Celldex Therapeutics (CLDX) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Program updates and clinical data

• Upcoming presentation of 52-week efficacy and safety data from the Phase II CSU study at EADV, covering 208 patients and both primary and secondary endpoints.

• Phase III studies in CSU have been initiated, with a larger patient population and a new loading dose regimen to improve onset and depth of response.

• CIndU 12-week full dataset will be presented in October, expanding the clinical evidence base.

• The bispecific antibody program, CDX-622, targeting TSLP and stem cell factor, is set to enter clinical trials this year.

Market potential and positioning

• The combined US and European market for biologically naive CSU and CIndU patients is estimated at 750,000, with a 50% Xolair failure rate.

• CIndU represents about 25% of the CSU market globally, with the largest subtypes being cold urticaria, symptomatic dermographism, and cholinergic urticaria.

• PN market opportunity is estimated at 75,000 biologically eligible patients in the US.

• If approved, the drug could address all CSU patient populations, including those refractory to omalizumab.

Mechanism of action and differentiation

• Barzolvolimab is a potent KIT inhibitor that eliminates mast cells, targeting the root cause of urticaria-driven symptoms.

• The antibody approach offers specificity and the ability to engineer for long half-life, with an allosteric mechanism preventing KIT receptor dimerization.

• The bispecific program aims to address diseases where mast cells are not the sole driver by also targeting TSLP.