ESMO 2023 BioNTech Data

BNT211: Phase 1/2a, FIH, Open-Label, Multicenter, Dose Escalation Trial in R/R Advanced CLDN6+ Solid Tumors (NCT04503278) ESMO 2022 (n=22) ESMO 2023 (n=44) Phase I dose escalation (manual product): Completed. Phase I dose escalation with an (automated product): Ongoing Inclusion criteria Monotherapy Combination* Monotherapy Combination ≥50% tumor cells with 2+/3+ CLDN6 positivity (immunohistochemistry) Measurable disease per RECIST v1.1 or elevated tumor marker, ECOG PS 0-1 1×107 CAR-T DL3 n=0 2-5x108 CAR-T DL2 n=9 DL2 n=6 + fixed CARVac 1×108 CAR-T DL1 n=4 DL1 n=3 + fixed CARVac DL2 n=4 1×108 CAR-T DL1 n=4 1×107 CAR-T DLO n=2 DL3 n=0 + fixed CARVac DL2 n=4 + fixed CARVac DL1 n=3 + fixed CARVac * Crossover to ombination not indicated 1×106 CAR-T Key endpoints Primary: Safety and tolerability, DLTs • ORR, DCR, DOR, PFS Secondary: Immunogenicity, Dosing: Escalating doses of CLDN6 CAR-T cells ± CLDN6 CARVAC Lymphodepletion prior to CAR-T cell infusion on Day 1 (DLTs assessed for 28 days) CLDN6 CARVac fixed dose (from Day 4, 50 µg then 100 µg) Q3W × 5, then Q6W Assessments: Efficacy assessments Q6W (RECIST v1.1) & tumor marker monitoring Aim of current analysis: Determine the safety and preliminary efficacy of the automated CLDN6-CAR T product CARVac Data cut-off: 10 Sep 2023. Crossover to combination not indicated. CAR = chimeric antigen receptor; CARVac = CAR T-cell amplifying RNA vaccine; CLDN6 = claudin-6; DCR = disease control rate; DL = dose level; DLT = dose-limiting toxicity; DoR = duration of response; ECOG PS = Eastern Cooperative Oncology Group performance status; ORR = objective response rate; PFS = progression-free survival; RECIST = response evaluation criteria in solid tumors; R/R = relapsed/refractory; QXW; every X weeks. 14 BIONTECH

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