FDA Grants Fast Track to Lin BioScience's LBS-007

Lin BioScience, a biopharmaceutical company listed on Taiwan OTC (6696), announced that its leading drug candidate, LBS-007, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for treating acute myeloid leukemia. This designation highlights LBS-007's potential to meet critical unmet medical needs in acute leukemia.

LBS-007, Lin BioScience’s investigational product for acute leukemia, is currently in a Phase 1/2 trial involving patients with relapsed or resistant acute leukemias. This trial is being conducted in the United States, Australia, and Taiwan. In addition to the Fast Track Designation, LBS-007 has also been granted Orphan Drug Designation for both acute myeloid leukemia and acute lymphocytic leukemia by the U.S. FDA.

Dr. Tom Lin, Chairman of Lin BioScience, expressed enthusiasm about this development. He noted that early indications of treatment response and potential effectiveness in addressing unmet medical needs are promising. The Fast Track Designation is a significant step forward, providing an expedited pathway to advance this therapy. Dr. Lin emphasized the company’s commitment to developing transformative solutions for patients in need.

Dr. Irene Wang, President and Chief Scientific Officer of Lin BioScience, highlighted the safety profile of LBS-007. She mentioned that during the Phase 1 dose escalation, no Definitely or Probably Related Adverse Effects were observed in patients receiving varying doses, indicating the drug's tolerability.

The Fast Track process is designed to expedite the development and review of drugs aimed at treating serious conditions and meeting unmet medical needs. It allows for frequent interactions with the FDA, including more regular meetings and written communications. Drugs with this designation are also eligible for Accelerated Approval, Priority Review, and Rolling Review, provided they meet certain criteria. These benefits can lead to quicker drug approval and earlier access for patients.

LBS-007, a non-ATP cell cycle inhibitor, targets a wide range of cancers by blocking the kinase activity of CDC7, a crucial cancer cell cycle regulator. By inhibiting CDC7, LBS-007 halts the proliferation of tumor cells, leading to cancer cell death. Preclinical studies have shown LBS-007's potent activity against both leukemia and multiple solid tumors.

Founded in 2016, Lin BioScience focuses on developing innovative therapies for unmet medical needs in areas such as cancer, ophthalmology, and metabolic diseases. The company has a robust pipeline with four primary drug candidates: LBS-008, LBS-009, LBS-007, and LBS-002. LBS-008 targets Geographic Atrophy in advanced dry age-related macular degeneration and Stargardt Disease type 1, while LBS-009 is for non-alcoholic steatohepatitis. LBS-007 is being developed for acute leukemia and solid tumors, and LBS-002 for primary and metastatic brain cancers.

Notably, LBS-008 has received various designations, including Orphan Drug Designation from the FDA, EMA, and PMDA, Fast Track Designation, and Rare Pediatric Disease designation from the FDA, and Sakigake Designation from Japan's Ministry of Health. Additionally, LBS-007 has been granted Orphan Drug Designation for acute lymphoblastic leukemia and acute myeloid leukemia, as well as Fast Track Designation for acute myeloid leukemia by the U.S. FDA.

Lin BioScience’s advancements with LBS-007 and other drug candidates reflect its dedication to addressing significant medical needs through innovative therapeutic solutions.