ESMO 2023 BioNTech Data

Phase 1 First-in-Human Trial (NCT04625205) Evaluating BNT221 in Advanced or Metastatic Melanoma Prescreening BNT221 infusion Production Post-infusion Follow-up Expansion cohorts -20 -16 -12 -4 AD1+2+3 +6 +30 +36 +52 Week Screening/Sequencing Lympho- depletion EOT Occurs every 6 weeks Inclusion criteria Adults 18-75 yrs, unresectable or metastatic melanoma Progressive disease or intolerant to aPD-1/PD-L1 and aCTLA-4 directed therapies; ≤3 prior regimens in metastatic setting At least 1 site RECIST 1.1 measurable disease (active CNS metastasis excluded) ECOG 0-1 No active auto-immune diseases BNT221 Monotheraphy dose finding 1 x 108-1 x 109 2 x 109-1 x 1010 Combination BNT221aPD-1 Tissue collection to evaluate immune response: Blood draw Biopsy Leukapheresis Key endpoints Primary: Safety + MTD BNT221 monotherapy, + aPD-1 Secondary: ORR (RECIST 1.1), response duration, clinical benefit rate Exploratory: Immune response in peripheral blood and tumor Immunogenicity, clinical activity correlation Drug product characterization, correlation with clinical activity and safety CNS: central nervous system; MTD: minimal residual disease; ORR: overall response rate; PD: progressive disease. BIONTECH

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