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DB 1305

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Drug Profile

DB 1305

Alternative Names: BNT-325; DB-1305

Latest Information Update: 12 Aug 2024

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At a glance

  • Originator Duality Biologics
  • Developer BioNTech; Duality Biologics
  • Class Antibodies; Antineoplastics; Drug conjugates; Immunoconjugates
  • 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
  • Available For Licensing Yes

Highest Development Phases

  • Phase I/II Solid tumours

Most Recent Events

  • 30 Jun 2024 Phase-I/II clinical trials in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease, Inoperable/Unresectable, Second-line therapy or greater, Recurrent) in Puerto Rico, China, USA (IV) (NCT05438329)
  • 01 Feb 2024 DB 1305 receives Fast Track designation for Solid tumours [IV,Injection] (Late-stage disease, Metastatic disease, Recurrent) in USA
  • 20 Oct 2023 Preliminary pharmacokinetics, adverse events and efficacy data from a phase I trial in Solid tumours presented at the 48th European Society for Medical Oncology Congress (ESMO-2023)

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