Ambrx Provides Ongoing Phase 1/2 APEX-01 Trial of ARX517 Safety and Efficacy Data

DENVER, Colo., Oct 16, 2023 ( Ambrx Biopharma, Inc. (NASDAQ: AMAM) stated, this morning, that it published two abstracts detailing updated safety and efficacy data from the ongoing Phase 1/2 trial, APEX-01 (NCT04662580), evaluating ARX517 for metastatic castration-resistant prostate cancer (mCRPC) and were made available as part of the 2023 European Society of Medical Oncology (ESMO) Congress 2023 meeting, taking place in Madrid, Spain, October 20-24, 2023.

Key updates from the newly published abstract include:

  • ≥50% PSA reduction observed across putative therapeutic dose levels ≥2.0 mg/kg – 3 of 3 in Cohort 6 (2.0 mg/kg), 2 of 3 in Cohort 7 (2.4 mg/kg) and 2 of 3 in Cohort 8 (2.88 mg/kg)
  • No drug-related severe adverse events (SAEs) and no dose limiting toxicities (DLTs) observed in any cohort
  • Pharmacokinetic (PK) data indicated strong ADC stability preventing premature release of anticancer payload

Ambrx Biopharma is trading at $16.63, up $2.58 (+18.36%), on 473.1K premarket shares traded.

Its 52-week range is $0.38 to $16.86. It’s near a 52-week high and hit a premarket high of $20.67, so this could be a big mover today.

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