Celldex Therapeutics (CLDX) Leerink’s Global Healthcare Conference 2025 summary

Program updates and clinical progress

• Barzolvolimab is being studied in five indications, with ongoing phase III studies in CSU and plans to start phase III in CIndU after FDA alignment in 2025.

• CDX-622, a bispecific antibody targeting TSLP and stem cell factor, is in healthy volunteer studies, with data expected later this year.

• Phase III EMBARQ program for CSU is enrolling globally at 460 centers, with two identical studies of 915 patients each, on track for a two-year enrollment timeline.

• CIndU phase III is planned to start by year-end, pending FDA discussions on endpoints and patient population.

• EoE proof-of-concept study increased dose and changed interval, with full data expected in the second half of the year.

Efficacy, safety, and competitive landscape

• Barzolvolimab showed a 71% complete response rate and 76% UAS7 ≤6 at 52 weeks in CSU, with a favorable safety profile including transient neutropenia and minor hair/skin changes.

• Quality-of-life improvements were significant, with 80% of CSU patients showing well-controlled urticaria and minimal disease impact after 52 weeks.

• CIndU study showed similar quality-of-life gains at 12 weeks, with high rates of clinically meaningful improvement.

• Barzolvolimab is positioned post-Xolair, with comfort for dermatologists to treat broader populations.

• Competitors include Xolair, Celltrion’s biosimilar, Remi, and Dupixent, with Barzolvolimab aiming for broader efficacy and safety.

Data readouts and future expectations

• 76-week CSU data (24 weeks off treatment) will assess durability, remission rates, and safety, with results expected in the first half of the year.

• CIndU 44-week data will follow in the second half, focusing on response durability and reversibility of side effects.

• EoE study will report full data in the second half, with primary endpoint on mast cell depletion and secondary endpoints aligned with regulatory guidance.

• Atopic dermatitis study is designed to minimize placebo response by focusing on moderate to severe, post-IL-13 or Dupi patients.

• CDX-622 healthy volunteer data will focus on pharmacokinetics, immunogenicity, tryptase reduction, TSLP engagement, and safety.