Drug Profile

BNT 329

Alternative Names: BNT-329

Latest Information Update: 24 Dec 2025

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At a glance

Originator BioNTech
Class Antineoplastics; Drug conjugates; Immunoconjugates; Monoclonal antibodies
Mechanism of Action DNA topoisomerase I inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity Yes

18 Nov 2025 Phase-I/II clinical trials in Solid tumours (Metastatic disease, Late-stage disease, Second-line therapy or greater) in USA (IV) (NCT07186842)
02 Oct 2025 Preclinical trials in Solid tumours in Germany (IV) prior to October 2025
02 Oct 2025 BioNTech SE plans a phase I/II trial for Solid tumours (Second-line therapy or greater, Metastatic disease, Inoperable/Unresectable, Late-stage disease) (IV) in October 2025 (NCT07186842)

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