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Macrophage in a mouse
The US Food and Drug Administration (FDA) has granted orphan drug designation to SRF231 for the treatment of multiple myeloma (MM).
SRF231 is a fully human antibody that inhibits the activity of CD47, a protein that is overexpressed on many cancer cells and prevents them from being engulfed and eliminated by macrophages.
Surface Oncology, the company developing SRF231, is currently conducting a phase 1 trial (NCT03512340) of SRF231 in patients with solid tumors and hematologic malignancies.
Preclinical research on SRF231 was presented at the 2016 ASH Annual Meeting.
SRF231 demonstrated “potent” activity against hematologic malignancies, according to researchers.
The team said SRF231 promoted macrophage-mediated phagocytic clearance of several hematologic primary tumor samples and cell lines in vitro.
SRF231 also demonstrated activity in murine xenograft models of hematologic malignancies. Specifically, the researchers observed “profound tumor growth inhibition” in models of MM, diffuse large B-cell lymphoma, and Burkitt lymphoma.
The team said SRF231 demonstrated activity when given alone or in combination with opsonizing antibodies.
Results also showed that SRF231 did not induce hemagglutination or phagocytosis of red blood cells in vitro.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
Orphan designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.