BioNTech Results Presentation Deck

BNT112 Phase 1/2: Fix Vac Off-the-Shelf mRNA Vaccine as Monotherapy and in Combination with PD-1 Inhibitor in Patients with Prostate Cancer BNT112 targets 5 prostate cancer tumor-associated shared antigens Part 1: Dose titration Monotherapy Only patients with mCRPC Metastatic castration-resistant ● ● 23 prostate cancer or localized prostate cancer Patients All patients Stage 4 at diagnosis Median age 68 years ● ● BNT112 mCRPC (n=9) 11 patients treated with monotherapy 3 with BNT112 + cemiplimab REDR 1:1 Part 2: Expansion cohorts Monotherapy and combination therapy mCRPC and LPC ● Did not meet DLT definition according to Safety Review. Committee BNT112 + cemiplimab mCRPC (n=33) BNT112 mCRPC (n=33) AEs mostly mild-to-moderate Most common related AEs: pyrexia and hypertension Dose reduction due to Grade 3 hypertension in 2 patients. Patients recovered within 24 hours 8 serious AEs in 5 patients unrelated to BNT112 No safety signals of concern 1:1 BNT112 + cemiplimab LPC (n=20) BNT112 LPC (n=20) Vaccine induced immune responses All ELISpot-evaluable patients (n=7) showed vaccine- induced immune response All 5 BNT112 tumor-associated antigens are immunogenic T cell responses to each antigen in at least 2 of 7 evaluable patients Signs of anti-tumor activity Decreased prostate-specific antigen (PSA) levels in 2 patients with monotherapy Data cutoff: 22 June 2021; mCRPC, metastatic castration-resistant prostate cancer; LPC, localized prostate cancer; REDR, recommended dose expansion range; AE, adverse event; DLT, dose-limiting toxicity; PSA, prostate-specific antigen ....... BIONTECH

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