Merrimack Pharmaceuticals' MM-141 Named FDA Orphan Drug For Pancreatic Cancer
By Cyndi Root
Merrimack Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) granted Orphan Drug designation to MM-141. The tetravalent bispecific antibody shows promise in treating pancreatic cancer. Orphan status provides Merrimack seven years of marketing exclusivity upon FDA approval. Ulrik Nielsen, Ph.D., CSO and co-founder of Merrimack, said, "Receiving orphan drug designation for MM-141 is an important regulatory advancement in the development of our clinical program. 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."
MM-141
MM-141 blocks tumor survival signals by targeting receptor complexes (IGF-1R and HER3) that activate signaling pathways, allowing tumor cells to grow. These cellular signaling pathways are also implicated in resistance to therapies. MM-141 blocks ligand-induced signaling, thereby affecting tumor cell proliferation. Merrimack is studying MM-141 for the treatment of advanced solid tumors in a Phase 1 trial. A Phase 2 study, expected to start in 2015, will test MM-141 in combination with nab-paclitaxel and gemcitabine in pancreatic cancer.
About Merrimack
Merrimack, headquartered in Cambridge, MA, focuses on medicines and companion diagnostics for cancer. MM-141 is Merrimack's sixth oncology candidate to enter clinical development, and the company has three other candidates in preclinical development. Merrimack's lead candidate, MM-398, was recently licensed to Baxter in an exclusive license and collaboration agreement. The deal gives Baxter worldwide rights to MM-398 except for the U.S. and Taiwan.
MM-398 is an irinotecan encapsulation in a nanoliposomal formulation designed to increase drug saturation and prolong cytotoxic effects. Merrimack states that it intends to submit a New Drug Application (NDA) for MM-398 in the treatment of metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.
In September 2014, Merrimack announced that a Phase 2 study of MM-121 with exemestane showed a statistically significant benefit in ER/PR-positive, HER2-negative metastatic breast cancer patients. The results were presented at the European Society of Medical Oncology (ESMO) as part of a presentation showing MM-121’s efficacy in a broad range of cancers. Merrimack recently regained the rights to MM-121 from Sanofi, with whom it had a five-year agreement to develop the agent. “Regaining MM-121 is an opportunity to capitalize on our leadership position among the other oncology companies that are pursuing ErbB3," said Robert Mulroy, President and CEO of Merrimack.”