David Martin: Good morning. I got a couple of questions. The first one is just a clarification. When you were speaking, Fahar, I think you said that we get PK/PD and initial efficacy results for cohort five in the first calendar quarter. In the press release, it kind of indicates only PK/PD and the efficacy will be an update for cohorts one through four. Just confirming, are we getting efficacy data for cohort five in Q1?
Fahar Merchant: I did not realize. Thanks, David for that particular question. But yes, let me sort of correct that. If the press release did not mention that, then apologies. But yes, the intent is for us to release the PK/PD, but also the tumor activity data from cohort five before the end of this quarter.
David Martin: Okay. Another clarification. So, with the patients with higher baseline lymphocyte counts in cohort five and six, you had anticipated that by using that inclusion criteria that you would get healthier patients. And yet, you’re saying that cohort five, cohort six are still very sick patients, and you’ll only start getting healthier patients in the dose expansion. So is that correct by selecting based on the higher baseline lymphocytes, you didn’t get healthier patients in five and six?
Fahar Merchant: Well, it’s not as you know, healthier patients is based on the healthier immune system, certainly, in cohorts five and six, you end up with patients with sort of a baseline lymphocyte count that is higher than what we enrolled in cohorts one, two and three. So, from that perspective, certainly, what we want to try and simulate is, obtain or realize that in cohorts €“ in the expansion cohorts, we will be looking at patients that have gone through fewer lines of therapy. And therefore, we expect that those patients enroll in that expansion cohort will likely have higher lymphocyte counts. So it’s in a sense for us to provide that information to gather that informations, we are better able to foresee what to expect going down the road.
But remember one thing about patients that have gone through multiple lines of therapy, it’s their lymphocyte count primarily from their immune health perspective. But then again, there are a host of other issues that we need to take care of or worry about, because remember, in the dose-escalation portion of where we are is really treating about a dozen different types of tumors in this particular portion of the trial. So trying to sort of come up with some kind of homogeneity or minimizing the variability here with sort of trying to stabilize and using 1,000 lymphocyte counts per se. But nevertheless, patients would have, as you know, gone through so many different type of therapies, some focused on immunotherapies others with different kinds of chemotherapies as well.
So we have a very diverse patient population in the dose-escalation phase, where not only are we dealing with different tumor types, but also different therapies that patients have received. And patient’s health is not only determined by the immune count, but also from other prognostic factors, age is a good example for instance. So that also, we cannot obviously restrict from that perspective. But there is a host of variations that we take into account. But the focus really now is planning for the dose expansion phase of the study, and identifying two or three different tumor types that are most likely to be beneficial to the patients, these patients certainly will not be onstage patients. And therefore, we expect the patients to be more homogeneous than we were in the Phase 1 dose-escalation part, where even if you have lymphocyte counts standardized, we still are dealing with 12 to 15 different tumor types.
So it’s a set of a combination of different, far too many parameters in the dose-escalation portion that we cannot really predict what would happen. But nevertheless €“
David Martin: Okay.
Fahar Merchant: Very encouraging to see that in cohort six, we were able to show promising data above the 1,000 lymphocyte count.
David Martin: Okay. Just one last quick question. With a new priming schedule, you say you get to the 60 dose faster. Can you remind me when your dose cohort that dosed at 60? Did you go right to 60 or did you start at 30 and went to 60?
Fahar Merchant: No, we started at 30 and there were two doses of 30 in the cohort four, and then went to 60. So, it took four weeks before we got to 60. In this case, we’ll get to 60 in two weeks.
David Martin: And you’re pretty comfortable that they’ll be able to tolerate getting to 60 that fast?
Fahar Merchant: Well, that’s the objective and that’s why we had a Safety Review Committee to make that final call.
David Martin: Okay. Okay, that’s it for me. Thanks.
Operator: Thank you. The next question is coming from RK of H.C. Wainwright. Please go ahead.
RK: Thank you. Good morning, Fahar. And a lot of my questions have been answered. When you get to Phase 2, I was just wondering, you know, among the four indications that seem to be the ones that you’re looking at during the stage of development, you know, how would you order them? Or would you consider just taking the pancreatic and the melanoma as indications to go forward?
Fahar Merchant: Yeah, we haven’t decided specifically on the tumor types so far. And I think we continue to review the data. We certainly will be collecting more data from cohort five, cohort six as well as historical data that we’ve seen so far from the first four cohorts. So we are working closely as to what indications to pursue it in the dose expansion, and we will provide an update as soon as we have had received feedback and guidance from our clinical advisors, KOLs, et cetera based on the growing body of evidence from the current study that we are conducting. So nothing’s been etched in stone at this moment.
RK: Okay. And then one last question for me. Any update on the BiSKIT program? Because we didn’t hear much today.
Fahar Merchant: Yes, so the BiSKIT program, since our last set of data we presented at our conference late last year, we continue to advance that particular program, we certainly are continuing to optimize the design of the molecule and generating more in vitro, in vivo studies and characterizing that molecule further. So we will, as we get an opportunity to present data at additional conferences, or submit a publication, we will be providing more evidence and more data at that time.
RK: Okay, thank you. Thank you for taking the questions.
Fahar Merchant: You’re welcome. Thank you.
Operator: Thank you. The next question is coming from Catherine Novack of Jones Research. Please go ahead.
