Duo Oncology Earns Orphan Designation

EMA Awards Lead Product DUO-207 Orphan Designation for Pancreatic Cancer

PITTSBURGH (PRWEB) February 21, 2022 – Duo Oncology, a life science company pioneering ultra-small cancer nanomedicines, is pleased to announce that the European Medicines Agency (EMA) has granted Orphan Designation to DUO-207 for the treatment of patients with pancreatic cancer.  DUO-207 is an ultra-small nanomedicine carrying a potent combination of gemcitabine and paclitaxel that penetrates deep into tumor tissue to extend the lives of, or even cure, cancer pancreatic patients.

The EMA’s Orphan Designation is granted to drugs or biological products intended for the treatment of rare diseases or conditions that impact fewer than 200,000 people in the Europe. This designation acts as a stimulus for the development of drugs for rare diseases and provides a 10-year period of market exclusivity as well as reduced fees for protocol assistance and the marketing authorization process. The granting of an orphan drug designation does not alter the standard regulatory requirements and process for obtaining marketing approval. More information about orphan drug designation can be found on the EMA’s Orphan Designation website.

“We are pleased to announce that the EMA has granted an orphan drug designation to DUO-207 for the treatment of pancreatic cancer,” said Sam Rothstein, Co-Founder and CEO of Duo Oncology. “This is our first milestone for the DUO-207 development program since its launch in February 2021 and an important first step towards clinical translation.”

Pancreatic cancer (PDAC) is the deadliest solid cancer generating almost 496,000 cases worldwide each year and causing over 466,000 deaths. Chemotherapy, particularly a combined regimen, remains the primary treatment option for the 90% of patients with inoperable PDAC. In patient-derived and murine tumors, DUO-207 outperformed existing chemotherapy combinations and created a favorable tumor immune microenvironment.

“We are encouraged by DUO-207’s initial pharmacology and anti-tumor activity data,” said Dr. Song Li, Director of the Center for Pharmacogenetics at the University of Pittsburgh and Duo Oncology Cofounder. “We plan to build upon this data as we work closely with regulatory agencies toward the goal of bringing DUO-207 to pancreatic cancer patients.”