Atreca, Inc. (NASDAQ:BCEL) Q4 2022 Earnings Call Transcript

Philippe Bishop: So I’ll try to address all the questions and points that you have raised. I think for the patients that are going to be enrolling the 30 to 40 patients that we expect to enroll that will be new. And with the changes that we have made going to centers that are more adept to enrolling Phase 2 patients as opposed to Phase 1, as you know Phase 1 units are highly specialized, and here what we have done is gone to sensors that are hybrid between academic centers and community centers where we’re seeing patients — a greater number of patients that would be eligible for our trial. So that’s one point to make. And what we expect to see there is distribution across the various tumor types that we’re seeking to enroll into.

Some of those centers are more likely to enroll individuals, for example, the lung cancer, others with breast cancer, but we’re also looking at centers that can help augment our database for head and neck and urothelial cancers as well. So we’re looking — our recruitment efforts are targeted at this point, and we’re looking to try to supplement those underrepresented patient populations. The goal for that is really to — for us to be able to look at where our strongest signal comes from. And there, we’ll be looking at, I think, response rates, obviously, responders. As you know, we have the lung cancer and the melanoma patients that have been durable. I think that’s notable. But what is new with the data that we’re presenting today is really this notion of disease control and the ability to see patients staying on study for a longer period of time.

So we’ll be incorporating a component of disease control into our decision algorithm. We plan to update you at some point about how we’re going to approach that and of course, on analytic principles. So with regards to the type of patients that we’re planning to see, the eligibility criteria remains as it is and will continue to remain as is for the time being. So we don’t really expect that the patients that will be seeing coming out will be much different. There will be individuals that have exhausted for the most part, standard of care and have either advanced or metastatic disease. So we would think that these patients will be similar to the ones that we’ve enrolled to date. We’re continuing to enrich our target as of today and those patients are getting enrolled at the 30-milligram per kilogram dose cohort.

John Orwin: And in terms of, I think, what we objectively need in terms of our response rate or durability either responses or disease control or generally, I think it depends also on the tumor type, right? As Philippe alluded to, some of these are tumor types where it’s not entirely uncommon to see patients with interim disease. And then there are other settings if we take our response with a 50% tumor reduction in lung cancer, that’s fifth line lung cancer, that’s a setting where we wouldn’t expect to see end-to-end disease. But then we have to overlay on top of that, what’s the unmet need, what would the regulatory hurdle be? Because the whole point of that randomized Phase 2 trial to really set up what could be a potential registration. No, I think it will be taking all of those things into consideration, and applying relatively high bar, particularly in any setting where there’s a well-established standard of care.

Roger Song: Got it. Yes. Just to clarify, what is the breakdown between the monotherapy and the combination therapy for the new 30 to 40 patients enrollment?