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FDA grants orphan drug status to MM-141 for pancreatic cancer
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The FDA granted orphan drug designation to an investigational tetravalent bispecific antibody for the treatment of patients with pancreatic cancer, its manufacturer announced today.
Based on preclinical research, MM-141 (Merrimack Pharmaceuticals) could inhibit oncogenic signaling through the PI3K/AKT/mTOR pathway by blocking ligand-induced signaling through insulin-like growth factor 1 and ErbB3 receptors and degrading oncogenic receptor complexes.
“Receiving orphan drug designation for MM-141 is an important regulatory advancement in the development of our clinical program,” Ulrik Nielsen, PhD, chief scientific officer and co-founder of Merrimack, said in a press release. “Pancreatic cancer is an aggressive and devastating disease, with a 5-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 based its decision in part on preliminary data from the monotherapy portion of a phase 1 study in the United States and Europe.
According to the company release, the investigational antibody is currently being explored in a phase 1 combination dose-escalation clinical study and is expected to enter phase 2 study testing in 2015 for use as a front-line treatment for pancreatic cancer in combination with nab-paclitaxel and gemcitabine.
The FDA Office of Orphan Products grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.