Why Ambrx Biopharma (AMAM) Shares Are Surging Today?

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.

Market News and Data brought to you by Benzinga APIs

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Why Ambrx Biopharma Shares Are Surging Today?

Comments