Lin BioScience Receives US FDA Approval for LBS-007 By Investing.com

• The Fast Track designation demonstrates the potential of LBS-007 in meeting the clinical needs of acute leukemia.
• LBS-007 is the Company’s investigational drug for the treatment of acute leukemia
• A Phase 1/2 trial in patients with relapsed or refractory acute leukemias is ongoing
• LBS-007, the Company’s lead product, has been granted orphan drug designations for acute myeloid leukemia and acute lymphocytic leukemia by the US FDA.

TAIPEI CITY, Taiwan, Nov. 27, 2024 (GLOBE NEWSWIRE) — Lin BioScience (6696. Taiwan OTC), a biopharmaceutical company focused on advancing the treatment of leukemia with significant unmet medical needs, today announced. that its lead pipeline, LBS-007, has been granted Fast Track Designation by the US Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia. Lin BioScience is currently conducting phase 1/2 trials in patients with relapsed or refractory leukemias in the US, Australia, and Taiwan, and has been granted orphan drug (ODD) approval for acute myeloid leukemia and acute lymphocytic leukemia in the US. FDA.

“We are pleased to see LBS-007 showing signs of an early response to treatment and the potential to help treat this unwanted medical condition,” said Dr. Tom Lin, Chairman of Lin BioScience. Receiving an FDA Fast Track Designation is an important milestone, providing a fast track to advancing the development of this promising treatment. We remain committed to providing innovative solutions to patients in need.

During the phase 1 dose increase, we did not see any definite or possible side effects in all patients who received low to high doses, showing that the protection is tolerable and reliable, said Dr. Irene Wang, President & CSO of Lin BioScience.

About Quick Selection
Fast Track is a system designed to facilitate the processing, and expedite the review, of medications to treat complications and address unmet medical needs. The goal is to find the new medicine needed by the patient as soon as possible. Fast Track handles a wide range of issues. Meeting an unmet medical need is defined as providing services that do not exist or providing services that may be better than existing treatments. When a drug receives Fast Track designation, it is subject to regular meetings with the FDA, regular written communication from the FDA, Fast Track Approval and Critical Review if requirements are met, and Rolling Review. Regular communication ensures that questions and issues are resolved quickly, which often leads to early drug approval and patient access.

About LBS-007
LBS-007 is a natural, non-ATP cell cycle inhibitor targeting multiple types of cancer. LBS-007 works by inhibiting the kinase activity of CDC7, a key regulator of cancer processes. Inhibiting CDC7 stops the proliferation of tumor cells and leads to the death of cancer cells. LBS-007 has shown potent activity against leukemia and several solid tumors in preclinical studies.

Media Contact:
Serena Chen
CFO
Office: (02) 8780-5008
Email: serenachen@linbioscience.com

About Lin BioScience:
Lin BioScience (6696. Taiwan OTC), founded in 2016, is a pharmaceutical company that focuses on unmet medical needs by developing early therapies for cancer, ophthalmology, and metabolic diseases. The company currently has four drugs in development, including LBS-008 (for Geographic Atrophy [GA] in dry age-related macular degeneration [AMD] and Stargardt disease 1 [STGD1]) and LBS-009 (for nonalcoholic steatohepatitis [NASH]), both made by subsidiary Belite Bio (NASDAQ: BLTE ), as well as LBS-007 (for acute leukemia and solid tumors) and LBS-002 (for primary and metastatic brain cancers) made by Lin BioScience.

Interestingly, LBS-008 has been granted Orphan Drug Designation (ODD) for the treatment of STGD1 from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Pharmaceuticals and Medical (TASE:) Devices Agency (PMDA) in Japan. It has also received Fast Track Designation and Rare Pediatric Disease (RPD) from the US FDA, along with Sakigake Designation from the Ministry of Health, Labor and Welfare (MHLW) in Japan. In addition, LBS-007 has been granted ODD for the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML), as well as Fast Track Designation for the treatment of AML, from the US FDA.

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Disclaimer:
This article is related to the information released at the same time contains forward-looking statements, based on the existing risks and possible uncertainties, including the market and other factors that are beyond the control of Lin BioScience (referred to here as the Company). These forward-looking statements are based on current forecasts and assessments, and the Company does not undertake to update such information, except as required by law.

Source: Lin BioScience, Inc.