ESMO 2023 BioNTech Data

BNT211 continues to show encouraging antitumor activity in patients with CLDN6-positive relapsed or refractory advanced solid tumors. Phase 1/2 FIH study (NCT04503278): Efficacy at all dose levels Haanen J. et al. Presented at ESMO 2023. Abstract #LBA35. 60 30 Change in target sum [%] 60 30 0 -90 GCT EOC Others Best response and change in target sum (all DLs) NR CLDN6 CAR-T <DL2 DL2 >DL2 Total Safety evaluable patients, n 10 27 7 44 Efficacy evaluable patients, n 9 22 7 38 Patients with PR/CR, n 1 13 3 17 Patients with SD, n 1 8 2 11 Patients with PD, n 7 1 2 10 ORR, % 11.1 59.1 42.9 44.7 DL BOR 2 2 2 2 3 2 2 2 3 2 221 222 3 2 2 2 DCR, % 22.2 95.5 71.4 73.7 1 1 2 0 3 2 2 1 1 3 2 2 1 10233 PD PD PD PD PD SD SD PD PD PR PR SD PD PD SD SD SD SD SD SD PR PR SD PR SD PR PD SD PR PR PR PR PR PR PR PR PR CR Data cut-off: 10 Sep 2023. Waterfall plot showing best percent change from baseline in sum of target lesion diameters for patients treated with CLDN6 CAR-T± CLDN6 CARVac (N = 38). One patient died prior to first assessment (NR = not reached) and BOR was defined as PD. Patients had non-measurable disease per RECIST 1.1 and BOR was assessed by tumor marker response. ** Patient achieved complete response after surgical removal of tumors. Response data was pending for 6 patients at the data cutoff. Dotted lines show standard response evaluation criteria used to determine objective tumor response for target lesions per RECIST 1.1 (CR = -100%, PR = 30 to -100%, SD = -30 to 20%, and PD = 20% or higher). Graph contains additional data from 5 patients entered manually into the database following the data cut-off date that was not available in formal outputs. BOR best overall response; CR = complete response; DCR disease control rate; DL dose level; EOC epithelial ovarian cancer; GCT = germ cell tumor; PD progressive disease; ORR = objective response rate; PR = partial response; SD = stable disease. BIONTECH

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