CanariaBio has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug product, MAb-AR20.5, targeting pancreatic cancer.
MAb-AR20.5 is an IgG1k type murine monoclonal antibody that attaches specifically to the circulating and tumour-associated antigen (MUC1) expressed on pancreatic cancer cells.
It is said to become the first monoclonal antibody to target MUC1 and receive ODD for pancreatic cancer.
In early studies, the antibody has shown potential by inducing MUC-1-specific immune responses in patients with advanced disease.
This specific targeting is aimed at providing a focused treatment strategy for patients who are diagnosed with this disease.
CanariaBio CEO Mike Na said: “Receiving orphan drug designation for MAb-AR20.5 is a significant milestone for CanariaBio and speaks to the potential promise of this novel therapeutic approach.
“We are deeply committed to advancing innovative treatments for patients with pancreatic cancer and remain hopeful that MAb-AR20.5 will offer a new lifeline for those affected.”
The company plans to commence clinical trials for evaluating the efficacy and safety of MAb-AR20.5 in pancreatic cancer patients.
ODD is granted to drugs and biologics that are intended to treat, diagnose, or prevent rare diseases or disorders that affect fewer than 200,000 people in the US.
The designation offers certain benefits, including user fee waivers, tax credits, and eligibility for a period of seven years of marketing exclusivity.