CanariaBio Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational drug product, MAb-AR20.5, an IgG1k type murine monoclonal antibody that binds specifically to the circulating and tumor-associated antigen (MUC1) expressed ubiquitously on pancreatic cancer cells. This milestone marks the first monoclonal antibody targeting Mucin 1 (MUC1) to receive this designation for pancreatic cancer.

Pancreatic cancer remains one of the most challenging malignancies to treat, with limited therapeutic options available. The MAb-AR20.5 has shown potential in early studies, by inducing MUC-1-specific immune responses in cancer patients with advanced disease. This specific targeting aims to provide a more focused and potentially more effective treatment strategy for patients diagnosed with this aggressive disease.

"Receiving Orphan Drug Designation for MAb-AR20.5 is a significant milestone for CanariaBio Inc. and speaks to the potential promise of this novel therapeutic approach," said Mike Na, the CEO of CanariaBio Inc. "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."

Orphan Drug Designation is granted by the FDA to drugs and biologics intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. This designation provides certain benefits, including tax credits, user fee waivers, and eligibility for seven years of marketing exclusivity.

CanariaBio Inc. is planning to initiate clinical trials to assess the safety and efficacy of MAb-AR20.5 in patients with pancreatic cancer. More details about the upcoming studies and trial sites will be made available in the coming months.