Correlation of pharmacodynamic activity, pharmacokinetics, and anti-product antibody responses to anti-IL-21R antibody therapeutics following IV administration to cynomolgus monkeys

Table 5 Formation of anti-Ab-01 antibodies (log Titer) after a single 10 mg/kg IV dosage of Ab-01 to male cynomolgus monkeys

TIME (DAYS)	ANIMAL 1	ANIMAL 2	ANIMAL 3
Pre-dose	Negative	Negative	Negative
15	Negative	Negative	Negative
22	Negative	Negative	Negative
36	Negative	2.13	Negative
50	Negative	3.43	Negative
71	ND	ND	Negative
92	Negative	ND	2.27
106	ND	ND	2.79
113	Negative	ND	ND
134	1.86	ND	ND
148	2.4	ND	ND

"ND" = Not determined
Formation of anti-Ab-01 antibodies (neutralizing and non-neutralizing) was assessed using an electrochemiluminescent paramagnetic bead assay, in which serum samples from Ab-01-dosed monkeys were tested for binding to biotinylated- Ab-01 and ruthenylated- Ab-01. Negative samples had no binding at the minimum required dilution of 1:25 and had a log titer < 1.40.

ISSN: 1479-5876