BioNTech Investor Day Presentation Deck slide image

BioNTech Investor Day Presentation Deck

BNT311: Initial results in dose escalation show a manageable safety profile with most AEs being Grade 1 or 2 ALT increased AST increased Anemia Asthenia Fatigue Hypothyroidism Back pain Decreased appetite Malignant neoplasm Nausea TEAES occurring in ≥10% of patients 10 20 Dose escalation cohort TEAE's occuring in ≥10% of patients Any TRAE TRAES in ≥10% patients, by preferred term ALT increased AST increased Hypothyroidism Fatigue 30 T 40 All grades, n (%) 43 (70.5) 14 (23.0) 13 (21.3) 11 (18.0) 8 (13.1) 50 Grade 1 Grade 2 Grade 3 Grade 4+ Grade 23, n (%) 17 (27.9) 5 (8.2) 2 (3.3) 1 (1.6) 1 (1.6) 100 Data cut-off: August 31, 2020. DLT, dose-limiting toxicity; MTD, maximum tolerated dose; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event. Garralda E, et al. SITC Annual Meeting 2020; Poster presentation 412. Protein therapeutics Treatment-related transaminase elevations occurred in 26.2% (Grade 23: 9.8%) and decreased with corticosteroid administration No treatment-related bilirubin increases or Grade 4 transaminase elevations 6 patients had DLTs: Grade 4 febrile neutropenia (n=2), Grade 3 nephritis (n=1), Grade 3 ALT increase (n=1), Grade 3 AST/ALT increase (n=1), Grade 3 transaminases increase (n=1) All six patients recovered without sequelae MTD was not reached BIONTECH 118
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