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ARX788 is a HER2 ADC with a precisely placed, non-cleavable payload that beat lapatinib-capecitabine in China and showed activity in brain metastases.
ARX788 is a HER2 antibody-drug conjugate in which the payload is attached at a precisely engineered non-natural amino acid (pAF), giving a homogeneous drug-to-antibody ratio of about 2; its non-cleavable linker limits the bystander effect but improves stability in circulation. Developed by Ambrx (acquired by Johnson & Johnson in 2024) and NovoCodex, it is aimed at HER2-positive metastatic breast cancer. The ACE-Breast-02 phase 3 trial showed PFS of 11.3 versus 8.2 months (HR 0.64) against lapatinib plus capecitabine, and ACE-Breast-06 showed intracranial activity in active brain metastases. Ocular and interstitial lung toxicities are the main concerns. It holds FDA Fast Track designation and a Chinese marketing application is planned; how it will be positioned against T-DXd is unclear. For a newcomer, it is a HER2 ADC with a precisely placed payload that showed activity in the brain.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Site-specific pAF conjugation gives homogeneous DAR ~2; non-cleavable linker limits bystander effect but improves stability. Connects to HER2.
1.ARX788's antibody arm binds HER2 on the surface of the cancer cell.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2024-01-08 | Ambrx Biopharma to Johnson & Johnson ARX517 (PSMA ADC) and ARX788 (HER2 ADC) with site-specific conjugation technology | Acquisition | not disclosed | $2.0bn | source |
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Query for this drug: (TITLE:"ARX788" OR ABSTRACT:"ARX788") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about ARX788, not a curated reading list.
Shares Site-specific conjugation & linker chemistry, Antibody-drug conjugate (ADC).
Shares Sequencing HER2 ADCs by payload after T-DXd, Antibody-drug conjugate (ADC).
Shares Site-specific conjugation & linker chemistry, HER2, Antibody-drug conjugate (ADC).
Shares Site-specific conjugation & linker chemistry, Antibody-drug conjugate (ADC).
Shares Site-specific conjugation & linker chemistry, Antibody-drug conjugate (ADC).
Shares ACE-Breast-02, HER2, HER2-positive breast cancer.
Shares Site-specific conjugation & linker chemistry, Antibody-drug conjugate (ADC).
Shares Sequencing HER2 ADCs by payload after T-DXd, HER2, HER2-positive breast cancer, Antibody-drug conjugate (ADC).