Incyclix Bio and Lilly Collaborate on Trial for INX-315 with Verzenio® and Fulvestrant in HR+/HER2- Breast Cancer

Incyclix Bio, LLC, a cutting-edge company specializing in cell cycle control, has announced a significant clinical trial collaboration with Eli Lilly and Company (Lilly). The partnership focuses on testing INX-315, a promising cyclin-dependent kinase 2 (CDK2) inhibitor, in combination with Lilly’s CDK4/6 inhibitor, Verzenio® (abemaciclib), and fulvestrant. This combination therapy is intended for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer who have not responded to previous CDK4/6 inhibitor treatments. The trial will be sponsored by Incyclix Bio, while Lilly will supply the Verzenio.

Patrick Roberts, Pharm.D., Ph.D., the Chief Executive Officer and Co-Founder of Incyclix Bio, expressed his enthusiasm about this collaboration with Lilly. He highlighted that this partnership is a crucial step towards making INX-315 available to patients battling advanced cancer. Roberts pointed out the promising results from previous studies involving Verzenio and fulvestrant, which have shown clinical benefits for patients with HR+, HER2- breast cancer who experienced disease progression after prior CDK4/6 inhibitor treatments. The upcoming trials will investigate whether the addition of INX-315 can further enhance clinical outcomes for these patients.

Under the agreement, while Lilly will provide the abemaciclib, Incyclix Bio will be responsible for conducting and sponsoring the combination study. Both companies will maintain their development and commercial rights to their respective treatments, which can be used either as standalone therapies or in combination with others.

Incyclix Bio’s focus is on developing highly precise treatments targeting the abnormal cell proliferation characteristic of many cancers. Their leading compound, INX-315, is a highly potent and selective CDK2 inhibitor currently being tested in clinical settings. The company has established itself as a scientific authority in the field of cyclin-dependent kinases (CDKs), exploring their potential as therapeutic targets for a range of cancers, including ovarian, breast, and lung cancers. Based in Research Triangle Park, NC, Incyclix Bio was founded by experts in the discovery, research, and development of CDK inhibitors.

This collaboration between Incyclix Bio and Eli Lilly represents a pivotal development in the ongoing fight against advanced and resistant cancers, offering new hope to patients through innovative combination therapies.