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Lin BioScience Achieves Fast Track Designation for LBS-007 in Acute Leukemia Treatment
Lin BioScience, a biopharmaceutical company dedicated to developing innovative therapies for cancer, has recently announced that its lead investigational drug, LBS-007, received Fast Track Designation from the U.S. Food and Drug Administration (FDA). This designation is a significant step forward in the quest to address the unmet medical needs associated with acute myeloid leukemia (AML). The news is particularly timely, as the company is currently involved in a Phase 1/2 clinical trial for patients suffering from relapsed or resistant forms of acute leukemia across the United States, Australia, and Taiwan.
Dr. Tom Lin, Chairman of Lin BioScience, expressed satisfaction with the early indications of treatment response from LBS-007, emphasizing the drug’s potential effectiveness in a field where options are limited. He stated, “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.”
The ongoing Phase 1 trial has reported no serious side effects related to the drug, highlighting a favorable safety profile that positions LBS-007 as a promising candidate in cancer therapeutics. Dr. Irene Wang, the company’s President and Chief Scientific Officer, noted, “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.”
Understanding Fast Track Designation
Fast Track Designation is a process established by the FDA intended to accelerate the development and review of new therapeutic agents that address serious health conditions and fulfill unmet medical needs. The initiative seeks to make important drugs available to patients sooner, categorizing unmet medical needs as the provision of new therapies or those that potentially outperform existing options. With this designation, the developers of LBS-007 can anticipate increased communication with the FDA and the opportunity for Accelerated Approval and Priority Review if specific criteria are satisfied.
Overview of LBS-007
LBS-007 operates as a non-ATP cell cycle inhibitor and is designed to target a range of cancers by inhibiting the kinase activity of CDC7, a critical regulator in the cancer cell cycle. This mechanism of action not only halts the proliferation of cancerous cells but also promotes their death, showcasing significant preclinical effectiveness against various forms of leukemia and other malignancies.
About Lin BioScience
Lin BioScience, established in 2016, is at the forefront of drug development focused on oncology, ophthalmology, and metabolic disorders. The company’s expanding pipeline includes multiple drug candidates, such as LBS-008, aimed at treating geographic atrophy in age-related macular degeneration and Stargardt disease type 1, and LBS-009, targeting non-alcoholic steatohepatitis. Notably, LBS-007 is also under development for solid tumors in addition to acute leukemia indications.
LBS-008 has already secured Orphan Drug Designation from regulatory authorities in the U.S., Europe, and Japan, along with Fast Track Designation and Rare Pediatric Disease designation from the FDA. This, and the swift progress of LBS-007, underscores Lin BioScience’s commitment to addressing critical gaps in cancer therapy.
For further details on Lin BioScience’s initiatives and drug development progress, updates can be found on platforms including LinkedIn and Facebook, or by visiting their official website.
Disclaimer:
This article includes forward-looking statements that involve potential risks and uncertainties related to the company’s plans and market conditions. Lin BioScience does not undertake any obligation to update these forward-looking statements unless required by law.
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