Incyclix Bio, LLC has received clearance from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND) application for their lead compound, INX-315, a potent and selective CDK2 inhibitor. The company's CEO and Co-Founder, Patrick Roberts, noted that CDK2 is a driver of cancer cell proliferation and a target with broad clinical potential, and the approval of the IND for INX-315 is a significant milestone in the development of precision treatments that regain cell cycle control and advance the care of cancer patients. The Phase 1/2 first-in-human study (INX-315-01) will assess the safety, pharmacokinetics, and preliminary antitumor activity of INX-315 in patients with advanced/metastatic cancers, specifically ER+/HER2- breast cancer that has progressed on a prior CDK4/6i regimen and CCNE1-amplified solid tumors that have progressed on standard of care treatment. The study will be open-label, dose-escalation, and dose-expansion and will take place in the United States and Australia.
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