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Inhibition of complement pathway activation with Pozelimab, a fully human antibody to complement component C5.

Adrianna Latuszek¹, Yashu Liu¹, Olav Olsen¹

¹Regeneron Pharmaceuticals, Inc., New York, NY, United States of America.

|May 9, 2020

Summary

A novel humanized C5 mouse model aids in evaluating anti-C5 antibodies for complement-mediated diseases. Pozelimab demonstrated promising pharmacokinetics and potent complement inhibition in preclinical studies.

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Area of Science:

Immunology
Pharmacology

Background:

Complement is crucial for innate immunity; dysregulation causes disease.
Complement component 5 (C5) is a therapeutic target for complement-mediated diseases.
Limited preclinical models hinder development of C5-targeted therapies.

Purpose of the Study:

To describe a novel humanized C5 mouse model.
To evaluate its utility in assessing anti-C5 antibody pharmacokinetics (PK) and pharmacodynamics (PD).
To assess pozelimab (REGN3918) efficacy and safety.

Main Methods:

Development of a humanized C5 mouse model.
Evaluation of a panel of fully human anti-C5 antibodies.
In vitro hemolysis assays.
PK/PD studies in humanized C5 mice and cynomolgus monkeys.

Main Results:

Humanized C5 mice showed differential antibody clearance rates.
Pozelimab exhibited high affinity for C5 and potent inhibition of hemolysis.
Pozelimab demonstrated prolonged PK and sustained ex vivo hemolytic activity suppression in mice and monkeys.
Switching from eculizumab to pozelimab normalized C5 levels and suppressed hemolysis without toxicity in humanized C5 mice.

Conclusions:

Humanized C5 mice are valuable for preclinical evaluation of anti-C5 therapeutics.
Pozelimab shows potential as a therapeutic for complement-mediated diseases.
This model aids in identifying new therapeutic candidates and treatment strategies.