165 0 Kommentare Ambrx Provides Safety and Efficacy Data from Ongoing Phase 1/2 APEX-01 Trial of ARX517 in mCRPC at ESMO Congress

Newly published abstract regarding dose escalation patients provides key updates including:

≥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 to host a live event / webcast to discuss additional data presented at ESMO on Sunday, October 22, 2023, at 8 p.m. CEST / 2 p.m. ET

SAN DIEGO, Oct. 16, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that 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) 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.

APEX-01 opened for enrollment in July 2021, and is the only ongoing clinical trial in the United States targeting PSMA with an antibody-drug conjugate (ADC). APEX-01 is a first-in-human, open-label, dose escalation and dose expansion study enrolling patients with mCRPC whose tumors have progressed on at least two prior FDA-approved treatments, including at least one second-generation androgen receptor pathway inhibitor. The inclusion criteria included one of the following: PSA progression defined by a minimum of two rising PSA values, radiographic progression by RECIST v1.1 or disease progression by the presence of new bone lesions.

The two clinical abstracts submitted to ESMO regarding the APEX-01 trial used a cutoff date of May 3, 2023. Ambrx will provide more mature data with a later data cutoff date, including a significantly greater number of patients from the dose expansion portion of APEX-01, in the ESMO posters and in its associated press release.

Ambrx will be hosting a Key Opinion Leader event at ESMO to discuss the data from these abstracts and posters, which will be live webcast on Sunday, October 22, 2023, at 8 p.m. CEST / 2 p.m. ET. Details regarding this event can be found on Ambrx’s website via this link https://ambrx.com/.