Lin BioScience Announces FDA Orphan Drug Designation for LBS-007 for the Treatment of Acute Lymphoblastic Leukemia
Cancer cell cycle inhibitor is Lin BioScience's second candidate to receive Orphan Drug Designation
SAN DIEGO, April 24, 2018 /PRNewswire/ -- Lin BioScience, a drug development company targeting unmet clinical needs in oncology, ophthalmology and metabolic diseases, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LBS-007 for acute lymphoblastic leukemia (ALL). ALL affected over 876,000 people globally in 2015 and resulted in about 111,000 deaths. In the US, it is the most common cause of cancer and cancer-related deaths in children. LBS-007 is a targeted therapy for the treatment of ALL and other hematological cancers and has also been effective at combating solid tumors.
"Our focus is to find treatments for untreatable diseases, and LBS-007 is the second candidate in our pipeline to receive Orphan Drug Designation in the last 6 months," stated Dr. Tom Lin, CEO of Lin BioScience. "We are pleased to reach this regulatory milestone with LBS-007 and we look forward to advancing the anti-cancer program into Phase 1 clinical trials later this year."
About LBS-007
LBS-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 and is expected to enter a first-in-human Phase 1 trial in drug-resistant and refractory acute leukemia patient population in Q4 of 2018.
About Orphan Drug Designation (ODD)
The US FDA Orphan Drug Designation provides incentives for companies to develop drugs for rare diseases affecting fewer than 200,000 patients. These incentives may include FDA assistance in clinical trial design, tax credits towards the cost of clinical trials, prescription drug user fee waivers, and potential market exclusivity for seven years following approval.
About Lin BioScience, Inc.
Lin BioScience, Inc. is a novel drug development company targeting untreatable diseases. Our therapeutic pipeline, which includes two candidates with FDA Orphan Drug Designation, is focused on meeting the unmet needs of patients suffering from cancer, macular degeneration, and liver disease. Lin BioScience is a resident company at JLABS in San Diego, California. For more information, please visit www.linbioscience.com.
SOURCE Lin BioScience, Inc.
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