Anti-CD28 Humanized Antibodies Formulated for Administration to Humans
AssigneeOse Immunotherapeutics
InventorBernard Vanhove
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Abstract
The present invention pertains to a novel and advantageous dosage regimen for a humanized pegylated monovalent anti-CD28 Fab′ antibody fragment, called “FR104”. This dosage regimen consists of between 0.05 and 1.5 mg/kg body weight of FR104, at a dosing schedule of once per week, once every two weeks, once every three weeks, once every four weeks, once every five weeks or once every 6 weeks, once every 7 weeks, once every 8 weeks or once every more than 8 weeks.
Claims15
An anti-CD28 Fab′ antibody fragment consisting of a heterodimer of (i) a first protein of SEQ ID NO:
- 1, which is pegylated at its C-terminus, and (ii) a second protein of SEQ ID NO:
- 2, for use in the treatment of any condition susceptible of being improved or prevented by inhibiting a T cell immune response, wherein a therapeutically effective amount of said anti-CD28 Fab′ antibody fragment is administered to a human subject in need thereof and wherein the therapeutically effective amount of the anti-CD28 Fab′ antibody fragment is between 0.05 and 1.5 mg/kg body weight at a dosing schedule of once per week, once every two weeks, once every three weeks, once every four weeks, once every five weeks or once every 6 weeks, once every 7 weeks, once every 8 weeks or once every more than 8 weeks.
A pharmaceutical composition for inhibiting a T cell immune response in a human subject in need thereof, comprising an anti-CD28 Fab′ antibody fragment which is a heterodimer of (i) a first protein of SEQ ID NO:
- 1, pegylated at its C-terminus, and (ii) a second protein of SEQ ID NO:
- 2 in an amount comprised between 3 and 120 mg, together with one or more pharmaceutically acceptable excipients.
A kit of parts comprising monthly doses of an anti-CD28 Fab′ antibody fragment, wherein each dose comprises an amount of 3 to 120 mg of an anti-CD28 Fab′ antibody fragment which is a heterodimer of (i) a first protein of SEQ ID NO:
- 1, pegylated at its C-terminus, and (ii) a second protein of SEQ ID NO:
- 2.
Dependencies are inferred from the claim text.