Lin BioScience, a biopharmaceutical company advancing clinical-stage drug development for novel treatments in acute leukemia with significant unmet needs, has announced that its lead candidate, LBS-007, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) to treat acute myeloid leukemia.
Lin BioScience is actively conducting phase 1/2 clinical trials involving patients with relapsed or resistant acute leukemias across the United States, Australia, and Taiwan. Additionally, the organization has secured orphan drug designation from the FDA for both acute myeloid and acute lymphocytic leukemia.
“We are excited to observe the early response and the therapeutic potential of LBS-007 in tackling these urgent unmet medical needs,” expressed Dr. Tom Lin, Lin BioScience’s chairman. “This Fast Track Designation by the FDA is a critical achievement that accelerates the pathway to further develop this promising treatment. Our commitment remains strong towards delivering innovative solutions for patients requiring new options.”
“During the dose escalation in phase 1, we have not detected any definite or probable adverse effects throughout the range of doses tested, indicating a very manageable and optimistic safety profile,” stated Dr. Irene Wang, the president and CSO of Lin BioScience.
Fast Track is a process devised to speed up the development and review of medications aimed at serious diseases, addressing previously unmet medical needs. It aims to ensure that vital new drugs reach patients without delay. Fast Track applies to drugs for a wide spectrum of serious conditions. Unmet medical needs refer to therapies that lack existing options or are potentially superior to current treatments. Once a drug is granted Fast Track status, it benefits from more frequent FDA meetings, written communications, accelerated approval, priority review if applicable, and rolling reviews. This ongoing dialogue often resolves issues briskly, potentially leading to faster drug approvals and access for patients. Fast Track designation underscores LBS-007’s potential in meeting acute leukemia’s unmet needs.
LBS-007 is a natural, non-ATP-dependent cell cycle inhibitor targeting a variety of cancers. By inhibiting CDC7’s kinase activity, a crucial regulator in the cancer cell cycle, LBS-007 disrupts tumor cell proliferation, leading to cell death. LBS-007 has displayed promising efficacy against leukemia and numerous solid tumor types in preclinical investigations. It remains Lin BioScience’s investigational treatment for acute leukemia, with ongoing phase 1/2 trials in patients facing relapsed or resistant acute leukemias.