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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
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On average, how many patients with B-cell acute lymphoblastic leukemia do you see in a year?