Pharma Update
Neoantigen vaccine: Autogene cevumeran
<+
Cancer Center
Memorial Sloan Kettering BIONTECH
Roche
1884
Substantially and durably expanded T-cells, correlating with delayed recurrence
Phase I results in surgically resectable PDAC (target n=20)
ASCO®
2022
Vaccine induced T-cell response associated with longer RFS
Tumor and
normal DNA
N
Resection
Tumor RNA
Neoantigen
prediction
mRNA
manufacture
Custom manufacture
neoantigen
mRNA vaccine
Week: 0
6
9
I
Dose/cycle: 1
Screen for
eligibility
Surgery
Atezolizumab
1 dose
Administer
vaccine
17
21
1
2 3 4 5 6 8
Individualized
neoantigen vaccine
Doses 1-8
mFOLFIRINOX
12 cycles
RFS (%)
100
Median RFS: Not reached
T
50
50
46
Follow-up
Median RFS: 13.7 months
10 11 12 9
0
Individualized
neoantigen vaccine
Dose 9
06
12
18
T
24
1
30
Months
Median follow-up: 18 months
Responder (n=8)
Non-responder (n=8)
P = 0.003
HR: 0.08 (95% CI 0.01-0.40)
Autogene cevumeran expanded polyclonal IFNy-producing neoantigen-specific CD8 + T-cells in 50% (n = 8/16) of patients from undetectable levels to large
fractions (median 2.9%) of all blood T-cells
Randomized trial in PDAC initiated, FPI expected Q3 2023
Planning to initiate additional studies in other tumors
Autogene cevumeran in partnership with BioNtech; Balachandran V et al., ASCO 2022; PDAC-pancreatic ductal adenocarcinoma; RFS-relapse free survival
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