Reni Benjamin: Got it. I’ll ask one more and then just hop back in the queue. As we think about WT1, and that program and the advancement of that program, I kind of look at CUE-101 as kind of the poster child. And so it begs the question, what potential combinations might you ultimately want to be exploring, as you move that program forward?
Matteo Levisetti: Yeah. So great question. Thank you. I think, clearly, as we learn more about the activity of CUE-102 and the different tumor types that the rational next step with regards to development would be to look at combinations. And potential combinations, I think, will likely depend on which tumor Type 1 is talking about. And so, we looked, for example, at gastric cancer, where we’ve seen this tumor reduction of 24 weeks duration. Considering a combination with anti-PD1 or checkpoint inhibitor, given the history of some, although limited activity in some subsets of gastric cancer, I think in other indications, like colorectal cancer, it would be very interesting to move up one or two lines of therapy and think of combinations, perhaps, even with chemotherapy or anti-VEGF therapy, for example.
But this is certainly an area of very active deliberation for us. And it, of course, dovetails, importantly, with our strategic ongoing activities with potential partners.
Reni Benjamin: That’s great.. Thanks for taking the questions. I’ll hop back in the queue.
Matteo Levisetti: Thanks, Reni.
Operator: Your next question comes from Ted Tenthoff from Piper Sandler. Your line is now open.
Ted Tenthoff: Great. Thank you very much. And, again, I appreciated all of the SITC and the update. Just kind of looking at now that you’ve really got Immuno-STAT proof-of-concept, what other are some of the antigens? I know that you’ve talked about KRAS in the past. Would potential partners be interested in looking at their own antigens on this active construct or are they more looking at kind of the existing products or maybe even kind of a mixture of both?
Daniel Passeri: Yeah. I’ll turn that over to Anish. Thanks, Ted.
Anish Suri: Yeah. Hi, Ted and thanks for the questions. So, Ted, as you well saw with some of what we’ve said in the expansion, going after primary cancer drivers is obviously a low-hanging fruit. So, mutated KRAS, you’re aware of the G12C small molecule covalent inhibitor from Mirati being approved and the Amgen compounds. We believe the valine and the aspartic acid, well appreciated, are much larger patient populations, particularly in the three major cancers of colorectal, lung, and pancreatic. And they do donate T cell epitopes. So, just in that space, for example, Ted, we’ve got four different KRAS molecules addressing G12B and G12D on a couple of different HLA alleles. We’ve also got strategies looking at other primary mutated cancer drivers.
And that is still early in the pipeline, but we have confidence they’ll be validated. We’ve got primary tumor drivers like MAGE-A4 and Cancer-Testes Antigens that offer very attractive opportunities and perhaps some level of validation through the ongoing work of others looking at TCR T cell therapy approaches. Of course, ours is with the biologic, so a very different application and perhaps a bit more easy to sort of think about from the commercial and patient accessibility viewpoint. We’ve got interest on these sets of antigens from certain sort of parties to what you referred to going after some of these primary drivers. But then, as you well know, there is a significant community out there that has been focused on discovering and doing their own work on bespoke antigens, which the platform can easily be deployed to drug those moieties.
To that end, Neo-STAT becomes a fantastic opportunity, and that’s one of the reasons we sort of highlighted that modality, even though that is an extension of the Immuno-STAT. The opportunity there is the fact that you can go after multiple antigens, Ted, and it’s the same core IL-2 framework. So, we do believe the efficiencies and the advantages that we’ve demonstrated, the CUE-101 and CUE-102, should apply to Neo-STAT as well. So, there’s, again, we look at this in three sort of broad buckets. We look at driver antigens, where single dominant antigens should have benefit. And CUE-101 is a great example because E7 is a viral proto-oncogene in the case of HPV-driven cancers. And by the way, that data is in head and neck cancer. That same molecule can go to other indications like cervical, penile, anal, vulva cancers as well.
CUE-102, with what Matteo just described, follows up a beautiful example of a onco-fetal antigen that is selectively expressed and has activity. And then KRAS, for obvious reasons, including the MAGE A4, PRAME follows suit. And then we’ve got this opportunity to go after multiple different antigens, where one can simply deploy the platform. And that’s the reason I highlighted the plug-and-play approach virtually has a potential to generate therapeutics.
Ted Tenthoff: Thanks. Super helpful. Really exciting time for the company. Thanks, guys.
Daniel Passeri: Thank you, Ted.
Operator: Your next question comes from Reni Benjamin from JMP Securities. Your line is now open.
Reni Benjamin: Hey, guys. Thanks for taking the follow-up. Yeah. You mentioned on the call partners and partnerships. And I guess, I’d like to just, if you can, provide a little bit additional color as to maybe how those discussions are going. Should we be thinking about, I don’t know, sort of the who’s who of checkpoint inhibitors are who you’re kind of talking to or are there other types of potential partners for one-on-one that you’re talking with? And I guess just as a follow-up to that does a partnership — is that necessary to move into a pivotal study or is that something that you believe after the FDA discussion is complete you might need to and want to take on your own? Thanks very much.
Daniel Passeri: You’re welcome. So, important question, Ren, and it’s a complex question, right? It doesn’t have a simple answer. So, let’s start-off with the last part of the question. It’s not necessary for going forward with a pivotal study, but I would say with the current market dynamics that the biotech sector, particularly oncology, is confronting with the headwinds in the capital markets, we have limited resources. And we’re trying to look at dynamically how do we continue to evolve the platform for maximizing patient reach and demonstrating the value of our platform for addressing serious disease, cancer, autoimmune, et cetera. So, we’re looking at partnering strategies that give us flexibility but still engaged in involvement in the drugs development.
We don’t want to become a licensing company. We want to become a strategic collaboration partner. And I would say Ono was a great example. We have a co-development option with them in that collaboration. In terms of the characterization of the companies we’re talking to, it’s the full spectrum. We’re certainly talking to the who’s who. I’d say what’s intriguing is, first of all, we very deliberately did not go out with a BD emphasis early on in our development. We wanted to build a sound, substantive data package based on rigor and solid data that we could stand on. We’re also getting sort of inbound inquiries, and that’s actually very encouraging. So, we’re talking to a spectrum of potential partners, and I would say a sort of spectrum of opportunities and different sort of structures that we’re assessing.
