Lin BioScience Receives U.S. FDA Fast Track Designation For LBS-007
27 11월 2024 - 5:00PM
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 DesignationFast 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.
About LBS-007LBS-007 is a natural, non-ATP
cell cycle inhibitor targeting a broad array of cancers. LBS-007
functions by blocking the kinase activity of CDC7, a key regulator
of the cancer cell cycle. Inhibiting CDC7 stops the proliferation
of tumor cells and results in cancer cell death. LBS-007 has
demonstrated very potent activity against leukemia and multiple
solid tumors in preclinical studies.
Media Contact:Serena Chen CFOOffice: (02)
8780-5008Email: serenachen@linbioscience.com
About Lin BioScience:Lin BioScience (6696.
Taiwan OTC), founded in 2016, is a drug development company focused
on unmet medical needs through developing first-in-class therapies
for cancer, ophthalmology, and metabolic diseases. The Company
currently has four primary drug candidates under development,
including LBS-008 (for Geographic Atrophy [GA] in advanced dry
age-related macular degeneration [AMD] and Stargardt Disease type 1
[STGD1]) and LBS-009 (for non-alcoholic steatohepatitis [NASH]),
both developed by its 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) developed by Lin
BioScience.
Significantly, LBS-008 has been granted Orphan Drug Designation
(ODD) for the treatment of STGD1 from the U.S. Food and Drug
Administration (FDA), the European Medicines Agency (EMA), and the
Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. It has
also received Fast Track Designation and Rare Pediatric Disease
(RPD) designation from the U.S. FDA, along with Sakigake
Designation from the Ministry of Health, Labour and Welfare (MHLW)
in Japan. Additionally, 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 U.S. FDA.
For more information, follow us
on LinkedIn, Facebook or visit us at
www.linbioscience.com.
Disclaimer:This press release and the
concurrently released related information contain forward-looking
statements, based on existing risks and potential uncertainties,
including market factors and other causes beyond the control of Lin
BioScience (referred to hereafter as the Company). These
forward-looking statements rely on current forecasts and
assessments, and the Company undertakes no obligation to update the
information, except as required by law.
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