DB-1311/BNT324

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DB-1311/BNT324

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・ A clinically advanced B7-H3 ADC candidate with global market potential

・ Combination potential as frontline treatment for prevalent cancers

・ Opt-in rights to co-develop and co-commercialize in the U.S.

Main highlights of drug design

・ Potent tumor killing while reducing off-target toxicities

・ High selectivity by targeting the 4IgB7-H3 isoform (predominantly found on B7-H3-overexpressing tumor cells)

Advantages and Characteristics

CLINICAL DATA

・ Promising efficacy observed in SCLC, CRPC, lung cancer cohorts
・ Acceptable and manageable safety profile, with low rates of TRAEs

DEVELOPMENT PLAN

・ SCLC: potential to combo immunotherapy for the front-line treatment
・ CRPC: FDA Fast Track Designation
・ ESCC: FDA Orphan Drug Designation
・ Preliminary efficacy data in SCCHN, HCC, CC, Melanoma

KEY EXPECTED CATALYSTS

・ SCLC: Oral Presentation in ESMO-Asia in 2024Q4
・ Initiating multiple global pivotal studies in 2025