The trial will evaluate AC0682’s tolerability, safety, pharmacokinetics, and initial anti-tumour activity in breast cancer patients. Credit: National Cancer Institute on Unsplash.

Accutar Biotechnology has announced the first subject dosing in a Phase I clinical trial of orally bioavailable chimeric degrader molecule, AC0682, for ER-positive breast cancer patients.

Conducted in China, the trial will evaluate the AC0682 treatment’s tolerability, safety, pharmacokinetics, and initial anti-tumour activity in these breast cancer patients.

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Accutar Biotechnology CEO Jie Fan said: “The initiation of this study marks the first programme from our chimeric degrader portfolio to enter the clinic in China, after the initiation of AC0682 Phase I study in the US late last year and the IND clearance by the China National Medical Products Administration (NMPA) earlier this year.

“Breast cancer is the most common cancer type among Chinese women. We look forward to accelerating the development of AC0682 globally with the goal of bringing transformative medicines to patients worldwide.”

AC0682 has been designed to act on ERα protein with selectivity and potency.

It is an investigational chimeric degrader of hormone-regulated transcription factor ERα to potentially treat ER-positive breast cancers.

ERα plays a significant role in the initiation as well as proliferation of breast cancer, and nearly 80% of these cancers express ERα.

AC0682 showed potent and selective ERα protein degradation in preclinical studies. Favourable pharmacological properties, and promising anti-tumour activity was observed in these studies in tumour models of ER-positive animals.

In March this year, Accutar Biotechnology dosed the first subject in the Phase I clinical trial of AC0176, its investigational therapy, for potential treatment of metastatic castration-resistant prostate cancer (mCRPC) patients.

This trial is designed to analyse AC0176’s safety, tolerability, pharmacokinetics and initial anti-tumour activity for mCRPC.