Celldex Therapeutics, Inc. · NASDAQ:CLDX
Celldex Therapeutics — EAACI Congress 2025
14 slides from Celldex Therapeutics's conference presentation, Jun 13, 2025
Slide 1: EAACI 2025
EAACI 2025 13-16 JUNE UNITED KINGDOM www.eaaci.org #EAACICongress2025
Slide 2: Treatment with Barzolvolimab Leads to Sustained Improvement in Angioedema in CSU
Treatment with Barzolvolimab Leads to Sustained Improvement in Angioedema in Patients with Chronic Spontaneous Urticaria (CSU): Results from 52 Weeks of Treatment Presenter: Dr. Martin Metz M. Metz1,2, M. Maurer1,2, I. Kobielusz-Gembala3, E. Mitha4, J. LeFlein5, M. Gotua6, B. Kwiek7, U. Chaudhry8, D
Slide 3: Disclosures
Disclosures Prof Martin Metz is or recently was a speaker and/or advisor for and/or has received research funding from AbbVie, Advanz, ALK-Abello, Allegria, Almirall, Amgen, Argenx, AstraZeneca, Astria, Attovia, Berlin-Chemie, Celldex, Celltrion, DeepApple, Escient, GA2LEN, Galderma, GSK, Incyte, Ja
Slide 4: Introduction
Introduction • Chronic spontaneous urticaria (CSU) is a mast cell driven disease characterized by itchy wheals, angioedema, or both • Angioedema occurs in approximately 50% of patients with CSU and is associated with increased severity and duration of disease, as well as decreased quality of life •
Slide 5: Study Design and Key Eligibility
Study Design and Key Eligibility • Randomized, double-blind, placebo-controlled, dose-finding study (NCT05368285) • Patients with moderate to severe CSU who remain symptomatic despite treatment with up to 4X labeled dose of antihistamines and includes patients with prior biologics • Primary Endpoint
Slide 6: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics • Well balanced across groups; majority (~70%) of patients had severe urticaria symptoms and angioedema at baseline Barzolvolimab Barzolvolimab Barzolvolimab Placebo 75 mg Q4W 150 mg Q4W 300 mg Q8W (n = 51) (n = 53) (n = 52) (n = 51) Age, years 42.2 (18-69)
Slide 7: Profound Improvements in UAS7 With Barzolvolimab Observed Early and Deepened to Week 52
Profound Improvements in UAS7 With Barzolvolimab 40 Observed Early and Deepened to Week 52 Placebo Control Period Active Treatment Period 35 (16 weeks) (36 weeks) Complete Response 30 Rate (UAS7=0) at 52W Mean (SE) UAS7 25 150 mg Q4W 71% 20 300 mg Q8W 52% 15 10 5 0 0 4 8 12 16 20 24 28 32 36 40 44 4
Slide 8: Barzolvolimab Demonstrated Rapid and Durable Improvement in Angioedema Symptoms through Week 52
Barzolvolimab Demonstrated Rapid and Durable Improvement in Angioedema Symptoms through Week 52 Placebo Controlled Period Active Treatment Period 70 (16 Weeks) (36 Weeks) 65 60 Mean (SE) AAS7 Score 55 50 45 40 35 30 25 20 15 10 5 0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 4
Slide 9: Robust and Durable Reduction in Angioedema Symptoms with Barzolvolimab Treatment at Week 52
Robust and Durable Reduction in Angioedema Symptoms with Barzolvolimab Treatment at Week 52 Mean Change from Baseline in AAS7 • Barzolvolimab improvement from baseline: 86% reduction for 150 mg Q4W and 82% reduction for 300 mg Q8W at Week 52 • Comparable improvement observed in omalizumab naïve and
Slide 10: Up to 77% of Patients Were Angioedema Free at 52 weeks
Up to 77% of Patients Were Angioedema Free at 52 weeks Proportion of Patients with AAS7=0 at Week 12 and Week 52 Modified intent to treat; observed data in subset of patients with positive AAS7 scores at baseline. Statistical significance achieved at Week 12 for 150 mg Q4W and 300mg Q8W barzolvolima
Slide 11: Patients Treated with Barzolvolimab Were Angioedema Free Up to 72% of the Time
Patients Treated with Barzolvolimab Were Angioedema Free Up to 72% of the Time Over the 52 Week Treatment Period Mean Angioedema Free Days Through Week 52 • Patients who received 150 mg Q4W and 300 mg Q8W were angioedema free 72% and 70% of the time over the 52-week period. • Placebo treated patient
Slide 12: Up to 87% of Patients Reported Clinically Meaningful Improvement in AAS7
Up to 87% of Patients Reported Clinically Meaningful Improvement (≥8 point) in AAS7 Proportion of Patients with at least 8 point improvement in AAS7 Modified intent to treat; observed data in subset of patients with positive AAS7 scores at baseline. Statistical significance achieved at Week 12 for a
Slide 13: Conclusions
Conclusions • Treatment with barzolvolimab resulted in rapid and sustained improvement in CSU symptoms through Week 52 • Barzovolimab demonstrated rapid, significant and sustained improvement in AAS7 in patients with moderate to severe CSU • Up to 87% of patients reported clinically meaningful impro
Slide 14: Acknowledgements
Acknowledgements We wish to thank all the investigators, study site staff and their patients who contributed to this trial. We are especially grateful to Professor Dr. Marcus Maurer for his partnership in advancing barzolvolimab. Dr. Maurer’s steadfast commitment to improving the lives of patients w