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ARX788, a Site-specific Anti-HER2 Antibody-Drug Conjugate ... - PubMed

ARX788 is a next-generation, site-specific anti-HER2 ADC that utilizes a unique nonnatural amino acid-enabled conjugation technology and a noncleavable Amberstatin (AS269) drug-linker to generate a homogeneous ADC with a drug-to-antibody ratio of 1.9. ARX788 exhibits high serum stability in mice and a relatively long ADC half-life of 12.5 days.

ACE-BREAST-03: A phase 2 trial evaluating ARX788, an anti-HER2 antibody ...

ARX788 is a next-generation anti-HER2 ADC stably conjugated to AS269 (a potent tubulin inhibitor). Proprietary site-specific oxime conjugation chemistry, enabled by incorporation of synthetic amino acids into the antibody construct, maximizes the delivery of the cytotoxic payload to tumor cells and minimizes systemic exposure of free payload.

Pipeline - Ambrx

ARX788 is a homogeneous and highly stable ADC, which targets the HER2 receptor and contains two AS269 cytotoxic payloads site-specifically conjugated to a trastuzumab-based antibody. ARX788 was designed to maximize potential anti-tumor activity by optimizing the number and position of the payloads and the chemical bonds that conjugate the ...

ARX788 Meets PFS End Point in HER2+ Metastatic Breast Cancer - OncLive

ARX788 has also demonstrated activity in vitro and in vivo models of HER2-positive breast and gastric cancers. 3 Specifically, ARX788 hindered growth on all 5 HER2-positive cell lines examined ...

ARX788 for Treating Patients with HER2-low Locally Advanced ...

ARX788 is an antibody-drug conjugate that targets HER2-low breast cancer cells. This trial tests its safety and effectiveness in patients with locally advanced or metastatic disease.

ARX788, a Site-specific Anti-HER2 Antibody-Drug Conjugate, Demonstrates ...

ARX788 is a next-generation, site-specific anti-HER2 ADC that utilizes a unique nonnatural amino acid-enabled conjugation technology and a noncleavable Amberstatin (AS269) drug-linker to generate a homogeneous ADC with a drug-to-antibody ratio of 1.9. ARX788 exhibits high serum stability in mice and a relatively long ADC half-life of 12.5 days.

Ambrx - ACE-Breast-02 Pivotal Phase 3 Study of Ambrx's ARX788 for the ...

ARX788 is an anti-HER2 antibody drug conjugate (ADC) developed by Ambrx and its partner NovoCodex. A pivotal Phase 3 study in China demonstrated a greater progression free survival benefit compared to the control, and NovoCodex plans to seek marketing approval.

PDF Phase 1 Dose Escalation Study of ARX788, a Next-Generation Anti ... - Ambrx

• ARX788-1711 is a phase 1, multicenter, dose-escalation (Part 1) and expansion (Parts 2-3) study of ARX788 monotherapy in patients with advanced solid tumors with HER2 expression or mutation. Eligibility was open to patients for whom standard-of-care therapy had failed or was an unacceptable option.

FDA Action Moves ARX788 Forward in the Treatment of HER2-Positive ...

Fast track designation was granted to the anti-HER2 antibody-drug conjugate ARX788 as monotherapy for the treatment of patients with advanced or metastatic HER2-positive breast cancer following at least 1 prior HER2-targeting regimen in the metastatic setting, announced the agent's developer Ambryx Inc. 1 A site-specific antibody-drug conjugate, ARX788 consists of an anti-HER2 monoclonal ...

ARX788 Displays Activity in HER2+ Advanced Breast Cancer

ARX788 is composed of an anti-HER2 monoclonal antibody site-specifically conjugated with AS269 and a monomethyl auristatin F payload. Preclinical data from patient-derived breast xenograft models ...

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