FDA Grants Orphan Drug Designation to SRF231 for Treatment of Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has 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, which prevents them from being engulfed and eliminated by macrophages.

“While the potential applications for SRF231 in oncology are quite broad, we are particularly excited about the opportunity to provide benefit to patients with multiple myeloma. We have already demonstrated the ability of our antibody to increase phagocytosis of myeloma cells and to shrink tumors in preclinical models,” said Rob Ross, MD, Chief Medical Officer of Surface Oncology.

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 company intends to evaluate the safety and efficacy of SRF231 in a targeted set of solid and hematologic malignancies.

More About SRF231

Preclinical results with SRF231, which were presented at the 2016 Society for Immunotherapy of Cancer Annual Meeting (Poster 423) and the 2016 American Society of Hematology Annual Meeting & Exposition by Holland et al, demonstrated its potent antitumor activity preclinically in several different tumor models and in combination with existing cancer modalities. These studies also showed that SRF231 does not induce hemagglutination, an important potential safety advantage.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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