Sean McCarthy: Yes, thanks for the question. So, what – maybe let’s start with what we know about interferon, so CX-801 being a conditionally active interferon. So we know that interferon has shown clinical activity in several tumor types in melanoma, in renal, in certain sarcomas, certain lymphomas. And the goal here with 801 actually as quite nicely demonstrated on our SITC post that the goal with 801 is to derive intra-tumoral immunity – anti-tumor immunity. So we’re looking to – and as we showed in the poster the preclinical data that we have shows that we are – 801 is very capable of inducing an immunogenic phenotype intra-tumorally. And so – and those tumor types where Interferon is active are generally speaking tumors that are immune competent.
So, those will be obvious places for us to consider going in early clinical development. The other – another thing to say here is that the strategy – another thing about the strategy of 801. And as also emphasized in our SITC poster is that mechanistically, we would absolutely expect based on preclinical studies, Interferon Alpha, localized it for an Alpha-2b to partner very well with checkpoint inhibition. And in fact, we showed some potent combination data in our poster last weekend. And so in the clinical program, we would also be looking to, I would say fairly quickly move into the combination setting, which makes obvious sense to really derive and leverage the full immunobiology of Interferon in checkpoint inhibitor combinations. Let me just make one other comment on EpCAM, since you met – you made the reference to our EpCAM as well, in terms of tumor types.
So, the strategy there is to bias our Phase 1 enrollment into CRC. But of course, EpCAM has expressed one of the things we love about this target is that EpCAM expressed in many, many solid tumors at high level. In fact, we believe that they are across the five major expressing cancer types for EpCAM. They are upwards of almost 300,000 potential treatable patients who are EpCAM positive across those tumor types. So, we will be focusing in CRC, but also enrolling additional tumor types as well, potentially looking for additional signals in the Phase 1 setting, so I hope that helps.
Jade Montgomery: Yes. That was great. Thanks. And I mean just more on both of those with the Phase 1 data, do you plan to trying to have that by the end of this year, or is that more of a 2025 timeline? What factors as well may influence do you think?
Sean McCarthy: Yes. So, the goal right now, where we are super focused as a company is to file the two INDs for 2051 and 801. Initiate clinical studies in 2024. I think as we have said for 2051, our goal is to get as far through Phase 1a in 2024 as we can. We are not ready at this point to give any guidance on data. That could take a little longer.
Jade Montgomery: Okay. Thanks for letting me know. Thanks.
Sean McCarthy: You’re welcome.
Operator: Thank you. One moment for our next question. Our next question comes from the line of Etzer Darout from BMO Capital Markets. Your line is open.
Lukas Shumway: Hi, this is Lukas Shumway on for Etzer. Thanks for taking my question. You have ongoing collaborations with Astellas and Regeneron. Can you give us an update as to how those are progressing? Maybe where we will see the biggest opportunities for the biospecifics from those and what types of programs you might see from those collaborations?
Sean McCarthy: Yes. Thanks for the question. And as we emphasized on the call, we are really thrilled to have such a large number of high quality partners to work with, it’s allowing us to expand the reach of the technology. And also it’s been an important means of financing for the company and I think will continue to be in the future. Both Astellas and Regeneron are focused in the field of biospecific immunotherapies. Our work with Astellas began a little earlier that that deal is a few years old now. Regeneron is a more recent deal about a year old. We did earn our first milestone in the Astellas relationship this year, which is very significant. That’s for one of the T-cell engagers that’s moving forward into IND enabling studies.
