Avenzo Therapeutics and Gilead Sciences are joining forces to explore a novel combination therapy for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. The collaboration will assess the potential of Avenzo's investigational CDK2 inhibitor, AVZO-021, in conjunction with Gilead's Trop-2 directed antibody-drug conjugate (ADC), Trodelvy (sacituzumab govitecan-hziy). This partnership aims to address the unmet need for more effective treatments in this common subtype of breast cancer.
Trial Design and Collaboration
Under the terms of the agreement, Gilead will supply Trodelvy to Avenzo, who will spearhead the clinical trial's execution and sponsorship. Both companies will retain full control over the development and commercialization of their individual assets, including the freedom to pursue monotherapy or other combination strategies. The study is a Phase Ib trial expected to begin in the fourth quarter of 2024.
Rationale for the Combination
AVZO-021 is a selective inhibitor of CDK2, a cyclin-dependent kinase involved in cell cycle progression. By blocking CDK2, AVZO-021 aims to halt the uncontrolled proliferation of cancer cells. Trodelvy, on the other hand, is an ADC that targets the Trop-2 protein, which is frequently overexpressed in breast cancer cells. Trodelvy delivers a cytotoxic payload directly to cancer cells expressing Trop-2, leading to their destruction. The combination of a CDK2 inhibitor and a Trop-2 directed ADC represents a rational approach to target breast cancer cells through complementary mechanisms.
Management Commentary
Athena Countouriotis, co-founder, president, and CEO of Avenzo Therapeutics, expressed enthusiasm about the collaboration, stating, "We are excited to advance our oncology pipeline by entering this clinical collaboration with Gilead to evaluate the combination potential of AVZO-021." Countouriotis further added, "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."
