On March 30, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for one of the company’s lead therapeutic candidates, SRF617, for the treatment of patients with pancreatic cancer (Press release, Surface Oncology, MAR 30, 2021, View Source [SID1234577356]).
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"We are pleased to receive this important designation from the FDA, which supports our conviction that new immunotherapies for pancreatic cancer are urgently needed," said Alison O’Neill, M.D., senior vice president, clinical development at Surface Oncology. "We are very encouraged by our clinical progress to date with SRF617, a highly innovative therapy with the potential to promote anti-tumor immunity in patients with cancer. SRF617 is in Phase 1/1b studies across a variety of solid tumors, including combination studies with gemcitabine and abraxane in patients with pancreatic cancer."
Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Programs with Orphan Drug status receive partial tax credit for clinical trial expenditures, waived user fees and eligibility for seven years of marketing exclusivity.
About SRF617:
SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, pancreatic cancer stromal cells within the tumor micro-environment express high levels of CD39 which may inhibit anti-cancer immune responses. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents.