Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007
Fast Track designation underscores LBS-007's potential in addressing the critical unmet medical need for acute leukemia treatment. LBS-007, Lin BioScience's lead investigational medicinal product, is currently under evaluation in a Phase 1/2 trial for patients with relapsed or resistant acute leukemias in the US, Australia, and Taiwan. The U.S. FDA has also granted orphan drug designations for acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) to LBS-007.
Dr. Tom Lin, Chairman of Lin BioScience, expressed enthusiasm about the early treatment response and potential efficacy of LBS-007, emphasizing the significance of the FDA Fast Track Designation in expediting the development of this promising therapy. Dr. Irene Wang, President & CSO of Lin BioScience, highlighted the safety profile of LBS-007, noting the absence of Definitely or Probably Related Adverse Effects in patients across low to high doses during the phase 1 dose escalation.
About Fast Track Designation: Fast Track is a process aimed at facilitating the development and expediting the review of drugs intended to treat serious conditions and fill unmet medical needs. It offers benefits such as more frequent meetings and written communication with the FDA, eligibility for Accelerated Approval and Priority Review, and Rolling Review, ensuring quicker resolution of questions and issues, which can lead to earlier drug approval and patient access.
About LBS-007: LBS-007 is a natural, non-ATP cell cycle inhibitor targeting a broad array of cancers. It functions by blocking the kinase activity of CDC7, a key regulator of the cancer cell cycle, thereby inhibiting tumor cell proliferation and inducing cancer cell death. Preclinical studies have demonstrated LBS-007's potent activity against leukemia and multiple solid tumors.
Lin BioScience, founded in 2016, is dedicated to developing first-in-class therapies for cancer, ophthalmology, and metabolic diseases, addressing significant unmet medical needs. The company's pipeline includes several promising drug candidates, with LBS-007 being a key focus for acute leukemia and solid tumors treatment.