Safety of antibody drug conjugates

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Elevations in liver transaminases were transient and reversible at 10 and 30 mg/Kg 180 160 140 120 100 80 60 40 Female Dose (mg/kg) - 0 Dose (mg/kg) - 3 Dose (mg/kg) - 10 Dose (mg/kg) - 30 -20 0 20 40 60 80 100 -20 0 20 40 60 80 100 -20 0 20 40 60 80 100 -20 0 20 40 60 80 100 Day • similar changes observed for AST • peak changes noted 2 days post-dose Genentech, Inc.
Mild decreases in platelets were transient and reversible at 30 mg/Kg 40 30 20 10 0 -10 -20 -30 -40 40 30 20 10 0 -10 -20 -30 -40 Dose (mg/kg) - 0 Dose (mg/kg) - 3 Dose (mg/kg) - 10 Dose (mg/kg) - 30 0 20 40 60 80 100 0 20 40 60 80 100 0 20 40 60 80 100 0 20 40 60 80 100 • peak changes noted 2 days post-dose Day Genentech, Inc.
Page 1 and 2: Safety Assessment of Antibody Drug
Page 3 and 4: An ADC is a Highly Complex Pro-drug
Page 5 and 6: Antibody Drug Conjugate Processing
Page 7 and 8: Designing an ADC Toxicology Program
Page 9 and 10: ADC Pipeline in 2009 Early Developm
Page 11 and 12: T-DM1 Nonclinical Program: Pivotal
Page 13 and 14: Toxicokinetic Assays Serum/plasma c
Page 15: T-DM1 Clinically Well-Tolerated in
Page 19 and 20: Non-reversible axonal degeneration
Page 21 and 22: Summary of Results for T-DM1 Precli
Page 23 and 24: T-DM1 Post-IND Strategy T-DM1 Devel
Page 25 and 26: Phase I Target Organs of Toxicity I
Page 27 and 28: Key Toxicity Messages for T-DM1 •

Safety of antibody drug conjugates

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