Accutar Biotechnology has dosed the first subject in the Phase I clinical trial of its investigational therapy, AC0176, to potentially treat metastatic castration-resistant prostate cancer (mCRPC) patients.
An orally bioavailable, chimeric degrader molecule, AC0176 is created to act on the androgen receptor (AR) with increased selectivity and potency.
The activation of AR, a hormone-regulated transcription factor, plays a crucial role in the development and progression of prostate cancer.
The open-label, multicentre trial will analyse the safety, tolerability, pharmacokinetics and initial anti-tumour activity of AC0176 in individuals with mCRPC.
It will enrol subjects who have advanced after receiving a minimum of two systemic therapies.
Establishing the recommended dose of AC176 that can be administered to trial subjects is one of the keys goals of the trial.
AC0176 was found to offer robust AR protein degradation with a wide coverage of AR mutants in preclinical studies.
It also was found to have favourable pharmacological properties and anti-tumour activity in animal models.
In December last year, the company obtained clearance for its investigational new drug application (IND) from the US Food and Drug Administration (FDA) to commence the trial of AC0176 for mCRPC.
Accutar Biotechnology CEO Jie Fan said: “The initiation of this study marks the second programme from our AI-enabled drug discovery platform and our chimeric degrader portfolio to enter the clinic.
“AC0176 was designed to potently degrade both AR wildtype and prevalent AR mutants which confer drug resistance to current AR-targeted therapies, including but not limited to L702H, T878A, H875Y, W742C.
“We are excited about the differentiated therapeutic profile of AC0176 and its broad potential to treat prostate cancer patients.”