BioNTech Results Presentation Deck

BNT122: Randomized Phase 2 Trial in Adjuvant Colorectal Cancer Phase 2, open-label, multicenter randomized trial BNT122 versus watchful waiting in ctDNA positive patients with surgically resected Stage II (high risk) / stage III colorectal cancer Adjuvant SOC chemotherapy: 12 24 weeks DOO ooo 30 Patients with resected stage II high-risk / stage III CRC post surgery Screening 1: ctDNA status Screening 2: neoantigen selection for vaccine manufacture Screening 3: final eligibility 1:1 R Treatment Arm: BNT122 15 doses (6x q1w, 2x q2w, 7x q6w n = 166 Primary Endpoints DFS patients in biomarker cohort skip screening 1 iNeST Manufacturing ≤ 20 neoepitopes Observational Arm watchful waiting Secondary Endpoints RFS, TTR, TTF, OS Change in ctDNA status ● Biomarker Cohort: BNT122 irrespective of ctDNA status n = 15 Exploratory Cohort: BNT122 recurrent disease at screening 3 n≤ 20 CRC, colorectal cancer; ctDNA, circulating tumor DNA; SOC, standard of care; q1w, once weekly; q2w, every two weeks; q6w, every six weeks; DFS, disease-free survival; RFS, relapse-free survival; TTR, time to response; TTF, time to treatment failure; OS, overall survival; https://www.clinical trials.gov/ct2/show/NCT04486378; BNT122/iNeST is partnered with Genentech/Roche BIONTECH

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