Celldex Therapeutics, Inc 12th Annual Cantor Fitzgerald Global Healthcare Conference
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Okay. Good morning, everybody. Thank you so much for being here. It's day two of Cantor's Global Healthcare Conference. I'm Kristin Kluska, one of the analysts at Cantor. Very happy to have the Celldex Therapeutics team here with me today. We have Anthony Marucci, the President and CEO, Dr. Tibor Keler, the CSO, and Teri Lawver, the CCO. Thank you all so much for being here.
Thank you for inviting us.
Appreciate it. There's clearly nothing going on at Celldex for this year, so I'm sure we'll think of something interesting to talk about instead.
Okay, great. Maybe just to kick things off, do you mind providing us with a high-level overview of the company?
Sure. We are an antibody company by birth and by trade. We have been in that area of the business for our whole lives. Our lead program, barzolvolimab, is an antibody that targets c-Kit, and it is currently in phase III development in three indications, CSU, symptomatic dermatographism, and cold urticaria. We had completed our phase III study in CSU back in February, and we are looking forward to presenting the data later on this year, as we have two phase III studies going on in CSU, and one of the largest studies, if not the largest study ever conducted in CSU, with nearly 2,000 patients. We look forward to doing that. Behind Barzol, we have several other antibody and bispecific programs. CDX-622 is currently in early stage development.
It is a stem cell factor by TSLP construct and early days with that program, but everything seems to be reading out very, very well.
We are very excited for these upcoming phase III data, which you have said could come in September or October.
Maybe to kick it off on that trial, the phase II one was very successful. How similar are the designs between that trial and the current ongoing phase III ones to replicate that success? What might be the added benefits of the loading dose that's newly being included?
Why don't we talk about the loading dose?
Yeah. Design-wise, the eligibility criteria is exactly the same between phase III and phase II. What we did modify was to include a loading dose before the two regimens that we tested in phase II, which was the 150 milligram Q4 week or the 300 milligram Q8 week. What we believe the loading dose will do, will not only more rapidly saturate the KIT receptor and reduce the mast cell and symptoms more rapidly, but it also helps us across the variety of sizes of these patients. Of course, we're giving a flat dose here. We think this just gets patients into the zone that they need to be in in terms of mast cell inhibition and gets there faster. We look forward to seeing how that works out for us.
Otherwise, the studies, other than being much larger and many more sites and countries, they are really very similar to the phase II design.
Okay. On that topic, we did get to see the effects of the loading dose with your recent PN data. What did that tell you?
Yeah. The loading dose was used in both dose regimens in PN. One of those is very similar to the doses we're using in phase III. One is actually even a higher dose. We saw exactly as expected in terms of the impact on circulating tryptase on mast cell inhibition. What was very pleasing is, despite this higher exposure, we really saw a very consistent safety, consistent with all of our experience with barzolvolimab, so a very good safety profile.
Okay. Bearing all of this in mind, can you remind us about the trial powering, the secondary endpoint hierarchy, and any other considerations into that design?
Sure. The study was powered for 90% power to detect a 10-point difference in the UAS7 score. What's important to know is we wanted to be able to have that powering for the subset of patients that are omalizumab refractory. For the overall population, this is powered much higher. It's quite overpowered. But we also wanted to be able to really have statistical analysis on specifically the omalizumab-refractory population. The hierarchy is as you would expect for a CSU trial. It's the UAS7 change from baseline at week 12. Then it's the itch and hive scores separately. We're also looking at the UAS7 equals zero, so no itch, no hives, really the hallmark for barzolvolimab in the studies to date. We will also, in the hierarchy, look at the very well-controlled patients, so UAS7 less than 6. We have an angioedema analysis, the AAS7 equals zero.
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