FDA Grants Orphan Drug Designation to Human Antibody for Treatment of Multiple Myeloma
Posted: Friday, August 3, 2018
Recently, the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to SRF231 for the treatment of patients with multiple myeloma. SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells.
SRF231 is currently being evaluated in a multicenter, open-label phase I trial to assess its safety and tolerability in multiple ascending doses, with the goal of establishing a recommended dose for further study. Following the dose-escalation phase, the safety and efficacy of SRF231 will be investigated in a targeted set of solid and hematologic malignancies.
Preclinical results regarding SRF231, which were presented at the 2016 Society for Immunotherapy of Cancer Annual Meeting and the 2016 American Society of Hematology Annual Meeting & Exposition, demonstrated its antitumor activity in several different tumor models and in combination with existing cancer modalities.
