DB-1305 /BNT325

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DB-1305 /BNT325

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· Well-positioned to address underserved needs in OC, NSCLC and TNBC

· Combination potential as backbone therapy in multiple solid tumors (NSCLC, TNBC, OC, CC)

Main highlights of drug design

First-wave DITAC-empowered Asset under Global Clinical Development

Advantages and Characteristics

CLINICAL DATA

· Out of 23 TROP2-expressing advanced solid tumors with a median of 3 prior lines of therapies(1)
1.uORR of 30.4% and uDCR of 87.0%
2.uORR of 46.2% and uDCR of 92.3% in 13 NSCLC patients
· Manageable safety profile with 44 patients treated(1)
≥Grade 3 TRAEs 34.1%

DEVELOPMENT PLAN

· OC
1.FDA Fast Track Designation in February 2024
2.Preliminary efficacy in an all-comer cohort of adv. PROC patients
· Combination therapy in multiple solid tumors
1.Exploring earlier lines in NSCLC, OC, CC and TNBC
2.FPI in combo with BNT327/PM8002 (PD-L1/VEGF bsAb) in June 2024

KEY EXPECTED CATALYSTS

· OC data readout in 2025H1
· Initiating global pivotal study in 2025