Jay Short: Yes. I think you know from past studies with other C24, if you could – 2 things, if you could potentially increase the dose or and/or if you could keep patients on more cycles, you do translate to better outcomes if you can manage the safety. And I think there’s a fair bit of literature around that. That’s not quite as mal objective. Could we, number one, get to a higher dose in combination with PD-1. That’s one question. The second question was, could we get beyond 3 to 4 cycles in the combination therapy with C24 PD-1? And the third question is, could we do both. And that’s what we’re on the precipice of answering.
And I think we’ve already answered a portion of it with the 5 mg plus 3 mgs that we cleared. And of course, we’d like to see a readout for a few more months. So all of these things going forward here are additive, but we’re at we’re the right time frame to look at it. And I think we’re going to have a great encouraging answer. I’m hopeful later this year.
Tony Butler: Very helpful.uch the case with PD-1. And with CTLA-4, there is support for that. And that actually was the origin
Operator: Thank you. And our next question is from Reni Benjamin with JMP Securities.
Reni Benjamin: You mentioned that you identified the RORE 2 positive tumors using the liquid biopsy. Can you talk a little bit about how many patients were identified? And what does this kind of tell you about the proportion of ROI patients in the real world versus kind of epidemiological studies and the numbers we get from that?
Jay Short: Yes, it’s kind of interesting. In melanoma, you’ll recall that we sold approximately 7% positivity rate for RORI in melanoma using an IHC histochemical assay — as we transition to the liquid biopsy, we haven’t given a definitive number, but I can tell you, it’s certainly double-digit positivity rate. So it’s clear that the liquid biopsy because we’ve done a lot of validation around this assay has — it seems to be more sensitive being able to pick up patients that are or to positive but at a lower — probably a more sensitive level, so we’re seeing more patients. So that’s an advantage that goes beyond the fact that it’s much easier to perform that assay. So I think the lesson here is that every assay has a certain sensitivity.
And of course, the only patients that we had studied — we had 1 patient in evaluable patients in Phase I. We had one valuable patient that had come across in the Phase II study. partly only 1 in 1 that were valuable because of the low positivity rate. Well, if you can start to move the positivity rate up, then you’re going to get a lot more patients wanting to come on board to do the study. It’s a lot easier to take a blood draw than it is to go and get a tumor biopsy from the patient. The question remaining is, what is that threshold that allows you to see that activity. But with ADCs, there’s a lot of history saying that there can be a wide range of reaction. And so like in our head and neck, we saw something in the teens, as TPS score in the teens that we saw a PR right on the first dose.
So long story short, this liquid biopsy is allowing us to see a larger number of patents from a positivity standpoint. The next question we’re hoping to answer is do we maintain a strong response rate in this group, and we should be able to answer that in the near future.
