Operator: Our next question is from the line of Mani Foroohar with Leerink. Please proceed with your question.
Lili Nsongo: Hi, good morning. This is Lili Nsongo on for Mani. Thank you for taking our question. I just wanted to ask if you could potentially give us an update on the progress of the manufacturing scaling for 301, both for clinical development and for potential commercialization. And then on the other side, second question in terms of the package for BLA. So we’re just timing. I think you had mentioned potential package readiness by 2025. By then we might have post marketing data from potentially two gene therapy program. I was wondering if you and how you would see that impacting potential pivotal design. Thank you.
Erick Lucera: Hi, this is Erick. I’ll take the first question with respect to the manufacturing, scaling, and timing. As a reminder, we’re very confident in what we’re doing and making the investments in manufacturing for the commercial launch. We haven’t specifically commented on the scale or timing, but just reiterate our confidence in everything we’re doing on a manufacturing standpoint.
Baisong Mei: Yes. This is Baisong, for your second part of your question, as we share that we will have 20 patient dose by January timeframe from next year and by middle of 2025, then we will have substantial data type, which is probably equivalent to the access BLA filing, which is accepted by FDA, which have like 20 patients in the efficacy data cohort. So they subsequently added additional 10 patients in their addendum with four months — additional four months data afterwards. So we expect that we will be able to file the FDA equivalent package to — we will have equivalent data package by middle of next year. But what exactly the FDA data — exactly BLA data package when it’s aligned with FDA, so that will help the agreement with FDA on that too.
And you mentioned about post marketing or the commercialization of these two molecules. And as I shared earlier that we do not see that recruitment momentum perspective. And you mentioned about data package. And we actually very excited about the outcome discussion. And we feel that these outcomes have further validation of CRISPR technology, further validation of the fetal hemoglobin as a for — as a mechanism of action to treat the sickle cell and beta thalassemia. So we actually see all those work have a positive impact to EDIT-301.
Operator: Thank you. Our final question comes from the line of Terence Flynn with Morgan Stanley. Please proceed with your question.
Unidentified Analyst: Great. Thank you for taking our question. This is Matt Gahr [ph] on for Terrence Flynn. So, looking to the future a bit, can you expand on your approach to target selection, how we should think about your pipeline evolving going forward? Also, as you think about tissue specific delivery for your future in vivo programs, how are you thinking about the advantages and disadvantages to investing in AAV and/or LNP? Thank you.
Linda Burkly: Yes. Hi, thank you very much for your question. So as far as target selection, our approach is really to apply criteria so that we are well-differentiated from standard of care. It’s very important that we’re delivering medicines that are meeting needs that the patients have that are not already met by existing therapeutics. And so we are going to look for targets in which we have high conviction, as well as targets that have high probability for technical as well as clinical and commercial success. And so I’m very excited here to have Caren having joined, so that I can partner with her as well as Baisong in triangulating this to very much select our targets. I think we’re really well-positioned now to be selecting these.
We are — as I said before, I think we’re very excited about the in vivo sickle cell disease TDT target because we already have emerging data supporting that target. And getting to your question about delivery, where our strategy which Gilmore described in January is non-viral delivery. And so we are prioritizing LNP delivery amongst the non-viral deliveries and working internally as well as through external partners to drive an approach for in vivo HSC targeting for our HBG12 promoter with an LNP strategy. As far as other targets and tissues, of course, LNPs are validated for delivery to liver, so we’re interested in that and I think we’re well-positioned there as well with our technology and especially with the recent deal that we saw announced and just showing the interest — continuing interest in farm in this space.
And — but we’re also interested in other tissues and so there are many targets out there amenable to Editas technology and we’re excited to move forward and we’ll certainly be sharing information with you as it emerges in the future at an appropriate time. Thank you.
Operator: Thank you everyone. This will conclude today’s conference. You may disconnect your lines at this time. We thank you for your participation.
