Avenzo Therapeutics has announced a clinical trial partnership and supply agreement with Gilead Sciences to assess a combination treatment regimen for breast cancer.

The regimen includes Avenzo's investigational CDK2 inhibitor, AVZO-021, and Gilead's Trop-2 directed antibody-drug conjugate (ADC), Trodelvy (sacituzumab govitecan-hziy).

The study will assess the combination regimen in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer.

Under the deal, Gilead will supply Trodelvy to Avenzo, who will be responsible for conducting and sponsoring the study.

For their respective assets, both companies will maintain all development and commercial rights. This includes rights for monotherapy or combination therapies.

Avenzo Therapeutics co-founder, president and CEO Athena Countouriotis said: “We are excited to advance our oncology pipeline by entering this clinical collaboration with Gilead to evaluate the combination potential of AVZO-021.

“We continue to believe AVZO-021 is a potential, best-in-class CDK2 selective inhibitor that may provide a new treatment option to patients. We look forward to initiating combination cohorts with Trodelvy, as well as CDK4/6 inhibitors, in the Phase Ib portion of the ongoing clinical study in the fourth quarter of 2024.”

In June this year, Gilead reported two-year interim data from the ongoing Phase III ASSURE study of seladelpar in patients with primary biliary cholangitis (PBC).

The open-label trial assessed the long-term safety and efficacy of seladelpar, an orally active peroxisome proliferator-activated receptor delta agonist.

The findings revealed quick and lasting improvements in cholestasis markers, with increased rates of liver biomarker normalisation and significant pruritus reduction.