Merrimack Pharmaceuticals, Inc. announced that the U.S. FDA has granted orphan drug designation to MM-121, its investigational drug candidate, for the treatment of heregulin positive non-small cell lung cancer.
MM-121 (seribantumab) is a fully human monoclonal antibody designed to block tumor survival signals and enhance the anti-tumor effect of combination therapies by targeting the cell surface receptor HER3 (ErbB3) in patients with high expression of the biomarker heregulin.
“This is an important regulatory step forward for the clinical development of MM-121 in non-small cell lung cancer and we are pleased to have access to additional support from the FDA in this indication,” said Sergio Santillana, M.D., MSc, Chief Medical Officer. “Merrimack is dedicated to designing and developing novel precision therapeutics that shape treatment strategies for patients, and our randomized Phase 2 clinical trial of MM-121 in heregulin positive non-small cell lung cancer is well underway. We look forward to expanding the development of MM-121 to a biomarker-selected population of breast cancer patients later this year.”
The FDA’s orphan drug designation is granted to drugs and biologics intended to treat rare diseases or conditions with a prevalence of fewer than 200,000 people in the U.S. This designation includes eligibility for a seven-year period of marketing exclusivity for MM-121 upon approval, as well as other development assistance and financial incentives.
MM-121 is currently being evaluated in the SHERLOC study, a global randomized Phase 2 study that will assess progression-free survival of MM-121 in combination with docetaxel versus docetaxel alone. The study is enrolling patients with heregulin positive non-small cell adenocarcinoma of the lung who have progressed after a platinum-containing regimen and may have received anti PD-1 or anti-PD-L1 therapy. Top-line data for the SHERLOC study are expected in the second half of 2018.
In addition, Merrimack will be evaluating MM-121 in the SHERBOC trial, a global randomized Phase 2, double-blind, placebo-controlled clinical study of MM-121 added to standard of care in patients with heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer. The first patient is expected to be dosed in the SHERBOC study by the end of 2017.
MM-121, also known as seribantumab, is Merrimack’s wholly owned, fully human anti-HER3 (ErbB3) monoclonal antibody that targets phenotypically distinct heregulin positive cancer cells within solid tumors. Heregulin positive cancer cells are characterized by their ability to escape the effects of targeted, cytotoxic and anti-endocrine therapies and potentially contribute to rapid clinical progression in patients whose tumor cells test positive for heregulin as detected by RNA-ISH. When used in the combination setting, seribantumab is designed to block the heregulin/HER3 signaling axis to make tumor cells more sensitive to the effects of the combination therapy.
Merrimack is a biopharmaceutical company based in Cambridge, Massachusetts that is outthinking cancer to ensure that patients and their families live fulfilling lives. Its mission is to transform cancer care through the smart design and development of targeted solutions based on a deep understanding of cancer pathways and biological markers. All of Merrimack’s development programs, including four clinical studies in distinct indications and six candidates in preclinical development, fit into its strategy of 1) understanding the biological problems it is trying to solve, 2) designing specific solutions and 3) developing those solutions for biomarker-selected patients. This three-pronged strategy seeks to ensure optimal patient outcomes. For more information, please visit Merrimack’s website at www.merrimack.com.
Geoffrey Grande, CFA