But also with the high-level interaction with agency. And this, of course, give us opportunity for potential priority review enrolling submission. So, we’re very excited to the direction. We’ll continue to have engagement and collaboration with FDA.
Brian Cheng: Thank you, Baisong.
Operator: Our next question comes from Eric Schmidt from Cantor Fitzgerald. Please proceed.
Eric Schmidt: Thanks for the question and congrats on the progress. Are you able to give the approximate number of patients, who are enrolled in the RUBY trial with sickle cell disease? And then it sounds like you’ve been able to make pretty good progress in enrollment in that study, despite the availability of commercial cell therapies. I was just wondering at centers that have both experimental and commercial cell therapy available, maybe Baisong could talk a little bit about what’s driving the decision to use the Editas product over others? Thanks.
Gilmore O’Neill: Thanks very much, Eric. Baisong would kind of date you on where our clinical trials.gov sets as a target for the cohort in our trial. And then obviously build on his perceptions of why we’re doing so well with enrollment even in the context of commercial therapies being available.
Baisong Mei: Yes. Yes, thanks Eric. We are very pleased with the momentum by the enrollment in both the EdiTHAL cohort and the adolescent cohort. And for the EdiTHAL cohort, we shared that in February with those we enrolled 40 patients. Now we enroll slightly more than 40 patients and therefore we closed the EdiTHAL cohort enrollment. And for adolescent cohort, we started like the beginning of this year. We already enrolled a multiple patients, and have multiple patient experience. We’re very pleased with that. Then as I mentioned, I’m on the road all the time to visit our investigators and the study sites. And then, they really feel that when is actually there our belief the reni-cel based on the MOA based on the data we have continued to sharing on that.
I also give credit the entire field in working on that with the two gene therapy approved for sickle cell, is also increased the interest in the direction of the gene therapy for sickle cell disease. So that’s how we see over the last year or so we see really great momentum that for reni-cel enrollment, especially after we release our data.
Operator: Our next question comes from Jay Olson from Oppenheimer & Company. Please proceed.
Jay Olson: Oh hi, congrats on all the progress and thank you for taking the question. Can you talk about the timing of the collaboration extension with Bristol? Was there some new data that triggered the new collaboration and is there any color on what new data Bristol may have seen? And then separately, can you talk about any work that you’ve done on developing a milder conditioning agent? Thank you.
Gilmore O’Neill: Well, what I would do is ask Erick to address the question about the BMS. What I do want to say, I can address the conditioning, which is that just at our last earnings, we talked that we are going to continue monitoring the space. We have significant contacts in the academic and non-academic worlds around the field. But we have actually really deployed our efforts, and our resources internally to focusing on our in vivo pipeline, including developing hematopoietic stem cells. The rationale for that being that, we see that where a milder conditioning therapy is actually approved, it would be used universally and adopted universally in transplant centers across multiple indications, including stem cell transplantation with hemoglobinopathies. And with that, I’m just going to pass to Erick, just to talk about the BMS deal.
Erick Lucera: Yes, thanks for the question. With respect to the timing of the renegotiation – or the extension, obviously, we put out a press release in the very recent past, a week or two ago, something like that. And that would give you an update on the timing. I’d say with respect to the data, Bristol-Myers, as you know, recently completed a portfolio review. And we were pleased to see that all of the projects that were working on them, are continuing to move forward. I think if – we would leave discussion of specific programs to them to talk about anything that they’re seeing in those programs, I would highlight the fact that at their most recent R&D day last September, which I think was the first one they’ve done in several years, they did mention six products on their pipeline chart, which were using our technology.
So I would refer you to their R&D disclosures from that meeting, to get an update on the work that they’re doing with us. But we are very excited about working with them. This has been a partnership that has survived several mergers and several portfolio reviews. So, we’re very excited about what we’re seeing.
Jay Olson: Thank you.
Operator: Our next question comes from Phil Nadeau from TD Cowen. Please proceed.
Unidentified Analyst: Hi, this is [Alex] on for Phil. Thanks for taking my question. So given the association between total hemoglobin levels and organ function, do you plan to utilize any quantitative endpoints, basically assessing end organ function in the RUBY trial? And if so, what might those look like? And when can we maybe expect initial data? Thanks.
Gilmore O’Neill: Thanks very much, Alex. I’m going to ask Baisong to address that question.
Baisong Mei: Yes, thanks, Alex. We certainly have measurements for the end organ function. We look into the several major organ system, to monitor the function improvement. For example, we monitor the liver function, not only with these different lab values, we look into pulmonary function to check the respiratory system. And we also have cardio echo and other measures talking to – measure the cardiovascular system and that too. So, we are looking forward to seeing more data on that and give us more understanding of the end organ function, may behave after the treatment. Just a reminder that we also, of course, look into the not only sickle cell, but also other area in terms of the anemia, how that impact function and how that correction of anemia may be able to improve that function after the treatment.
And in sickle cell specifically, over the last couple of years, you already see more publications about end organ function given after the allogenic transplant, to treat sickle cell patients. We are very excited on that. But just to be very honest to ourselves, right, this field is still fairly new and we see some really good publication and direction in this. And we’re looking forward to our own study, as well as the literature on this field.
Unidentified Analyst: Good. Thank you.
Operator: Our next question comes from Yanan Zhu from Wells Fargo. Please proceed.
Yanan Zhu: Thanks for taking our questions. So first on the differentiation of total hemoglobin normalization, I was wondering, have you had feedback from sickle cell treaters on that differentiation and whether there’s any hesitancy or pushback that perhaps the current level of hemoglobin achieved by the marketed product is sufficient? How much of that kind of thinking is out there? And on the in vivo side, I was wondering, are you focused on first in class targets, or perhaps not first in class targets, but hoping to have a differentiation on, specificity and transduction efficiency, et cetera? Thanks.
Gilmore O’Neill: Thanks very much, Yanan. So I’m going to ask Baisong to talk about the differentiation of total hemoglobin. And then I’ll ask Linda just to talk about our approach to first in class, or clear differentiation and where we would see that with our approach to function upregulation?
Baisong Mei: Thanks, Yanan. I mean, certainly we talk about the investigators as well as the KOLs and sickle cell treaters for our differentiation. And how we may be able to see and what is the position of this molecule. And when we’re talking to those hematologists and sickle cell treaters that see our data, and when hematologists mentioned that it is no brainer, it is better if you have a 16-gram per deciliter versus 10-gram per deciliter of total hemoglobin. And then they also, I mentioned that they introduced as of our study, and there are quite a few knowledgeable hematologists. They see the difference among several molecules. And one investigator said that he was waiting for our trial and did not participate other. So those are the anecdotal examples on that. As I mentioned earlier, we certainly want to look forward to see the clinical data.
Gilmore O’Neill: It’s also worth highlighting, of course, that the FDA has recognized that a 1-gram per deciliter difference is meaningful, or certainly likely to predict a clinically meaningful benefit and that they use that threshold to give an extended approval to Oxbryta in the past.
Baisong Mei: Yes. Talking about that, this is also, when we communicate with FDA, this is also a point we have been discussing with FDA too.
Gilmore O’Neill: So thanks very much, Baisong, Linda, just regarding in vivo and where our focus is.
