On November 5, 2014 Merrimack Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to their investigational drug candidate MM-141 for the treatment of pancreatic cancer (Press release Merrimack, NOV 5, 2014, View Source [SID:1234500923]). MM-141 is a tetravalent bispecific antibody designed to block tumor survival signals by targeting receptor complexes containing IGF-1R and ErbB3 (HER3). The IGF-1R and HER3 complexes both activate a major cellular signaling pathway that allows tumor cells to grow and develop resistance to therapies.

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"Receiving orphan drug designation for MM-141 is an important regulatory advancement in the development of our clinical program," said Ulrik Nielsen, Ph.D., Chief Scientific Officer and Co-Founder of Merrimack. "Pancreatic cancer is an aggressive and devastating disease, with a five year survival rate of 6% and a low early detection rate. Merrimack is dedicated to changing the landscape of this disease for patients across all lines of therapy. 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."

The FDA’s Office of Orphan Products Development (OOPD) designates orphan status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States. This orphan drug designation will potentially provide Merrimack Pharmaceuticals with seven-year marketing exclusivity for MM-141 and other benefits if the drug is approved by the FDA.

MM-141 is Merrimack’s sixth oncology candidate to enter clinical development and is currently being tested in a Phase 1 dose-escalation clinical study. A Phase 2 study testing MM-141 in combination with nab-paclitaxel and gemcitabine in front line pancreatic cancer is expected to start in 2015.