Orphan drug designation for pancreatic cancer candidate
CAMBRIDGE, Mass.—The U.S. Food and Drug Administration (FDA) has granted MM-141 orphan drug designation for the treatment of pancreatic cancer, Merrimack Pharmaceuticals Inc. reported recently. The investigational compound is a tetravalent bispecific antibody designed to block tumor survival signals by targeting receptor complexes containing IGF-1R and ErbB3. This designation grants Merrimack seven-year marketing exclusivity for MM-141 should the drug receive FDA approval. A Phase 2 study investigating MM-141 combined with nab-paclitaxel and gemcitabine in frontline pancreatic cancer is expected to start next year.
Dr. Ulrik Nielsen, Merrimack's chief scientific officer and co-founder, called the designation “an important regulatory advancement in the development of our clinical program,” adding that “We look forward to advancing the clinical development of MM-141 as we believe that it has the potential to significantly inhibit tumor survival signaling and address pathways of therapeutic resistance in this indication.”