In This Article:
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Fast Track designation indicates LBS-007’s potential in filling the unmet medical need of acute leukemia
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LBS-007 is the Company’s investigational medicinal product for the treatment of acute leukemia
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A Phase 1/2 trial in patients with relapsed or resistant acute leukemias is ongoing
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LBS-007, the Company’s lead asset, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA
TAIPEI CITY, Taiwan, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Lin BioScience (6696. Taiwan OTC), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting acute leukemia that have significant unmet medical needs, today announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia. Lin BioScience is currently conducting a phase 1/2 trial in patients with relapsed or resistant acute leukemias in the US, Australia, and Taiwan, and has been granted for orphan drug designation (ODD) for acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA.
“We are thrilled to see LBS-007 showing signs of early treatment response and potential efficacy in addressing this critical unmet medical need,” said Dr. Tom Lin, Chairman of Lin BioScience. “Receiving FDA Fast Track Designation is a significant milestone, offering an expedited pathway to advance the development of this promising therapy. We remain deeply committed to delivering transformative solutions for patients in need.”
“During the phase 1 dose escalation, we have not observed any Definitely or Probably Related Adverse Effects in all patients who have received low to high doses, demonstrating the safety profile is very tolerable and promising,” said Dr. Irene Wang, President & CSO of Lin BioScience.
About Fast Track Designation
Fast Track is a process designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapies. Once a drug receives Fast Track designation, it is eligible for more frequent meetings with the FDA, more frequent written communication from the FDA, Accelerated Approval and Priority Review if relevant criteria are met, and Rolling Review. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.