Merrimack Receives Orphan Drug Designation for MM-121 for the Treatment of Heregulin Positive Non-small Cell Lung Cancer.
M2 PHARMA-November 2, 2017-Merrimack Receives Orphan Drug Designation for MM-121 for the Treatment of Heregulin Positive Non-small Cell Lung Cancer
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- The US Food and Drug Administration has granted orphan drug designation to MM-121, US-based Merrimack Pharmaceuticals, Inc.'s (NASDAQ: MACK) investigational drug candidate, for the treatment of heregulin positive non-small cell lung cancer, the company said.
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.
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 US.
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 randomised 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 randomised 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 characterised 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.
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|Date:||Nov 2, 2017|
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