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HAE1

Development stage: Preclinical
Lead developer: Genentech
Modality: Monoclonal Antibodies → Antibody-Based Therapeutics

Overview

HAE1 is a high-affinity anti-IgE monoclonal antibody developed as a second-generation molecule leveraging in vitro, preclinical, and clinical data from the first-generation anti-IgE antibody omalizumab. The development of HAE1 utilized quantitative pharmacology approaches, including mechanism-based pharmacokinetic/pharmacodynamic modeling informed by omalizumab studies. The primary goal was to suppress free IgE levels to achieve clinical response (e.g., lower exacerbation rates), with target free IgE levels set at ≤10 IU/ml. Clinical trial simulations were used to select doses for phase II trials[5].

Targets

IgE (Immunoglobulin E)

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