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ARX 788

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Drug Profile

ARX 788

Alternative Names: Antibody-drug conjugate - Ambrx/Zhejiang Medicine; ARX-788; JNJ-0683; NCB-001

Latest Information Update: 23 May 2025

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At a glance

  • Originator Ambrx
  • Developer Ambrx; NovoCodex Biopharmaceuticals
  • Class Antineoplastics; Drug conjugates; Immunoconjugates; Immunotoxins; Monoclonal antibodies; Small molecules
  • Mechanism of Action Tubulin inhibitors
  • Orphan Drug Status

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

    Yes - Gastric cancer
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II/III HER2 positive breast cancer
  • Suspended Breast cancer; Gastric cancer; Solid tumours

Most Recent Events

  • 10 Dec 2024 Adverse events data from the phase II/III ACE-Breast-02 trial in HER2 positive breast-cancer presented at the 47th Annual San Antonio Breast Cancer Symposium (SABCS-2024)
  • 10 Dec 2024 Efficacy and adverse event data from the phase Ib/II trial in HER2-positive-breast-cancer was presented at the 47th Annual San Antonio Breast Cancer Symposium 2024(SABCS-2024)
  • 29 Oct 2024 NovoCodex Biopharmaceuticals plans a phase II trial for HER2-positive breast cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Recurrent) (IV, Infusion) in November 2024 (NCT06663748)

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