BioNTech Results Presentation Deck
BNT311: Phase 1 / 2a - Safety profile
TEAES occurring in ≥10% of patients
ALT increased
AST increased
Anemia
Asthenia
Fatigue
Hypothyroidism
Back pain
Decreased appetite
Malignant neoplasm
Nausea
0
17
Dose escalation cohort
10
TRAES occurring in ≥10% of patients
Any TRAE
TRAES in >10% of patients, by preferred term
Transaminase elevation
Hypothyroidism
Fatigue
20
All grades, n (%)
43 (70.5)
16 (26.2)
11 (18.0)
8 (13.1)
30
All patients
(N=61)
Grade 3, n (%)
15 (24.6)
6 (9.8)
0
1 (1.6)
T
40
50
Grade 4, n (%)
3 (4.9)
0
1 (1.6)
0
Grade 1
Grade 2
Grade 3
Grade 4+
100
The most common treatment-related
adverse events were transaminase
elevations, hypothyroidism and fatigue
Treatment-related transaminase
elevations occurred in 26.2% of
patients (9.8% of patients had grade 3
transaminase elevations)
There were no patients with Grade 4
transaminase, or treatment-related
bilirubin increases
MTD has not been reached
BIONTECHView entire presentation