BioNTech Results Presentation Deck
BNT311: Safety Trial in Patients With Malignant Solid Tumors (NCT03917381)
Phase 1
Dose Escalation
N = 61
Metastatic or unresectable solid
tumors in patients who are not
candidates for standard therapy
50 mg
25 mg
80 mg
100 mg
140 mg
BNT311/GEN 1046: intravenous flat dose
every 3 weeks until disease progression
or unacceptable toxicity
15
200 mg
400 mg
Cycle
Q3W
1200 mg
800 mg
RP2D
Study Endpoints
Safety and tolerability
PK/PD
Anti-tumor activity
Biomarkers
N =
Phase 2a
Dose Expansion
Up to 40 per cohort
EC1: NSCLC ≤ 2-4L p. ICI
EC2: NSCLC ≤ 2-4L ICI n.
EC3: Urothelial Ca ≤ 2-4L p. ICI
EC4: Endometrial Ca ≤ 2-4L ICI n.
EC5: TNBC ≤ 2-4L CPI n./ p. ICI
EC6: SCCHN ≤ 2-4L CPI n./ p. ICI
EC7: Cervical Ca ≤ 2-4L ICI n.
=
p. ICI post immune checkpoint inhibition
CPI n. check point inhibitor naive
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