ESMO 2023 BioNTech Data

FIH Phase 1/2 to Evaluate Safety, Tolerability and Antitumor Activity of BNT325/DB-13051 in Patients with Advanced/Metastatic Solid Tumors Phase 1/2a study design (NCT05438329) Multicenter, non-randomized, open-label, multiple-dose, first-in-human (FIH) study, n = 235 Inclusion criteria . Advanced/unresectable, recurrent or metastatic solid tumors Relapsed or progressed on or after standard systemic treatments ECOG 0-1 Adequate organ function (©) Key endpoints Part 1: Dose Escalation Part 2a: Dose expansion progression, withdrawal DB-1305 Indications DL5 Q3W DB-1305 DL4 Q3W RP2D Q3W • Small cell lung cancer (SCLC) • HR+/HER2-neg breast cancer Disease DB-1305 DL3 Q3W DB-1305 DL2 Q3W DB-1305 DL1 Q3W Primary: Phase 1: Assessment of DLT, TEAE, SAE, MTD, RP2D. Phase 2a: TEAES, SAES, ORR Secondary: Pharmacokinetic measures (AUC, Cmax, Tmax, T1/2) • NSCLC with no EGFR- sensitizing mutation, ALK gene translocation or onco- driver gene mutations ⚫ TNBC without prior sacituzumab govite can treatment • TNBC with treatment failure on sacituzumab govitecan of consent, unacceptable toxicity 1. Partnered with DualityBio. ECOG = Eastern Cooperative Oncology Group; DL = dose level; Q3W = every three weeks; RP2D = recommended Phase 2 dose; HR = hormone receptor; HER2 = human epidermal growth factor 2 receptor; NSCLC = non-small cell lung cancer; TNBC = triple negative breast cancer; DLT = dose- limiting toxicity; TEAE = treatment emergent adverse events; SAE = serious adverse events; MTD = maximum tolerated dose; ORR = objective response rate; AUC = Area under concentration-time curve; Cmax = maximum observed plasma concentration; Tmax = time to Cmax; T1/2 = terminal elimination half-life 8 BIONTECH

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