FDA Grants Orphan Drug Designation to Surface Oncology’s SRF231 for the Treatment of Multiple Myeloma
Surface Oncology, Inc.
Jul. 30, 2018
CAMBRIDGE, Mass., July 30, 2018 (GLOBE NEWSWIRE) -- Surface Oncology (NASDAQ: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s lead investigational candidate 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, M.D., chief medical officer of Surface Oncology. “Receiving orphan designation for SRF231 represents an important milestone as we continue to progress the program in the clinic in multiple myeloma and other cancer types.”
The FDA’s Office of Orphan Products Development (OOPD) designates orphan status to drugs and biologics intended for the treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. The designation provides certain benefits to the drug developer including the potential for seven years of market exclusivity upon FDA approval, prescription drug user fee waivers and tax credits for qualified clinical trials.
SRF231 is currently being evaluated in a multi-center, open-label Phase I trial to assess 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.
SRF231 is a fully human monoclonal antibody therapeutic targeting CD47, a protein overexpressed on many cancer cells which prevents them from being engulfed and eliminated by macrophage mediated phagocytosis. SRF231 preclinical results presented at the 2016 Society for Immunotherapy of Cancer (SITC) and the American Society of Hematology (ASH) meetings demonstrated that SRF231 has potent anti-tumor activity preclinically in several different tumor models and in combination with existing cancer modalities. Importantly, preclinical studies also showed that SRF231 does not induce hemagglutination, an important potential safety advantage.
ABOUT SURFACE ONCOLOGY
Surface Oncology is an immuno-oncology company developing next-generation antibody therapies focused on the tumor microenvironment with lead programs targeting CD47, CD73, CD39 and IL-27. Surface’s novel cancer immunotherapies are designed to achieve a clinically meaningful and sustained anti-tumor response and may be used alone or in combination with other therapies. The company has a pipeline of seven novel immunotherapies and a strategic collaboration with Novartis focused on up to three next-generation cancer immunotherapies. For more information, please visit www.surfaceoncology.com.
Seth Lewis firstname.lastname@example.org 617-655-5031
Ann Stanesa, Ten Bridge Communications Ann@tenbridgecommunications.com 617-230-0347