APEX-01 is enrolling patients with tumours that have advanced following treatment with a minimum of two FDA-approved prostate cancer therapies. Credit: Peakstock / shutterstock.com.

The US Food and Drug Administration (FDA) has awarded fast track designation for Ambrx Biopharma’s ARX517 to treat metastatic castration-resistant prostate cancer (mCRPC).

The investigational therapy is an anti-PSMA [human prostate-specific membrane antigen] antibody-drug conjugate (ADC) intended for patients who advance on an androgen receptor pathway inhibitor. 

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Fast track status aids in the development and expedites the review process of drugs for serious conditions with unmet medical needs.

The ADC is being evaluated in the first-in-human, open-label Phase I/II APEX-01 trial in mCRPC patients.

This is the only trial underway in the US analysing an ADC that acts on PSMA.

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The dose escalation and dose expansion study is enrolling patients with tumours that have advanced following treatment with a minimum of two FDA-approved prostate cancer therapies.

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These participants must have PSA progression defined by at least two rising PSA values, radiographic progression based on RECIST v 1.1, or progression of condition based on the presence of new bone lesions.  

Ambrx Biopharma CEO Daniel O’Connor stated: “This fast track designation represents a significant milestone for Ambrx.

“Enabled by our expanded genetic code site-specific conjugation technology, ARX517 has the potential to be a more effective and tolerable treatment option for these patients.”

The company is planning to present updated preliminary data from APEX-01 at a major medical meeting later this year.