Dr. Garo Armen: So, I’ll answered the first question is that’s okay and then turn it over to Dr. O’Day. With regard to non-small cell lung cancer, when we observe the kind of sustainable, robust patient outcomes in the form of response rates. We made a decision just about a month ago. to expand that cohort significantly so that we can justify starting perhaps a very large even a Phase 3 trial or a Phase 2 trial, randomized Phase 2 trial that will be expandable. So in the interest of that, we made a decision to expand our cohort to at least 30 patients, perhaps more, to at least 30 patients. And we expect that, that will be accomplished within the next several months. And with that information, we will take it to the next step.
If we can the kind of impressive results we’ve seen in a very small patient population, if that could be sustainable, then it will justify our next steps for an expanded trial. And as you know, lung cancer is a very large indication. And even though there are some and it had cancer for the most part, but there are a number of patients that fail current therapies, including I-O regimens in combination with other agents and that’s the patient population that we’ve targeted in our Phase 1 trial that would be the patient population targeted in our expanded cohorts, and that’s the patent population that we will go after in our registration strategy. But Dr. O’Day, if you want to answer the colorectal question.
Dr. Steven O’Day: Yes. Thanks, Matt. For the colorectal question, I think the question was that the monotherapy arms in the colorectal trial contribution of components. So, our Phase 2 trial is designed to look at contribution of components with botensilimab in addition to the combination. We don’t feel that PD-1 monotherapy is required for contribution given its lack of essentially zero response rate in this setting and so, we will be looking at the contribution of botensilimab. It wouldn’t be ethical to treat with a PD-1-only arm in that disease setting.
Matt Phipps: Just another kind of follow-up. Do you expect any milestones this year from your numerous collaborations? And just how much of a priority is additional business development for you this year?
Dr. Garo Armen: Yes. There is the potential of several milestones this year. I don’t want to quantify them or identify the source of them. But these will be — when they come through, there will be significant milestones, not $5 million or $10 million.
Operator: Mayank Mamtani with B. Riley. Your line is open.
Mayank Mamtani: I appreciate the level of detail. So on the phase — on the two Phase 3 trials that you’re talking about initiating in 2023, can you just talk a little bit about like the differences in kind of what you’re trying to achieve? Like for example, for the CRC confirmatory study, how that differs from the ongoing randomized safety data in terms of target patient population, so your objectives? And then on the Phase 3 lung cancer study that you just touched on — like what are sort of the key goals there? Is it late line patients? Is it replacing I-O chemo regimens in certain settings and specifically are you looking to combine bot with bal in lung cancer? Or are you — you may consider using an external PD-1, L1? And then I have a couple of follow-ups.
Dr. Garo Armen: So obviously, the Phase 3 CRC population that we’re targeting is going to be along the same lines as our Phase 2 population, so that we can show the kind of robust responses that we’ve seen already so far, which will be repeated in a randomized setting as backed in the Phase 2 randomized trial. And will we use bal or approve PD-1 in non-small cell lung cancer. Well, right now, the plan is to use bal, right now. But it’s also a function of potential partnerships that we may engage in because as you know, there are companies out there with their own Phase 1– I mean, with their own PD-1 or PD-L1 agents and very eager to become more competitive with something that will offer superior performance. And so with those partnerships, we may engage in some creative structures that allows them to also have a head start with their own PD-1 that may have had exposure in lung cancer. So that remains to be determined.
