We’ve got a drug that could be seen as an alternative. In fact, we tested it as a single agent, but rather than to pick one NF-κB down regulator versus another, we found that they work synergistically. So what we’re looking to do is find those indications within NHL where the disease is sufficiently aggressive that we can get an answer quickly, where the unmet need is critical, where these patients really don’t have very good options and ideally where it’s an orphan sized indication where we can get a very attractive regulatory path. Well, all three of those boxes get checked with primary CNS lymphoma. Our mechanism of action supports that that’s a great indication or great setting for this combination. Our preclinical data of course backed that up.
And there are early treatment or early days in the clinic show that not only is that true, but it looks like small-n we may be able to address ibrutinib resistance, which is a particular problem in PCNSL, it’s a problem in NHL more broadly, but it’s a particular problem in primary CNS lymphoma. So that’s where we’re headed. It’s going to be the combination of ibrutinib plus emavusertib in the orphan indication of primary CNS lymphoma.
Yale Jen: So that would be post-ibrutinib treatment. And what do – what’s the size of the study initially you are planning and what sort of endpoint you are thinking?
Jim Dentzer: That’s right. So it’s post-ibrutinib. So these patients, in general, ibrutinib can give nice responses. As you know, in NHL, oftentimes ibrutinib can get a partial response. It doesn’t very often get a complete response, but it can really help patients for a period of time. But typically these patients all relapse. We are going to capture them at that point and then add emavusertib to the therapy and hope to regain that response that they had once had and hopefully deepen it. So that’s the plan. We’ve got a small number of patients to-date that we’ve reported out. Our goal is to try and get to 20 patients. If we can get 20 patients of data, and we can show that, again, reasonable sized population, but still small, that it looks like this is a compelling therapy.
That it looks to be something that’s a good option for these patients that have relapsed on ibrutinib. We would want to go to the FDA to have a discussion about what the pivotal design needs to look like at that point. So look for an N equals 20 is our goal for this study.
Yale Jen: So would you anticipate more of the PR or actually maybe some – convert to CR or how should we, overall thinking about in terms of the threshold you feel that’s worth to discuss with the FDA?
Jim Dentzer: Yes, so what we’d be looking for is a couple things. First, obviously it would be great to have a higher ORR. It would be great within the responses to have more of those PRs become CRs. And then lastly, we’d be looking at duration. In this group, because they will have already relapsed on ibrutinib any of those outcomes is positive outcome. And of course, we’ll be examining those data very closely.
Yale Jen: Okay, great. That’s very helpful and congrats. You can starting the trial in both sides of the chemo and cancers and we look forward to readout in the future.
Jim Dentzer: Thank you very much, Yale and appreciate your support. Thank you for calling in.
Operator: The next question will come from Li Watsek with Cantor Fitzgerald. Please go ahead.
Unidentified Analyst: Hi Jim and Diantha, this is Rosemary on for Li. Firstly, congrats on a great quarter again.
Jim Dentzer: Thank you.
