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U.S. FDA grants fast track designation to cell cycle inhibitor LBS-007
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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
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.2
- GlobeNewswire. Lin BioScience receives U.S. FDA fast track designation for LBS-007. https://www.globenewswire.com/news-release/2024/11/27/2987977/0/en/Lin-BioScience-Receives-U-S-FDA-Fast-Track-Designation-For-LBS-007.html. Published Nov 27, 2024. Accessed Nov 27, 2024.
- ClinicalTrials.gov. The safety and tolerability of LBS-007 in patients with relapsed or resistant acute leukaemias. https://clinicaltrials.gov/study/NCT05756322?intr=LBS-007&rank=1. Updated Oct 15, 2024. Accessed Nov 27, 2024.
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