U.S. FDA grants fast track designation to cell cycle inhibitor LBS-007

On November 27, 2024, the U.S. Food and Drug Administration (FDA) granted fast track designation to LBS-007, a natural non-ATP cell cycle inhibitor, which is in development for the treatment of patients with relapsed/resistant (R/R) acute leukemias.¹ It previously received orphan drug designation by the U.S. FDA on April 24, 2018, for the treatment of acute lymphoblastic leukemia (ALL).²

LBS-007 inhibits the kinase activity of cell division cycle 7 (CDC7), which regulates the cancer cell cycle, thereby disrupting tumor cell proliferation and triggering cancer cell death. Its potent anti-leukemia activity has been demonstrated in preclinical studies.¹ Currently, an open-label, multicenter, phase I/II trial (NCT05756322) is ongoing to investigate the safety, tolerability, and maximum tolerated dose of LBS-007 in patients with acute leukemias.³