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Ambrx Shares Surge After Encouraging Early Safety, Efficacy Data From Breast Cancer Candidate

  • Ambrx Biopharma Inc (NASDAQ: AMAM) announced preliminary safety and efficacy data from its Phase 2 ACE‑Breast-03 study.

  • The data presented demonstrated a 51.7% overall response rate (ORR) and 100% disease control rate (DCR) after treatment with ARX788 in HER2-positive mBC patients who are resistant or refractory to T-DM1.

  • ACE-Breast-03 is a Phase 2 study of ARX788 for patients whose metastatic disease is resistant or refractory to T-DXd, T-DM1, or tucatinib-containing regimens.

  • Related: Ambrx Biopharma Stops Working On Breast Cancer Candidate, Cites Competition As The Reason.

  • Patients had a median time on therapy of 7.2 months, and treatment remains ongoing.

  • None of the patients experienced drug-related serious adverse events (SAEs), and all adverse events (AEs) were well tolerated, with no treatment discontinuations from AEs.

  • Two Phase 3 studies and one registration-enabled Phase 2 study with ARX788 conducted by Amrbrx's partner, NovoCodex Biopharmaceuticals, are ongoing in China, with projected readouts in 2023.

  • Price Action: AMAM shares are up 180.6% at $1.15 during the premarket session on the last check Friday.

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