NEW YORK – Regor Therapeutics on Monday announced that it has received US Food and Drug Administration clearance to conduct a Phase I trial of its CDK2/4/6 inhibitor, RGT-419B, for advanced, hormone receptor positive, HER2-negative breast cancer patients.
Following the go-ahead from the FDA, Regor plans to evaluate RGT-419B both as a single agent and in combination with other approved therapies specifically for hormone receptor-positive, HER2-negative breast cancer patients who are resistant to currently approved CDK4/6 inhibitors.
According to the Shanghai-based firm, the agent has demonstrated superior single-agent activity to abemaciclib (Eli Lilly's Verzenio) and palbociclib (Pfizer's Ibrance) in preclinical research. The agent also augmented tumor cell suppression when used together with selective estrogen receptor degraders or PI3K signaling pathway inhibitors. Regor believes RGT-419B can help patients overcome resistance to CDK4/6 inhibitors currently on the market.
"Achieving an optimal selectivity profile against several CDKs by leveraging Regor's proprietary CARD platform, this innovative drug is entering clinical stage development in the US," Xianyang Qiu, Regor's founder and CEO, said in a statement. "We are excited by this opportunity to bring new and differentiated treatment options to the many patients suffering from breast cancer worldwide."