ESMO 2023 BioNTech Data

BNT325/DB-13051 Was Tolerable and TRAES Were Manageable in Lower Dose Levels Phase 1/2a FIH study (NCT05438329): Safety Marathe O. et al. Presented at ESMO 2023. Poster #689P. Overall safety Summary of AEs (≥20%) and all AESI (n=44) TEAES TRAES AESI* 2 mg/kg (n=1) n (%) 4 mg/kg (n=20) n (%) 5 mg/kg (n=17) n (%) 6 mg/kg (n=6) n (%) Total Any TRAES 0 19 (95.0) 15 (88.2) 6 (100) (n=44) n (%) 40 (90.9) All grade n (%) Grade ≥3 n (%) All grade n (%) Stomatitis 33 (75.0) Grade ≥3 0 7 (35.0) 5 (29.4) 3 (50.0) 15 (34.1) Nausea 13 (29.5) 10 (22.7) 1 (2.3) 33 (75.0) Grade ≥3 n (%) 10 (22.7) All grade n (%) 33 (75.0) Grade ≥3 n (%) 10 (22.7) 12 (27.3) 1 (2.3) Serious TRAES 3 (15.0) 4 (23.5) 3 (50.0) 10 (22.7) Lymphocyte count 10 (22.7) 6 (13.6) 0 decreased Lead to dose reduction 1 (5.0) 2 (11.8) 3 (50.0) 6 (13.6) Infusion related 9 (20.5) 0 9 (20.5) 0 9 (25.0) 0 Lead to dose interruption 0 6 (30.0) 5 (29.4) 4 (66.7) 15 (34.1) reaction Lead to dose 0 1 (5.0) 0 0 1 (2.3) Decreased appetite 9 (20.5) 0 7 (15.9) 0 discontinuation Mucosal 1 (2.3) 1 (2.3) 1 (2.3) 1 (2.3) 1 (2.3) 1 (2.3) Dose-limiting toxicities 0 0 0 3 (50) 3 (6.8) inflammation One patient died by suicide on day 18 after first dose and one patient experienced double pneumonia related AE on day 49. Interstitial lung disease 1 (2.3) 0 1 (2.3) 0 1 (2.3) * AESI includes interstitial lung disease/pneumonitis, infusion related reaction, diarrhea, stomatitis/mucosal inflammation, and combined elevations of aminotransferases and bilirubin. BNT325/DB-1305 was tolerable and all AEs were manageable in lower dose levels (i.e., 2 and 4 mg/kg) • Three patients dosed at 6 mg/kg experienced dose-limiting toxicities (i.e., stomatitis, febrile neutropenia, and white blood cell decreased), and the maximum tolerated dose was established as 5 mg/kg • No TEAEs led to death 1. Partnered with Duality Bio. TRAE treatment related adverse event; FIH = first in human, AESI-Adverse event of special interest, TEAE -Treatment emergent adverse event,. 11 BIONTECH

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