ORYZON Announces FDA Orphan Drug Designation Granted to Iadademstat for Treatment of Small Cell Lung Cancer
Excerpt from the Press Release:
- Now has orphan drug designation for SCLC and AML
MADRID, Spain and CAMBRIDGE, Mass., June 08, 2022 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s clinical stage LSD1 inhibitor iadademstat for the treatment of patients with small cell lung cancer (SCLC). Iadademstat is an oral, highly potent and selective inhibitor of the epigenetic enzyme LSD1, a chromatin remodeler that interacts with a variety of transcription factors involved in SCLC, other solid tumors and hematological cancers such as acute myeloid leukemia (AML).
“Receiving Orphan Drug Designation for iadademstat in SCLC is an important recognition of the role that targeted drugs with new mechanisms of action may bring to this patient community, where we do not yet have any potentially curative medicines”, said Dr. Douglas Faller, Oryzon’s Global CMO. “Iadademstat is a novel epigenetic targeted approach to the treatment of this rapidly fatal tumor. The drug has two independent and complementary actions against SCLC – iadademstat epigenetically reprograms the genome of the tumor cell, while also greatly increasing the ability of the patient’s own immune system to recognize and destroy the cancer. Prior clinical studies of iadademstat have demonstrated its activity and manageable safety profile in the treatment of SCLC.”
Dr. Carlos Buesa, Oryzon’s CEO, said: “We are really excited with the new Orphan Drug designation for iadademstat in SCLC by the FDA. This will facilitate and expedite our development of this targeted agent in this disease with great unmet medical need.”
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