- Ambrx Biopharma Inc AMAM announced initial data from its ongoing Phase 1 APEX-01 trial of ARX517, Ambrx's proprietary anti-PSMA ADC, in prostate cancer patients.
- APEX-01 opened for enrollment in July 2021, and this is the first data being reported in the study.
- The primary endpoints are safety, tolerability, and pharmacokinetics. The key secondary endpoint is the objective decline of prostate-specific antigen (PSA) from baseline and/or tumor shrinkage.
- PSA is a protein produced by the prostate gland and is commonly used as a biomarker to diagnose and follow prostate cancer.
- To date, 22 prostate cancer patients have been dosed across seven dose-level Cohorts.
- Related: Ambrx Shares Surge After Encouraging Early Safety, Efficacy Data From Breast Cancer Candidate.
- Of 22 patients evaluable for safety, no drug-related severe adverse events (SAEs) or grade ≥3 treatment-related AEs have been observed. ARX517 was well-tolerated, with grade 1 or 2 treatment-related adverse events being reported.
- PSA reductions of >30% have been observed in Cohorts 2-5, beginning at the second to the lowest dose, 0.64 mg/kg.
- In Cohort 6 (2.0 mg/kg dose), 3 of 3 (100%) patients experienced a greater than 50% reduction in PSA levels.
- 2 of 3 patients experienced a greater than 90% reduction in PSA levels.
- Three patients have been dosed in Cohort 7 with no DLTs.
- Ambrx plans to report further information regarding ARX517 and the APEX-01 study at its upcoming Analyst and Investor Day scheduled for February 24.
- Price Action: AMAM shares are up 45.50% at $2.63 on the last check Thursday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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