma, but that won't be reported out until next year.
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Operator [17]
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The next question is from the line of Biren Amin with Jefferies.
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Biren N. Amin, Jefferies LLC, Research Division - MD and Senior Equity Research Analyst [18]
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I think last month you disclosed that you enrolled 15 patients in the 343 Phase I trial through 6 cohorts. So given your comments today that you've enrolled more patients in a 3+3 typical design, did those additional patients come in at cohort 7? And I guess, what led to your choice to increase patient enrollment beyond a 3+3? Was it DLTs or some other reason?
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Louis A. Matis, Pieris Pharmaceuticals, Inc. - Senior VP & Chief Development Officer [19]
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Yes. So we've actually -- we're moving forward seamlessly through all of the cohorts. As I said, we have (inaudible) tremendous enthusiasm. And actually to be honest, the reason that we're increasing the enrollment in different cohorts is because we have so many patients that are being brought in or being proposed to us by all the sites, we're letting every patient that the sites wish to enroll to get enrolled because the higher the numbers we get at each dose cohort, the more reliable the data will be from the standpoint of what we see at a particular dose with respect to immunologic activity, safety and so forth. So really, it's -- the reason why we're enrolling more patients is a good one. It's -- and all of the investigators are extremely appreciative of the fact that they're not having to [particularly] compete at each dose level for getting their patient in. So that's the primary reason. And since then, we've been enrolling seamlessly through each cohort. Again, if the patient gets treated and with the safety at 3 weeks, if there's a go, we start enrolling the next cohort. And so we've had no delays whatsoever.
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